0.1.0 - ci-build

EUAITransparencyIG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EU AI System Device

Official URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-device Version: 0.1.0
Draft as of 2026-06-18 Computable Name: EU_AIDevice

A Device profile representing an AI system or software component, including system identification, versioning, intended purpose, and selected regulatory documentation metadata.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* Device Item used in healthcare
Constraints: dev-1
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dataTransfer S 1..1 (Complex) Third-Country Transfer Data
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/third-country-data-transfer
.... extension:modelCard S 1..1 Reference(DocumentReference) Model Card Reference
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ext-model-card
... Slices for identifier 1..* Identifier Instance identifier
Slice: Unordered, Open by value:type
.... identifier:euDatabaseId S 1..1 Identifier EU AI database registration identifier
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type SΣ 1..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: eu-ai-database-id
....... display 1..1 string Representation defined by the system
Fixed Value: EU AI Database Identifier
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣC 1..1 string The value that is unique
Example General: 123456
... status ?!Σ 0..1 code active | inactive | entered-in-error
Binding: FHIRDeviceStatus (required): The record status of the device.
... manufacturer S 1..1 string Name of the AI developer/manufacturer
... name SC 1..* BackboneElement The name or names of the device as known to the manufacturer and/or patient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value SΣ 1..1 string System Name
.... type Σ 1..1 code registered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.
.... display ?!ΣC 0..1 boolean The preferred device name
... version S 1..* BackboneElement The actual design of the device or software version running on the device
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value S 1..1 string System Version
... conformsTo S 1..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... specification 1..1 CodeableConcept QMS Certification
Binding: DeviceSpecificationType (example): The type of version indicated for the device.
... Slices for property 4..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
Slice: Unordered, Open by value:type
.... property:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
..... value[x] 1..1 Value of the property
...... valueQuantity Quantity
...... valueCodeableConcept CodeableConcept
...... valueString string
...... valueBoolean boolean
...... valueInteger integer
...... valueRange Range
...... valueAttachment Attachment
.... property:ceMark S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ce-mark
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 boolean Value of the property
.... property:notifiedBody S 0..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: notified-body-id
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 string Value of the property
.... property:expectedLifetime S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: expected-lifetime
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 Quantity Value of the property
.... property:medicalPurpose S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: medical-purpose
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 string Value of the property
.... property:targetPopulation S 1..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: target-population
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 CodeableConcept Value of the property
... owner S 1..1 Reference(EU AI Responsible Organization) Healthcare provider responsible for the AI system
... contact S 2..* ContactPoint Manufacturer Contact AND DPO Contact Details
... note S 1..* Annotation Maintenance Requirements

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.identifier:euDatabaseId.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Device.identifier:euDatabaseId.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Device.status Base required FHIR Device Status 📍5.0.0 FHIR Std.
Device.name.type Base required Device Name Type 📍5.0.0 FHIR Std.
Device.conformsTo.specification Base example Device Specification Type 📍5.0.0 FHIR Std.
Device.property.type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:ceMark.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:notifiedBody.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:expectedLifetime.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:medicalPurpose.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:targetPopulation.​type Base example Device Property Type 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dev-1 error Device only one Device.name.display SHALL be true when there is more than one Device.name name.where(display=true).count() <= 1
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device 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-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dataTransfer S 1..1 (Complex) Third-Country Transfer Data
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/third-country-data-transfer
.... extension:modelCard S 1..1 Reference(DocumentReference) Model Card Reference
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ext-model-card
... Slices for identifier 1..* Identifier Instance identifier
Slice: Unordered, Open by value:type
.... identifier:euDatabaseId S 1..1 Identifier EU AI database registration identifier
..... type S 1..1 CodeableConcept Description of identifier
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: eu-ai-database-id
....... display 1..1 string Representation defined by the system
Fixed Value: EU AI Database Identifier
..... system S 1..1 uri The namespace for the identifier value
..... value S 1..1 string The value that is unique
... manufacturer S 1..1 string Name of the AI developer/manufacturer
.... value S 1..1 string System Name
... version S 1..* BackboneElement The actual design of the device or software version running on the device
.... value S 1..1 string System Version
... conformsTo S 1..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
.... specification 1..1 CodeableConcept QMS Certification
... Slices for property 4..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
Slice: Unordered, Open by value:type
.... property:ceMark S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ce-mark
..... value[x] 1..1 boolean Value of the property
.... property:notifiedBody S 0..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: notified-body-id
..... value[x] 1..1 string Value of the property
.... property:expectedLifetime S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: expected-lifetime
..... value[x] 1..1 Quantity Value of the property
.... property:medicalPurpose S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: medical-purpose
..... value[x] 1..1 string Value of the property
.... property:targetPopulation S 1..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: target-population
..... value[x] 1..1 CodeableConcept Value of the property
... owner S 1..1 Reference(EU AI Responsible Organization) Healthcare provider responsible for the AI system
... contact S 2..* ContactPoint Manufacturer Contact AND DPO Contact Details
... note S 1..* Annotation Maintenance Requirements

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* Device Item used in healthcare
Constraints: dev-1
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dataTransfer S 1..1 (Complex) Third-Country Transfer Data
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/third-country-data-transfer
.... extension:modelCard S 1..1 Reference(DocumentReference) Model Card Reference
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ext-model-card
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier 1..* Identifier Instance identifier
Slice: Unordered, Open by value:type
.... identifier:euDatabaseId S 1..1 Identifier EU AI database registration identifier
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type SΣ 1..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: eu-ai-database-id
....... display 1..1 string Representation defined by the system
Fixed Value: EU AI Database Identifier
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... displayName 0..1 string The name used to display by default when the device is referenced
... definition 0..1 CodeableReference(DeviceDefinition) The reference to the definition for the device
... udiCarrier Σ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ 1..1 string Mandatory fixed portion of UDI
.... issuer Σ 1..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!Σ 0..1 code active | inactive | entered-in-error
Binding: FHIRDeviceStatus (required): The record status of the device.
... availabilityStatus 0..1 CodeableConcept lost | damaged | destroyed | available
Binding: FHIRDeviceAvailabilityStatus (extensible): The availability status reason of the device.
... biologicalSourceEvent 0..1 Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
... manufacturer S 1..1 string Name of the AI developer/manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber 0..1 string Serial number assigned by the manufacturer
... name SC 1..* BackboneElement The name or names of the device as known to the manufacturer and/or patient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value SΣ 1..1 string System Name
.... type Σ 1..1 code registered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.
.... display ?!ΣC 0..1 boolean The preferred device name
... modelNumber 0..1 string The manufacturer's model number for the device
... partNumber 0..1 string The part number or catalog number of the device
... category 0..* CodeableConcept Indicates a high-level grouping of the device
Binding: FHIRDeviceCategory (example): Categories of medical devices.
... type 0..* CodeableConcept The kind or type of device
Binding: DeviceType (example): Codes to identify medical devices.
... version S 1..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
Binding: DeviceVersionType (example): The type of version indicated for the device.
.... component 0..1 Identifier The hardware or software module of the device to which the version applies
.... installDate 0..1 dateTime The date the version was installed on the device
.... value S 1..1 string System Version
... conformsTo S 1..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... category 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement
Binding: DeviceSpecificationCategory (example): The kind of standards used by the device.
.... specification 1..1 CodeableConcept QMS Certification
Binding: DeviceSpecificationType (example): The type of version indicated for the device.
.... version 0..1 string Specific form or variant of the standard
... Slices for property 4..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
Slice: Unordered, Open by value:type
.... property:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
..... value[x] 1..1 Value of the property
...... valueQuantity Quantity
...... valueCodeableConcept CodeableConcept
...... valueString string
...... valueBoolean boolean
...... valueInteger integer
...... valueRange Range
...... valueAttachment Attachment
.... property:ceMark S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ce-mark
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 boolean Value of the property
.... property:notifiedBody S 0..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: notified-body-id
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 string Value of the property
.... property:expectedLifetime S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: expected-lifetime
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 Quantity Value of the property
.... property:medicalPurpose S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: medical-purpose
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 string Value of the property
.... property:targetPopulation S 1..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: target-population
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 CodeableConcept Value of the property
... mode 0..1 CodeableConcept The designated condition for performing a task
Binding: FHIRDeviceOperationMode (example): Operational mode of a device.
... cycle 0..1 Count The series of occurrences that repeats during the operation of the device
... duration 0..1 Duration A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
... owner S 1..1 Reference(EU AI Responsible Organization) Healthcare provider responsible for the AI system
... contact S 2..* ContactPoint Manufacturer Contact AND DPO Contact Details
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... endpoint 0..* Reference(Endpoint) Technical endpoints providing access to electronic services provided by the device
... gateway 0..* CodeableReference(Device) Linked device acting as a communication/data collector, translator or controller
... note S 1..* Annotation Maintenance Requirements
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
Binding: DeviceSafety (example)
... parent 0..1 Reference(Device) The higher level or encompassing device that this device is a logical part of

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base required All Languages 📍5.0.0 FHIR Std.
Device.identifier:euDatabaseId.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Device.identifier:euDatabaseId.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Device.udiCarrier.entryType Base required UDI Entry Type 📍5.0.0 FHIR Std.
Device.status Base required FHIR Device Status 📍5.0.0 FHIR Std.
Device.availabilityStatus Base extensible FHIR Device Availability Status 📍5.0.0 FHIR Std.
Device.name.type Base required Device Name Type 📍5.0.0 FHIR Std.
Device.category Base example FHIR Device Category 📍5.0.0 FHIR Std.
Device.type Base example Device Type 📍5.0.0 FHIR Std.
Device.version.type Base example Device Version Type 📍5.0.0 FHIR Std.
Device.conformsTo.category Base example Device Specification Category 📍5.0.0 FHIR Std.
Device.conformsTo.specification Base example Device Specification Type 📍5.0.0 FHIR Std.
Device.property.type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:ceMark.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:notifiedBody.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:expectedLifetime.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:medicalPurpose.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:targetPopulation.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.mode Base example FHIR Device Operation Mode 📍5.0.0 FHIR Std.
Device.safety Base example Device Safety 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dev-1 error Device only one Device.name.display SHALL be true when there is more than one Device.name name.where(display=true).count() <= 1
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device 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-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from Device

Summary

Mandatory: 17 elements
Must-Support: 20 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Device.identifier
  • The element 1 is sliced based on the value of Device.property

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* Device Item used in healthcare
Constraints: dev-1
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dataTransfer S 1..1 (Complex) Third-Country Transfer Data
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/third-country-data-transfer
.... extension:modelCard S 1..1 Reference(DocumentReference) Model Card Reference
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ext-model-card
... Slices for identifier 1..* Identifier Instance identifier
Slice: Unordered, Open by value:type
.... identifier:euDatabaseId S 1..1 Identifier EU AI database registration identifier
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type SΣ 1..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: eu-ai-database-id
....... display 1..1 string Representation defined by the system
Fixed Value: EU AI Database Identifier
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣC 1..1 string The value that is unique
Example General: 123456
... status ?!Σ 0..1 code active | inactive | entered-in-error
Binding: FHIRDeviceStatus (required): The record status of the device.
... manufacturer S 1..1 string Name of the AI developer/manufacturer
... name SC 1..* BackboneElement The name or names of the device as known to the manufacturer and/or patient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value SΣ 1..1 string System Name
.... type Σ 1..1 code registered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.
.... display ?!ΣC 0..1 boolean The preferred device name
... version S 1..* BackboneElement The actual design of the device or software version running on the device
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value S 1..1 string System Version
... conformsTo S 1..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... specification 1..1 CodeableConcept QMS Certification
Binding: DeviceSpecificationType (example): The type of version indicated for the device.
... Slices for property 4..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
Slice: Unordered, Open by value:type
.... property:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
..... value[x] 1..1 Value of the property
...... valueQuantity Quantity
...... valueCodeableConcept CodeableConcept
...... valueString string
...... valueBoolean boolean
...... valueInteger integer
...... valueRange Range
...... valueAttachment Attachment
.... property:ceMark S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ce-mark
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 boolean Value of the property
.... property:notifiedBody S 0..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: notified-body-id
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 string Value of the property
.... property:expectedLifetime S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: expected-lifetime
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 Quantity Value of the property
.... property:medicalPurpose S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: medical-purpose
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 string Value of the property
.... property:targetPopulation S 1..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: target-population
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 CodeableConcept Value of the property
... owner S 1..1 Reference(EU AI Responsible Organization) Healthcare provider responsible for the AI system
... contact S 2..* ContactPoint Manufacturer Contact AND DPO Contact Details
... note S 1..* Annotation Maintenance Requirements

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.identifier:euDatabaseId.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Device.identifier:euDatabaseId.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Device.status Base required FHIR Device Status 📍5.0.0 FHIR Std.
Device.name.type Base required Device Name Type 📍5.0.0 FHIR Std.
Device.conformsTo.specification Base example Device Specification Type 📍5.0.0 FHIR Std.
Device.property.type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:ceMark.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:notifiedBody.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:expectedLifetime.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:medicalPurpose.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:targetPopulation.​type Base example Device Property Type 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dev-1 error Device only one Device.name.display SHALL be true when there is more than one Device.name name.where(display=true).count() <= 1
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device 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-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dataTransfer S 1..1 (Complex) Third-Country Transfer Data
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/third-country-data-transfer
.... extension:modelCard S 1..1 Reference(DocumentReference) Model Card Reference
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ext-model-card
... Slices for identifier 1..* Identifier Instance identifier
Slice: Unordered, Open by value:type
.... identifier:euDatabaseId S 1..1 Identifier EU AI database registration identifier
..... type S 1..1 CodeableConcept Description of identifier
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: eu-ai-database-id
....... display 1..1 string Representation defined by the system
Fixed Value: EU AI Database Identifier
..... system S 1..1 uri The namespace for the identifier value
..... value S 1..1 string The value that is unique
... manufacturer S 1..1 string Name of the AI developer/manufacturer
.... value S 1..1 string System Name
... version S 1..* BackboneElement The actual design of the device or software version running on the device
.... value S 1..1 string System Version
... conformsTo S 1..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
.... specification 1..1 CodeableConcept QMS Certification
... Slices for property 4..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
Slice: Unordered, Open by value:type
.... property:ceMark S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ce-mark
..... value[x] 1..1 boolean Value of the property
.... property:notifiedBody S 0..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: notified-body-id
..... value[x] 1..1 string Value of the property
.... property:expectedLifetime S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: expected-lifetime
..... value[x] 1..1 Quantity Value of the property
.... property:medicalPurpose S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: medical-purpose
..... value[x] 1..1 string Value of the property
.... property:targetPopulation S 1..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... type 1..1 CodeableConcept Code that specifies the property being represented
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: target-population
..... value[x] 1..1 CodeableConcept Value of the property
... owner S 1..1 Reference(EU AI Responsible Organization) Healthcare provider responsible for the AI system
... contact S 2..* ContactPoint Manufacturer Contact AND DPO Contact Details
... note S 1..* Annotation Maintenance Requirements

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* Device Item used in healthcare
Constraints: dev-1
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dataTransfer S 1..1 (Complex) Third-Country Transfer Data
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/third-country-data-transfer
.... extension:modelCard S 1..1 Reference(DocumentReference) Model Card Reference
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ext-model-card
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier 1..* Identifier Instance identifier
Slice: Unordered, Open by value:type
.... identifier:euDatabaseId S 1..1 Identifier EU AI database registration identifier
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type SΣ 1..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: eu-ai-database-id
....... display 1..1 string Representation defined by the system
Fixed Value: EU AI Database Identifier
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... displayName 0..1 string The name used to display by default when the device is referenced
... definition 0..1 CodeableReference(DeviceDefinition) The reference to the definition for the device
... udiCarrier Σ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ 1..1 string Mandatory fixed portion of UDI
.... issuer Σ 1..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!Σ 0..1 code active | inactive | entered-in-error
Binding: FHIRDeviceStatus (required): The record status of the device.
... availabilityStatus 0..1 CodeableConcept lost | damaged | destroyed | available
Binding: FHIRDeviceAvailabilityStatus (extensible): The availability status reason of the device.
... biologicalSourceEvent 0..1 Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
... manufacturer S 1..1 string Name of the AI developer/manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber 0..1 string Serial number assigned by the manufacturer
... name SC 1..* BackboneElement The name or names of the device as known to the manufacturer and/or patient
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value SΣ 1..1 string System Name
.... type Σ 1..1 code registered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.
.... display ?!ΣC 0..1 boolean The preferred device name
... modelNumber 0..1 string The manufacturer's model number for the device
... partNumber 0..1 string The part number or catalog number of the device
... category 0..* CodeableConcept Indicates a high-level grouping of the device
Binding: FHIRDeviceCategory (example): Categories of medical devices.
... type 0..* CodeableConcept The kind or type of device
Binding: DeviceType (example): Codes to identify medical devices.
... version S 1..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
Binding: DeviceVersionType (example): The type of version indicated for the device.
.... component 0..1 Identifier The hardware or software module of the device to which the version applies
.... installDate 0..1 dateTime The date the version was installed on the device
.... value S 1..1 string System Version
... conformsTo S 1..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... category 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement
Binding: DeviceSpecificationCategory (example): The kind of standards used by the device.
.... specification 1..1 CodeableConcept QMS Certification
Binding: DeviceSpecificationType (example): The type of version indicated for the device.
.... version 0..1 string Specific form or variant of the standard
... Slices for property 4..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
Slice: Unordered, Open by value:type
.... property:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
..... value[x] 1..1 Value of the property
...... valueQuantity Quantity
...... valueCodeableConcept CodeableConcept
...... valueString string
...... valueBoolean boolean
...... valueInteger integer
...... valueRange Range
...... valueAttachment Attachment
.... property:ceMark S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ce-mark
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 boolean Value of the property
.... property:notifiedBody S 0..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: notified-body-id
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 string Value of the property
.... property:expectedLifetime S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: expected-lifetime
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 Quantity Value of the property
.... property:medicalPurpose S 1..1 BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: medical-purpose
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 string Value of the property
.... property:targetPopulation S 1..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: DeviceType (example): Device property type.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: target-population
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] 1..1 CodeableConcept Value of the property
... mode 0..1 CodeableConcept The designated condition for performing a task
Binding: FHIRDeviceOperationMode (example): Operational mode of a device.
... cycle 0..1 Count The series of occurrences that repeats during the operation of the device
... duration 0..1 Duration A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
... owner S 1..1 Reference(EU AI Responsible Organization) Healthcare provider responsible for the AI system
... contact S 2..* ContactPoint Manufacturer Contact AND DPO Contact Details
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... endpoint 0..* Reference(Endpoint) Technical endpoints providing access to electronic services provided by the device
... gateway 0..* CodeableReference(Device) Linked device acting as a communication/data collector, translator or controller
... note S 1..* Annotation Maintenance Requirements
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
Binding: DeviceSafety (example)
... parent 0..1 Reference(Device) The higher level or encompassing device that this device is a logical part of

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base required All Languages 📍5.0.0 FHIR Std.
Device.identifier:euDatabaseId.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Device.identifier:euDatabaseId.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Device.udiCarrier.entryType Base required UDI Entry Type 📍5.0.0 FHIR Std.
Device.status Base required FHIR Device Status 📍5.0.0 FHIR Std.
Device.availabilityStatus Base extensible FHIR Device Availability Status 📍5.0.0 FHIR Std.
Device.name.type Base required Device Name Type 📍5.0.0 FHIR Std.
Device.category Base example FHIR Device Category 📍5.0.0 FHIR Std.
Device.type Base example Device Type 📍5.0.0 FHIR Std.
Device.version.type Base example Device Version Type 📍5.0.0 FHIR Std.
Device.conformsTo.category Base example Device Specification Category 📍5.0.0 FHIR Std.
Device.conformsTo.specification Base example Device Specification Type 📍5.0.0 FHIR Std.
Device.property.type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:ceMark.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:notifiedBody.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:expectedLifetime.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:medicalPurpose.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.property:targetPopulation.​type Base example Device Property Type 📍5.0.0 FHIR Std.
Device.mode Base example FHIR Device Operation Mode 📍5.0.0 FHIR Std.
Device.safety Base example Device Safety 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dev-1 error Device only one Device.name.display SHALL be true when there is more than one Device.name name.where(display=true).count() <= 1
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device 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-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from Device

Summary

Mandatory: 17 elements
Must-Support: 20 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Device.identifier
  • The element 1 is sliced based on the value of Device.property

 

Other representations of profile: CSV, Excel, Schematron