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HdBe-MedicalDevice

Profile	Description	Status	URL
HdBe-MedicalDevice	Medical devices are any internally implanted and external devices and/or aids used by the patient (in the past) to reduce the effects of functional limitations in organ systems or to facilitate the treatment of a disease.	draft	https://fhir.healthdata.be/StructureDefinition/HdBe-MedicalDevice
HdBe-MedicalDevice.Product	This profile defines the actual medical device (internally or externally).	draft	https://fhir.healthdata.be/StructureDefinition/HdBe-MedicalDevice.Product

UML overview profiles

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HdBe-MedicalDevice

DeviceUseStatement	I		DeviceUseStatement	Element id DeviceUseStatement Short description MedicalDevice Alternate names MedischHulpmiddel Definition A record of a device being used by a patient where the record is the result of a report from the patient or another clinician. Data type DeviceUseStatement Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim: Entity. Role, or Act workflow: Event quick: DeviceUsePerformanceOccurrence zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.1 HdBe-MedicalDevice: MedicalDevice
id	Σ	0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id DeviceUseStatement.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id DeviceUseStatement.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id DeviceUseStatement.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id DeviceUseStatement.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id DeviceUseStatement.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
healthProfessional	I	0..1	Extension(pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner))	Element id DeviceUseStatement.extension:healthProfessional Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner)) Extension URL https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.extension:healthProfessional.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.extension:healthProfessional.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id DeviceUseStatement.extension:healthProfessional.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional Mappings rim: N/A
value[x]	I	0..1		Element id DeviceUseStatement.extension:healthProfessional.value[x] Short description HealthProfessional Alternate names Zorgverlener Definition The healthcare professional involved in the indication for use of the medical device implant. Comments Each occurence of the CBB HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of HdBe-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of HdBe-HealthProfessional-Practitioner). The reference to the Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Only in rare circumstances, there is just a Practitioner instance, in which case it is that instance which will be referenced here. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: N/A rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.9 HdBe-MedicalDevice: MedicalDevice.HealthProfessional
valueReference			pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner)	There are no (further) constraints on this element Data type pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner)
location	I	0..1	Extension(Reference(HdBe-HealthcareOrganization))	Element id DeviceUseStatement.extension:location Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Reference(HdBe-HealthcareOrganization)) Extension URL https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.extension:location.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.extension:location.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id DeviceUseStatement.extension:location.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location Mappings rim: N/A
value[x]		0..1		Element id DeviceUseStatement.extension:location.value[x] Short description Location Alternate names Locatie Definition The healthcare organization at which use of the medical device was initiated or where the aid was implanted. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.8 HdBe-MedicalDevice: MedicalDevice.Location
valueReference			Reference(HdBe-HealthcareOrganization)	There are no (further) constraints on this element Data type Reference(HdBe-HealthcareOrganization)
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier	Σ	0..*	Identifier	There are no (further) constraints on this element Element id DeviceUseStatement.identifier Short description External identifier for this record Definition An external identifier for this statement such as an IRI. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier workflow: Event.identifier w5: FiveWs.identifier quick: ClinicalStatement.identifier
basedOn	Σ I	0..*	Reference(ServiceRequest)	There are no (further) constraints on this element Element id DeviceUseStatement.basedOn Short description Fulfills plan, proposal or order Alternate names fulfills Definition A plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement. Requirements Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(ServiceRequest) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.basedOn v2: ORC in proximity to EVN segment rim: .outboundRelationship[typeCode=FLFS].target
status	Σ ?!	1..1	codeBinding	Element id DeviceUseStatement.status Short description active \| completed \| entered-in-error + Definition A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed. Comments This element is implictly mapped to the CBB concepts start_date and end_date. Unless the status is explicitly recorded, the following guidance applies: When start_date is in the future, `.status` will usually be set to intended. When start_date is in the past and end_date has a value and in the future or end_date has no value, `.status` will usually be set to active. When end_date has a value and is in the past, `.status` will usually be set to completed. Data type code Binding A coded concept indicating the current status of the Device Usage. DeviceUseStatementStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.status w5: FiveWs.status rim: .statusCode quick: …status zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.11 zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.14 HdBe-MedicalDevice: MedicalDevice.StartDate HdBe-MedicalDevice: MedicalDevice.EndDate
subject	Σ I	1..1	Reference(Patient \| Group \| HdBe-Patient)	Element id DeviceUseStatement.subject Short description Patient using device Definition The patient who used the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| Group \| HdBe-Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.subject w5: FiveWs.subject[x] quick: ClinicalStatement.subject w5: FiveWs.subject
derivedFrom	Σ I	0..*	Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference)	Element id DeviceUseStatement.derivedFrom Short description Supporting information Definition Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement. Comments The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from. Data type Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference) Sliced: Unordered, Open, by resolve()(Profile) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
procedure-request	Σ I	0..*	Reference(HdBe-Procedure request)	Element id DeviceUseStatement.derivedFrom:procedure-request Short description Procedure Alternate names Verrichting Definition The procedure which has the purpose if placing this product in or on the body. Comments Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed. Data type Reference(HdBe-Procedure request) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) zib-procedure-v5.2-2020EN: NL-CM:14.1.7 HdBe-Procedure: MedicalDevice
procedure-event	Σ I	0..*	Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference \| HdBe-Procedure event)	Element id DeviceUseStatement.derivedFrom:procedure-event Short description Procedure Definition The procedure which has the purpose of placing this product in or on the body. Comments Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed. Data type Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference \| HdBe-Procedure event) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) zib-procedure-v5.2-2020EN: NL-CM:14.1.7 HdBe-Procedure: MedicalDevice
timing[x]	Σ	0..1		Element id DeviceUseStatement.timing[x] Short description How often the device was used Definition How often the device was used. Sliced: Unordered, Open, by $this(Type) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.occurrence[x] w5: FiveWs.done[x] quick: DeviceUse.applicationSchedule
timingTiming			Timing	There are no (further) constraints on this element Data type Timing
timingDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
timingPeriod	Σ	0..1	Period	Element id DeviceUseStatement.timing[x]:timingPeriod Short description How often the device was used Definition How often the device was used. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.occurrence[x] w5: FiveWs.done[x] quick: DeviceUse.applicationSchedule
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.timing[x]:timingPeriod.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.timing[x]:timingPeriod.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
start	Σ I	0..1	dateTime	Element id DeviceUseStatement.timing[x]:timingPeriod.start Short description StartDate Alternate names BeginDatum Definition The start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted. Comments If the low element is missing, the meaning is that the low boundary is not known. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: DR.1 rim: ./low zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.11 HdBe-MedicalDevice: MedicalDevice.StartDate
end	Σ I	0..1	dateTime	Element id DeviceUseStatement.timing[x]:timingPeriod.end Short description EndDate Alternate names EindDatum Definition The end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted. Comments The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03. Meaning when missing If the end of the period is missing, it means that the period is ongoing Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: DR.2 rim: ./high zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.14 HdBe-MedicalDevice: MedicalDevice.EndDate
recordedOn	Σ	0..1	dateTime	There are no (further) constraints on this element Element id DeviceUseStatement.recordedOn Short description When statement was recorded Definition The time at which the statement was made/recorded. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.recorded quick: ClinicalStatement.statementDateTime
source	Σ I	0..1	Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson)	There are no (further) constraints on this element Element id DeviceUseStatement.source Short description Who made the statement Definition Who reported the device was being used by the patient. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.performer.actor w5: FiveWs.actor
device	Σ I	1..1	Reference(Device \| HdBe-MedicalDevice.Product)	Element id DeviceUseStatement.device Short description Reference to device used Definition The details of the device used. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Device \| HdBe-MedicalDevice.Product) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.actor quick: DeviceUse.device
reasonCode	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id DeviceUseStatement.reasonCode Short description Why device was used Definition Reason or justification for the use of the device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.reasonCode w5: FiveWs.why[x] quick: Action.indication.reason
reasonReference	Σ I	0..*	Reference(Condition \| Observation \| DiagnosticReport \| DocumentReference \| Media)	Element id DeviceUseStatement.reasonReference Short description Why was DeviceUseStatement performed? Definition Indicates another resource whose existence justifies this DeviceUseStatement. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Condition \| Observation \| DiagnosticReport \| DocumentReference \| Media) Sliced: Unordered, Open, by resolve()(Profile) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.reasonReference w5: FiveWs.why[x] v2: EVN.4 or by domain rim: .outboundRelationship[typeCode=RSON].target
indication	Σ I	0..*	Reference(HdBe-Problem)	Element id DeviceUseStatement.reasonReference:indication Short description Indication Alternate names Indicatie Definition The medical reason for use of the medical device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(HdBe-Problem) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.reasonReference w5: FiveWs.why[x] v2: EVN.4 or by domain rim: .outboundRelationship[typeCode=RSON].target zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.7 HdBe-MedicalDevice: MedicalDevice.Indication
functionalOrMentalStatus	Σ I	0..*	Reference(HdBe-FunctionalOrMentalStatus)	Element id DeviceUseStatement.reasonReference:functionalOrMentalStatus Short description FunctionalOrMentalStatus Alternate names FunctioneleOfMentaleStatus Definition The association between a CBB MedicalDevice and another zib or other functional model. Comments There are several CBBs that reference CBB MedicalDevice on a functional level, but for which the direction of the reference in FHIR is reversed. Consult the mappings on this element for an overview of which zib concepts are mapped to this element. Note that some CBBs have a reference to MedicalDevice that is further constrained (e.g. with additional constraints on ProductType or AnatomicalLocation), such as HearingFunction and VisualFunction. For these CBBs separate DeviceUseStatement profiles have been created (based on this profile) which also include a specific slice on which their respective MedicalDevice concept mapping is present. Data type Reference(HdBe-FunctionalOrMentalStatus) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.reasonReference w5: FiveWs.why[x] v2: EVN.4 or by domain rim: .outboundRelationship[typeCode=RSON].target zib-functionalormentalstatus-v3.2-2020EN: NL-CM:4.26.5 HdBe-FunctionalOrMentalStatus: MedicalDevice
bodySite	Σ	0..1	HdBe-AnatomicalLocationBinding	Element id DeviceUseStatement.bodySite Short description Location / AnatomicalLocation Alternate names Locatie, AnatomischeLocatie Definition Patient’s anatomical location of the medical device used. Requirements Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type HdBe-AnatomicalLocation Binding Codes describing anatomical locations. May include laterality. Location (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.note rim: targetSiteCode zib-anatomicallocation-v1.0-2020EN: NL-CM:20.7.4 HdBe-AnatomicalLocation: Location zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.15 HdBe-MedicalDevice: MedicalDevice.AnatomicalLocation
note		0..1	Annotation	There are no (further) constraints on this element Element id DeviceUseStatement.note Short description Addition details (comments, instructions) Definition Details about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act workflow: Event.note quick: ClinicalStatement.additionalText
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id DeviceUseStatement.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id DeviceUseStatement.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text	Σ	1..1	markdown	Element id DeviceUseStatement.note.text Short description Comment Alternate names Toelichting Definition Comment about use or information on the medical device used. Comments Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/ Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.10 HdBe-MedicalDevice: MedicalDevice.Comment

DeviceUseStatement	I		DeviceUseStatement	Element id DeviceUseStatement Short description MedicalDevice Alternate names MedischHulpmiddel Definition A record of a device being used by a patient where the record is the result of a report from the patient or another clinician. Data type DeviceUseStatement Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim: Entity. Role, or Act workflow: Event quick: DeviceUsePerformanceOccurrence zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.1 HdBe-MedicalDevice: MedicalDevice
id	Σ	0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id DeviceUseStatement.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id DeviceUseStatement.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id DeviceUseStatement.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id DeviceUseStatement.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id DeviceUseStatement.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
healthProfessional	I	0..1	Extension(pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner))	Element id DeviceUseStatement.extension:healthProfessional Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner)) Extension URL https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.extension:healthProfessional.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.extension:healthProfessional.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id DeviceUseStatement.extension:healthProfessional.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional Mappings rim: N/A
value[x]	I	0..1		Element id DeviceUseStatement.extension:healthProfessional.value[x] Short description HealthProfessional Alternate names Zorgverlener Definition The healthcare professional involved in the indication for use of the medical device implant. Comments Each occurence of the CBB HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of HdBe-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of HdBe-HealthProfessional-Practitioner). The reference to the Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Only in rare circumstances, there is just a Practitioner instance, in which case it is that instance which will be referenced here. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: N/A rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.9 HdBe-MedicalDevice: MedicalDevice.HealthProfessional
valueReference			pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner)	There are no (further) constraints on this element Data type pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner)
location	I	0..1	Extension(Reference(HdBe-HealthcareOrganization))	Element id DeviceUseStatement.extension:location Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Reference(HdBe-HealthcareOrganization)) Extension URL https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.extension:location.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.extension:location.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id DeviceUseStatement.extension:location.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location Mappings rim: N/A
value[x]		0..1		Element id DeviceUseStatement.extension:location.value[x] Short description Location Alternate names Locatie Definition The healthcare organization at which use of the medical device was initiated or where the aid was implanted. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.8 HdBe-MedicalDevice: MedicalDevice.Location
valueReference			Reference(HdBe-HealthcareOrganization)	There are no (further) constraints on this element Data type Reference(HdBe-HealthcareOrganization)
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier	Σ	0..*	Identifier	There are no (further) constraints on this element Element id DeviceUseStatement.identifier Short description External identifier for this record Definition An external identifier for this statement such as an IRI. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier workflow: Event.identifier w5: FiveWs.identifier quick: ClinicalStatement.identifier
basedOn	Σ I	0..*	Reference(ServiceRequest)	There are no (further) constraints on this element Element id DeviceUseStatement.basedOn Short description Fulfills plan, proposal or order Alternate names fulfills Definition A plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement. Requirements Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(ServiceRequest) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.basedOn v2: ORC in proximity to EVN segment rim: .outboundRelationship[typeCode=FLFS].target
status	Σ ?!	1..1	codeBinding	Element id DeviceUseStatement.status Short description active \| completed \| entered-in-error + Definition A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed. Comments This element is implictly mapped to the CBB concepts start_date and end_date. Unless the status is explicitly recorded, the following guidance applies: When start_date is in the future, `.status` will usually be set to intended. When start_date is in the past and end_date has a value and in the future or end_date has no value, `.status` will usually be set to active. When end_date has a value and is in the past, `.status` will usually be set to completed. Data type code Binding A coded concept indicating the current status of the Device Usage. DeviceUseStatementStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.status w5: FiveWs.status rim: .statusCode quick: …status zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.11 zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.14 HdBe-MedicalDevice: MedicalDevice.StartDate HdBe-MedicalDevice: MedicalDevice.EndDate
subject	Σ I	1..1	Reference(Patient \| Group \| HdBe-Patient)	Element id DeviceUseStatement.subject Short description Patient using device Definition The patient who used the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| Group \| HdBe-Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.subject w5: FiveWs.subject[x] quick: ClinicalStatement.subject w5: FiveWs.subject
derivedFrom	Σ I	0..*	Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference)	Element id DeviceUseStatement.derivedFrom Short description Supporting information Definition Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement. Comments The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from. Data type Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference) Sliced: Unordered, Open, by resolve()(Profile) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
procedure-request	Σ I	0..*	Reference(HdBe-Procedure request)	Element id DeviceUseStatement.derivedFrom:procedure-request Short description Procedure Alternate names Verrichting Definition The procedure which has the purpose if placing this product in or on the body. Comments Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed. Data type Reference(HdBe-Procedure request) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) zib-procedure-v5.2-2020EN: NL-CM:14.1.7 HdBe-Procedure: MedicalDevice
procedure-event	Σ I	0..*	Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference \| HdBe-Procedure event)	Element id DeviceUseStatement.derivedFrom:procedure-event Short description Procedure Definition The procedure which has the purpose of placing this product in or on the body. Comments Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed. Data type Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference \| HdBe-Procedure event) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) zib-procedure-v5.2-2020EN: NL-CM:14.1.7 HdBe-Procedure: MedicalDevice
timing[x]	Σ	0..1		Element id DeviceUseStatement.timing[x] Short description How often the device was used Definition How often the device was used. Sliced: Unordered, Open, by $this(Type) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.occurrence[x] w5: FiveWs.done[x] quick: DeviceUse.applicationSchedule
timingTiming			Timing	There are no (further) constraints on this element Data type Timing
timingDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
timingPeriod	Σ	0..1	Period	Element id DeviceUseStatement.timing[x]:timingPeriod Short description How often the device was used Definition How often the device was used. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.occurrence[x] w5: FiveWs.done[x] quick: DeviceUse.applicationSchedule
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.timing[x]:timingPeriod.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.timing[x]:timingPeriod.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
start	Σ I	0..1	dateTime	Element id DeviceUseStatement.timing[x]:timingPeriod.start Short description StartDate Alternate names BeginDatum Definition The start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted. Comments If the low element is missing, the meaning is that the low boundary is not known. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: DR.1 rim: ./low zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.11 HdBe-MedicalDevice: MedicalDevice.StartDate
end	Σ I	0..1	dateTime	Element id DeviceUseStatement.timing[x]:timingPeriod.end Short description EndDate Alternate names EindDatum Definition The end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted. Comments The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03. Meaning when missing If the end of the period is missing, it means that the period is ongoing Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: DR.2 rim: ./high zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.14 HdBe-MedicalDevice: MedicalDevice.EndDate
recordedOn	Σ	0..1	dateTime	There are no (further) constraints on this element Element id DeviceUseStatement.recordedOn Short description When statement was recorded Definition The time at which the statement was made/recorded. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.recorded quick: ClinicalStatement.statementDateTime
source	Σ I	0..1	Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson)	There are no (further) constraints on this element Element id DeviceUseStatement.source Short description Who made the statement Definition Who reported the device was being used by the patient. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.performer.actor w5: FiveWs.actor
device	Σ I	1..1	Reference(Device \| HdBe-MedicalDevice.Product)	Element id DeviceUseStatement.device Short description Reference to device used Definition The details of the device used. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Device \| HdBe-MedicalDevice.Product) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.actor quick: DeviceUse.device
reasonCode	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id DeviceUseStatement.reasonCode Short description Why device was used Definition Reason or justification for the use of the device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.reasonCode w5: FiveWs.why[x] quick: Action.indication.reason
reasonReference	Σ I	0..*	Reference(Condition \| Observation \| DiagnosticReport \| DocumentReference \| Media)	Element id DeviceUseStatement.reasonReference Short description Why was DeviceUseStatement performed? Definition Indicates another resource whose existence justifies this DeviceUseStatement. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Condition \| Observation \| DiagnosticReport \| DocumentReference \| Media) Sliced: Unordered, Open, by resolve()(Profile) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.reasonReference w5: FiveWs.why[x] v2: EVN.4 or by domain rim: .outboundRelationship[typeCode=RSON].target
indication	Σ I	0..*	Reference(HdBe-Problem)	Element id DeviceUseStatement.reasonReference:indication Short description Indication Alternate names Indicatie Definition The medical reason for use of the medical device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(HdBe-Problem) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.reasonReference w5: FiveWs.why[x] v2: EVN.4 or by domain rim: .outboundRelationship[typeCode=RSON].target zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.7 HdBe-MedicalDevice: MedicalDevice.Indication
functionalOrMentalStatus	Σ I	0..*	Reference(HdBe-FunctionalOrMentalStatus)	Element id DeviceUseStatement.reasonReference:functionalOrMentalStatus Short description FunctionalOrMentalStatus Alternate names FunctioneleOfMentaleStatus Definition The association between a CBB MedicalDevice and another zib or other functional model. Comments There are several CBBs that reference CBB MedicalDevice on a functional level, but for which the direction of the reference in FHIR is reversed. Consult the mappings on this element for an overview of which zib concepts are mapped to this element. Note that some CBBs have a reference to MedicalDevice that is further constrained (e.g. with additional constraints on ProductType or AnatomicalLocation), such as HearingFunction and VisualFunction. For these CBBs separate DeviceUseStatement profiles have been created (based on this profile) which also include a specific slice on which their respective MedicalDevice concept mapping is present. Data type Reference(HdBe-FunctionalOrMentalStatus) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.reasonReference w5: FiveWs.why[x] v2: EVN.4 or by domain rim: .outboundRelationship[typeCode=RSON].target zib-functionalormentalstatus-v3.2-2020EN: NL-CM:4.26.5 HdBe-FunctionalOrMentalStatus: MedicalDevice
bodySite	Σ	0..1	HdBe-AnatomicalLocationBinding	Element id DeviceUseStatement.bodySite Short description Location / AnatomicalLocation Alternate names Locatie, AnatomischeLocatie Definition Patient’s anatomical location of the medical device used. Requirements Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type HdBe-AnatomicalLocation Binding Codes describing anatomical locations. May include laterality. Location (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.note rim: targetSiteCode zib-anatomicallocation-v1.0-2020EN: NL-CM:20.7.4 HdBe-AnatomicalLocation: Location zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.15 HdBe-MedicalDevice: MedicalDevice.AnatomicalLocation
note		0..1	Annotation	There are no (further) constraints on this element Element id DeviceUseStatement.note Short description Addition details (comments, instructions) Definition Details about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act workflow: Event.note quick: ClinicalStatement.additionalText
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id DeviceUseStatement.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id DeviceUseStatement.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text	Σ	1..1	markdown	Element id DeviceUseStatement.note.text Short description Comment Alternate names Toelichting Definition Comment about use or information on the medical device used. Comments Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/ Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.10 HdBe-MedicalDevice: MedicalDevice.Comment

DeviceUseStatement	I		DeviceUseStatement	Element id DeviceUseStatement Short description MedicalDevice Alternate names MedischHulpmiddel Definition A record of a device being used by a patient where the record is the result of a report from the patient or another clinician. Data type DeviceUseStatement Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim: Entity. Role, or Act workflow: Event quick: DeviceUsePerformanceOccurrence zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.1 HdBe-MedicalDevice: MedicalDevice
id	Σ	0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id DeviceUseStatement.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id DeviceUseStatement.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id DeviceUseStatement.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id DeviceUseStatement.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id DeviceUseStatement.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
healthProfessional	I	0..1	Extension(pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner))	Element id DeviceUseStatement.extension:healthProfessional Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner)) Extension URL https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.extension:healthProfessional.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.extension:healthProfessional.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id DeviceUseStatement.extension:healthProfessional.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional Mappings rim: N/A
value[x]	I	0..1		Element id DeviceUseStatement.extension:healthProfessional.value[x] Short description HealthProfessional Alternate names Zorgverlener Definition The healthcare professional involved in the indication for use of the medical device implant. Comments Each occurence of the CBB HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of HdBe-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of HdBe-HealthProfessional-Practitioner). The reference to the Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Only in rare circumstances, there is just a Practitioner instance, in which case it is that instance which will be referenced here. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: N/A rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.9 HdBe-MedicalDevice: MedicalDevice.HealthProfessional
valueReference			pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner)	There are no (further) constraints on this element Data type pattern HealthProfessional Reference(HdBe-HealthProfessional PractitionerRole \| HdBe-HealthProfessional Practitioner)
location	I	0..1	Extension(Reference(HdBe-HealthcareOrganization))	Element id DeviceUseStatement.extension:location Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Reference(HdBe-HealthcareOrganization)) Extension URL https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.extension:location.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.extension:location.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id DeviceUseStatement.extension:location.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location Mappings rim: N/A
value[x]		0..1		Element id DeviceUseStatement.extension:location.value[x] Short description Location Alternate names Locatie Definition The healthcare organization at which use of the medical device was initiated or where the aid was implanted. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.8 HdBe-MedicalDevice: MedicalDevice.Location
valueReference			Reference(HdBe-HealthcareOrganization)	There are no (further) constraints on this element Data type Reference(HdBe-HealthcareOrganization)
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier	Σ	0..*	Identifier	There are no (further) constraints on this element Element id DeviceUseStatement.identifier Short description External identifier for this record Definition An external identifier for this statement such as an IRI. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier workflow: Event.identifier w5: FiveWs.identifier quick: ClinicalStatement.identifier
basedOn	Σ I	0..*	Reference(ServiceRequest)	There are no (further) constraints on this element Element id DeviceUseStatement.basedOn Short description Fulfills plan, proposal or order Alternate names fulfills Definition A plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement. Requirements Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(ServiceRequest) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.basedOn v2: ORC in proximity to EVN segment rim: .outboundRelationship[typeCode=FLFS].target
status	Σ ?!	1..1	codeBinding	Element id DeviceUseStatement.status Short description active \| completed \| entered-in-error + Definition A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed. Comments This element is implictly mapped to the CBB concepts start_date and end_date. Unless the status is explicitly recorded, the following guidance applies: When start_date is in the future, `.status` will usually be set to intended. When start_date is in the past and end_date has a value and in the future or end_date has no value, `.status` will usually be set to active. When end_date has a value and is in the past, `.status` will usually be set to completed. Data type code Binding A coded concept indicating the current status of the Device Usage. DeviceUseStatementStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.status w5: FiveWs.status rim: .statusCode quick: …status zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.11 zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.14 HdBe-MedicalDevice: MedicalDevice.StartDate HdBe-MedicalDevice: MedicalDevice.EndDate
subject	Σ I	1..1	Reference(Patient \| Group \| HdBe-Patient)	Element id DeviceUseStatement.subject Short description Patient using device Definition The patient who used the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| Group \| HdBe-Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.subject w5: FiveWs.subject[x] quick: ClinicalStatement.subject w5: FiveWs.subject
derivedFrom	Σ I	0..*	Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference)	Element id DeviceUseStatement.derivedFrom Short description Supporting information Definition Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement. Comments The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from. Data type Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference) Sliced: Unordered, Open, by resolve()(Profile) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
procedure-request	Σ I	0..*	Reference(HdBe-Procedure request)	Element id DeviceUseStatement.derivedFrom:procedure-request Short description Procedure Alternate names Verrichting Definition The procedure which has the purpose if placing this product in or on the body. Comments Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed. Data type Reference(HdBe-Procedure request) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) zib-procedure-v5.2-2020EN: NL-CM:14.1.7 HdBe-Procedure: MedicalDevice
procedure-event	Σ I	0..*	Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference \| HdBe-Procedure event)	Element id DeviceUseStatement.derivedFrom:procedure-event Short description Procedure Definition The procedure which has the purpose of placing this product in or on the body. Comments Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed. Data type Reference(ServiceRequest \| Procedure \| Claim \| Observation \| QuestionnaireResponse \| DocumentReference \| HdBe-Procedure event) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) zib-procedure-v5.2-2020EN: NL-CM:14.1.7 HdBe-Procedure: MedicalDevice
timing[x]	Σ	0..1		Element id DeviceUseStatement.timing[x] Short description How often the device was used Definition How often the device was used. Sliced: Unordered, Open, by $this(Type) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.occurrence[x] w5: FiveWs.done[x] quick: DeviceUse.applicationSchedule
timingTiming			Timing	There are no (further) constraints on this element Data type Timing
timingDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
timingPeriod	Σ	0..1	Period	Element id DeviceUseStatement.timing[x]:timingPeriod Short description How often the device was used Definition How often the device was used. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.occurrence[x] w5: FiveWs.done[x] quick: DeviceUse.applicationSchedule
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.timing[x]:timingPeriod.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.timing[x]:timingPeriod.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
start	Σ I	0..1	dateTime	Element id DeviceUseStatement.timing[x]:timingPeriod.start Short description StartDate Alternate names BeginDatum Definition The start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted. Comments If the low element is missing, the meaning is that the low boundary is not known. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: DR.1 rim: ./low zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.11 HdBe-MedicalDevice: MedicalDevice.StartDate
end	Σ I	0..1	dateTime	Element id DeviceUseStatement.timing[x]:timingPeriod.end Short description EndDate Alternate names EindDatum Definition The end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted. Comments The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03. Meaning when missing If the end of the period is missing, it means that the period is ongoing Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: DR.2 rim: ./high zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.14 HdBe-MedicalDevice: MedicalDevice.EndDate
recordedOn	Σ	0..1	dateTime	There are no (further) constraints on this element Element id DeviceUseStatement.recordedOn Short description When statement was recorded Definition The time at which the statement was made/recorded. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.recorded quick: ClinicalStatement.statementDateTime
source	Σ I	0..1	Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson)	There are no (further) constraints on this element Element id DeviceUseStatement.source Short description Who made the statement Definition Who reported the device was being used by the patient. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.performer.actor w5: FiveWs.actor
device	Σ I	1..1	Reference(Device \| HdBe-MedicalDevice.Product)	Element id DeviceUseStatement.device Short description Reference to device used Definition The details of the device used. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Device \| HdBe-MedicalDevice.Product) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.actor quick: DeviceUse.device
reasonCode	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id DeviceUseStatement.reasonCode Short description Why device was used Definition Reason or justification for the use of the device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.reasonCode w5: FiveWs.why[x] quick: Action.indication.reason
reasonReference	Σ I	0..*	Reference(Condition \| Observation \| DiagnosticReport \| DocumentReference \| Media)	Element id DeviceUseStatement.reasonReference Short description Why was DeviceUseStatement performed? Definition Indicates another resource whose existence justifies this DeviceUseStatement. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Condition \| Observation \| DiagnosticReport \| DocumentReference \| Media) Sliced: Unordered, Open, by resolve()(Profile) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.reasonReference w5: FiveWs.why[x] v2: EVN.4 or by domain rim: .outboundRelationship[typeCode=RSON].target
indication	Σ I	0..*	Reference(HdBe-Problem)	Element id DeviceUseStatement.reasonReference:indication Short description Indication Alternate names Indicatie Definition The medical reason for use of the medical device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(HdBe-Problem) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.reasonReference w5: FiveWs.why[x] v2: EVN.4 or by domain rim: .outboundRelationship[typeCode=RSON].target zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.7 HdBe-MedicalDevice: MedicalDevice.Indication
functionalOrMentalStatus	Σ I	0..*	Reference(HdBe-FunctionalOrMentalStatus)	Element id DeviceUseStatement.reasonReference:functionalOrMentalStatus Short description FunctionalOrMentalStatus Alternate names FunctioneleOfMentaleStatus Definition The association between a CBB MedicalDevice and another zib or other functional model. Comments There are several CBBs that reference CBB MedicalDevice on a functional level, but for which the direction of the reference in FHIR is reversed. Consult the mappings on this element for an overview of which zib concepts are mapped to this element. Note that some CBBs have a reference to MedicalDevice that is further constrained (e.g. with additional constraints on ProductType or AnatomicalLocation), such as HearingFunction and VisualFunction. For these CBBs separate DeviceUseStatement profiles have been created (based on this profile) which also include a specific slice on which their respective MedicalDevice concept mapping is present. Data type Reference(HdBe-FunctionalOrMentalStatus) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.reasonReference w5: FiveWs.why[x] v2: EVN.4 or by domain rim: .outboundRelationship[typeCode=RSON].target zib-functionalormentalstatus-v3.2-2020EN: NL-CM:4.26.5 HdBe-FunctionalOrMentalStatus: MedicalDevice
bodySite	Σ	0..1	HdBe-AnatomicalLocationBinding	Element id DeviceUseStatement.bodySite Short description Location / AnatomicalLocation Alternate names Locatie, AnatomischeLocatie Definition Patient’s anatomical location of the medical device used. Requirements Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type HdBe-AnatomicalLocation Binding Codes describing anatomical locations. May include laterality. Location (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.note rim: targetSiteCode zib-anatomicallocation-v1.0-2020EN: NL-CM:20.7.4 HdBe-AnatomicalLocation: Location zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.15 HdBe-MedicalDevice: MedicalDevice.AnatomicalLocation
note		0..1	Annotation	There are no (further) constraints on this element Element id DeviceUseStatement.note Short description Addition details (comments, instructions) Definition Details about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act workflow: Event.note quick: ClinicalStatement.additionalText
id		0..1	string	There are no (further) constraints on this element Element id DeviceUseStatement.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceUseStatement.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id DeviceUseStatement.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id DeviceUseStatement.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text	Σ	1..1	markdown	Element id DeviceUseStatement.note.text Short description Comment Alternate names Toelichting Definition Comment about use or information on the medical device used. Comments Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/ Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.10 HdBe-MedicalDevice: MedicalDevice.Comment

Mapping FHIR profile to CBB

Path	map	CBB	comment
DeviceUseStatement	MedicalDevice	HdBe-MedicalDevice
DeviceUseStatement.extension:healthProfessional.value[x]	MedicalDevice.HealthProfessional	HdBe-MedicalDevice
DeviceUseStatement.extension:location.value[x]	MedicalDevice.Location	HdBe-MedicalDevice
DeviceUseStatement.status	MedicalDevice.StartDate	HdBe-MedicalDevice	implicit, main mapping is on DeviceUseStatement.timingPeriod.start
DeviceUseStatement.status	MedicalDevice.EndDate	HdBe-MedicalDevice	implicit, main mapping is on DeviceUseStatement.timingPeriod.end
DeviceUseStatement.derivedFrom:procedure-request	MedicalDevice	HdBe-Procedure	Reversed reference for CBB Procedure.medical_device
DeviceUseStatement.derivedFrom:procedure-event	MedicalDevice	HdBe-Procedure	Reversed reference for CBB Procedure.medical_device
DeviceUseStatement.timing[x]:timingPeriod.start	MedicalDevice.StartDate	HdBe-MedicalDevice
DeviceUseStatement.timing[x]:timingPeriod.end	MedicalDevice.EndDate	HdBe-MedicalDevice
DeviceUseStatement.reasonReference:indication	MedicalDevice.Indication	HdBe-MedicalDevice
DeviceUseStatement.reasonReference:functionalOrMentalStatus	MedicalDevice	HdBe-FunctionalOrMentalStatus	Reversed reference for CBB FunctionalOrMentalStatus.medical_device
DeviceUseStatement.bodySite	MedicalDevice.AnatomicalLocation	HdBe-MedicalDevice
DeviceUseStatement.note.text	MedicalDevice.Comment	HdBe-MedicalDevice

zib MedicalDevice difference

Concept	Category	Description

HdBe-MedicalDevice.Product

Device	I		Device	Element id Device Short description Product Alternate names Product Definition The medical device (internally or externally). Data type Device Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim: Entity. Role, or Act rim: Device zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.2 HdBe-MedicalDevice: MedicalDevice.Product
id	Σ	0..1	string	There are no (further) constraints on this element Element id Device.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Device.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Device.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id Device.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id Device.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Device.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier		0..*	Identifier	Element id Device.identifier Short description Instance identifier Definition Additional unique identification code(s) of the product. The UDI (Unique Device Identifier) is the preferred identification code, consisting of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). This code should not be mapped here, but in the specified udiCarrier. Additionally, other codes can be registered here if needed. Such as: `- a serial number. - a NIHDI notification code (medical devices on the Belgian market: https://www.vas.ehealth.fgov.be/registers/sadm/web/search/public). - an identification code as indicated on the Nominative lists published by NIHDI: https://webappsa.riziv-inami.fgov.be/IRREQPublic/nl/Home/SearchNominative). Devices on these Nominative lists meet certain criteria for reimbursement.` Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.identifier rim: .id udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty. HdBe-MedicalDevice: MedicalDevice.Product.ProductId zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.4
definition	I	0..1	Reference(DeviceDefinition)	There are no (further) constraints on this element Element id Device.definition Short description The reference to the definition for the device Definition The reference to the definition for the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(DeviceDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
udiCarrier	Σ	0..1	BackboneElement	Element id Device.udiCarrier Short description Unique Device Identifier (UDI) Barcode string Definition Unique device identifier (UDI) assigned to device label or package. The UDI is the preferred identifier code. When having an UDI, it is preferred to sent at least the deviceIdentifier, issuer and carrierHRF. Comments UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.identifier rim: .id and .code HdBe-MedicalDevice: MedicalDevice.Product.ProductId zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.4
id		0..1	string	There are no (further) constraints on this element Element id Device.udiCarrier.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.udiCarrier.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.udiCarrier.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
deviceIdentifier	Σ	0..1	string	There are no (further) constraints on this element Element id Device.udiCarrier.deviceIdentifier Short description Mandatory fixed portion of UDI Alternate names DI Definition The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: Role.id.extension udi: The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
issuer		0..1	uri	There are no (further) constraints on this element Element id Device.udiCarrier.issuer Short description UDI Issuing Organization Alternate names Barcode System Definition Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.id.root udi: All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
jurisdiction		0..1	uri	There are no (further) constraints on this element Element id Device.udiCarrier.jurisdiction Short description Regional UDI authority Definition The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Requirements Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.scoper
carrierAIDC	Σ	0..1	base64Binary	There are no (further) constraints on this element Element id Device.udiCarrier.carrierAIDC Short description UDI Machine Readable Barcode String Alternate names Automatic Identification and Data Capture Definition The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded. Comments The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data type base64Binary Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.id.extension udi: A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
carrierHRF	Σ	0..1	string	There are no (further) constraints on this element Element id Device.udiCarrier.carrierHRF Short description UDI Human Readable Barcode String Alternate names Human Readable Form Definition The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. Comments If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.id.extension udi: A unique device identifier (UDI) on a device label in plain text
entryType		0..1	codeBinding	There are no (further) constraints on this element Element id Device.udiCarrier.entryType Short description barcode \| rfid \| manual + Definition A coded entry to indicate how the data was entered. Requirements Supports a way to distinguish hand entered from machine read data. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding Codes to identify how UDI data was entered. UDIEntryType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: NA
status	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id Device.status Short description active \| inactive \| entered-in-error \| unknown Definition Status of the Device availability. Comments This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid. Data type code Binding The availability status of the device. FHIRDeviceStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.status rim: .statusCode
statusReason		0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id Device.statusReason Short description online \| paused \| standby \| offline \| not-ready \| transduc-discon \| hw-discon \| off Definition Reason for the dtatus of the Device availability. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding The availability status reason of the device. FHIRDeviceStatusReason (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD w5: FiveWs.status
distinctIdentifier		0..1	string	There are no (further) constraints on this element Element id Device.distinctIdentifier Short description The distinct identification string Alternate names Distinct Identification Code (DIC) Definition The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. Comments For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c). Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
manufacturer		0..1	string	There are no (further) constraints on this element Element id Device.manufacturer Short description Name of device manufacturer Definition A name of the manufacturer. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].scoper.name udi: N/A
manufactureDate		0..1	dateTime	Element id Device.manufactureDate Short description Date when the device was made Definition The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11). Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .existenceTime.low udi: The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
expirationDate		0..1	dateTime	Element id Device.expirationDate Short description Date and time of expiry of this device (if applicable) Definition The expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17). Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .expirationTime udi: the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
lotNumber		0..1	string	Element id Device.lotNumber Short description Lot number of manufacture Definition The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10). Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
serialNumber		0..1	string	Element id Device.serialNumber Short description Serial number assigned by the manufacturer Definition The serial number assigned by the organization when the device was manufactured. In the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21). Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
deviceName		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.deviceName Short description The name of the device as given by the manufacturer Definition This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.deviceName.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.deviceName.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.deviceName.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
name		1..1	string	There are no (further) constraints on this element Element id Device.deviceName.name Short description The name of the device Alternate names Σ Definition The name of the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
type		1..1	codeBinding	There are no (further) constraints on this element Element id Device.deviceName.type Short description udi-label-name \| user-friendly-name \| patient-reported-name \| manufacturer-name \| model-name \| other Definition The type of deviceName. UDILabelName \| UserFriendlyName \| PatientReportedName \| ManufactureDeviceName \| ModelName. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding The type of name the device is referred by. DeviceNameType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].code
modelNumber		0..1	string	There are no (further) constraints on this element Element id Device.modelNumber Short description The model number for the device Definition The model number for the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .softwareName (included as part)
partNumber		0..1	string	There are no (further) constraints on this element Element id Device.partNumber Short description The part number of the device Definition The part number of the device. Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
type		0..1	CodeableConceptBinding	Element id Device.type Short description ProductType Alternate names ProductType Definition The code of the type of product. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Codes to identify medical devices. ProductType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.3 HdBe-MedicalDevice: MedicalDevice.Product.ProductType
specialization		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.specialization Short description The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication Definition The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.specialization.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.specialization.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.specialization.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
systemType		1..1	CodeableConcept	There are no (further) constraints on this element Element id Device.specialization.systemType Short description The standard that is used to operate and communicate Alternate names Σ Definition The standard that is used to operate and communicate. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
version		0..1	string	There are no (further) constraints on this element Element id Device.specialization.version Short description The version of the standard that is used to operate and communicate Definition The version of the standard that is used to operate and communicate. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x]
version		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.version Short description The actual design of the device or software version running on the device Definition The actual design of the device or software version running on the device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.version.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.version.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.version.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
type		0..1	CodeableConcept	There are no (further) constraints on this element Element id Device.version.type Short description The type of the device version Alternate names Σ Definition The type of the device version. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
component		0..1	Identifier	There are no (further) constraints on this element Element id Device.version.component Short description A single component of the device version Definition A single component of the device version. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.what[x]
value		1..1	string	There are no (further) constraints on this element Element id Device.version.value Short description The version text Definition The version text. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
property		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.property Short description The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties Definition The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.property.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.property.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.property.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
type		1..1	CodeableConcept	There are no (further) constraints on this element Element id Device.property.type Short description Code that specifies the property DeviceDefinitionPropetyCode (Extensible) Definition Code that specifies the property DeviceDefinitionPropetyCode (Extensible). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
valueQuantity	I	0..*	Quantity	There are no (further) constraints on this element Element id Device.property.valueQuantity Short description Property value as a quantity Definition Property value as a quantity. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Quantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
valueCode		0..*	CodeableConcept	There are no (further) constraints on this element Element id Device.property.valueCode Short description Property value as a code, e.g., NTP4 (synced to NTP) Definition Property value as a code, e.g., NTP4 (synced to NTP). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
patient	I	0..1	Reference(Patient \| HdBe-Patient)	Element id Device.patient Short description Patient to whom Device is affixed Definition Patient information, If the device is affixed to a person. Requirements If the device is implanted in a patient, then need to associate the device to the patient. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| HdBe-Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.subject[x] rim: .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT] w5: FiveWs.subject
owner	I	0..1	Reference(Organization)	There are no (further) constraints on this element Element id Device.owner Short description Organization responsible for device Definition An organization that is responsible for the provision and ongoing maintenance of the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.source rim: .playedRole[typeCode=OWN].scoper
contact	I	0..*	ContactPoint	There are no (further) constraints on this element Element id Device.contact Short description Details for human/organization for support Definition Contact details for an organization or a particular human that is responsible for the device. Comments used for troubleshooting etc. Data type ContactPoint Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` cpt-2: A system is required if a value is provided. `value.empty() or system.exists()` Mappings rim: n/a v2: XTN rim: TEL servd: ContactPoint w5: FiveWs.source rim: .scopedRole[typeCode=CON].player
location	I	0..1	Reference(Location)	There are no (further) constraints on this element Element id Device.location Short description Where the device is found Definition The place where the device can be found. Requirements Device.location can be used to track device location. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.where[x] rim: .playedRole[typeCode=LOCE].scoper
url		0..1	uri	There are no (further) constraints on this element Element id Device.url Short description Network address to contact device Definition A network address on which the device may be contacted directly. Comments If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.where[x] rim: .telecom
note		0..1	Annotation	There are no (further) constraints on this element Element id Device.note Short description Device notes and comments Definition Descriptive information, usage information or implantation information that is not captured in an existing element. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act rim: .text
id		0..1	string	There are no (further) constraints on this element Element id Device.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id Device.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id Device.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text	Σ	1..1	markdown	Element id Device.note.text Short description ProductDescription Alternate names ProductOmschrijving Definition Textual description of the product. Comments Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/ Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.13 HdBe-MedicalDevice: MedicalDevice.ProductDescription
safety	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id Device.safety Short description Safety Characteristics of Device Definition Provides additional safety characteristics about a medical device. For example devices containing latex. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD rim: NA
parent	I	0..1	Reference(Device)	There are no (further) constraints on this element Element id Device.parent Short description The parent device Definition The parent device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

Device	I		Device	Element id Device Short description Product Alternate names Product Definition The medical device (internally or externally). Data type Device Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim: Entity. Role, or Act rim: Device zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.2 HdBe-MedicalDevice: MedicalDevice.Product
id	Σ	0..1	string	There are no (further) constraints on this element Element id Device.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Device.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Device.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id Device.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id Device.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Device.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier		0..*	Identifier	Element id Device.identifier Short description Instance identifier Definition Additional unique identification code(s) of the product. The UDI (Unique Device Identifier) is the preferred identification code, consisting of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). This code should not be mapped here, but in the specified udiCarrier. Additionally, other codes can be registered here if needed. Such as: `- a serial number. - a NIHDI notification code (medical devices on the Belgian market: https://www.vas.ehealth.fgov.be/registers/sadm/web/search/public). - an identification code as indicated on the Nominative lists published by NIHDI: https://webappsa.riziv-inami.fgov.be/IRREQPublic/nl/Home/SearchNominative). Devices on these Nominative lists meet certain criteria for reimbursement.` Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.identifier rim: .id udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty. HdBe-MedicalDevice: MedicalDevice.Product.ProductId zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.4
definition	I	0..1	Reference(DeviceDefinition)	There are no (further) constraints on this element Element id Device.definition Short description The reference to the definition for the device Definition The reference to the definition for the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(DeviceDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
udiCarrier	Σ	0..1	BackboneElement	Element id Device.udiCarrier Short description Unique Device Identifier (UDI) Barcode string Definition Unique device identifier (UDI) assigned to device label or package. The UDI is the preferred identifier code. When having an UDI, it is preferred to sent at least the deviceIdentifier, issuer and carrierHRF. Comments UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.identifier rim: .id and .code HdBe-MedicalDevice: MedicalDevice.Product.ProductId zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.4
id		0..1	string	There are no (further) constraints on this element Element id Device.udiCarrier.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.udiCarrier.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.udiCarrier.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
deviceIdentifier	Σ	0..1	string	There are no (further) constraints on this element Element id Device.udiCarrier.deviceIdentifier Short description Mandatory fixed portion of UDI Alternate names DI Definition The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: Role.id.extension udi: The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
issuer		0..1	uri	There are no (further) constraints on this element Element id Device.udiCarrier.issuer Short description UDI Issuing Organization Alternate names Barcode System Definition Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.id.root udi: All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
jurisdiction		0..1	uri	There are no (further) constraints on this element Element id Device.udiCarrier.jurisdiction Short description Regional UDI authority Definition The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Requirements Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.scoper
carrierAIDC	Σ	0..1	base64Binary	There are no (further) constraints on this element Element id Device.udiCarrier.carrierAIDC Short description UDI Machine Readable Barcode String Alternate names Automatic Identification and Data Capture Definition The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded. Comments The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data type base64Binary Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.id.extension udi: A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
carrierHRF	Σ	0..1	string	There are no (further) constraints on this element Element id Device.udiCarrier.carrierHRF Short description UDI Human Readable Barcode String Alternate names Human Readable Form Definition The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. Comments If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.id.extension udi: A unique device identifier (UDI) on a device label in plain text
entryType		0..1	codeBinding	There are no (further) constraints on this element Element id Device.udiCarrier.entryType Short description barcode \| rfid \| manual + Definition A coded entry to indicate how the data was entered. Requirements Supports a way to distinguish hand entered from machine read data. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding Codes to identify how UDI data was entered. UDIEntryType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: NA
status	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id Device.status Short description active \| inactive \| entered-in-error \| unknown Definition Status of the Device availability. Comments This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid. Data type code Binding The availability status of the device. FHIRDeviceStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.status rim: .statusCode
statusReason		0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id Device.statusReason Short description online \| paused \| standby \| offline \| not-ready \| transduc-discon \| hw-discon \| off Definition Reason for the dtatus of the Device availability. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding The availability status reason of the device. FHIRDeviceStatusReason (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD w5: FiveWs.status
distinctIdentifier		0..1	string	There are no (further) constraints on this element Element id Device.distinctIdentifier Short description The distinct identification string Alternate names Distinct Identification Code (DIC) Definition The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. Comments For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c). Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
manufacturer		0..1	string	There are no (further) constraints on this element Element id Device.manufacturer Short description Name of device manufacturer Definition A name of the manufacturer. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].scoper.name udi: N/A
manufactureDate		0..1	dateTime	Element id Device.manufactureDate Short description Date when the device was made Definition The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11). Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .existenceTime.low udi: The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
expirationDate		0..1	dateTime	Element id Device.expirationDate Short description Date and time of expiry of this device (if applicable) Definition The expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17). Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .expirationTime udi: the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
lotNumber		0..1	string	Element id Device.lotNumber Short description Lot number of manufacture Definition The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10). Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
serialNumber		0..1	string	Element id Device.serialNumber Short description Serial number assigned by the manufacturer Definition The serial number assigned by the organization when the device was manufactured. In the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21). Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
deviceName		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.deviceName Short description The name of the device as given by the manufacturer Definition This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.deviceName.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.deviceName.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.deviceName.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
name		1..1	string	There are no (further) constraints on this element Element id Device.deviceName.name Short description The name of the device Alternate names Σ Definition The name of the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
type		1..1	codeBinding	There are no (further) constraints on this element Element id Device.deviceName.type Short description udi-label-name \| user-friendly-name \| patient-reported-name \| manufacturer-name \| model-name \| other Definition The type of deviceName. UDILabelName \| UserFriendlyName \| PatientReportedName \| ManufactureDeviceName \| ModelName. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding The type of name the device is referred by. DeviceNameType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].code
modelNumber		0..1	string	There are no (further) constraints on this element Element id Device.modelNumber Short description The model number for the device Definition The model number for the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .softwareName (included as part)
partNumber		0..1	string	There are no (further) constraints on this element Element id Device.partNumber Short description The part number of the device Definition The part number of the device. Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
type		0..1	CodeableConceptBinding	Element id Device.type Short description ProductType Alternate names ProductType Definition The code of the type of product. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Codes to identify medical devices. ProductType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.3 HdBe-MedicalDevice: MedicalDevice.Product.ProductType
specialization		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.specialization Short description The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication Definition The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.specialization.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.specialization.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.specialization.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
systemType		1..1	CodeableConcept	There are no (further) constraints on this element Element id Device.specialization.systemType Short description The standard that is used to operate and communicate Alternate names Σ Definition The standard that is used to operate and communicate. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
version		0..1	string	There are no (further) constraints on this element Element id Device.specialization.version Short description The version of the standard that is used to operate and communicate Definition The version of the standard that is used to operate and communicate. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x]
version		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.version Short description The actual design of the device or software version running on the device Definition The actual design of the device or software version running on the device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.version.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.version.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.version.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
type		0..1	CodeableConcept	There are no (further) constraints on this element Element id Device.version.type Short description The type of the device version Alternate names Σ Definition The type of the device version. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
component		0..1	Identifier	There are no (further) constraints on this element Element id Device.version.component Short description A single component of the device version Definition A single component of the device version. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.what[x]
value		1..1	string	There are no (further) constraints on this element Element id Device.version.value Short description The version text Definition The version text. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
property		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.property Short description The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties Definition The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.property.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.property.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.property.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
type		1..1	CodeableConcept	There are no (further) constraints on this element Element id Device.property.type Short description Code that specifies the property DeviceDefinitionPropetyCode (Extensible) Definition Code that specifies the property DeviceDefinitionPropetyCode (Extensible). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
valueQuantity	I	0..*	Quantity	There are no (further) constraints on this element Element id Device.property.valueQuantity Short description Property value as a quantity Definition Property value as a quantity. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Quantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
valueCode		0..*	CodeableConcept	There are no (further) constraints on this element Element id Device.property.valueCode Short description Property value as a code, e.g., NTP4 (synced to NTP) Definition Property value as a code, e.g., NTP4 (synced to NTP). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
patient	I	0..1	Reference(Patient \| HdBe-Patient)	Element id Device.patient Short description Patient to whom Device is affixed Definition Patient information, If the device is affixed to a person. Requirements If the device is implanted in a patient, then need to associate the device to the patient. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| HdBe-Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.subject[x] rim: .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT] w5: FiveWs.subject
owner	I	0..1	Reference(Organization)	There are no (further) constraints on this element Element id Device.owner Short description Organization responsible for device Definition An organization that is responsible for the provision and ongoing maintenance of the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.source rim: .playedRole[typeCode=OWN].scoper
contact	I	0..*	ContactPoint	There are no (further) constraints on this element Element id Device.contact Short description Details for human/organization for support Definition Contact details for an organization or a particular human that is responsible for the device. Comments used for troubleshooting etc. Data type ContactPoint Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` cpt-2: A system is required if a value is provided. `value.empty() or system.exists()` Mappings rim: n/a v2: XTN rim: TEL servd: ContactPoint w5: FiveWs.source rim: .scopedRole[typeCode=CON].player
location	I	0..1	Reference(Location)	There are no (further) constraints on this element Element id Device.location Short description Where the device is found Definition The place where the device can be found. Requirements Device.location can be used to track device location. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.where[x] rim: .playedRole[typeCode=LOCE].scoper
url		0..1	uri	There are no (further) constraints on this element Element id Device.url Short description Network address to contact device Definition A network address on which the device may be contacted directly. Comments If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.where[x] rim: .telecom
note		0..1	Annotation	There are no (further) constraints on this element Element id Device.note Short description Device notes and comments Definition Descriptive information, usage information or implantation information that is not captured in an existing element. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act rim: .text
id		0..1	string	There are no (further) constraints on this element Element id Device.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id Device.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id Device.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text	Σ	1..1	markdown	Element id Device.note.text Short description ProductDescription Alternate names ProductOmschrijving Definition Textual description of the product. Comments Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/ Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.13 HdBe-MedicalDevice: MedicalDevice.ProductDescription
safety	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id Device.safety Short description Safety Characteristics of Device Definition Provides additional safety characteristics about a medical device. For example devices containing latex. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD rim: NA
parent	I	0..1	Reference(Device)	There are no (further) constraints on this element Element id Device.parent Short description The parent device Definition The parent device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

Device	I		Device	Element id Device Short description Product Alternate names Product Definition The medical device (internally or externally). Data type Device Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim: Entity. Role, or Act rim: Device zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.2 HdBe-MedicalDevice: MedicalDevice.Product
id	Σ	0..1	string	There are no (further) constraints on this element Element id Device.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Device.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Device.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id Device.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id Device.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Device.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier		0..*	Identifier	Element id Device.identifier Short description Instance identifier Definition Additional unique identification code(s) of the product. The UDI (Unique Device Identifier) is the preferred identification code, consisting of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). This code should not be mapped here, but in the specified udiCarrier. Additionally, other codes can be registered here if needed. Such as: `- a serial number. - a NIHDI notification code (medical devices on the Belgian market: https://www.vas.ehealth.fgov.be/registers/sadm/web/search/public). - an identification code as indicated on the Nominative lists published by NIHDI: https://webappsa.riziv-inami.fgov.be/IRREQPublic/nl/Home/SearchNominative). Devices on these Nominative lists meet certain criteria for reimbursement.` Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.identifier rim: .id udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty. HdBe-MedicalDevice: MedicalDevice.Product.ProductId zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.4
definition	I	0..1	Reference(DeviceDefinition)	There are no (further) constraints on this element Element id Device.definition Short description The reference to the definition for the device Definition The reference to the definition for the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(DeviceDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
udiCarrier	Σ	0..1	BackboneElement	Element id Device.udiCarrier Short description Unique Device Identifier (UDI) Barcode string Definition Unique device identifier (UDI) assigned to device label or package. The UDI is the preferred identifier code. When having an UDI, it is preferred to sent at least the deviceIdentifier, issuer and carrierHRF. Comments UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.identifier rim: .id and .code HdBe-MedicalDevice: MedicalDevice.Product.ProductId zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.4
id		0..1	string	There are no (further) constraints on this element Element id Device.udiCarrier.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.udiCarrier.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.udiCarrier.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
deviceIdentifier	Σ	0..1	string	There are no (further) constraints on this element Element id Device.udiCarrier.deviceIdentifier Short description Mandatory fixed portion of UDI Alternate names DI Definition The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: Role.id.extension udi: The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
issuer		0..1	uri	There are no (further) constraints on this element Element id Device.udiCarrier.issuer Short description UDI Issuing Organization Alternate names Barcode System Definition Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.id.root udi: All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
jurisdiction		0..1	uri	There are no (further) constraints on this element Element id Device.udiCarrier.jurisdiction Short description Regional UDI authority Definition The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Requirements Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.scoper
carrierAIDC	Σ	0..1	base64Binary	There are no (further) constraints on this element Element id Device.udiCarrier.carrierAIDC Short description UDI Machine Readable Barcode String Alternate names Automatic Identification and Data Capture Definition The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded. Comments The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data type base64Binary Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.id.extension udi: A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
carrierHRF	Σ	0..1	string	There are no (further) constraints on this element Element id Device.udiCarrier.carrierHRF Short description UDI Human Readable Barcode String Alternate names Human Readable Form Definition The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. Comments If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role.id.extension udi: A unique device identifier (UDI) on a device label in plain text
entryType		0..1	codeBinding	There are no (further) constraints on this element Element id Device.udiCarrier.entryType Short description barcode \| rfid \| manual + Definition A coded entry to indicate how the data was entered. Requirements Supports a way to distinguish hand entered from machine read data. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding Codes to identify how UDI data was entered. UDIEntryType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: NA
status	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id Device.status Short description active \| inactive \| entered-in-error \| unknown Definition Status of the Device availability. Comments This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid. Data type code Binding The availability status of the device. FHIRDeviceStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.status rim: .statusCode
statusReason		0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id Device.statusReason Short description online \| paused \| standby \| offline \| not-ready \| transduc-discon \| hw-discon \| off Definition Reason for the dtatus of the Device availability. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding The availability status reason of the device. FHIRDeviceStatusReason (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD w5: FiveWs.status
distinctIdentifier		0..1	string	There are no (further) constraints on this element Element id Device.distinctIdentifier Short description The distinct identification string Alternate names Distinct Identification Code (DIC) Definition The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. Comments For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c). Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
manufacturer		0..1	string	There are no (further) constraints on this element Element id Device.manufacturer Short description Name of device manufacturer Definition A name of the manufacturer. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].scoper.name udi: N/A
manufactureDate		0..1	dateTime	Element id Device.manufactureDate Short description Date when the device was made Definition The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11). Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .existenceTime.low udi: The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
expirationDate		0..1	dateTime	Element id Device.expirationDate Short description Date and time of expiry of this device (if applicable) Definition The expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17). Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .expirationTime udi: the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
lotNumber		0..1	string	Element id Device.lotNumber Short description Lot number of manufacture Definition The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10). Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
serialNumber		0..1	string	Element id Device.serialNumber Short description Serial number assigned by the manufacturer Definition The serial number assigned by the organization when the device was manufactured. In the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21). Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
deviceName		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.deviceName Short description The name of the device as given by the manufacturer Definition This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.deviceName.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.deviceName.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.deviceName.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
name		1..1	string	There are no (further) constraints on this element Element id Device.deviceName.name Short description The name of the device Alternate names Σ Definition The name of the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
type		1..1	codeBinding	There are no (further) constraints on this element Element id Device.deviceName.type Short description udi-label-name \| user-friendly-name \| patient-reported-name \| manufacturer-name \| model-name \| other Definition The type of deviceName. UDILabelName \| UserFriendlyName \| PatientReportedName \| ManufactureDeviceName \| ModelName. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding The type of name the device is referred by. DeviceNameType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].code
modelNumber		0..1	string	There are no (further) constraints on this element Element id Device.modelNumber Short description The model number for the device Definition The model number for the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .softwareName (included as part)
partNumber		0..1	string	There are no (further) constraints on this element Element id Device.partNumber Short description The part number of the device Definition The part number of the device. Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
type		0..1	CodeableConceptBinding	Element id Device.type Short description ProductType Alternate names ProductType Definition The code of the type of product. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Codes to identify medical devices. ProductType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.3 HdBe-MedicalDevice: MedicalDevice.Product.ProductType
specialization		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.specialization Short description The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication Definition The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.specialization.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.specialization.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.specialization.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
systemType		1..1	CodeableConcept	There are no (further) constraints on this element Element id Device.specialization.systemType Short description The standard that is used to operate and communicate Alternate names Σ Definition The standard that is used to operate and communicate. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
version		0..1	string	There are no (further) constraints on this element Element id Device.specialization.version Short description The version of the standard that is used to operate and communicate Definition The version of the standard that is used to operate and communicate. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x]
version		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.version Short description The actual design of the device or software version running on the device Definition The actual design of the device or software version running on the device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.version.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.version.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.version.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
type		0..1	CodeableConcept	There are no (further) constraints on this element Element id Device.version.type Short description The type of the device version Alternate names Σ Definition The type of the device version. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
component		0..1	Identifier	There are no (further) constraints on this element Element id Device.version.component Short description A single component of the device version Definition A single component of the device version. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.what[x]
value		1..1	string	There are no (further) constraints on this element Element id Device.version.value Short description The version text Definition The version text. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
property		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.property Short description The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties Definition The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Device.property.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.property.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.property.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
type		1..1	CodeableConcept	There are no (further) constraints on this element Element id Device.property.type Short description Code that specifies the property DeviceDefinitionPropetyCode (Extensible) Definition Code that specifies the property DeviceDefinitionPropetyCode (Extensible). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
valueQuantity	I	0..*	Quantity	There are no (further) constraints on this element Element id Device.property.valueQuantity Short description Property value as a quantity Definition Property value as a quantity. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Quantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
valueCode		0..*	CodeableConcept	There are no (further) constraints on this element Element id Device.property.valueCode Short description Property value as a code, e.g., NTP4 (synced to NTP) Definition Property value as a code, e.g., NTP4 (synced to NTP). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
patient	I	0..1	Reference(Patient \| HdBe-Patient)	Element id Device.patient Short description Patient to whom Device is affixed Definition Patient information, If the device is affixed to a person. Requirements If the device is implanted in a patient, then need to associate the device to the patient. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| HdBe-Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.subject[x] rim: .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT] w5: FiveWs.subject
owner	I	0..1	Reference(Organization)	There are no (further) constraints on this element Element id Device.owner Short description Organization responsible for device Definition An organization that is responsible for the provision and ongoing maintenance of the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.source rim: .playedRole[typeCode=OWN].scoper
contact	I	0..*	ContactPoint	There are no (further) constraints on this element Element id Device.contact Short description Details for human/organization for support Definition Contact details for an organization or a particular human that is responsible for the device. Comments used for troubleshooting etc. Data type ContactPoint Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` cpt-2: A system is required if a value is provided. `value.empty() or system.exists()` Mappings rim: n/a v2: XTN rim: TEL servd: ContactPoint w5: FiveWs.source rim: .scopedRole[typeCode=CON].player
location	I	0..1	Reference(Location)	There are no (further) constraints on this element Element id Device.location Short description Where the device is found Definition The place where the device can be found. Requirements Device.location can be used to track device location. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.where[x] rim: .playedRole[typeCode=LOCE].scoper
url		0..1	uri	There are no (further) constraints on this element Element id Device.url Short description Network address to contact device Definition A network address on which the device may be contacted directly. Comments If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.where[x] rim: .telecom
note		0..1	Annotation	There are no (further) constraints on this element Element id Device.note Short description Device notes and comments Definition Descriptive information, usage information or implantation information that is not captured in an existing element. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act rim: .text
id		0..1	string	There are no (further) constraints on this element Element id Device.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id Device.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id Device.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text	Σ	1..1	markdown	Element id Device.note.text Short description ProductDescription Alternate names ProductOmschrijving Definition Textual description of the product. Comments Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/ Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text zib-medicaldevice-v3.3.1-2020EN: NL-CM:10.1.13 HdBe-MedicalDevice: MedicalDevice.ProductDescription
safety	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id Device.safety Short description Safety Characteristics of Device Definition Provides additional safety characteristics about a medical device. For example devices containing latex. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD rim: NA
parent	I	0..1	Reference(Device)	There are no (further) constraints on this element Element id Device.parent Short description The parent device Definition The parent device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

Mapping FHIR profile to CBB

Path	map	CBB
Device	MedicalDevice.Product	HdBe-MedicalDevice
Device.identifier	MedicalDevice.Product.ProductId	HdBe-MedicalDevice
Device.udiCarrier	MedicalDevice.Product.ProductId	HdBe-MedicalDevice
Device.type	MedicalDevice.Product.ProductType	HdBe-MedicalDevice
Device.note.text	MedicalDevice.ProductDescription	HdBe-MedicalDevice

zib MedicalDevice.Product difference

Concept	Category	Description
Description	textual	Replaced duplicat CBB concept description with somehting specific for the Device profile.
`device`	textual	Removed Instructions as they are not applicable and described in the added to the specific elements.
`identifier`	slicing	Removed slicing on identifier because the CBB did not define multiple CodeSystems in the definition of the productId.
`identifier`	cardinality	Relaxed the cardinality from 0..1 to 0..* as multiple product identifications codes could be possible.
`Identifier`	textual	Added guidance on the placement of productId codes.
`udiCarrier`	slicing	Removed slicing on identifier because the CBB did not define multiple CodeSystems in the definition of the productId.
`udiCarrier`	textual	Added guidance on the placement of productId codes.
`type`	terminology	Loosened the binding strength from required to extensible (zib issue #1536).

Terminology Bindings

Path	Name	Strength	URL	ConceptMap
DeviceUseStatement.bodySite	Location	required	https://fhir.healthdata.be/ValueSet/Location	No bound ConceptMap
Device.type	ProductType	extensible	https://fhir.healthdata.be/ValueSet/ProductType	No bound ConceptMap