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	2026-07-23T15:08:33+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.
experimental
fhirVersion	4.0.1
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
id	Σ	0..1	id	Logical id of this artifact	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created
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
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
contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored	?!	0..*	Extension	Extensions that cannot be ignored
identifier	S	0..*	Identifier	Instance identifier	S	0..*	Identifier	Instance identifier
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
udiCarrier	Σ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string	Σ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
deviceIdentifier	Σ	0..1	string	Mandatory fixed portion of UDI	Σ	0..1	string	Mandatory fixed portion of UDI
issuer		0..1	uri	UDI Issuing Organization		0..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	Σ	0..1	string	UDI Human Readable Barcode String	Σ	0..1	string	UDI Human Readable Barcode String
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.
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: ?? (required): The availability status of the device.	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: ?? (required): The availability status of the 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.
distinctIdentifier		0..1	string	The distinct identification string		0..1	string	The distinct identification string
manufacturer	S	0..1	string	Name of device manufacturer	S	0..1	string	Name of device manufacturer
manufactureDate	S	0..1	dateTime	Date when the device was made	S	0..1	dateTime	Date when the device was made
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)
lotNumber		0..1	string	Lot number of manufacture		0..1	string	Lot number of manufacture
serialNumber		0..1	string	Serial number assigned by the manufacturer		0..1	string	Serial number assigned by the manufacturer
deviceName	S	0..*	BackboneElement	The name of the device as given by the manufacturer	S	0..*	BackboneElement	The name of the device as given by the manufacturer
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		1..1	string	The name of the device		1..1	string	The name of the device
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.
modelNumber	S	0..1	string	The model number for the device	S	0..1	string	The model number for the device
partNumber		0..1	string	The part number of the device		0..1	string	The part number of the 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"}]}
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
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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
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
version	S	0..*	BackboneElement	The actual design of the device or software version running on the device	S	0..*	BackboneElement	The actual design of the device or software version running on the device
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	CodeableConcept	The type of the device version		0..1	CodeableConcept	The type of the device version
component		0..1	Identifier	A single component of the device version		0..1	Identifier	A single component of the device version
value		1..1	string	The version text		1..1	string	The version text
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
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
valueQuantity		0..*	Quantity	Property value as a quantity		0..*	Quantity	Property value as a quantity
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)
patient		0..1	Reference(Patient)	Patient to whom Device is affixed		0..1	Reference(Patient)	Patient to whom Device is affixed
owner	S	0..1	Reference(Organization)	Organization responsible for device	S	0..1	Reference(Organization)	Organization responsible for device
contact	S	0..*	ContactPoint	Details for human/organization for support	S	0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found		0..1	Reference(Location)	Where the device is found
url	S	0..1	uri	Network address to contact device	S	0..1	uri	Network address to contact device
note	S	0..*	Annotation	Device notes and comments	S	0..*	Annotation	Device notes and comments
safety	SΣ	0..*	CodeableConcept	Safety Characteristics of Device	SΣ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device)	The parent device		0..1	Reference(Device)	The parent device
Documentation for this format