3.5. Retrieve MedMij Core - Treatment objective (zib2020/R4)
3.5.1. Overview
| Id | 900000103 |
| Data service name without version (English) | Retrieve MedMij Core - Treatment objective (zib2020/R4) |
| Data service name without version (Dutch) | Verzamelen MedMij Core - Behandeldoel (zib2020/R4) |
| Data service version | 1.0.0-rc.2 |
| System role(s) | MMC-TOR-zib2020/R4-rc.2 (PHR) MMC-TOB-zib2020/R4-rc.2 (XIS) |
| Used in Implementation Guide(s) | Dental Care |
3.5.2. Functional model
| CIM | zib TreatmentObjective |
| Functional version | 3.2(2020) |
The functional model can be found on ART-DECOR. Moreover, the following concepts from the Base Logical Model are applicable:
| Concept id | Logical element |
|---|---|
| medmij-core-dataelement-115 | IdentificationNumber |
| medmij-core-dataelement-116 | Patient |
| medmij-core-dataelement-117 | HealthcareProvider |
| medmij-core-dataelement-119 | EffectiveDateTime |
| medmij-core-dataelement-123 | CareType |
The corresponding mappings to FHIR of these concepts are provided below.
3.5.3. Technical specification
| FHIR profile(s) | http://nictiz.nl/fhir/StructureDefinition/nl-core-TreatmentObjective http://nictiz.nl/fhir/StructureDefinition/nl-core-MedicalDevice http://nictiz.nl/fhir/StructureDefinition/nl-core-MedicalDevice.Product |
| FHIR package | nictiz.fhir.nl.r4.nl-core version 0.12.0-beta.4 or compatible |
| FHIR version | R4 |
| Search request | GET [base]/Goal Specific guidance on the response message is provided below. |
| Must Support | Goal
|
| CapabilityStatement(s) | Treatment Objective (Retrieve) Treatment Objective (Serve) |
The FHIR profiles are included below.
| NlcoreTreatmentObjective (Goal) | C | ZibTreatmentObjective | |
| id | Σ | 0..1 | id |
| meta | Σ | 0..1 | Meta |
| implicitRules | Σ ?! | 0..1 | uri |
| language | 0..1 | codeBinding | |
| text | 0..1 | Narrative | |
| contained | 0..* | Resource | |
| extension | C | 0..* | Extension |
| modifierExtension | ?! C | 0..* | Extension |
| identifier | 0..* | Identifier | |
| lifecycleStatus | Σ ?! | 1..1 | codeBinding |
| achievementStatus | Σ | 0..1 | CodeableConceptBinding |
| category | Σ | 0..* | CodeableConcept |
| priority | Σ | 0..1 | CodeableConceptBinding |
| description | Σ | 1..1 | CodeableConcept |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| coding | Σ | 0..* | Coding |
| text | Σ | 0..1 | string |
| subject | Σ C | 1..1 | Reference(Group | Organization | Patient | NlcorePatient) |
| start[x] | Σ | 0..1 | |
| startCodeableConcept | CodeableConcept | ||
| startDate | date | ||
| target | C | 0..* | BackboneElement |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| measure | Σ C | 0..1 | CodeableConceptBinding |
| detail[x] | Σ C | 0..1 | |
| detailBoolean | boolean | ||
| detailInteger | integer | ||
| detailQuantity | Quantity | ||
| detailRange | Range | ||
| detailRatio | Ratio | ||
| detailString | string | ||
| detailCodeableConcept | Σ C | 0..1 | CodeableConceptBinding |
| due[x] | Σ | 0..1 | |
| dueDuration | Duration | ||
| dueDate | Σ | 0..1 | date |
| statusDate | Σ | 0..1 | date |
| statusReason | 0..1 | string | |
| expressedBy | Σ C | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) |
| addresses | C | 0..1 | Reference(Condition | MedicationStatement | NutritionOrder | Observation | RiskAssessment | ServiceRequest | NlcoreProblem) |
| note | 0..1 | Annotation | |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| author[x] | Σ | 0..1 | |
| authorReference | Reference(Organization | Patient | Practitioner | RelatedPerson) | ||
| authorString | string | ||
| time | Σ | 0..1 | dateTime |
| text | Σ | 1..1 | markdown |
| outcomeCode | 0..* | CodeableConcept | |
| outcomeReference | C | 0..* | Reference(Observation) |
| Mapping name | Concept id | FHIR element | Comments |
|---|---|---|---|
| zib-functionalormentalstatus-v3.2-2020EN | NL-CM:4.26.1 | Goal | FunctionalOrMentalStatus |
| zib-functionalormentalstatus-v3.2-2020EN | NL-CM:4.26.2 | Goal.description.text | StatusName (implicit, main mapping is on Goal.target.measure) |
| zib-functionalormentalstatus-v3.2-2020EN | NL-CM:4.26.3 | Goal.description.text | StatusValue (implicit, main mapping is on Goal.target.detailCodeableConcept) |
| zib-functionalormentalstatus-v3.2-2020EN | NL-CM:4.26.2 | Goal.target.measure | StatusName |
| zib-functionalormentalstatus-v3.2-2020EN | NL-CM:4.26.3 | Goal.target.detail[x]:detailCodeableConcept | StatusValue |
| zib-functionalormentalstatus-v3.2-2020EN | NL-CM:4.26.6 | Goal.target.due[x]:dueDate | StatusDate |
| zib-functionalormentalstatus-v3.2-2020EN | NL-CM:4.26.4 | Goal.note.text | Comment |
| zib-treatmentobjective-v3.2-2020EN | NL-CM:13.5.1 | Goal | TreatmentObjective |
| zib-treatmentobjective-v3.2-2020EN | NL-CM:13.5.3 | Goal | DesiredHealthCondition |
| zib-treatmentobjective-v3.2-2020EN | NL-CM:13.5.5 | Goal.description.text | DesiredHealthcareResult |
| zib-treatmentobjective-v3.2-2020EN | NL-CM:13.5.4 | Goal.addresses | Problem |
--- We have skipped the narrative for better readability of the resource ---
</text>
</telecom>
</contact>
<description value="The treatment objective describes the desired result of the treatment/interventions in terms of the patient’s diagnosed problem. The objective and target date are entered in addition to the target value. Comparing the healthcare results to the treatment objective provides insight into the effectivity of the treatment/interventions." />
<purpose value="A derived profile from [zib-TreatmentObjective](http://nictiz.nl/fhir/StructureDefinition/zib-TreatmentObjective) to provide a version better suited for implementation purposes. This profile augments the base profile with elements found in the various use cases that have adopted the zib." />
<copyright value="Copyright and related rights waived via CC0, https://creativecommons.org/publicdomain/zero/1.0/. This does not apply to information from third parties, for example a medical terminology system. The implementer alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize third party IP in connection with the specification or otherwise." />
</mapping>
</mapping>
<definition value="Describes the intended objective(s) for a patient, group or organization care, for example, weight loss, restoring an activity of daily living, obtaining herd immunity via immunization, meeting a process improvement objective, etc." />
<comment value="On the zib level, zib TreatmentObjective uses a reference to zib FunctionalOrMentalStatus (in future context). In FHIR the concepts from FunctionalOrMentalStatus are represented directly in the the Goal resource, with the exception of the reference to zib MedicalDevice; this reference is represented by the core extension resource-pertainsToGoal in the [nl-core-MedicalDevice](http://nictiz.nl/fhir/StructureDefinition/nl-core-MedicalDevice) profile." />
</base>
<human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" />
</constraint>
<human value="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" />
<expression value="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()" />
<xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))" />
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" />
<xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" />
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a security label" />
</constraint>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." />
</extension>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." />
<comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation." />
</base>
</extension>
</type>
</element>
<definition value="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." />
</base>
</type>
</constraint>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
<isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation" />
</element>
<comment value="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)." />
</base>
</type>
</constraint>
</extension>
</extension>
</extension>
</binding>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" />
</mapping>
</element>
<definition value="Business identifiers assigned to this goal by the performer or other systems which remain constant as the resource is updated and propagates from server to server." />
<comment value="This is a business identifier, not a resource identifier (see [discussion](resource.html#identifiers)). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number." />
<requirements value="Allows identification of the goal as it is known by various participating systems and in a way that remains consistent across servers." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<short value="proposed | planned | accepted | active | on-hold | completed | cancelled | entered-in-error | rejected" />
<comment value="No zib concept can be mapped (implicitly) to this element. Unless `.lifecycleStatus` is explicitly recorded, TreatmentObjectives may assumed to be _active_." />
</base>
</type>
</constraint>
<isModifierReason value="This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid" />
</extension>
<description value="Codes that reflect the current state of a goal and whether the goal is still being targeted." />
</binding>
</mapping>
</mapping>
</mapping>
</element>
<short value="in-progress | improving | worsening | no-change | achieved | sustaining | not-achieved | no-progress | not-attainable" />
<definition value="Describes the progression, or lack thereof, towards the goal against the target." />
</base>
</type>
</constraint>
</extension>
<description value="Indicates the progression, or lack thereof, towards the goal against the target." />
</binding>
</mapping>
</element>
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</element>
<definition value="Identifies the mutually agreed level of importance associated with reaching/sustaining the goal." />
<comment value="Extensions are available to track priorities as established by each participant (i.e. Priority from the patient's perspective, different practitioners' perspectives, family member's perspectives)\n\nThe ordinal extension on Coding can be used to convey a numerically comparable ranking to priority. (Keep in mind that different coding systems may use a "low value=important"." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</element>
<definition value="Human-readable and/or coded description of a specific desired objective of care, such as "control blood pressure" or "negotiate an obstacle course" or "dance with child at wedding"." />
<requirements value="Without a description of what's trying to be achieved, element has no purpose." />
</base>
</type>
</constraint>
</extension>
<description value="Codes providing the details of a particular goal. This will generally be system or implementation guide-specific. In many systems, only the text element will be used." />
</binding>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true." />
<requirements value="Allows for alternative encodings within a code system, and translations to other code systems." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</extension>
<comment value="This element is used to represent the zib concept DesiredHealthcareResult (NL-CM:13.5.5) if present. If instead DesiredHealthCondition::FunctionalOrMentalStatus is used (NL-CM:13.5.3), this element should be populated with a textual representation containg at least FunctionalOrMentalStatus.StatusName (NL-CM:4.26.2) and FunctionalOrMentalStatus.StatusValue (NL-CM:4.26.3).\n\nReceiving systems that need to map back to the zib could look at `.target.measure` and `.target.detailCodeableConcept`; if these elements are absent, this element represents zib concept DesiredHealthcareResult. If present, the discrete data can be found in the aforementioned elements." />
<requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Identifies the patient, group or organization for whom the goal is being established." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<requirements value="Goals can be established prior to there being an intention to start pursuing them; e.g. Goals for post-surgical recovery established prior to surgery." />
</base>
</type>
</type>
</constraint>
</extension>
</binding>
</mapping>
</element>
<comment value="When multiple targets are present for a single goal instance, all targets must be met for the overall goal to be met." />
<requirements value="Allows the progress of the goal to be monitored against an observation or due date. Target is 0..* to support Observations with multiple components, such as blood pressure goals with both a systolic and diastolic target." />
</base>
</type>
</constraint>
<xpath value="(exists(f:*[starts-with(local-name(.), 'detail')]) and exists(f:measure)) or not(exists(f:*[starts-with(local-name(.), 'detail')]))" />
</constraint>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
<definition value="Coded description of the functional or mental status or limitation.\nCode systems used include:\n\n* SNOMED CT\n* ICF (International Classification of Functioning, Disability and Health)\n* NOC (Nursing Outcomes Classification)\n* OMAHA" />
</base>
</type>
</constraint>
</extension>
<description value="Codes to identify the value being tracked, e.g. body weight, blood pressure, or hemoglobin A1c level." />
<valueSet value="http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.121.11.4--20200901000000" />
</binding>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="The target value of the focus to be achieved to signify the fulfillment of the goal, e.g. 150 pounds, 7.0%. Either the high or low or both values of the range can be specified. When a low value is missing, it indicates that the goal is achieved at any focus value at or below the high value. Similarly, if the high value is missing, it indicates that the goal is achieved at any focus value at or above the low value." />
<comment value="A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Goal.target.measure defines a coded value." />
</base>
</type>
</type>
</type>
</type>
</type>
</type>
</type>
</constraint>
</extension>
<description value="Codes to identify the target value of the focus to be achieved to signify the fulfillment of the goal." />
</binding>
</element>
<definition value="The extent to which the patient is limited by the functional or mental condition.\n\nIf both the status name and the status value are recorded in code, then both values must come from the same code system. If the patient uses a medical device, the evaluation of the extent of the limitation will take place without this aid.\n\nThe answer codes must be selected from the subselection of the code system corresponding with the request in accordance with the rules applicable to that system." />
<comment value="A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Goal.target.measure defines a coded value." />
</base>
</type>
</constraint>
</extension>
<description value="Codes to identify the target value of the focus to be achieved to signify the fulfillment of the goal." />
<valueSet value="http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.121.11.3--20200901000000" />
</binding>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="Indicates either the date or the duration after start by which the goal should be met." />
</base>
</type>
</type>
</constraint>
</mapping>
</element>
<definition value="Indicates the date of the DesiredHealthCondition by which the goal should be met." />
<comment value="Please note that this definition differs from that of zib FunctionalOrMentalStatus. However, [ZIB-1657](https://nictiz.atlassian.net/browse/ZIB-1657) clarifies that in the current context, the StatusDate should be interpreted this way." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Identifies when the current status. I.e. When initially created, when achieved, when cancelled, etc." />
</base>
</type>
</constraint>
</mapping>
</element>
<comment value="This will typically be captured for statuses such as rejected, on-hold or cancelled, but could be present for others." />
</base>
</type>
</constraint>
</element>
<comment value="This is the individual responsible for establishing the goal, not necessarily who recorded it. (For that, use the Provenance resource.)." />
</base>
</type>
</constraint>
</mapping>
</element>
<requirements value="Allows specific goals to explicitly linked to the concerns they're dealing with - makes the goal more understandable." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<comment value="May be used for progress notes, concerns or other related information that doesn't actually describe the goal itself." />
<requirements value="There's a need to capture information about the goal that doesn't actually describe the goal." />
</base>
</type>
</constraint>
</mapping>
<map value=".inboundRelationship[typeCode=SUBJ].source[classCode=OBS, moodCode=EVN, code="annotation"].value" />
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<comment value="Organization is used when there's no need for specific attribution as to who made the comment." />
</base>
</type>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Identifies the change (or lack of change) at the point when the status of the goal is assessed." />
</base>
</type>
</constraint>
</extension>
<description value="The result of the goal; e.g. "25% increase in shoulder mobility", "Anxiety reduced to moderate levels". "15 kg weight loss sustained over 6 months"." />
</binding>
</element>
<comment value="The goal outcome is independent of the outcome of the related activities. For example, if the Goal is to achieve a target body weight of 150 lb and a care plan activity is defined to diet, then the care plan’s activity outcome could be calories consumed whereas goal outcome is an observation for the actual body weight measured." />
</base>
</type>
</constraint>
</element>
</snapshot>
<comment value="On the zib level, zib TreatmentObjective uses a reference to zib FunctionalOrMentalStatus (in future context). In FHIR the concepts from FunctionalOrMentalStatus are represented directly in the the Goal resource, with the exception of the reference to zib MedicalDevice; this reference is represented by the core extension resource-pertainsToGoal in the [nl-core-MedicalDevice](http://nictiz.nl/fhir/StructureDefinition/nl-core-MedicalDevice) profile." />
</element>
</type>
</element>
</type>
</element>
</differential>
</StructureDefinition>
{
--- We have skipped the narrative for better readability of the resource ---
},
{
]
}
],
"description": "The treatment objective describes the desired result of the treatment/interventions in terms of the patient’s diagnosed problem. The objective and target date are entered in addition to the target value. Comparing the healthcare results to the treatment objective provides insight into the effectivity of the treatment/interventions.",
"purpose": "A derived profile from [zib-TreatmentObjective](http://nictiz.nl/fhir/StructureDefinition/zib-TreatmentObjective) to provide a version better suited for implementation purposes. This profile augments the base profile with elements found in the various use cases that have adopted the zib.",
"copyright": "Copyright and related rights waived via CC0, https://creativecommons.org/publicdomain/zero/1.0/. This does not apply to information from third parties, for example a medical terminology system. The implementer alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize third party IP in connection with the specification or otherwise.",
{
},
{
}
],
{
"definition": "Describes the intended objective(s) for a patient, group or organization care, for example, weight loss, restoring an activity of daily living, obtaining herd immunity via immunization, meeting a process improvement objective, etc.",
"comment": "On the zib level, zib TreatmentObjective uses a reference to zib FunctionalOrMentalStatus (in future context). In FHIR the concepts from FunctionalOrMentalStatus are represented directly in the the Goal resource, with the exception of the reference to zib MedicalDevice; this reference is represented by the core extension resource-pertainsToGoal in the [nl-core-MedicalDevice](http://nictiz.nl/fhir/StructureDefinition/nl-core-MedicalDevice) profile.",
"Behandeldoel",
"GewensteGezondheidstoestand",
"FunctioneleOfMentaleStatus",
"nl-core-TreatmentObjective"
],
},
{
},
{
"human": "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",
"expression": "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()",
"xpath": "not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
},
{
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
},
{
},
{
{
},
{
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
}
],
}
],
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
},
{
{
}
],
}
],
},
{
"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.",
},
],
{
}
],
},
{
"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.",
"comment": "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.",
},
],
{
}
],
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
},
{
"comment": "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).",
},
],
{
}
],
{
},
{
},
{
}
],
}
},
{
"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.",
"comment": "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.",
"narrative",
"html",
"xhtml",
"display"
],
},
],
{
}
],
]
},
{
"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.",
"comment": "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.",
"inline resources",
"anonymous resources",
"contained resources"
],
},
],
]
},
{
"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.",
"comment": "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.",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
]
},
{
"definition": "Business identifiers assigned to this goal by the performer or other systems which remain constant as the resource is updated and propagates from server to server.",
"comment": "This is a business identifier, not a resource identifier (see [discussion](resource.html#identifiers)). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.",
"requirements": "Allows identification of the goal as it is known by various participating systems and in a way that remains consistent across servers.",
},
],
{
}
],
]
},
{
"short": "proposed | planned | accepted | active | on-hold | completed | cancelled | entered-in-error | rejected",
"comment": "No zib concept can be mapped (implicitly) to this element. Unless `.lifecycleStatus` is explicitly recorded, TreatmentObjectives may assumed to be _active_.",
},
],
{
}
],
"isModifierReason": "This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid",
{
}
],
"description": "Codes that reflect the current state of a goal and whether the goal is still being targeted.",
},
{
},
{
},
{
}
]
},
{
"short": "in-progress | improving | worsening | no-change | achieved | sustaining | not-achieved | no-progress | not-attainable",
},
],
{
}
],
{
}
],
},
]
},
{
},
],
{
}
],
{
}
],
},
]
},
{
"definition": "Identifies the mutually agreed level of importance associated with reaching/sustaining the goal.",
"comment": "Extensions are available to track priorities as established by each participant (i.e. Priority from the patient's perspective, different practitioners' perspectives, family member's perspectives)\n\nThe ordinal extension on Coding can be used to convey a numerically comparable ranking to priority. (Keep in mind that different coding systems may use a \"low value=important\".",
},
],
{
}
],
{
}
],
},
]
},
{
"definition": "Human-readable and/or coded description of a specific desired objective of care, such as \"control blood pressure\" or \"negotiate an obstacle course\" or \"dance with child at wedding\".",
},
],
{
}
],
{
}
],
"description": "Codes providing the details of a particular goal. This will generally be system or implementation guide-specific. In many systems, only the text element will be used.",
},
{
},
{
},
{
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
{
}
],
"comment": "This element is used to represent the zib concept DesiredHealthcareResult (NL-CM:13.5.5) if present. If instead DesiredHealthCondition::FunctionalOrMentalStatus is used (NL-CM:13.5.3), this element should be populated with a textual representation containg at least FunctionalOrMentalStatus.StatusName (NL-CM:4.26.2) and FunctionalOrMentalStatus.StatusValue (NL-CM:4.26.3).\n\nReceiving systems that need to map back to the zib could look at `.target.measure` and `.target.detailCodeableConcept`; if these elements are absent, this element represents zib concept DesiredHealthcareResult. If present, the discrete data can be found in the aforementioned elements.",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"GewenstZorgresultaat"
],
},
],
{
}
],
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "Identifies the patient, group or organization for whom the goal is being established.",
},
{
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Group",
"http://hl7.org/fhir/StructureDefinition/Organization",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Patient"
]
}
],
{
}
],
{
},
{
},
{
},
{
}
]
},
{
"requirements": "Goals can be established prior to there being an intention to start pursuing them; e.g. Goals for post-surgical recovery established prior to surgery.",
},
],
{
}
],
{
}
],
},
]
},
{
"comment": "When multiple targets are present for a single goal instance, all targets must be met for the overall goal to be met.",
"requirements": "Allows the progress of the goal to be monitored against an observation or due date. Target is 0..* to support Observations with multiple components, such as blood pressure goals with both a systolic and diastolic target.",
},
],
"gol-1"
],
{
},
{
"xpath": "(exists(f:*[starts-with(local-name(.), 'detail')]) and exists(f:measure)) or not(exists(f:*[starts-with(local-name(.), 'detail')]))"
}
],
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"definition": "Coded description of the functional or mental status or limitation.\nCode systems used include:\n\n* SNOMED CT\n* ICF (International Classification of Functioning, Disability and Health)\n* NOC (Nursing Outcomes Classification)\n* OMAHA",
"StatusNaam"
],
},
],
"gol-1"
],
{
}
],
{
}
],
"description": "Codes to identify the value being tracked, e.g. body weight, blood pressure, or hemoglobin A1c level.",
"valueSet": "http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.121.11.4--20200901000000"
},
{
}
]
},
{
},
"definition": "The target value of the focus to be achieved to signify the fulfillment of the goal, e.g. 150 pounds, 7.0%. Either the high or low or both values of the range can be specified. When a low value is missing, it indicates that the goal is achieved at any focus value at or below the high value. Similarly, if the high value is missing, it indicates that the goal is achieved at any focus value at or above the low value.",
"comment": "A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Goal.target.measure defines a coded value.",
},
{
},
{
},
{
},
{
},
{
},
{
},
{
}
],
"gol-1"
],
{
}
],
{
}
],
"description": "Codes to identify the target value of the focus to be achieved to signify the fulfillment of the goal."
}
},
{
"definition": "The extent to which the patient is limited by the functional or mental condition.\n\nIf both the status name and the status value are recorded in code, then both values must come from the same code system. If the patient uses a medical device, the evaluation of the extent of the limitation will take place without this aid.\n\nThe answer codes must be selected from the subselection of the code system corresponding with the request in accordance with the rules applicable to that system.",
"comment": "A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Goal.target.measure defines a coded value.",
"StatusWaarde"
],
},
],
"gol-1"
],
{
}
],
{
}
],
"description": "Codes to identify the target value of the focus to be achieved to signify the fulfillment of the goal.",
"valueSet": "http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.121.11.3--20200901000000"
},
{
}
]
},
{
},
"definition": "Indicates either the date or the duration after start by which the goal should be met.",
},
],
{
}
],
]
},
{
"comment": "Please note that this definition differs from that of zib FunctionalOrMentalStatus. However, [ZIB-1657](https://nictiz.atlassian.net/browse/ZIB-1657) clarifies that in the current context, the StatusDate should be interpreted this way.",
"StatusDatum"
],
},
],
{
}
],
{
},
{
}
]
},
{
"definition": "Identifies when the current status. I.e. When initially created, when achieved, when cancelled, etc.",
},
],
{
}
],
]
},
{
"comment": "This will typically be captured for statuses such as rejected, on-hold or cancelled, but could be present for others.",
},
],
{
}
],
},
{
"comment": "This is the individual responsible for establishing the goal, not necessarily who recorded it. (For that, use the Provenance resource.).",
},
{
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson"
]
}
],
{
}
],
]
},
{
"requirements": "Allows specific goals to explicitly linked to the concerns they're dealing with - makes the goal more understandable.",
"Probleem"
],
},
{
"http://hl7.org/fhir/StructureDefinition/Condition",
"http://hl7.org/fhir/StructureDefinition/Observation",
"http://hl7.org/fhir/StructureDefinition/MedicationStatement",
"http://hl7.org/fhir/StructureDefinition/NutritionOrder",
"http://hl7.org/fhir/StructureDefinition/ServiceRequest",
"http://hl7.org/fhir/StructureDefinition/RiskAssessment",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Problem"
]
}
],
{
}
],
{
},
{
},
{
}
]
},
{
"comment": "May be used for progress notes, concerns or other related information that doesn't actually describe the goal itself.",
"requirements": "There's a need to capture information about the goal that doesn't actually describe the goal.",
},
],
{
}
],
{
},
{
"map": ".inboundRelationship[typeCode=SUBJ].source[classCode=OBS, moodCode=EVN, code=\"annotation\"].value"
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"comment": "Organization is used when there's no need for specific attribution as to who made the comment.",
},
{
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson",
"http://hl7.org/fhir/StructureDefinition/Organization"
]
},
{
}
],
{
}
],
{
},
{
}
]
},
{
},
],
{
}
],
]
},
{
"Toelichting"
],
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "Identifies the change (or lack of change) at the point when the status of the goal is assessed.",
},
],
{
}
],
{
}
],
"description": "The result of the goal; e.g. \"25% increase in shoulder mobility\", \"Anxiety reduced to moderate levels\". \"15 kg weight loss sustained over 6 months\".",
}
},
{
"comment": "The goal outcome is independent of the outcome of the related activities. For example, if the Goal is to achieve a target body weight of 150 lb and a care plan activity is defined to diet, then the care plan’s activity outcome could be calories consumed whereas goal outcome is an observation for the actual body weight measured.",
},
],
{
}
],
}
]
},
{
"comment": "On the zib level, zib TreatmentObjective uses a reference to zib FunctionalOrMentalStatus (in future context). In FHIR the concepts from FunctionalOrMentalStatus are represented directly in the the Goal resource, with the exception of the reference to zib MedicalDevice; this reference is represented by the core extension resource-pertainsToGoal in the [nl-core-MedicalDevice](http://nictiz.nl/fhir/StructureDefinition/nl-core-MedicalDevice) profile.",
"nl-core-TreatmentObjective"
]
},
{
{
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Group",
"http://hl7.org/fhir/StructureDefinition/Organization",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Patient"
]
}
]
},
{
{
"http://hl7.org/fhir/StructureDefinition/Condition",
"http://hl7.org/fhir/StructureDefinition/Observation",
"http://hl7.org/fhir/StructureDefinition/MedicationStatement",
"http://hl7.org/fhir/StructureDefinition/NutritionOrder",
"http://hl7.org/fhir/StructureDefinition/ServiceRequest",
"http://hl7.org/fhir/StructureDefinition/RiskAssessment",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Problem"
]
}
]
}
]
}
}
| Mapping name | Concept id | FHIR element | Comments |
|---|---|---|---|
| zib-anatomicallocation-v1.0-2020EN | NL-CM:20.7.4 | DeviceUseStatement.bodySite | Location |
| zib-functionalormentalstatus-v3.2-2020EN | NL-CM:4.26.5 | DeviceUseStatement.extension:treatmentObjective.value[x] | Reversed reference for zib FunctionalOrMentalStatus.MedicalDevice, when using zib FunctionalOrMentalStatus in the context of zib TreatmentObjective |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.1 | DeviceUseStatement | MedicalDevice |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.9 | DeviceUseStatement.extension:healthProfessional.value[x] | HealthProfessional |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.8 | DeviceUseStatement.extension:location.value[x] | Location |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.11 | DeviceUseStatement.status | StartDate (implicit, main mapping is on DeviceUseStatement.timingPeriod.start) |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.14 | DeviceUseStatement.status | EndDate (implicit, main mapping is on DeviceUseStatement.timingPeriod.end) |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.11 | DeviceUseStatement.timing[x]:timingPeriod.start | StartDate |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.14 | DeviceUseStatement.timing[x]:timingPeriod.end | EndDate |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.7 | DeviceUseStatement.reasonReference:indication | Indication |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.15 | DeviceUseStatement.bodySite | AnatomicalLocation |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.10 | DeviceUseStatement.note.text | Comment |
| zib-procedure-v5.2-2020EN | NL-CM:14.1.7 | DeviceUseStatement.derivedFrom:procedure-request | Reversed reference for zib Procedure.MedicalDevice |
| zib-procedure-v5.2-2020EN | NL-CM:14.1.7 | DeviceUseStatement.derivedFrom:procedure-event | Reversed reference for zib Procedure.MedicalDevice |
| zib-stoma-v3.3-2020EN | NL-CM:5.2.3 | DeviceUseStatement.reasonReference:stoma | Reversed reference for zib Stoma.StomaMaterial |
--- We have skipped the narrative for better readability of the resource ---
</text>
</telecom>
</contact>
<description value="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." />
<purpose value="A derived profile from [zib-MedicalDevice](http://nictiz.nl/fhir/StructureDefinition/zib-MedicalDevice) to provide a version better suited for implementation purposes. This profile augments the base profile with elements found in the various use cases that have adopted the zib." />
<copyright value="Copyright and related rights waived via CC0, https://creativecommons.org/publicdomain/zero/1.0/. This does not apply to information from third parties, for example a medical terminology system. The implementer alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize third party IP in connection with the specification or otherwise." />
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
<definition value="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." />
</base>
<human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" />
</constraint>
<human value="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" />
<expression value="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()" />
<xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))" />
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" />
<xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" />
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a security label" />
</constraint>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." />
</extension>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." />
<comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation." />
</base>
</extension>
</type>
</element>
<definition value="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." />
</base>
</type>
</constraint>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
<isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation" />
</element>
<comment value="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)." />
</base>
</type>
</constraint>
</extension>
</extension>
</extension>
</binding>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
</extension>
</extension>
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<comment value="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." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="The health professional involved in the indication for use of the medical device implant." />
<comment value="Each occurrence of the zib HealthProfessional is normally represented by _two_ FHIR resources: a PractitionerRole resource (instance of [nl-core-HealthProfessional-PractitionerRole](http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-PractitionerRole)) and a Practitioner resource (instance of [nl-core-HealthProfessional-Practitioner](http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-Practitioner)). 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. Receiving systems can then retrieve the reference to the Practitioner resource from that PractitionerRole instance.\n\nIn rare circumstances, there is only a Practitioner instance, in which case it is that instance which will be referenced here. However, since this should be the exception, the nl-core-HealthProfessional-Practitioner profile is not explicitly mentioned as a target profile." />
</base>
<targetProfile value="http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-PractitionerRole" />
</type>
</constraint>
</mapping>
</mapping>
</element>
</extension>
</extension>
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<comment value="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." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="The healthcare provider at which use of the medical device was initiated or where the aid was implanted." />
<comment value="Please note that this zib concept (Location::HealthcareProvider) is also mapped on the `Procedure.location` element in profile [nl-core-Procedure-event](http://nictiz.nl/fhir/StructureDefinition/nl-core-Procedure-event). The reason for this is that this zib concept aligns with the Location::HealthcareProvider concept in zib Procedure (NL-CM:14.1.5), but only for the situation that the Procedure is about placing the implant which is described using this instance of zib MedicalDevice. In this situation, the current extension is redundant and it is advised to only use `Procedure.location` in profile nl-core-Procedure-event to represent the Location concept." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Indicates that the resource is related to either the measurement, achievement or progress towards the referenced goal. For example, a Procedure to exercise pertainsToGoal of losing weight." />
<comment value="This extension is limited to subject-specific activity-related resources (events & intents). I.e. This can't be put on Goal or Patient. This association isn't for the purpose of goal management, but for things such as noting that a particular observation result, prescription or other activity is pertinent to the achievement (or possibly non-achievement) of the referenced goal." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
</base>
</type>
</constraint>
</constraint>
</element>
<comment value="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." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/extensibility.html) for a list)." />
<comment value="Zib TreatmentObjective (represented by the Goal resource in FHIR) can use the data model of zib FunctionalOrMentalStatus to describe the desired treatment objective, which in turn may refer zib MedicalDevice to indicate the intent to use that device for reaching the treatment objective.\n\nIn FHIR, the modeling deviates somewhat from this approach:\n\n* Both zib TreatmentObjective and the desired zib FunctionalOrMentalStatus are represented using the [nl-core-TreatmentObjective](http://nictiz.nl/fhir/nl-core-TreatmentObjective) profile on the Goal resource.\n* The reference from TreatmentObjective::FunctionalOrMentalStatus::MedicalDevice is in the opposite direction, to the Goal resource.\n\nThis extension may thus be used to represent the link zib TreatmentObjective -> zib FunctionalOrMentalStatus -> zib MedicalDevice. In this situation, it is expected that `DeviceUseStatement.status` is set to _intended_." />
</base>
</type>
</constraint>
</mapping>
<comment value="Reversed reference for zib FunctionalOrMentalStatus.MedicalDevice, when using zib FunctionalOrMentalStatus in the context of zib TreatmentObjective" />
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" />
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="A plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement." />
<requirements value="Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="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." />
<comment value="This element is implictly mapped to the zib concepts NL-CM:10.1.11 (StartDate) and NL-CM:10.1.14 (EndDate). Unless the status is explicitly recorded, the following guidance applies:\n\n* When StartDate is in the future, `.status` will usually be set to _intended_.\n* When StartDate is in the past and EndDate has a value and in the future or EndDate has no value, `.status` will usually be set to _active_.\n* When EndDate has a value and is in the past, `.status` will usually be set to _completed_." />
</base>
</type>
</constraint>
<isModifierReason value="This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid" />
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement." />
<comment value="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." />
</base>
</type>
</constraint>
</element>
<definition value="The procedure which has the purpose of placing this product in or on the body." />
<comment value="* Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.\n* Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents requested procedures, while slice `procedure-event` represents performed procedures." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="The procedure which has the purpose of placing this product in or on the body." />
<comment value="* Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.\n* Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents performed procedures, while slice `procedure-request` represents requested procedures." />
</base>
</type>
</constraint>
</mapping>
</element>
</discriminator>
</slicing>
</base>
</type>
</type>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="The start date of the first use or implant of the medical device. A "vague" date, such as only the year, is permitted." />
<comment value="If the low element is missing, the meaning is that the low boundary is not known." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The end date of the last use or explant of the medical device. A "vague" date, such as only the year, is permitted." />
<comment value="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." />
</base>
</type>
<meaningWhenMissing value="If the end of the period is missing, it means that the period is ongoing" />
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="Indicates another resource whose existence justifies this DeviceUseStatement." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Indicates another resource whose existence justifies this DeviceUseStatement." />
<comment value="Please note that on a functional level, zib Stoma references zib MedicalDevice, but in FHIR this direction is reversed." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
</extension>
</extension>
<comment value="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." />
<requirements value="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](null.html)." />
</base>
</type>
</constraint>
</extension>
<valueSet value="http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.121.11.11--20200901000000" />
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<comment value="Organization is used when there's no need for specific attribution as to who made the comment." />
</base>
</type>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</snapshot>
</element>
</element>
<comment value="Each occurrence of the zib HealthProfessional is normally represented by _two_ FHIR resources: a PractitionerRole resource (instance of [nl-core-HealthProfessional-PractitionerRole](http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-PractitionerRole)) and a Practitioner resource (instance of [nl-core-HealthProfessional-Practitioner](http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-Practitioner)). 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. Receiving systems can then retrieve the reference to the Practitioner resource from that PractitionerRole instance.\n\nIn rare circumstances, there is only a Practitioner instance, in which case it is that instance which will be referenced here. However, since this should be the exception, the nl-core-HealthProfessional-Practitioner profile is not explicitly mentioned as a target profile." />
<targetProfile value="http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-PractitionerRole" />
</type>
</element>
</element>
<comment value="Please note that this zib concept (Location::HealthcareProvider) is also mapped on the `Procedure.location` element in profile [nl-core-Procedure-event](http://nictiz.nl/fhir/StructureDefinition/nl-core-Procedure-event). The reason for this is that this zib concept aligns with the Location::HealthcareProvider concept in zib Procedure (NL-CM:14.1.5), but only for the situation that the Procedure is about placing the implant which is described using this instance of zib MedicalDevice. In this situation, the current extension is redundant and it is advised to only use `Procedure.location` in profile nl-core-Procedure-event to represent the Location concept." />
</type>
</element>
</element>
<comment value="Zib TreatmentObjective (represented by the Goal resource in FHIR) can use the data model of zib FunctionalOrMentalStatus to describe the desired treatment objective, which in turn may refer zib MedicalDevice to indicate the intent to use that device for reaching the treatment objective.\n\nIn FHIR, the modeling deviates somewhat from this approach:\n\n* Both zib TreatmentObjective and the desired zib FunctionalOrMentalStatus are represented using the [nl-core-TreatmentObjective](http://nictiz.nl/fhir/nl-core-TreatmentObjective) profile on the Goal resource.\n* The reference from TreatmentObjective::FunctionalOrMentalStatus::MedicalDevice is in the opposite direction, to the Goal resource.\n\nThis extension may thus be used to represent the link zib TreatmentObjective -> zib FunctionalOrMentalStatus -> zib MedicalDevice. In this situation, it is expected that `DeviceUseStatement.status` is set to _intended_." />
</type>
</element>
</type>
</element>
</type>
</element>
</type>
</element>
</type>
</element>
</type>
</element>
</type>
</element>
</type>
</element>
</differential>
</StructureDefinition>
{
--- We have skipped the narrative for better readability of the resource ---
},
{
]
}
],
"description": "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.",
"purpose": "A derived profile from [zib-MedicalDevice](http://nictiz.nl/fhir/StructureDefinition/zib-MedicalDevice) to provide a version better suited for implementation purposes. This profile augments the base profile with elements found in the various use cases that have adopted the zib.",
"copyright": "Copyright and related rights waived via CC0, https://creativecommons.org/publicdomain/zero/1.0/. This does not apply to information from third parties, for example a medical terminology system. The implementer alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize third party IP in connection with the specification or otherwise.",
{
},
{
},
{
},
{
},
{
}
],
{
"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.",
"MedischHulpmiddel",
"nl-core-MedicalDevice"
],
},
{
},
{
"human": "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",
"expression": "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()",
"xpath": "not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
},
{
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
},
{
},
{
{
},
{
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
}
],
}
],
{
},
{
},
{
},
{
}
]
},
{
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
},
{
{
}
],
}
],
},
{
"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.",
},
],
{
}
],
},
{
"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.",
"comment": "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.",
},
],
{
}
],
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
},
{
"comment": "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).",
},
],
{
}
],
{
},
{
},
{
}
],
}
},
{
"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.",
"comment": "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.",
"narrative",
"html",
"xhtml",
"display"
],
},
],
{
}
],
]
},
{
"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.",
"comment": "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.",
"inline resources",
"anonymous resources",
"contained resources"
],
},
],
]
},
{
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
{
},
{
}
],
"comment": "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.",
"extensions",
"user content"
],
},
{
"http://nictiz.nl/fhir/StructureDefinition/ext-MedicalDevice.HealthProfessional"
]
}
],
"ele-1"
],
{
},
{
}
],
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"xmlAttr"
],
"comment": "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.",
},
{
{
}
],
}
],
]
},
{
"definition": "The health professional involved in the indication for use of the medical device implant.",
"comment": "Each occurrence of the zib HealthProfessional is normally represented by _two_ FHIR resources: a PractitionerRole resource (instance of [nl-core-HealthProfessional-PractitionerRole](http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-PractitionerRole)) and a Practitioner resource (instance of [nl-core-HealthProfessional-Practitioner](http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-Practitioner)). 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. Receiving systems can then retrieve the reference to the Practitioner resource from that PractitionerRole instance.\n\nIn rare circumstances, there is only a Practitioner instance, in which case it is that instance which will be referenced here. However, since this should be the exception, the nl-core-HealthProfessional-Practitioner profile is not explicitly mentioned as a target profile.",
"Zorgverlener"
],
},
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-PractitionerRole"
]
}
],
{
}
],
{
},
{
}
]
},
{
{
},
{
}
],
"comment": "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.",
"extensions",
"user content"
],
},
{
"http://nictiz.nl/fhir/StructureDefinition/ext-MedicalDevice.Location"
]
}
],
"ele-1"
],
{
},
{
}
],
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"xmlAttr"
],
"comment": "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.",
},
{
{
}
],
}
],
]
},
{
"definition": "The healthcare provider at which use of the medical device was initiated or where the aid was implanted.",
"comment": "Please note that this zib concept (Location::HealthcareProvider) is also mapped on the `Procedure.location` element in profile [nl-core-Procedure-event](http://nictiz.nl/fhir/StructureDefinition/nl-core-Procedure-event). The reason for this is that this zib concept aligns with the Location::HealthcareProvider concept in zib Procedure (NL-CM:14.1.5), but only for the situation that the Procedure is about placing the implant which is described using this instance of zib MedicalDevice. In this situation, the current extension is redundant and it is advised to only use `Procedure.location` in profile nl-core-Procedure-event to represent the Location concept.",
"Locatie"
],
},
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthcareProvider"
]
}
],
{
}
],
{
},
{
}
]
},
{
"definition": "Indicates that the resource is related to either the measurement, achievement or progress towards the referenced goal. For example, a Procedure to exercise pertainsToGoal of losing weight.",
"comment": "This extension is limited to subject-specific activity-related resources (events & intents). I.e. This can't be put on Goal or Patient. This association isn't for the purpose of goal management, but for things such as noting that a particular observation result, prescription or other activity is pertinent to the achievement (or possibly non-achievement) of the referenced goal.",
"extensions",
"user content"
],
},
{
"http://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal"
]
}
],
"ele-1"
],
{
},
{
}
],
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
},
],
{
},
{
}
],
},
{
"xmlAttr"
],
"comment": "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.",
},
{
{
}
],
}
],
]
},
{
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/extensibility.html) for a list).",
"comment": "Zib TreatmentObjective (represented by the Goal resource in FHIR) can use the data model of zib FunctionalOrMentalStatus to describe the desired treatment objective, which in turn may refer zib MedicalDevice to indicate the intent to use that device for reaching the treatment objective.\n\nIn FHIR, the modeling deviates somewhat from this approach:\n\n* Both zib TreatmentObjective and the desired zib FunctionalOrMentalStatus are represented using the [nl-core-TreatmentObjective](http://nictiz.nl/fhir/nl-core-TreatmentObjective) profile on the Goal resource.\n* The reference from TreatmentObjective::FunctionalOrMentalStatus::MedicalDevice is in the opposite direction, to the Goal resource.\n\nThis extension may thus be used to represent the link zib TreatmentObjective -> zib FunctionalOrMentalStatus -> zib MedicalDevice. In this situation, it is expected that `DeviceUseStatement.status` is set to _intended_.",
},
{
"http://hl7.org/fhir/StructureDefinition/Goal",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-TreatmentObjective"
]
}
],
{
}
],
{
},
{
"comment": "Reversed reference for zib FunctionalOrMentalStatus.MedicalDevice, when using zib FunctionalOrMentalStatus in the context of zib TreatmentObjective"
}
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
]
},
{
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"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.",
"fulfills"
],
},
{
}
],
{
}
],
{
},
{
},
{
}
]
},
{
"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.",
"comment": "This element is implictly mapped to the zib concepts NL-CM:10.1.11 (StartDate) and NL-CM:10.1.14 (EndDate). Unless the status is explicitly recorded, the following guidance applies:\n\n* When StartDate is in the future, `.status` will usually be set to _intended_.\n* When StartDate is in the past and EndDate has a value and in the future or EndDate has no value, `.status` will usually be set to _active_.\n* When EndDate has a value and is in the past, `.status` will usually be set to _completed_.",
},
],
{
}
],
"isModifierReason": "This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid",
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
},
{
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Group",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Patient"
]
}
],
{
}
],
{
},
{
},
{
},
{
}
]
},
{
},
"definition": "Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement.",
"comment": "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.",
},
{
"http://hl7.org/fhir/StructureDefinition/ServiceRequest",
"http://hl7.org/fhir/StructureDefinition/Procedure",
"http://hl7.org/fhir/StructureDefinition/Claim",
"http://hl7.org/fhir/StructureDefinition/Observation",
"http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse",
"http://hl7.org/fhir/StructureDefinition/DocumentReference"
]
}
],
{
}
],
},
{
"comment": "* Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.\n* Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents requested procedures, while slice `procedure-event` represents performed procedures.",
"Verrichting"
],
},
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Procedure-request"
]
}
],
{
}
],
{
}
]
},
{
"comment": "* Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.\n* Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents performed procedures, while slice `procedure-request` represents requested procedures.",
"Verrichting"
],
},
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Procedure-event"
]
}
],
{
}
],
{
}
]
},
{
},
},
],
{
}
],
{
},
{
},
{
}
]
},
{
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"definition": "The start date of the first use or implant of the medical device. A \"vague\" date, such as only the year, is permitted.",
"BeginDatum"
],
},
],
"per-1"
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "The end date of the last use or explant of the medical device. A \"vague\" date, such as only the year, is permitted.",
"comment": "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.",
"EindDatum"
],
},
],
"per-1"
],
{
}
],
{
},
{
},
{
}
]
},
{
},
],
{
}
],
{
},
{
}
]
},
{
},
{
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson"
]
}
],
{
}
],
{
},
{
}
]
},
{
},
{
"http://hl7.org/fhir/StructureDefinition/Device",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-MedicalDevice.Product"
]
}
],
{
}
],
]
},
{
},
],
{
}
],
{
},
{
},
{
}
]
},
{
},
},
{
"http://hl7.org/fhir/StructureDefinition/Condition",
"http://hl7.org/fhir/StructureDefinition/Observation",
"http://hl7.org/fhir/StructureDefinition/DiagnosticReport",
"http://hl7.org/fhir/StructureDefinition/DocumentReference",
"http://hl7.org/fhir/StructureDefinition/Media"
]
}
],
{
}
],
{
},
{
},
{
},
{
}
]
},
{
"Indicatie"
],
},
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Problem"
]
}
],
{
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
"comment": "Please note that on a functional level, zib Stoma references zib MedicalDevice, but in FHIR this direction is reversed.",
"Stoma"
],
},
{
}
],
{
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
{
},
{
}
],
"comment": "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.",
"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](null.html).",
"Locatie",
"AnatomischeLocatie",
"nl-core-AnatomicalLocation"
],
},
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-AnatomicalLocation"
]
}
],
"ele-1"
],
{
}
],
{
}
],
"valueSet": "http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.121.11.11--20200901000000"
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"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.",
},
],
{
}
],
{
},
{
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"comment": "Organization is used when there's no need for specific attribution as to who made the comment.",
},
{
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson",
"http://hl7.org/fhir/StructureDefinition/Organization"
]
},
{
}
],
{
}
],
{
},
{
}
]
},
{
},
],
{
}
],
]
},
{
"Toelichting"
],
},
],
{
}
],
{
},
{
},
{
}
]
}
]
},
{
},
{
},
{
"comment": "Each occurrence of the zib HealthProfessional is normally represented by _two_ FHIR resources: a PractitionerRole resource (instance of [nl-core-HealthProfessional-PractitionerRole](http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-PractitionerRole)) and a Practitioner resource (instance of [nl-core-HealthProfessional-Practitioner](http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-Practitioner)). 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. Receiving systems can then retrieve the reference to the Practitioner resource from that PractitionerRole instance.\n\nIn rare circumstances, there is only a Practitioner instance, in which case it is that instance which will be referenced here. However, since this should be the exception, the nl-core-HealthProfessional-Practitioner profile is not explicitly mentioned as a target profile.",
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthProfessional-PractitionerRole"
]
}
]
},
{
},
{
"comment": "Please note that this zib concept (Location::HealthcareProvider) is also mapped on the `Procedure.location` element in profile [nl-core-Procedure-event](http://nictiz.nl/fhir/StructureDefinition/nl-core-Procedure-event). The reason for this is that this zib concept aligns with the Location::HealthcareProvider concept in zib Procedure (NL-CM:14.1.5), but only for the situation that the Procedure is about placing the implant which is described using this instance of zib MedicalDevice. In this situation, the current extension is redundant and it is advised to only use `Procedure.location` in profile nl-core-Procedure-event to represent the Location concept.",
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-HealthcareProvider"
]
}
]
},
{
},
{
"comment": "Zib TreatmentObjective (represented by the Goal resource in FHIR) can use the data model of zib FunctionalOrMentalStatus to describe the desired treatment objective, which in turn may refer zib MedicalDevice to indicate the intent to use that device for reaching the treatment objective.\n\nIn FHIR, the modeling deviates somewhat from this approach:\n\n* Both zib TreatmentObjective and the desired zib FunctionalOrMentalStatus are represented using the [nl-core-TreatmentObjective](http://nictiz.nl/fhir/nl-core-TreatmentObjective) profile on the Goal resource.\n* The reference from TreatmentObjective::FunctionalOrMentalStatus::MedicalDevice is in the opposite direction, to the Goal resource.\n\nThis extension may thus be used to represent the link zib TreatmentObjective -> zib FunctionalOrMentalStatus -> zib MedicalDevice. In this situation, it is expected that `DeviceUseStatement.status` is set to _intended_.",
{
"http://hl7.org/fhir/StructureDefinition/Goal",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-TreatmentObjective"
]
}
]
},
{
{
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Group",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Patient"
]
}
]
},
{
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Procedure-request"
]
}
]
},
{
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Procedure-event"
]
}
]
},
{
{
"http://hl7.org/fhir/StructureDefinition/Device",
"http://nictiz.nl/fhir/StructureDefinition/nl-core-MedicalDevice.Product"
]
}
]
},
{
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-Problem"
]
}
]
},
{
{
}
]
},
{
{
"http://nictiz.nl/fhir/StructureDefinition/nl-core-AnatomicalLocation"
]
}
]
}
]
}
}
| NlcoreMedicalDeviceProduct (Device) | C | ZibMedicalDeviceProduct | |
| id | Σ | 0..1 | id |
| meta | Σ | 0..1 | Meta |
| implicitRules | Σ ?! | 0..1 | uri |
| language | 0..1 | codeBinding | |
| text | 0..1 | Narrative | |
| contained | 0..* | Resource | |
| extension | C | 0..* | Extension |
| modifierExtension | ?! C | 0..* | Extension |
| identifier | 0..1 | Identifier | |
| gs1ProductID | 0..1 | IdentifierPattern | |
| hibcProductID | 0..1 | IdentifierPattern | |
| definition | C | 0..1 | Reference(DeviceDefinition) |
| udiCarrier | Σ | 0..1 | BackboneElement |
| (All Slices) | |||
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| deviceIdentifier | Σ | 0..1 | string |
| issuer | 0..1 | uri | |
| jurisdiction | 0..1 | uri | |
| carrierAIDC | Σ | 0..1 | base64Binary |
| carrierHRF | Σ | 0..1 | string |
| entryType | 0..1 | codeBinding | |
| gs1UdiCarrier | Σ | 0..1 | BackboneElement |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| deviceIdentifier | Σ | 0..1 | string |
| issuer | 0..1 | uriPattern | |
| jurisdiction | 0..1 | uri | |
| carrierAIDC | Σ | 0..1 | base64Binary |
| carrierHRF | Σ | 0..1 | string |
| entryType | 0..1 | codeBinding | |
| hibcUdiCarrier | Σ | 0..1 | BackboneElement |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| deviceIdentifier | Σ | 0..1 | string |
| issuer | 0..1 | uriPattern | |
| jurisdiction | 0..1 | uri | |
| carrierAIDC | Σ | 0..1 | base64Binary |
| carrierHRF | Σ | 0..1 | string |
| entryType | 0..1 | codeBinding | |
| status | Σ ?! | 0..1 | codeBinding |
| statusReason | 0..* | CodeableConceptBinding | |
| distinctIdentifier | 0..1 | string | |
| manufacturer | 0..1 | string | |
| manufactureDate | 0..1 | dateTime | |
| expirationDate | 0..1 | dateTime | |
| lotNumber | 0..1 | string | |
| serialNumber | 0..1 | string | |
| deviceName | 0..* | BackboneElement | |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| name | 1..1 | string | |
| type | 1..1 | codeBinding | |
| modelNumber | 0..1 | string | |
| partNumber | 0..1 | string | |
| type | 0..1 | CodeableConceptBinding | |
| specialization | 0..* | BackboneElement | |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| systemType | 1..1 | CodeableConcept | |
| version | 0..1 | string | |
| version | 0..* | BackboneElement | |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| type | 0..1 | CodeableConcept | |
| component | 0..1 | Identifier | |
| value | 1..1 | string | |
| property | 0..* | BackboneElement | |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| type | 1..1 | CodeableConcept | |
| valueQuantity | C | 0..* | Quantity |
| valueCode | 0..* | CodeableConcept | |
| patient | C | 0..1 | Reference(Patient) |
| owner | C | 0..1 | Reference(Organization) |
| contact | C | 0..* | ContactPoint |
| location | C | 0..1 | Reference(Location) |
| url | 0..1 | uri | |
| note | 0..1 | Annotation | |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| author[x] | Σ | 0..1 | |
| authorReference | Reference(Organization | Patient | Practitioner | RelatedPerson) | ||
| authorString | string | ||
| time | Σ | 0..1 | dateTime |
| text | Σ | 1..1 | markdown |
| safety | Σ | 0..* | CodeableConcept |
| parent | C | 0..1 | Reference(Device) |
| Mapping name | Concept id | FHIR element | Comments |
|---|---|---|---|
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.2 | Device | Product |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.4 | Device.identifier:gs1ProductID | ProductID |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.4 | Device.identifier:hibcProductID | ProductID |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.4 | Device.udiCarrier:gs1UdiCarrier.carrierHRF | ProductID |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.4 | Device.udiCarrier:hibcUdiCarrier.carrierHRF | ProductID |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.3 | Device.type | ProductType |
| zib-medicaldevice-v3.3.1-2020EN | NL-CM:10.1.13 | Device.note.text | ProductDescription |
--- We have skipped the narrative for better readability of the resource ---
</text>
</telecom>
</contact>
<description value="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." />
<purpose value="A derived profile from [zib-MedicalDevice.Product](http://nictiz.nl/fhir/StructureDefinition/zib-MedicalDevice.Product) to provide a version better suited for implementation purposes. This profile augments the base profile with elements found in the various use cases that have adopted the zib." />
<copyright value="Copyright and related rights waived via CC0, https://creativecommons.org/publicdomain/zero/1.0/. This does not apply to information from third parties, for example a medical terminology system. The implementer alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize third party IP in connection with the specification or otherwise." />
</mapping>
<comment value="Frequently used coding systems to identify devices are Health Industry Bar Code (HIBC) or GS1's Global Trade Item Number (GTIN). If one of these systems is used, the device identification happens on the basis of a UDI. Next to these two, other systems to identify devices are allowed by the zib, as long as such a system allows for unique identification of the device.\n\nIn all cases the full identifier will be populated in `.identifier`. If the identifier is a UDI in particular, it should also be populated in `udiCarrier.carrierHRF`, and the element `udiCarrier.issuer` is used to indicate which 'coding system' is used. Moreover the identifier may be broken down into several parts in that case, namely `.udiCarrier.deviceIdentifier`, `.manufactureDate`, `.expirationDate`, `.lotNumber` and `.serialNumber`. For GTIN, guidance is given at the respective elements in this profile and is based on <https://www.gs1.org/industries/healthcare/udi>. For HIBC please consult the the Supplier Labeling Standard that can be found at <https://www.hibcc.org/udi-labeling-standards/barcode-standards/>, as conversion into the several parts is less straightforward." />
</base>
<human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" />
</constraint>
<human value="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" />
<expression value="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()" />
<xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))" />
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" />
<xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" />
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a security label" />
</constraint>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." />
</extension>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." />
<comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation." />
</base>
</extension>
</type>
</element>
<definition value="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." />
</base>
</type>
</constraint>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
<isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation" />
</element>
<comment value="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)." />
</base>
</type>
</constraint>
</extension>
</extension>
</extension>
</binding>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" />
</mapping>
</element>
</discriminator>
</slicing>
<definition value="Unique instance identifiers assigned to a device by manufacturers other organizations or owners." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="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." />
</mapping>
</element>
<definition value="Unique identification of the product, such as the serial number. The `identifier` may only be used if it also identifies the resource." />
<comment value="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." />
</base>
</type>
</patternIdentifier>
</constraint>
</mapping>
</mapping>
<map value="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." />
</mapping>
</mapping>
</element>
<definition value="Unique identification of the product, such as the serial number. The `identifier` may only be used if it also identifies the resource." />
<comment value="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." />
</base>
</type>
</patternIdentifier>
</constraint>
</mapping>
</mapping>
<map value="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." />
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</element>
</discriminator>
</slicing>
<definition value="Unique device identifier (UDI) assigned to device label or package. Note that a udiCarrier is only applicable if the zib concept ProductID actually contains a UDI, e.g. an ID according to GTIN or HIBC." />
<comment value="UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
<definition value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device." />
</mapping>
</element>
<definition value="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :\n1) GS1: \nhttp://hl7.org/fhir/NamingSystem/gs1-di, \n2) HIBCC:\nhttp://hl7.org/fhir/NamingSystem/hibcc-dI, \n3) ICCBBA for blood containers:\nhttp://hl7.org/fhir/NamingSystem/iccbba-blood-di, \n4) ICCBA for other devices:\nhttp://hl7.org/fhir/NamingSystem/iccbba-other-di." />
</base>
</type>
</constraint>
</mapping>
<map value="All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.\nGS1 DIs: \n http://hl7.org/fhir/NamingSystem/gs1\nHIBCC DIs:\n http://hl7.org/fhir/NamingSystem/hibcc\nICCBBA DIs for blood containers:\n http://hl7.org/fhir/NamingSystem/iccbba-blood\nICCBA DIs for other devices:\n http://hl7.org/fhir/NamingSystem/iccbba-other" />
</mapping>
</element>
<definition value="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 value="Allows a recipient of a UDI to know which database will contain the UDI-associated metadata." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
<map value="A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology." />
</mapping>
</element>
<definition value="The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device." />
<comment value="If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</element>
<definition value="Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold." />
<comment value="UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
<definition value="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.\nIn the GS1 standard this element represents the GTIN itself - e.g. 01234567891234 - as part of the Application Identifier (AI), namely AI(01)." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device." />
</mapping>
</element>
<definition value="Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID." />
</base>
</type>
</constraint>
</mapping>
<map value="All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.\nGS1 DIs: \n http://hl7.org/fhir/NamingSystem/gs1\nHIBCC DIs:\n http://hl7.org/fhir/NamingSystem/hibcc\nICCBBA DIs for blood containers:\n http://hl7.org/fhir/NamingSystem/iccbba-blood\nICCBA DIs for other devices:\n http://hl7.org/fhir/NamingSystem/iccbba-other" />
</mapping>
</element>
<definition value="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 value="Allows a recipient of a UDI to know which database will contain the UDI-associated metadata." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
<map value="A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology." />
</mapping>
</element>
<definition value="The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device." />
<comment value="If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</element>
<definition value="Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold." />
<comment value="UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
<definition value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device." />
</mapping>
</element>
<definition value="Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID." />
</base>
</type>
</constraint>
</mapping>
<map value="All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.\nGS1 DIs: \n http://hl7.org/fhir/NamingSystem/gs1\nHIBCC DIs:\n http://hl7.org/fhir/NamingSystem/hibcc\nICCBBA DIs for blood containers:\n http://hl7.org/fhir/NamingSystem/iccbba-blood\nICCBA DIs for other devices:\n http://hl7.org/fhir/NamingSystem/iccbba-other" />
</mapping>
</element>
<definition value="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 value="Allows a recipient of a UDI to know which database will contain the UDI-associated metadata." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
<map value="A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology." />
</mapping>
</element>
<definition value="The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device." />
<comment value="If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</element>
<comment value="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." />
</base>
</type>
</constraint>
<isModifierReason value="This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid" />
</extension>
</binding>
</mapping>
</mapping>
</element>
<short value="online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off" />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</element>
<definition value="The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product." />
<comment value="For example, this applies to devices in the United States regulated under *Code of Federal Regulation 21CFR§1271.290(c)*." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="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." />
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. \nIn the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11)." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="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”." />
</mapping>
</element>
<definition value="The expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.\nIn the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17)." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="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”." />
</mapping>
</element>
<definition value="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.\nIn the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10)." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="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." />
</mapping>
</element>
<definition value="The serial number assigned by the organization when the device was manufactured.\nIn the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21)." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="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." />
</base>
</type>
</constraint>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
</base>
</type>
</constraint>
</element>
<short value="udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other" />
<definition value="The type of deviceName.\nUDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</extension>
<valueSet value="http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000" />
</binding>
</mapping>
</element>
<short value="The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication" />
<definition value="The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication." />
</base>
</type>
</constraint>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</mapping>
</element>
</base>
</type>
</constraint>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</mapping>
</element>
</base>
</type>
</constraint>
</element>
<short value="The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties" />
<definition value="The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties." />
</base>
</type>
</constraint>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="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." />
<requirements value="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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</element>
<comment value="According to <https://www.hl7.org/fhir/r4/compartmentdefinition-patient.html>, this reference may not be populated. Therefore, no reference to the nl-core-Patient profile is defined here." />
<requirements value="If the device is implanted in a patient, then need to associate the device to the patient." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="An organization that is responsible for the provision and ongoing maintenance of the device." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Contact details for an organization or a particular human that is responsible for the device." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<comment value="If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Descriptive information, usage information or implantation information that is not captured in an existing element." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<comment value="Organization is used when there's no need for specific attribution as to who made the comment." />
</base>
</type>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Provides additional safety characteristics about a medical device. For example devices containing latex." />
</base>
</type>
</constraint>
</mapping>
</element>
</base>
</type>
</constraint>
</element>
</snapshot>
</element>
<comment value="According to <https://www.hl7.org/fhir/r4/compartmentdefinition-patient.html>, this reference may not be populated. Therefore, no reference to the nl-core-Patient profile is defined here." />
</element>
</differential>
</StructureDefinition>
{
--- We have skipped the narrative for better readability of the resource ---
},
{
]
}
],
"description": "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.",
"purpose": "A derived profile from [zib-MedicalDevice.Product](http://nictiz.nl/fhir/StructureDefinition/zib-MedicalDevice.Product) to provide a version better suited for implementation purposes. This profile augments the base profile with elements found in the various use cases that have adopted the zib.",
"copyright": "Copyright and related rights waived via CC0, https://creativecommons.org/publicdomain/zero/1.0/. This does not apply to information from third parties, for example a medical terminology system. The implementer alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize third party IP in connection with the specification or otherwise.",
{
}
],
{
"comment": "Frequently used coding systems to identify devices are Health Industry Bar Code (HIBC) or GS1's Global Trade Item Number (GTIN). If one of these systems is used, the device identification happens on the basis of a UDI. Next to these two, other systems to identify devices are allowed by the zib, as long as such a system allows for unique identification of the device.\n\nIn all cases the full identifier will be populated in `.identifier`. If the identifier is a UDI in particular, it should also be populated in `udiCarrier.carrierHRF`, and the element `udiCarrier.issuer` is used to indicate which 'coding system' is used. Moreover the identifier may be broken down into several parts in that case, namely `.udiCarrier.deviceIdentifier`, `.manufactureDate`, `.expirationDate`, `.lotNumber` and `.serialNumber`. For GTIN, guidance is given at the respective elements in this profile and is based on <https://www.gs1.org/industries/healthcare/udi>. For HIBC please consult the the Supplier Labeling Standard that can be found at <https://www.hibcc.org/udi-labeling-standards/barcode-standards/>, as conversion into the several parts is less straightforward.",
"Product",
"nl-core-MedicalDevice.Product"
],
},
{
},
{
"human": "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",
"expression": "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()",
"xpath": "not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
},
{
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
},
{
},
{
{
},
{
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
}
],
}
],
{
},
{
},
{
}
]
},
{
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
},
{
{
}
],
}
],
},
{
"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.",
},
],
{
}
],
},
{
"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.",
"comment": "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.",
},
],
{
}
],
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
},
{
"comment": "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).",
},
],
{
}
],
{
},
{
},
{
}
],
}
},
{
"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.",
"comment": "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.",
"narrative",
"html",
"xhtml",
"display"
],
},
],
{
}
],
]
},
{
"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.",
"comment": "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.",
"inline resources",
"anonymous resources",
"contained resources"
],
},
],
]
},
{
"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.",
"comment": "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.",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
]
},
{
},
"definition": "Unique instance identifiers assigned to a device by manufacturers other organizations or owners.",
"comment": "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.",
},
],
{
}
],
{
},
{
},
{
"map": "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."
}
]
},
{
"definition": "Unique identification of the product, such as the serial number. The `identifier` may only be used if it also identifies the resource.",
"comment": "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.",
"ProductID"
],
},
],
},
{
}
],
{
},
{
},
{
"map": "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."
},
{
}
]
},
{
"definition": "Unique identification of the product, such as the serial number. The `identifier` may only be used if it also identifies the resource.",
"comment": "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.",
"ProductID"
],
},
],
},
{
}
],
{
},
{
},
{
"map": "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."
},
{
}
]
},
{
},
{
"http://hl7.org/fhir/StructureDefinition/DeviceDefinition"
]
}
],
{
}
],
},
{
},
"definition": "Unique device identifier (UDI) assigned to device label or package. Note that a udiCarrier is only applicable if the zib concept ProductID actually contains a UDI, e.g. an ID according to GTIN or HIBC.",
"comment": "UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device.",
},
],
{
}
],
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"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.",
"DI"
],
},
],
{
}
],
{
},
{
},
{
"map": "The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."
}
]
},
{
"definition": "Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :\n1) GS1: \nhttp://hl7.org/fhir/NamingSystem/gs1-di, \n2) HIBCC:\nhttp://hl7.org/fhir/NamingSystem/hibcc-dI, \n3) ICCBBA for blood containers:\nhttp://hl7.org/fhir/NamingSystem/iccbba-blood-di, \n4) ICCBA for other devices:\nhttp://hl7.org/fhir/NamingSystem/iccbba-other-di.",
"Barcode System"
],
},
],
{
}
],
{
},
{
"map": "All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.\nGS1 DIs: \n http://hl7.org/fhir/NamingSystem/gs1\nHIBCC DIs:\n http://hl7.org/fhir/NamingSystem/hibcc\nICCBBA DIs for blood containers:\n http://hl7.org/fhir/NamingSystem/iccbba-blood\nICCBA DIs for other devices:\n http://hl7.org/fhir/NamingSystem/iccbba-other"
}
]
},
{
"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.",
},
],
{
}
],
]
},
{
"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.",
"comment": "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.",
"Automatic Identification and Data Capture"
],
},
],
{
}
],
{
},
{
"map": "A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."
}
]
},
{
"definition": "The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.",
"comment": "If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.",
"Human Readable Form"
],
},
],
{
}
],
{
},
{
}
]
},
{
},
],
{
}
],
{
}
],
},
]
},
{
"definition": "Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.",
"comment": "UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device.",
},
],
{
}
],
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"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.\nIn the GS1 standard this element represents the GTIN itself - e.g. 01234567891234 - as part of the Application Identifier (AI), namely AI(01).",
"DI"
],
},
],
{
}
],
{
},
{
},
{
"map": "The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."
}
]
},
{
"definition": "Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID.",
"Barcode System"
],
},
],
{
}
],
{
},
{
"map": "All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.\nGS1 DIs: \n http://hl7.org/fhir/NamingSystem/gs1\nHIBCC DIs:\n http://hl7.org/fhir/NamingSystem/hibcc\nICCBBA DIs for blood containers:\n http://hl7.org/fhir/NamingSystem/iccbba-blood\nICCBA DIs for other devices:\n http://hl7.org/fhir/NamingSystem/iccbba-other"
}
]
},
{
"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.",
},
],
{
}
],
]
},
{
"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.",
"comment": "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.",
"Automatic Identification and Data Capture"
],
},
],
{
}
],
{
},
{
"map": "A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."
}
]
},
{
"definition": "The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.",
"comment": "If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.",
"Human Readable Form",
"ProductID"
],
},
],
{
}
],
{
},
{
},
{
}
]
},
{
},
],
{
}
],
{
}
],
},
]
},
{
"definition": "Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.",
"comment": "UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device.",
},
],
{
}
],
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"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.",
"DI"
],
},
],
{
}
],
{
},
{
},
{
"map": "The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."
}
]
},
{
"definition": "Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID.",
"Barcode System"
],
},
],
{
}
],
{
},
{
"map": "All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.\nGS1 DIs: \n http://hl7.org/fhir/NamingSystem/gs1\nHIBCC DIs:\n http://hl7.org/fhir/NamingSystem/hibcc\nICCBBA DIs for blood containers:\n http://hl7.org/fhir/NamingSystem/iccbba-blood\nICCBA DIs for other devices:\n http://hl7.org/fhir/NamingSystem/iccbba-other"
}
]
},
{
"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.",
},
],
{
}
],
]
},
{
"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.",
"comment": "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.",
"Automatic Identification and Data Capture"
],
},
],
{
}
],
{
},
{
"map": "A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."
}
]
},
{
"definition": "The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.",
"comment": "If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.",
"Human Readable Form",
"ProductID"
],
},
],
{
}
],
{
},
{
},
{
}
]
},
{
},
],
{
}
],
{
}
],
},
]
},
{
"comment": "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.",
},
],
{
}
],
"isModifierReason": "This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid",
{
}
],
},
]
},
{
},
],
{
}
],
{
}
],
},
]
},
{
"definition": "The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.",
"comment": "For example, this applies to devices in the United States regulated under *Code of Federal Regulation 21CFR§1271.290(c)*.",
"Distinct Identification Code (DIC)"
],
},
],
{
}
],
{
},
{
},
{
"map": "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."
}
]
},
{
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. \nIn the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11).",
},
],
{
}
],
{
},
{
},
{
"map": "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”."
}
]
},
{
"definition": "The expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.\nIn the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17).",
},
],
{
}
],
{
},
{
},
{
"map": "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”."
}
]
},
{
"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.\nIn the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10).",
},
],
{
}
],
{
},
{
},
{
"map": "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."
}
]
},
{
"definition": "The serial number assigned by the organization when the device was manufactured.\nIn the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21).",
},
],
{
}
],
{
},
{
}
]
},
{
"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.",
},
],
{
}
],
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"Σ"
],
},
],
{
}
],
},
{
"short": "udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other",
"definition": "The type of deviceName.\nUDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.",
},
],
{
}
],
{
}
],
},
{
},
{
}
]
},
{
},
],
{
}
],
{
},
{
}
]
},
{
},
],
{
}
],
{
},
{
}
]
},
{
"ProductType"
],
},
],
{
}
],
{
}
],
"valueSet": "http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000"
},
]
},
{
"short": "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.",
},
],
{
}
],
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"Σ"
],
},
],
{
}
],
},
{
},
],
{
}
],
]
},
{
},
],
{
}
],
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"Σ"
],
},
],
{
}
],
},
{
},
],
{
}
],
]
},
{
},
],
{
}
],
},
{
"short": "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.",
},
],
{
}
],
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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.",
"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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
},
],
{
}
],
},
{
},
],
{
}
],
},
{
},
],
{
}
],
},
{
"comment": "According to <https://www.hl7.org/fhir/r4/compartmentdefinition-patient.html>, this reference may not be populated. Therefore, no reference to the nl-core-Patient profile is defined here.",
"requirements": "If the device is implanted in a patient, then need to associate the device to the patient.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "An organization that is responsible for the provision and ongoing maintenance of the device.",
},
{
}
],
{
}
],
{
},
{
}
]
},
{
"definition": "Contact details for an organization or a particular human that is responsible for the device.",
},
],
{
}
],
{
},
{
}
]
},
{
},
],
{
}
],
{
},
{
}
]
},
{
"comment": "If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.",
},
],
{
}
],
]
},
{
"definition": "Descriptive information, usage information or implantation information that is not captured in an existing element.",
},
],
{
}
],
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"comment": "Organization is used when there's no need for specific attribution as to who made the comment.",
},
{
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson",
"http://hl7.org/fhir/StructureDefinition/Organization"
]
},
{
}
],
{
}
],
{
},
{
}
]
},
{
},
],
{
}
],
]
},
{
"ProductOmschrijving"
],
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "Provides additional safety characteristics about a medical device. For example devices containing latex.",
},
],
{
}
],
]
},
{
},
],
{
}
],
}
]
},
{
},
{
"comment": "According to <https://www.hl7.org/fhir/r4/compartmentdefinition-patient.html>, this reference may not be populated. Therefore, no reference to the nl-core-Patient profile is defined here."
}
]
}
}
3.5.3.1. Specific technical specifications
3.5.3.1.1. Base Logical Model concepts
Note that the relevant concepts from the Base Logical Model listed above, are mapped as follows to the Goal resource:
| Concept id | Logical element | FHIR element |
|---|---|---|
| medmij-core-dataelement-115 | IdentificationNumber | .identifier |
| medmij-core-dataelement-116 | Patient | .subject |
| medmij-core-dataelement-117 | HealthcareProvider | .expressedBy (via PractitionerRole.organization) |
| medmij-core-dataelement-119 | EffectiveDateTime | .startDate |
| medmij-core-dataelement-123 | CareType | .meta.tag |
3.5.3.1.2. XIS: response message
Even though the PHR only requests the Goal resources corresponding to the TreatmentObjective CIM, the XIS SHALL include all DeviceUseStatement resources corresponding to the MedicalDevice concept (NL-CM:4.26.5) in the Bundle (provided the medical device data is present in the source system). Moreover, the XIS is encouraged to also include the Device resources referenced from these DeviceUseStatement resources via .device, but is not required to do so, as these can alternatively be retrieved by the PHR via a read.