Profile Comparison between http://hl7.org/fhir/uv/aitransparency/StructureDefinition/AI-Device vs http://hl7.org/fhir/uv/aitransparency/StructureDefinition/AI-Device

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/Device
copyright
date	2025-12-09T18:35:29+00:00	2026-10-06T22:37:01+00:00	Values Differ
description	A Device that represents an AI system, such as a Large Language Model (LLM) or other AI model. This profile includes a recommended set of codes for Device.type to indicate the type of AI system. The extension AIKind is used to specify the more specific kind(s) of AI technology and techniques employed by the AI system. The extension ModelCardDescription is used to reference a Model-Card that is always used with the AI system.	A Device that represents an AI system, such as a Large Language Model (LLM) or other AI model. This profile requires Device.type to be `Artificial-Intelligence`. The extension AIKind is used to specify the more specific kind(s) of AI technology and techniques employed by the AI system. The extension ModelCardDescription is used to reference a Model-Card that is always used with the AI system.	Values Differ
experimental
fhirVersion	4.0.1
jurisdiction
jurisdiction / jurisdiction[0]	http://unstats.un.org/unsd/methods/m49/m49.htm#001
kind	resource
name	AIDevice
publisher	HL7 International / Electronic Health Records
purpose
status	active
title	AI Device
type	Device
url	http://hl7.org/fhir/uv/aitransparency/StructureDefinition/AI-Device
version	1.0.0-ballot	1.0.0-current	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	R Type	R Description & Constraints	Comments
Device		0..*	Device	Item used in healthcare		0..*	Device	Item used in healthcare
Device.id	Σ This element is included in summaries.	0..1	id	Logical id of this artifact	Σ This element is included in summaries.	0..1	id	Logical id of this artifact
Device.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
Device.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Device.language		0..1	code	Language of the resource content Binding: ?? (preferred): A human language. Additional Bindings Purpose ?? Max Binding		0..1	code	Language of the resource content Binding: ?? (preferred): A human language. Additional Bindings Purpose ?? Max Binding
Device.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		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
Device.contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
Device.Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them		0..*	Extension	Extension Slice: Unordered, Open by value:url Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Device.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Device.identifier	S This element must be supported.	0..*	Identifier	Instance identifier	S This element must be supported.	0..*	Identifier	Instance identifier
Device.definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
Device.udiCarrier	Σ This element is included in summaries.	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string	Σ This element is included in summaries.	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
Device.udiCarrier.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.udiCarrier.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.udiCarrier.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.udiCarrier.deviceIdentifier	Σ This element is included in summaries.	0..1	string	Mandatory fixed portion of UDI	Σ This element is included in summaries.	0..1	string	Mandatory fixed portion of UDI
Device.udiCarrier.issuer		0..1	uri	UDI Issuing Organization		0..1	uri	UDI Issuing Organization
Device.udiCarrier.jurisdiction		0..1	uri	Regional UDI authority		0..1	uri	Regional UDI authority
Device.udiCarrier.carrierAIDC	Σ This element is included in summaries.	0..1	base64Binary	UDI Machine Readable Barcode String	Σ This element is included in summaries.	0..1	base64Binary	UDI Machine Readable Barcode String
Device.udiCarrier.carrierHRF	Σ This element is included in summaries.	0..1	string	UDI Human Readable Barcode String	Σ This element is included in summaries.	0..1	string	UDI Human Readable Barcode String
Device.udiCarrier.entryType		0..1	code	barcode | rfid | manual + Binding: ?? (required): Codes to identify how UDI data was entered.		0..1	code	barcode | rfid | manual + Binding: ?? (required): Codes to identify how UDI data was entered.
Device.status	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	active | inactive | entered-in-error | unknown Binding: ?? (required): The availability status of the device.	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	active | inactive | entered-in-error | unknown Binding: ?? (required): The availability status of the device.
Device.statusReason		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: ?? (extensible): The availability status reason of the device.		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: ?? (extensible): The availability status reason of the device.
Device.distinctIdentifier		0..1	string	The distinct identification string		0..1	string	The distinct identification string
Device.manufacturer	S This element must be supported.	0..1	string	Name of device manufacturer	S This element must be supported.	0..1	string	Name of device manufacturer
Device.manufactureDate	S This element must be supported.	0..1	dateTime	Date when the device was made	S This element must be supported.	0..1	dateTime	Date when the device was made
Device.expirationDate		0..1	dateTime	Date and time of expiry of this device (if applicable)		0..1	dateTime	Date and time of expiry of this device (if applicable)
Device.lotNumber		0..1	string	Lot number of manufacture		0..1	string	Lot number of manufacture
Device.serialNumber		0..1	string	Serial number assigned by the manufacturer		0..1	string	Serial number assigned by the manufacturer
Device.deviceName	S This element must be supported.	0..*	BackboneElement	The name of the device as given by the manufacturer	S This element must be supported.	0..*	BackboneElement	The name of the device as given by the manufacturer
Device.deviceName.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.deviceName.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.deviceName.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.deviceName.name		1..1	string	The name of the device		1..1	string	The name of the device
Device.deviceName.type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: ?? (required): The type of name the device is referred by.		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: ?? (required): The type of name the device is referred by.
Device.modelNumber	S This element must be supported.	0..1	string	The model number for the device	S This element must be supported.	0..1	string	The model number for the device
Device.partNumber		0..1	string	The part number of the device		0..1	string	The part number of the device
Device.type		1..1	CodeableConcept	The kind or type of device Binding: ?? (example): Codes to identify medical devices. Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS","code":"Artificial-Intelligence"}]}		1..1	CodeableConcept	The kind or type of device Binding: ?? (example): Codes to identify medical devices. Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS","code":"Artificial-Intelligence"}]}
Device.specialization		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
Device.specialization.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.specialization.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.specialization.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.specialization.systemType		1..1	CodeableConcept	The standard that is used to operate and communicate		1..1	CodeableConcept	The standard that is used to operate and communicate
Device.specialization.version		0..1	string	The version of the standard that is used to operate and communicate		0..1	string	The version of the standard that is used to operate and communicate
Device.version	S This element must be supported.	0..*	BackboneElement	The actual design of the device or software version running on the device	S This element must be supported.	0..*	BackboneElement	The actual design of the device or software version running on the device
Device.version.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.version.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.version.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.version.type		0..1	CodeableConcept	The type of the device version		0..1	CodeableConcept	The type of the device version
Device.version.component		0..1	Identifier	A single component of the device version		0..1	Identifier	A single component of the device version
Device.version.value		1..1	string	The version text		1..1	string	The version text
Device.property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
Device.property.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.property.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.property.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.property.type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
Device.property.valueQuantity		0..*	Quantity	Property value as a quantity		0..*	Quantity	Property value as a quantity
Device.property.valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
Device.patient		0..1	Reference(Patient)	Patient to whom Device is affixed		0..1	Reference(Patient)	Patient to whom Device is affixed
Device.owner	S This element must be supported.	0..1	Reference(Organization)	Organization responsible for device	S This element must be supported.	0..1	Reference(Organization)	Organization responsible for device
Device.contact	S This element must be supported.	0..*	ContactPoint	Details for human/organization for support	S This element must be supported.	0..*	ContactPoint	Details for human/organization for support
Device.location		0..1	Reference(Location)	Where the device is found		0..1	Reference(Location)	Where the device is found
Device.url	S This element must be supported.	0..1	uri	Network address to contact device	S This element must be supported.	0..1	uri	Network address to contact device
Device.note	S This element must be supported.	0..*	Annotation	Device notes and comments		0..*	Annotation	Device notes and comments	Elements differ in definition for mustSupport: 'true' vs 'false'
Device.safety	S This element must be supported. Σ This element is included in summaries.	0..*	CodeableConcept	Safety Characteristics of Device	S This element must be supported. Σ This element is included in summaries.	0..*	CodeableConcept	Safety Characteristics of Device
Device.parent		0..1	Reference(Device)	The parent device		0..1	Reference(Device)	The parent device
Documentation for this format