AI Transparency on FHIR
1.0.0-current - STU1 Ballot
AI Transparency on FHIR
1.0.0-current - STU1 Ballot
AI Transparency on FHIR, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 1.0.0-current built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/aitransparency-ig/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/AI-Device | Version: 1.0.0-current | ||||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: AIDevice | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.79.42.1 | |||||
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.
Usages:
You can also check for usages in the FHIR IG Statistics
Description Differentials, Snapshots, and other representations.
| Name | Flags | Card. | Type | Description & Constraints Filter:  |
|---|---|---|---|---|
  Device |
0..* | Device | Item used in healthcare | |
  implicitRules |
0..1 | uri | A set of rules under which this content was created | |
  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 | |
   extension:aiKind |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device type codes for Artificial Intelligence (preferred) | |
 extension:modelCardDescription |
0..* | Reference(AI Model-Card DocumentReference) | Model-Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |
 modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |
 identifier |
0..* | Identifier | Instance identifier | |
| status |
0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | |
| manufacturer |
0..1 | string | Name of device manufacturer | |
| manufactureDate |
0..1 | dateTime | Date when the device was made | |
| deviceName |
0..* | BackboneElement | The name of the device as given by the manufacturer | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| name |
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: DeviceNameType (required): The type of name the device is referred by. | |
| modelNumber |
0..1 | string | The model number for the device | |
| type |
1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. 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://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |
| version |
0..1 | string | Version of the system - if relevant | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |
| 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 | |
| version |
0..* | BackboneElement | The actual design of the device or software version running on the device | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| value |
1..1 | string | The version text | |
 owner |
0..1 | Reference(Organization) | Organization responsible for device | |
| contact |
0..* | ContactPoint | Details for human/organization for support | |
| url |
0..1 | uri | Network address to contact device | |
| safety |
0..* | CodeableConcept | Safety Characteristics of Device | |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | example | Device Type | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-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: |
|---|---|---|---|---|
| Device |
0..* | Device | Item used in healthcare | |
| 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 | |
| extension:aiKind |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device type codes for Artificial Intelligence (preferred) | |
| extension:modelCardDescription |
0..* | Reference(AI Model-Card DocumentReference) | Model-Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |
 identifier |
0..* | Identifier | Instance identifier | |
| manufacturer |
0..1 | string | Name of device manufacturer | |
| manufactureDate |
0..1 | dateTime | Date when the device was made | |
| deviceName |
0..* | BackboneElement | The name of the device as given by the manufacturer | |
| modelNumber |
0..1 | string | The model number for the device | |
| type |
1..1 | CodeableConcept | The kind or type of device 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://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |
| version |
0..* | BackboneElement | The actual design of the device or software version running on the device | |
| owner |
0..1 | Reference(Organization) | Organization responsible for device | |
| contact |
0..* | ContactPoint | Details for human/organization for support | |
| url |
0..1 | uri | Network address to contact device | |
| safety |
0..* | CodeableConcept | Safety Characteristics of Device | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| Device |
0..* | Device | Item used in healthcare | |||||
| id |
0..1 | id | Logical id of this artifact | |||||
| meta |
0..1 | Meta | Metadata about the resource | |||||
| implicitRules |
0..1 | uri | A set of rules under which this content was created | |||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| 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 |
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 | |||||
| extension:aiKind |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device type codes for Artificial Intelligence (preferred) | |||||
| extension:modelCardDescription |
0..* | Reference(AI Model-Card DocumentReference) | Model-Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |||||
| identifier |
0..* | Identifier | Instance identifier | |||||
| definition |
0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
| udiCarrier |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| deviceIdentifier |
0..1 | string | Mandatory fixed portion of UDI | |||||
| issuer |
0..1 | uri | UDI Issuing Organization | |||||
| jurisdiction |
0..1 | uri | Regional UDI authority | |||||
| carrierAIDC |
0..1 | base64Binary | UDI Machine Readable Barcode String | |||||
| carrierHRF |
0..1 | string | UDI Human Readable Barcode String | |||||
| entryType |
0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
| status |
0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | |||||
| statusReason |
0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
| distinctIdentifier |
0..1 | string | The distinct identification string | |||||
| manufacturer |
0..1 | string | Name of device 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 | |||||
| deviceName |
0..* | BackboneElement | The name of the device as given by the manufacturer | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| name |
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: DeviceNameType (required): The type of name the device is referred by. | |||||
| modelNumber |
0..1 | string | The model number for the device | |||||
| partNumber |
0..1 | string | The part number of the device | |||||
| type |
1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. 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://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |||||
| 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 | |||||
| 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 | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| systemType |
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 | |||||
| version |
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 | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| type |
0..1 | CodeableConcept | The type of the device version | |||||
| component |
0..1 | Identifier | A single component of the device version | |||||
| value |
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 | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| type |
1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
| valueQuantity |
0..* | Quantity | Property value as a quantity | |||||
| valueCode |
0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
| patient |
0..1 | Reference(Patient) | Patient to whom Device is affixed | |||||
| owner |
0..1 | Reference(Organization) | Organization responsible for device | |||||
| 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 | |||||
| note |
0..* | Annotation | Device notes and comments | |||||
| safety |
0..* | CodeableConcept | Safety Characteristics of Device | |||||
| parent |
0..1 | Reference(Device) | The parent device | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| Device.udiCarrier.entryType | Base | required | UDIEntryType | 📍4.0.1 | FHIR Std. |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.statusReason | Base | extensible | FHIRDeviceStatusReason | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | example | Device Type | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-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: 1 element
Must-Support: 10 elements
Extensions
This structure refers to these extensions:
Maturity: 2
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Device |
0..* | Device | Item used in healthcare | |
| implicitRules |
0..1 | uri | A set of rules under which this content was created | |
| 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 | |
| extension:aiKind |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device type codes for Artificial Intelligence (preferred) | |
| extension:modelCardDescription |
0..* | Reference(AI Model-Card DocumentReference) | Model-Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |
| identifier |
0..* | Identifier | Instance identifier | |
| status |
0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | |
| manufacturer |
0..1 | string | Name of device manufacturer | |
| manufactureDate |
0..1 | dateTime | Date when the device was made | |
| deviceName |
0..* | BackboneElement | The name of the device as given by the manufacturer | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| name |
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: DeviceNameType (required): The type of name the device is referred by. | |
| modelNumber |
0..1 | string | The model number for the device | |
| type |
1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. 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://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |
| version |
0..1 | string | Version of the system - if relevant | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |
| 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 | |
| version |
0..* | BackboneElement | The actual design of the device or software version running on the device | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| value |
1..1 | string | The version text | |
| owner |
0..1 | Reference(Organization) | Organization responsible for device | |
| contact |
0..* | ContactPoint | Details for human/organization for support | |
| url |
0..1 | uri | Network address to contact device | |
| safety |
0..* | CodeableConcept | Safety Characteristics of Device | |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | example | Device Type | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-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: |
|---|---|---|---|---|
| Device |
0..* | Device | Item used in healthcare | |
| 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 | |
| extension:aiKind |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device type codes for Artificial Intelligence (preferred) | |
| extension:modelCardDescription |
0..* | Reference(AI Model-Card DocumentReference) | Model-Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |
| identifier |
0..* | Identifier | Instance identifier | |
| manufacturer |
0..1 | string | Name of device manufacturer | |
| manufactureDate |
0..1 | dateTime | Date when the device was made | |
| deviceName |
0..* | BackboneElement | The name of the device as given by the manufacturer | |
| modelNumber |
0..1 | string | The model number for the device | |
| type |
1..1 | CodeableConcept | The kind or type of device 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://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |
| version |
0..* | BackboneElement | The actual design of the device or software version running on the device | |
| owner |
0..1 | Reference(Organization) | Organization responsible for device | |
| contact |
0..* | ContactPoint | Details for human/organization for support | |
| url |
0..1 | uri | Network address to contact device | |
| safety |
0..* | CodeableConcept | Safety Characteristics of Device | |
| Documentation for this format | ||||
Snapshot ViewView
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| Device |
0..* | Device | Item used in healthcare | |||||
| id |
0..1 | id | Logical id of this artifact | |||||
| meta |
0..1 | Meta | Metadata about the resource | |||||
| implicitRules |
0..1 | uri | A set of rules under which this content was created | |||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| 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 |
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 | |||||
| extension:aiKind |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device type codes for Artificial Intelligence (preferred) | |||||
| extension:modelCardDescription |
0..* | Reference(AI Model-Card DocumentReference) | Model-Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |||||
| identifier |
0..* | Identifier | Instance identifier | |||||
| definition |
0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
| udiCarrier |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| deviceIdentifier |
0..1 | string | Mandatory fixed portion of UDI | |||||
| issuer |
0..1 | uri | UDI Issuing Organization | |||||
| jurisdiction |
0..1 | uri | Regional UDI authority | |||||
| carrierAIDC |
0..1 | base64Binary | UDI Machine Readable Barcode String | |||||
| carrierHRF |
0..1 | string | UDI Human Readable Barcode String | |||||
| entryType |
0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
| status |
0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | |||||
| statusReason |
0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
| distinctIdentifier |
0..1 | string | The distinct identification string | |||||
| manufacturer |
0..1 | string | Name of device 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 | |||||
| deviceName |
0..* | BackboneElement | The name of the device as given by the manufacturer | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| name |
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: DeviceNameType (required): The type of name the device is referred by. | |||||
| modelNumber |
0..1 | string | The model number for the device | |||||
| partNumber |
0..1 | string | The part number of the device | |||||
| type |
1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. 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://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |||||
| 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 | |||||
| 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 | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| systemType |
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 | |||||
| version |
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 | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| type |
0..1 | CodeableConcept | The type of the device version | |||||
| component |
0..1 | Identifier | A single component of the device version | |||||
| value |
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 | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| type |
1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
| valueQuantity |
0..* | Quantity | Property value as a quantity | |||||
| valueCode |
0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
| patient |
0..1 | Reference(Patient) | Patient to whom Device is affixed | |||||
| owner |
0..1 | Reference(Organization) | Organization responsible for device | |||||
| 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 | |||||
| note |
0..* | Annotation | Device notes and comments | |||||
| safety |
0..* | CodeableConcept | Safety Characteristics of Device | |||||
| parent |
0..1 | Reference(Device) | The parent device | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| Device.udiCarrier.entryType | Base | required | UDIEntryType | 📍4.0.1 | FHIR Std. |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.statusReason | Base | extensible | FHIRDeviceStatusReason | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | example | Device Type | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-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: 1 element
Must-Support: 10 elements
Extensions
This structure refers to these extensions:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2024+ HL7 International / Electronic Health Records.
Package hl7.fhir.uv.aitransparency#1.0.0-current based on FHIR 4.0.1.
Generated
2026-10-06
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