NHS England FHIR Implementation Guide (deprecated)

SDS-Device

Conformance url
`https://fhir.nhs.uk/StructureDefinition/SDS-Device`

with Device

Device	I		Device	There are no (further) constraints on this element Element Id Device Short description Item used in healthcare Definition A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Data Type Device Constraints dom-2:If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4:If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3:If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6:A resource should have narrative for robust management text.`div`.exists() dom-5:If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim:Entity. Role, or Act rim:Device
extension	I	0..*	Extension	Element Id Device.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim:n/a rim:N/A
managingOrganisation	S I	1..1	Extension(Reference())	Element Id Device.extension:managingOrganisation Short description Managing or manufacturing organisation providing an Accredited System Alternate names extensions, user content Definition ODS reference that represents the managing or manufacturing organisation providing an Accredited System Comments Reference to the managing, manufacturing or supplying organisation of an Accredited System. Data Type Extension(Reference()) Extension URL https://fhir.nhs.uk/StructureDefinition/Extension-SDS-ManagingOrganisation Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim:n/a rim:N/A
identifier	S	0..*	Identifier	Element Id Device.identifier Short description Instance identifier Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data Type Identifier Sliced: Unordered, Open, by system(Value) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.identifier rim:.id udi:The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
NhsSpineASID	S	1..1	Identifier	Element Id Device.identifier:NhsSpineASID Short description NHS Spine Accredited System Identifier Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.identifier rim:.id udi:The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data Type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:N/A rim:Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data Type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD v2:CX.5 rim:Role.code or implied by context
system	Σ	0..1	uriFixed Value	Element Id Device.identifier:NhsSpineASID.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed Value https://fhir.nhs.uk/Id/nhsSpineASID Mappings rim:n/a v2:CX.4 / EI-2-4 rim:II.root or Role.id.root servd:./IdentifierType
value	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings rim:n/a v2:CX.1 / EI.1 rim:II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd:./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration. Data Type Period Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` per-1:If present, start SHALL have a lower value than end `start.hasValue().not() or end.hasValue().not() or (start <= end)` Mappings rim:n/a v2:DR rim:IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2:CX.7 + CX.8 rim:Role.effectiveTime or implied by context servd:./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(Organization)	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data Type Reference(Organization) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2:CX.4 / (CX.4,CX.9,CX.10) rim:II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd:./IdentifierIssuingAuthority
NhsMhsPartyKey	S	1..1	Identifier	Element Id Device.identifier:NhsMhsPartyKey Short description Nhs Mhs Party Key Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.identifier rim:.id udi:The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data Type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:N/A rim:Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data Type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD v2:CX.5 rim:Role.code or implied by context
system	Σ	0..1	uriFixed Value	Element Id Device.identifier:NhsMhsPartyKey.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed Value https://fhir.nhs.uk/Id/nhsMhsPartyKey Mappings rim:n/a v2:CX.4 / EI-2-4 rim:II.root or Role.id.root servd:./IdentifierType
value	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings rim:n/a v2:CX.1 / EI.1 rim:II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd:./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration. Data Type Period Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` per-1:If present, start SHALL have a lower value than end `start.hasValue().not() or end.hasValue().not() or (start <= end)` Mappings rim:n/a v2:DR rim:IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2:CX.7 + CX.8 rim:Role.effectiveTime or implied by context servd:./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(Organization)	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data Type Reference(Organization) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2:CX.4 / (CX.4,CX.9,CX.10) rim:II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd:./IdentifierIssuingAuthority
NhsEndpointServiceId	S	1..1	Identifier	Element Id Device.identifier:NhsEndpointServiceId Short description NHS Endpoint Service Id Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.identifier rim:.id udi:The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data Type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:N/A rim:Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data Type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD v2:CX.5 rim:Role.code or implied by context
system	Σ	0..1	uriFixed Value	Element Id Device.identifier:NhsEndpointServiceId.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed Value https://fhir.nhs.uk/Id/nhsEndpointServiceId Mappings rim:n/a v2:CX.4 / EI-2-4 rim:II.root or Role.id.root servd:./IdentifierType
value	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings rim:n/a v2:CX.1 / EI.1 rim:II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd:./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration. Data Type Period Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` per-1:If present, start SHALL have a lower value than end `start.hasValue().not() or end.hasValue().not() or (start <= end)` Mappings rim:n/a v2:DR rim:IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2:CX.7 + CX.8 rim:Role.effectiveTime or implied by context servd:./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(Organization)	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data Type Reference(Organization) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2:CX.4 / (CX.4,CX.9,CX.10) rim:II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd:./IdentifierIssuingAuthority
definition	I	0..1	Reference(DeviceDefinition)	There are no (further) constraints on this element Element Id Device.definition Short description The reference to the definition for the device Definition The reference to the definition for the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(DeviceDefinition) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
udiCarrier	Σ	0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.udiCarrier Short description Unique Device Identifier (UDI) Barcode string 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. Comments UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.identifier rim:.id and .code
deviceIdentifier	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.udiCarrier.deviceIdentifier Short description Mandatory fixed portion of UDI Alternate names DI Definition The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:Role.id.extension udi:The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
issuer		0..1	uri	There are no (further) constraints on this element Element Id Device.udiCarrier.issuer Short description UDI Issuing Organization Alternate names Barcode System Definition Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:Role.id.root udi:All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
jurisdiction		0..1	uri	There are no (further) constraints on this element Element Id Device.udiCarrier.jurisdiction Short description Regional UDI authority Definition The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Requirements Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:Role.scoper
carrierAIDC	Σ	0..1	base64Binary	There are no (further) constraints on this element Element Id Device.udiCarrier.carrierAIDC Short description UDI Machine Readable Barcode String Alternate names Automatic Identification and Data Capture Definition The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded. Comments The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data Type base64Binary Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:Role.id.extension udi:A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
carrierHRF	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.udiCarrier.carrierHRF Short description UDI Human Readable Barcode String Alternate names Human Readable Form Definition The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. Comments If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:Role.id.extension udi:A unique device identifier (UDI) on a device label in plain text
entryType		0..1	codeBinding	There are no (further) constraints on this element Element Id Device.udiCarrier.entryType Short description barcode \| rfid \| manual + Definition A coded entry to indicate how the data was entered. Requirements Supports a way to distinguish hand entered from machine read data. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type code Binding Codes to identify how UDI data was entered. UDIEntryType (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:NA
status	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element Id Device.status Short description active \| inactive \| entered-in-error \| unknown Definition Status of the Device availability. Comments This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid. Data Type code Binding The availability status of the device. FHIRDeviceStatus (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.status rim:.statusCode
statusReason		0..*	CodeableConceptBinding	There are no (further) constraints on this element Element Id Device.statusReason Short description online \| paused \| standby \| offline \| not-ready \| transduc-discon \| hw-discon \| off Definition Reason for the dtatus of the Device availability. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Binding The availability status reason of the device. FHIRDeviceStatusReason (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD w5:FiveWs.status
distinctIdentifier		0..1	string	There are no (further) constraints on this element Element Id Device.distinctIdentifier Short description The distinct identification string Alternate names Distinct Identification Code (DIC) Definition The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. Comments For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c). Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.lotNumberText udi:The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
manufacturer		0..1	string	There are no (further) constraints on this element Element Id Device.manufacturer Short description Name of device manufacturer Definition A name of the manufacturer. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.playedRole[typeCode=MANU].scoper.name udi:N/A
manufactureDate		0..1	dateTime	There are no (further) constraints on this element Element Id Device.manufactureDate Short description Date when the device was made Definition The date and time when the device was manufactured. Data Type dateTime Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.existenceTime.low udi:The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
expirationDate		0..1	dateTime	There are no (further) constraints on this element Element Id Device.expirationDate Short description Date and time of expiry of this device (if applicable) Definition The date and time beyond which this device is no longer valid or should not be used (if applicable). Data Type dateTime Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.expirationTime udi:the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
lotNumber		0..1	string	There are no (further) constraints on this element Element Id Device.lotNumber Short description Lot number of manufacture Definition Lot number assigned by the manufacturer. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.lotNumberText udi:The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
serialNumber		0..1	string	There are no (further) constraints on this element Element Id Device.serialNumber Short description Serial number assigned by the manufacturer Definition The serial number assigned by the organization when the device was manufactured. Comments Alphanumeric Maximum 20. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.playedRole[typeCode=MANU].id
deviceName		0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.deviceName Short description The name of the device as given by the manufacturer Definition This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
name		1..1	string	There are no (further) constraints on this element Element Id Device.deviceName.name Short description The name of the device Alternate names Σ Definition The name of the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
type		1..1	codeBinding	There are no (further) constraints on this element Element Id Device.deviceName.type Short description udi-label-name \| user-friendly-name \| patient-reported-name \| manufacturer-name \| model-name \| other Definition The type of deviceName. UDILabelName \| UserFriendlyName \| PatientReportedName \| ManufactureDeviceName \| ModelName. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type code Binding The type of name the device is referred by. DeviceNameType (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.playedRole[typeCode=MANU].code
modelNumber		0..1	string	There are no (further) constraints on this element Element Id Device.modelNumber Short description The model number for the device Definition The model number for the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.softwareName (included as part)
partNumber		0..1	string	There are no (further) constraints on this element Element Id Device.partNumber Short description The part number of the device Definition The part number of the device. Comments Alphanumeric Maximum 20. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.playedRole[typeCode=MANU].id
type		0..1	CodeableConcept	There are no (further) constraints on this element Element Id Device.type Short description The kind or type of device Definition The kind or type of device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Binding Codes to identify medical devices. DeviceType (example) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
specialization		0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.specialization Short description The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication Definition The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
systemType		1..1	CodeableConcept	There are no (further) constraints on this element Element Id Device.specialization.systemType Short description The standard that is used to operate and communicate Alternate names Σ Definition The standard that is used to operate and communicate. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
version		0..1	string	There are no (further) constraints on this element Element Id Device.specialization.version Short description The version of the standard that is used to operate and communicate Definition The version of the standard that is used to operate and communicate. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x]
version		0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.version Short description The actual design of the device or software version running on the device Definition The actual design of the device or software version running on the device. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
type		0..1	CodeableConcept	There are no (further) constraints on this element Element Id Device.version.type Short description The type of the device version Alternate names Σ Definition The type of the device version. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
component		0..1	Identifier	There are no (further) constraints on this element Element Id Device.version.component Short description A single component of the device version Definition A single component of the device version. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.what[x]
value		1..1	string	There are no (further) constraints on this element Element Id Device.version.value Short description The version text Definition The version text. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
property		0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.property Short description The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties Definition The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
type		1..1	CodeableConcept	There are no (further) constraints on this element Element Id Device.property.type Short description Code that specifies the property DeviceDefinitionPropetyCode (Extensible) Definition Code that specifies the property DeviceDefinitionPropetyCode (Extensible). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
valueQuantity	I	0..*	Quantity	There are no (further) constraints on this element Element Id Device.property.valueQuantity Short description Property value as a quantity Definition Property value as a quantity. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data Type Quantity Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3:If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim:n/a v2:SN (see also Range) or CQ rim:PQ, IVL<PQ>, MO, CO, depending on the values
valueCode		0..*	CodeableConcept	There are no (further) constraints on this element Element Id Device.property.valueCode Short description Property value as a code, e.g., NTP4 (synced to NTP) Definition Property value as a code, e.g., NTP4 (synced to NTP). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
patient	I	0..1	Reference(Patient)	There are no (further) constraints on this element Element Id Device.patient Short description Patient to whom Device is affixed Definition Patient information, If the device is affixed to a person. Requirements If the device is implanted in a patient, then need to associate the device to the patient. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(Patient) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5:FiveWs.subject[x] rim:.playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT] w5:FiveWs.subject
owner	S I	1..1	Reference(Organization)	There are no (further) constraints on this element Element Id Device.owner Short description Organization responsible for device Definition An organization that is responsible for the provision and ongoing maintenance of the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(Organization) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5:FiveWs.source rim:.playedRole[typeCode=OWN].scoper
contact	I	0..*	ContactPoint	There are no (further) constraints on this element Element Id Device.contact Short description Details for human/organization for support Definition Contact details for an organization or a particular human that is responsible for the device. Comments used for troubleshooting etc. Data Type ContactPoint Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` cpt-2:A system is required if a value is provided. `value.empty() or system.exists()` Mappings rim:n/a v2:XTN rim:TEL servd:ContactPoint w5:FiveWs.source rim:.scopedRole[typeCode=CON].player
location	I	0..1	Reference(Location)	There are no (further) constraints on this element Element Id Device.location Short description Where the device is found Definition The place where the device can be found. Requirements Device.location can be used to track device location. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(Location) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5:FiveWs.where[x] rim:.playedRole[typeCode=LOCE].scoper
url		0..1	uri	There are no (further) constraints on this element Element Id Device.url Short description Network address to contact device Definition A network address on which the device may be contacted directly. Comments If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.where[x] rim:.telecom
note		0..*	Annotation	There are no (further) constraints on this element Element Id Device.note Short description Device notes and comments Definition Descriptive information, usage information or implantation information that is not captured in an existing element. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data Type Annotation Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:N/A rim:Act rim:.text
safety	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element Id Device.safety Short description Safety Characteristics of Device Definition Provides additional safety characteristics about a medical device. For example devices containing latex. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD rim:NA
parent	I	0..1	Reference(Device)	There are no (further) constraints on this element Element Id Device.parent Short description The parent device Definition The parent device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(Device) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)

from Device

Device	I		Device	There are no (further) constraints on this element Element Id Device Short description Item used in healthcare Definition A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Data Type Device Constraints dom-2:If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4:If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3:If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6:A resource should have narrative for robust management text.`div`.exists() dom-5:If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim:Entity. Role, or Act rim:Device
extension	I	0..*	Extension	Element Id Device.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data Type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim:n/a rim:N/A
managingOrganisation	S I	1..1	Extension(Reference())	Element Id Device.extension:managingOrganisation Short description Managing or manufacturing organisation providing an Accredited System Alternate names extensions, user content Definition ODS reference that represents the managing or manufacturing organisation providing an Accredited System Comments Reference to the managing, manufacturing or supplying organisation of an Accredited System. Data Type Extension(Reference()) Extension URL https://fhir.nhs.uk/StructureDefinition/Extension-SDS-ManagingOrganisation Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim:n/a rim:N/A
identifier	S	0..*	Identifier	Element Id Device.identifier Short description Instance identifier Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data Type Identifier Sliced: Unordered, Open, by system(Value) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.identifier rim:.id udi:The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
NhsSpineASID	S	1..1	Identifier	Element Id Device.identifier:NhsSpineASID Short description NHS Spine Accredited System Identifier Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.identifier rim:.id udi:The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data Type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:N/A rim:Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data Type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD v2:CX.5 rim:Role.code or implied by context
system	Σ	0..1	uriFixed Value	Element Id Device.identifier:NhsSpineASID.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed Value https://fhir.nhs.uk/Id/nhsSpineASID Mappings rim:n/a v2:CX.4 / EI-2-4 rim:II.root or Role.id.root servd:./IdentifierType
value	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings rim:n/a v2:CX.1 / EI.1 rim:II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd:./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration. Data Type Period Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` per-1:If present, start SHALL have a lower value than end `start.hasValue().not() or end.hasValue().not() or (start <= end)` Mappings rim:n/a v2:DR rim:IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2:CX.7 + CX.8 rim:Role.effectiveTime or implied by context servd:./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(Organization)	There are no (further) constraints on this element Element Id Device.identifier:NhsSpineASID.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data Type Reference(Organization) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2:CX.4 / (CX.4,CX.9,CX.10) rim:II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd:./IdentifierIssuingAuthority
NhsMhsPartyKey	S	1..1	Identifier	Element Id Device.identifier:NhsMhsPartyKey Short description Nhs Mhs Party Key Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.identifier rim:.id udi:The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data Type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:N/A rim:Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data Type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD v2:CX.5 rim:Role.code or implied by context
system	Σ	0..1	uriFixed Value	Element Id Device.identifier:NhsMhsPartyKey.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed Value https://fhir.nhs.uk/Id/nhsMhsPartyKey Mappings rim:n/a v2:CX.4 / EI-2-4 rim:II.root or Role.id.root servd:./IdentifierType
value	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings rim:n/a v2:CX.1 / EI.1 rim:II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd:./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration. Data Type Period Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` per-1:If present, start SHALL have a lower value than end `start.hasValue().not() or end.hasValue().not() or (start <= end)` Mappings rim:n/a v2:DR rim:IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2:CX.7 + CX.8 rim:Role.effectiveTime or implied by context servd:./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(Organization)	There are no (further) constraints on this element Element Id Device.identifier:NhsMhsPartyKey.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data Type Reference(Organization) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2:CX.4 / (CX.4,CX.9,CX.10) rim:II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd:./IdentifierIssuingAuthority
NhsEndpointServiceId	S	1..1	Identifier	Element Id Device.identifier:NhsEndpointServiceId Short description NHS Endpoint Service Id Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.identifier rim:.id udi:The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data Type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:N/A rim:Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data Type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD v2:CX.5 rim:Role.code or implied by context
system	Σ	0..1	uriFixed Value	Element Id Device.identifier:NhsEndpointServiceId.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed Value https://fhir.nhs.uk/Id/nhsEndpointServiceId Mappings rim:n/a v2:CX.4 / EI-2-4 rim:II.root or Role.id.root servd:./IdentifierType
value	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings rim:n/a v2:CX.1 / EI.1 rim:II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd:./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration. Data Type Period Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` per-1:If present, start SHALL have a lower value than end `start.hasValue().not() or end.hasValue().not() or (start <= end)` Mappings rim:n/a v2:DR rim:IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2:CX.7 + CX.8 rim:Role.effectiveTime or implied by context servd:./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(Organization)	There are no (further) constraints on this element Element Id Device.identifier:NhsEndpointServiceId.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data Type Reference(Organization) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2:CX.4 / (CX.4,CX.9,CX.10) rim:II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd:./IdentifierIssuingAuthority
definition	I	0..1	Reference(DeviceDefinition)	There are no (further) constraints on this element Element Id Device.definition Short description The reference to the definition for the device Definition The reference to the definition for the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(DeviceDefinition) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
udiCarrier	Σ	0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.udiCarrier Short description Unique Device Identifier (UDI) Barcode string 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. Comments UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.identifier rim:.id and .code
deviceIdentifier	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.udiCarrier.deviceIdentifier Short description Mandatory fixed portion of UDI Alternate names DI Definition The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:Role.id.extension udi:The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
issuer		0..1	uri	There are no (further) constraints on this element Element Id Device.udiCarrier.issuer Short description UDI Issuing Organization Alternate names Barcode System Definition Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:Role.id.root udi:All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
jurisdiction		0..1	uri	There are no (further) constraints on this element Element Id Device.udiCarrier.jurisdiction Short description Regional UDI authority Definition The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Requirements Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:Role.scoper
carrierAIDC	Σ	0..1	base64Binary	There are no (further) constraints on this element Element Id Device.udiCarrier.carrierAIDC Short description UDI Machine Readable Barcode String Alternate names Automatic Identification and Data Capture Definition The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded. Comments The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data Type base64Binary Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:Role.id.extension udi:A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
carrierHRF	Σ	0..1	string	There are no (further) constraints on this element Element Id Device.udiCarrier.carrierHRF Short description UDI Human Readable Barcode String Alternate names Human Readable Form Definition The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. Comments If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:Role.id.extension udi:A unique device identifier (UDI) on a device label in plain text
entryType		0..1	codeBinding	There are no (further) constraints on this element Element Id Device.udiCarrier.entryType Short description barcode \| rfid \| manual + Definition A coded entry to indicate how the data was entered. Requirements Supports a way to distinguish hand entered from machine read data. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type code Binding Codes to identify how UDI data was entered. UDIEntryType (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:NA
status	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element Id Device.status Short description active \| inactive \| entered-in-error \| unknown Definition Status of the Device availability. Comments This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid. Data Type code Binding The availability status of the device. FHIRDeviceStatus (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.status rim:.statusCode
statusReason		0..*	CodeableConceptBinding	There are no (further) constraints on this element Element Id Device.statusReason Short description online \| paused \| standby \| offline \| not-ready \| transduc-discon \| hw-discon \| off Definition Reason for the dtatus of the Device availability. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Binding The availability status reason of the device. FHIRDeviceStatusReason (extensible) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD w5:FiveWs.status
distinctIdentifier		0..1	string	There are no (further) constraints on this element Element Id Device.distinctIdentifier Short description The distinct identification string Alternate names Distinct Identification Code (DIC) Definition The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. Comments For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c). Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.lotNumberText udi:The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
manufacturer		0..1	string	There are no (further) constraints on this element Element Id Device.manufacturer Short description Name of device manufacturer Definition A name of the manufacturer. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.playedRole[typeCode=MANU].scoper.name udi:N/A
manufactureDate		0..1	dateTime	There are no (further) constraints on this element Element Id Device.manufactureDate Short description Date when the device was made Definition The date and time when the device was manufactured. Data Type dateTime Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.existenceTime.low udi:The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
expirationDate		0..1	dateTime	There are no (further) constraints on this element Element Id Device.expirationDate Short description Date and time of expiry of this device (if applicable) Definition The date and time beyond which this device is no longer valid or should not be used (if applicable). Data Type dateTime Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.expirationTime udi:the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
lotNumber		0..1	string	There are no (further) constraints on this element Element Id Device.lotNumber Short description Lot number of manufacture Definition Lot number assigned by the manufacturer. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.lotNumberText udi:The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
serialNumber		0..1	string	There are no (further) constraints on this element Element Id Device.serialNumber Short description Serial number assigned by the manufacturer Definition The serial number assigned by the organization when the device was manufactured. Comments Alphanumeric Maximum 20. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.playedRole[typeCode=MANU].id
deviceName		0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.deviceName Short description The name of the device as given by the manufacturer Definition This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
name		1..1	string	There are no (further) constraints on this element Element Id Device.deviceName.name Short description The name of the device Alternate names Σ Definition The name of the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
type		1..1	codeBinding	There are no (further) constraints on this element Element Id Device.deviceName.type Short description udi-label-name \| user-friendly-name \| patient-reported-name \| manufacturer-name \| model-name \| other Definition The type of deviceName. UDILabelName \| UserFriendlyName \| PatientReportedName \| ManufactureDeviceName \| ModelName. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type code Binding The type of name the device is referred by. DeviceNameType (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.playedRole[typeCode=MANU].code
modelNumber		0..1	string	There are no (further) constraints on this element Element Id Device.modelNumber Short description The model number for the device Definition The model number for the device. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.softwareName (included as part)
partNumber		0..1	string	There are no (further) constraints on this element Element Id Device.partNumber Short description The part number of the device Definition The part number of the device. Comments Alphanumeric Maximum 20. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x] rim:.playedRole[typeCode=MANU].id
type		0..1	CodeableConcept	There are no (further) constraints on this element Element Id Device.type Short description The kind or type of device Definition The kind or type of device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Binding Codes to identify medical devices. DeviceType (example) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
specialization		0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.specialization Short description The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication Definition The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
systemType		1..1	CodeableConcept	There are no (further) constraints on this element Element Id Device.specialization.systemType Short description The standard that is used to operate and communicate Alternate names Σ Definition The standard that is used to operate and communicate. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
version		0..1	string	There are no (further) constraints on this element Element Id Device.specialization.version Short description The version of the standard that is used to operate and communicate Definition The version of the standard that is used to operate and communicate. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.what[x]
version		0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.version Short description The actual design of the device or software version running on the device Definition The actual design of the device or software version running on the device. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
type		0..1	CodeableConcept	There are no (further) constraints on this element Element Id Device.version.type Short description The type of the device version Alternate names Σ Definition The type of the device version. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
component		0..1	Identifier	There are no (further) constraints on this element Element Id Device.version.component Short description A single component of the device version Definition A single component of the device version. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.what[x]
value		1..1	string	There are no (further) constraints on this element Element Id Device.version.value Short description The version text Definition The version text. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
property		0..*	BackboneElement	There are no (further) constraints on this element Element Id Device.property Short description The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties Definition The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
type		1..1	CodeableConcept	There are no (further) constraints on this element Element Id Device.property.type Short description Code that specifies the property DeviceDefinitionPropetyCode (Extensible) Definition Code that specifies the property DeviceDefinitionPropetyCode (Extensible). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
valueQuantity	I	0..*	Quantity	There are no (further) constraints on this element Element Id Device.property.valueQuantity Short description Property value as a quantity Definition Property value as a quantity. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data Type Quantity Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3:If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim:n/a v2:SN (see also Range) or CQ rim:PQ, IVL<PQ>, MO, CO, depending on the values
valueCode		0..*	CodeableConcept	There are no (further) constraints on this element Element Id Device.property.valueCode Short description Property value as a code, e.g., NTP4 (synced to NTP) Definition Property value as a code, e.g., NTP4 (synced to NTP). Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
patient	I	0..1	Reference(Patient)	There are no (further) constraints on this element Element Id Device.patient Short description Patient to whom Device is affixed Definition Patient information, If the device is affixed to a person. Requirements If the device is implanted in a patient, then need to associate the device to the patient. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(Patient) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5:FiveWs.subject[x] rim:.playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT] w5:FiveWs.subject
owner	S I	1..1	Reference(Organization)	There are no (further) constraints on this element Element Id Device.owner Short description Organization responsible for device Definition An organization that is responsible for the provision and ongoing maintenance of the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(Organization) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5:FiveWs.source rim:.playedRole[typeCode=OWN].scoper
contact	I	0..*	ContactPoint	There are no (further) constraints on this element Element Id Device.contact Short description Details for human/organization for support Definition Contact details for an organization or a particular human that is responsible for the device. Comments used for troubleshooting etc. Data Type ContactPoint Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` cpt-2:A system is required if a value is provided. `value.empty() or system.exists()` Mappings rim:n/a v2:XTN rim:TEL servd:ContactPoint w5:FiveWs.source rim:.scopedRole[typeCode=CON].player
location	I	0..1	Reference(Location)	There are no (further) constraints on this element Element Id Device.location Short description Where the device is found Definition The place where the device can be found. Requirements Device.location can be used to track device location. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(Location) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5:FiveWs.where[x] rim:.playedRole[typeCode=LOCE].scoper
url		0..1	uri	There are no (further) constraints on this element Element Id Device.url Short description Network address to contact device Definition A network address on which the device may be contacted directly. Comments If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.where[x] rim:.telecom
note		0..*	Annotation	There are no (further) constraints on this element Element Id Device.note Short description Device notes and comments Definition Descriptive information, usage information or implantation information that is not captured in an existing element. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data Type Annotation Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:N/A rim:Act rim:.text
safety	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element Id Device.safety Short description Safety Characteristics of Device Definition Provides additional safety characteristics about a medical device. For example devices containing latex. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data Type CodeableConcept Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD rim:NA
parent	I	0..1	Reference(Device)	There are no (further) constraints on this element Element Id Device.parent Short description The parent device Definition The parent device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data Type Reference(Device) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1:SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim:n/a rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)

SDS-Device-Example