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

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: Trust AI System Device

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

Usages:

• Refer to this Profile: Trust AI Execution Audit Event, Trust AI Generated Observation and Trust AI Provenance
• Examples for this Profile: Device/device-riskassist-ai and Device/dr-ai-device

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.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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		3..*	Extension	Extension Slice: Unordered, Open by value:url
extension:modelCard	S	1..1	Reference(Trust AI Model Card)	Reference to the AI model card URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card
extension:dataTransfer	S	1..1	(Complex)	Third-Country Transfer Data URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer
extension:conformityDeclaration	S	1..1	Reference(DocumentReference)	Reference to the EU Conformity Declaration URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference
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 database registration number
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	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/trust-ai-transparency/CodeSystem/trust-ai-identifier-type-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: trust-ai-registration-number
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
system	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	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 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	Σ	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		1..1	string	System Version
conformsTo	S	0..*	BackboneElement	Applicable standards and certifications
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
specification	S	1..1	CodeableConcept	Standard, specification, or 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	CE marking status
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:notifiedBody	S	0..1	BackboneElement	Notified body identification number
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:expectedLifetime	S	1..1	BackboneElement	Expected system lifetime
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:intendedPurpose	S	1..1	BackboneElement	Intended purpose
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: intended-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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:targetPopulation	S	1..*	BackboneElement	Target population
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
owner	S	1..1	Reference(Trust AI Responsible Organization)	Organization responsible for the AI system
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:intendedPurpose.​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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
Slices for extension		3..*	Extension	Extension Slice: Unordered, Open by value:url
extension:modelCard	S	1..1	Reference(Trust AI Model Card)	Reference to the AI model card URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card
extension:dataTransfer	S	1..1	(Complex)	Third-Country Transfer Data URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer
extension:conformityDeclaration	S	1..1	Reference(DocumentReference)	Reference to the EU Conformity Declaration URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference
Slices for identifier		1..*	Identifier	Instance identifier Slice: Unordered, Open by value:type
identifier:euDatabaseId	S	1..1	Identifier	EU database registration number
type		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/trust-ai-transparency/CodeSystem/trust-ai-identifier-type-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: trust-ai-registration-number
system		1..1	uri	The namespace for the identifier value
value		1..1	string	The value that is unique
manufacturer	S	1..1	string	Name of the AI manufacturer
name	S	1..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient
value		1..1	string	System Name
version	S	1..*	BackboneElement	The actual design of the device or software version running on the device
value		1..1	string	System Version
conformsTo	S	0..*	BackboneElement	Applicable standards and certifications
specification	S	1..1	CodeableConcept	Standard, specification, or 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	CE marking status
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ce-mark
property:notifiedBody	S	0..1	BackboneElement	Notified body identification number
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: notified-body-id
property:expectedLifetime	S	1..1	BackboneElement	Expected system lifetime
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: expected-lifetime
property:intendedPurpose	S	1..1	BackboneElement	Intended purpose
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: intended-purpose
property:targetPopulation	S	1..*	BackboneElement	Target population
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: target-population
owner	S	1..1	Reference(Trust AI Responsible Organization)	Organization responsible for the AI system
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Bindings Purpose 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		3..*	Extension	Extension Slice: Unordered, Open by value:url
extension:modelCard	S	1..1	Reference(Trust AI Model Card)	Reference to the AI model card URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card
extension:dataTransfer	S	1..1	(Complex)	Third-Country Transfer Data URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer
extension:conformityDeclaration	S	1..1	Reference(DocumentReference)	Reference to the EU Conformity Declaration URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference
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 database registration number
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	Σ	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/trust-ai-transparency/CodeSystem/trust-ai-identifier-type-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: trust-ai-registration-number
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
system	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	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 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	Σ	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		1..1	string	System Version
conformsTo	S	0..*	BackboneElement	Applicable standards and certifications
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	S	1..1	CodeableConcept	Standard, specification, or 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	CE marking status
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:notifiedBody	S	0..1	BackboneElement	Notified body identification number
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:expectedLifetime	S	1..1	BackboneElement	Expected system lifetime
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:intendedPurpose	S	1..1	BackboneElement	Intended purpose
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: intended-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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:targetPopulation	S	1..*	BackboneElement	Target population
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
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(Trust AI Responsible Organization)	Organization responsible for the AI system
contact		0..*	ContactPoint	Details for human/organization for support
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		0..*	Annotation	Device notes and comments
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
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:intendedPurpose.​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: 16 elements
Must-Support: 15 elements

Structures

This structure refers to these other structures:

• Trust AI Responsible Organization (http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-organization)

Extensions

This structure refers to these extensions:

• http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card
• http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer
• http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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		3..*	Extension	Extension Slice: Unordered, Open by value:url
extension:modelCard	S	1..1	Reference(Trust AI Model Card)	Reference to the AI model card URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card
extension:dataTransfer	S	1..1	(Complex)	Third-Country Transfer Data URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer
extension:conformityDeclaration	S	1..1	Reference(DocumentReference)	Reference to the EU Conformity Declaration URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference
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 database registration number
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	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/trust-ai-transparency/CodeSystem/trust-ai-identifier-type-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: trust-ai-registration-number
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
system	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	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 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	Σ	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		1..1	string	System Version
conformsTo	S	0..*	BackboneElement	Applicable standards and certifications
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
specification	S	1..1	CodeableConcept	Standard, specification, or 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	CE marking status
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:notifiedBody	S	0..1	BackboneElement	Notified body identification number
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:expectedLifetime	S	1..1	BackboneElement	Expected system lifetime
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:intendedPurpose	S	1..1	BackboneElement	Intended purpose
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: intended-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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:targetPopulation	S	1..*	BackboneElement	Target population
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
owner	S	1..1	Reference(Trust AI Responsible Organization)	Organization responsible for the AI system
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:intendedPurpose.​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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
Slices for extension		3..*	Extension	Extension Slice: Unordered, Open by value:url
extension:modelCard	S	1..1	Reference(Trust AI Model Card)	Reference to the AI model card URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card
extension:dataTransfer	S	1..1	(Complex)	Third-Country Transfer Data URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer
extension:conformityDeclaration	S	1..1	Reference(DocumentReference)	Reference to the EU Conformity Declaration URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference
Slices for identifier		1..*	Identifier	Instance identifier Slice: Unordered, Open by value:type
identifier:euDatabaseId	S	1..1	Identifier	EU database registration number
type		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/trust-ai-transparency/CodeSystem/trust-ai-identifier-type-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: trust-ai-registration-number
system		1..1	uri	The namespace for the identifier value
value		1..1	string	The value that is unique
manufacturer	S	1..1	string	Name of the AI manufacturer
name	S	1..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient
value		1..1	string	System Name
version	S	1..*	BackboneElement	The actual design of the device or software version running on the device
value		1..1	string	System Version
conformsTo	S	0..*	BackboneElement	Applicable standards and certifications
specification	S	1..1	CodeableConcept	Standard, specification, or 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	CE marking status
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ce-mark
property:notifiedBody	S	0..1	BackboneElement	Notified body identification number
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: notified-body-id
property:expectedLifetime	S	1..1	BackboneElement	Expected system lifetime
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: expected-lifetime
property:intendedPurpose	S	1..1	BackboneElement	Intended purpose
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: intended-purpose
property:targetPopulation	S	1..*	BackboneElement	Target population
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
code		1..1	code	Symbol in syntax defined by the system Fixed Value: target-population
owner	S	1..1	Reference(Trust AI Responsible Organization)	Organization responsible for the AI system
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Bindings Purpose 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		3..*	Extension	Extension Slice: Unordered, Open by value:url
extension:modelCard	S	1..1	Reference(Trust AI Model Card)	Reference to the AI model card URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card
extension:dataTransfer	S	1..1	(Complex)	Third-Country Transfer Data URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer
extension:conformityDeclaration	S	1..1	Reference(DocumentReference)	Reference to the EU Conformity Declaration URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference
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 database registration number
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	Σ	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/trust-ai-transparency/CodeSystem/trust-ai-identifier-type-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: trust-ai-registration-number
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
system	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	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 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	Σ	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		1..1	string	System Version
conformsTo	S	0..*	BackboneElement	Applicable standards and certifications
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	S	1..1	CodeableConcept	Standard, specification, or 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	CE marking status
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:notifiedBody	S	0..1	BackboneElement	Notified body identification number
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:expectedLifetime	S	1..1	BackboneElement	Expected system lifetime
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:intendedPurpose	S	1..1	BackboneElement	Intended purpose
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: intended-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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
property:targetPopulation	S	1..*	BackboneElement	Target population
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/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs
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		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
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(Trust AI Responsible Organization)	Organization responsible for the AI system
contact		0..*	ContactPoint	Details for human/organization for support
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		0..*	Annotation	Device notes and comments
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
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:intendedPurpose.​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: 16 elements
Must-Support: 15 elements

Structures

This structure refers to these other structures:

• Trust AI Responsible Organization (http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-organization)

Extensions

This structure refers to these extensions:

• http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card
• http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer
• http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference

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