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 0.1.0 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: 0.1.0 | |||
| Standards status: Trial-use | Maturity Level: 0 | Computable Name: AIDevice | ||
A Device that represents an AI system, such as a Large Language Model (LL M) 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.
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | Device | Item used in healthcare | |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
![]() ![]() ![]() |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device.type codes for AI/LLM (extensible) | |
![]() ![]() ![]() |
0..* | Reference(AI Model Card DocumentReference) | Model Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() |
S | 0..* | Identifier | Instance identifier |
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
![]() ![]() |
S | 0..1 | string | Name of device manufacturer |
![]() ![]() |
S | 0..1 | dateTime | Date when the device was made |
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
1..1 | string | The name of the device | |
![]() ![]() ![]() |
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. | |
![]() ![]() |
S | 0..1 | string | The model number for the device |
![]() ![]() |
1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. Required Pattern: At least the following | |
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |
![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |
![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |
![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |
![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |
![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |
![]() ![]() |
S | 0..* | BackboneElement | The actual design of the device or software version running on the device |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
1..1 | string | The version text | |
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device |
![]() ![]() |
S | 0..* | ContactPoint | Details for human/organization for support |
![]() ![]() |
S | 0..1 | uri | Network address to contact device |
![]() ![]() |
S | 0..* | Annotation | Device notes and comments |
![]() ![]() |
SΣ | 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: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | Device | Item used in healthcare | |
![]() ![]() |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
![]() ![]() ![]() |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device.type codes for AI/LLM (extensible) | |
![]() ![]() ![]() |
0..* | Reference(AI Model Card DocumentReference) | Model Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |
![]() ![]() |
S | 0..* | Identifier | Instance identifier |
![]() ![]() |
S | 0..1 | string | Name of device manufacturer |
![]() ![]() |
S | 0..1 | dateTime | Date when the device was made |
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer |
![]() ![]() |
S | 0..1 | string | The model number for the device |
![]() ![]() |
1..1 | CodeableConcept | The kind or type of device Required Pattern: At least the following | |
![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |
![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |
![]() ![]() |
S | 0..* | BackboneElement | The actual design of the device or software version running on the device |
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device |
![]() ![]() |
S | 0..* | ContactPoint | Details for human/organization for support |
![]() ![]() |
S | 0..1 | uri | Network address to contact device |
![]() ![]() |
S | 0..* | Annotation | Device notes and comments |
![]() ![]() |
S | 0..* | CodeableConcept | Safety Characteristics of Device |
Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
![]() |
0..* | Device | Item used in healthcare | |||||
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
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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 | |||||
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0..* | Resource | Contained, inline Resources | |||||
![]() ![]() |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device.type codes for AI/LLM (extensible) | |||||
![]() ![]() ![]() |
0..* | Reference(AI Model Card DocumentReference) | Model Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |||||
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
![]() ![]() |
S | 0..* | Identifier | Instance identifier | ||||
![]() ![]() |
0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
![]() ![]() |
Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
Σ | 0..1 | string | Mandatory fixed portion of UDI | ||||
![]() ![]() ![]() |
0..1 | uri | UDI Issuing Organization | |||||
![]() ![]() ![]() |
0..1 | uri | Regional UDI authority | |||||
![]() ![]() ![]() |
Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
![]() ![]() ![]() |
Σ | 0..1 | string | UDI Human Readable Barcode String | ||||
![]() ![]() ![]() |
0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||
![]() ![]() |
0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
![]() ![]() |
0..1 | string | The distinct identification string | |||||
![]() ![]() |
S | 0..1 | string | Name of device manufacturer | ||||
![]() ![]() |
S | 0..1 | dateTime | Date when the device was made | ||||
![]() ![]() |
0..1 | dateTime | Date and time of expiry of this device (if applicable) | |||||
![]() ![]() |
0..1 | string | Lot number of manufacture | |||||
![]() ![]() |
0..1 | string | Serial number assigned by the manufacturer | |||||
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
1..1 | string | The name of the device | |||||
![]() ![]() ![]() |
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. | |||||
![]() ![]() |
S | 0..1 | string | The model number for the device | ||||
![]() ![]() |
0..1 | string | The part number of the device | |||||
![]() ![]() |
1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. Required Pattern: At least the following | |||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |||||
![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |||||
![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |||||
![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |||||
![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |||||
![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |||||
![]() ![]() |
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..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
1..1 | CodeableConcept | The standard that is used to operate and communicate | |||||
![]() ![]() ![]() |
0..1 | string | The version of the standard that is used to operate and communicate | |||||
![]() ![]() |
S | 0..* | BackboneElement | The actual design of the device or software version running on the device | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
0..1 | CodeableConcept | The type of the device version | |||||
![]() ![]() ![]() |
0..1 | Identifier | A single component of the device version | |||||
![]() ![]() ![]() |
1..1 | string | The version text | |||||
![]() ![]() |
0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
![]() ![]() ![]() |
0..* | Quantity | Property value as a quantity | |||||
![]() ![]() ![]() |
0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
![]() ![]() |
0..1 | Reference(Patient) | Patient to whom Device is affixed | |||||
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device | ||||
![]() ![]() |
S | 0..* | ContactPoint | Details for human/organization for support | ||||
![]() ![]() |
0..1 | Reference(Location) | Where the device is found | |||||
![]() ![]() |
S | 0..1 | uri | Network address to contact device | ||||
![]() ![]() |
S | 0..* | Annotation | Device notes and comments | ||||
![]() ![]() |
SΣ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||
![]() ![]() |
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: 11 elements
Extensions
This structure refers to these extensions:
Maturity: 0
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | Device | Item used in healthcare | |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
![]() ![]() ![]() |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device.type codes for AI/LLM (extensible) | |
![]() ![]() ![]() |
0..* | Reference(AI Model Card DocumentReference) | Model Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() |
S | 0..* | Identifier | Instance identifier |
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
![]() ![]() |
S | 0..1 | string | Name of device manufacturer |
![]() ![]() |
S | 0..1 | dateTime | Date when the device was made |
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
1..1 | string | The name of the device | |
![]() ![]() ![]() |
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. | |
![]() ![]() |
S | 0..1 | string | The model number for the device |
![]() ![]() |
1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. Required Pattern: At least the following | |
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |
![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |
![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |
![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |
![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |
![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |
![]() ![]() |
S | 0..* | BackboneElement | The actual design of the device or software version running on the device |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
1..1 | string | The version text | |
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device |
![]() ![]() |
S | 0..* | ContactPoint | Details for human/organization for support |
![]() ![]() |
S | 0..1 | uri | Network address to contact device |
![]() ![]() |
S | 0..* | Annotation | Device notes and comments |
![]() ![]() |
SΣ | 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: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | Device | Item used in healthcare | |
![]() ![]() |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
![]() ![]() ![]() |
0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device.type codes for AI/LLM (extensible) | |
![]() ![]() ![]() |
0..* | Reference(AI Model Card DocumentReference) | Model Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |
![]() ![]() |
S | 0..* | Identifier | Instance identifier |
![]() ![]() |
S | 0..1 | string | Name of device manufacturer |
![]() ![]() |
S | 0..1 | dateTime | Date when the device was made |
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer |
![]() ![]() |
S | 0..1 | string | The model number for the device |
![]() ![]() |
1..1 | CodeableConcept | The kind or type of device Required Pattern: At least the following | |
![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |
![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |
![]() ![]() |
S | 0..* | BackboneElement | The actual design of the device or software version running on the device |
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device |
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S | 0..* | ContactPoint | Details for human/organization for support |
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S | 0..1 | uri | Network address to contact device |
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S | 0..* | Annotation | Device notes and comments |
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S | 0..* | CodeableConcept | Safety Characteristics of Device |
Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
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0..* | Device | Item used in healthcare | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
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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 | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
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0..* | CodeableConcept | Specific kind of AI technology URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.AIKind Binding: Recommended Device.type codes for AI/LLM (extensible) | |||||
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0..* | Reference(AI Model Card DocumentReference) | Model Card URL: http://hl7.org/fhir/uv/aitransparency/StructureDefinition/aitransparency.modelCardDescription | |||||
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?! | 0..* | Extension | Extensions that cannot be ignored | ||||
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S | 0..* | Identifier | Instance identifier | ||||
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0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
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Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | string | Mandatory fixed portion of UDI | ||||
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0..1 | uri | UDI Issuing Organization | |||||
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0..1 | uri | Regional UDI authority | |||||
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Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
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Σ | 0..1 | string | UDI Human Readable Barcode String | ||||
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0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
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?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||
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0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
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0..1 | string | The distinct identification string | |||||
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S | 0..1 | string | Name of device manufacturer | ||||
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S | 0..1 | dateTime | Date when the device was made | ||||
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0..1 | dateTime | Date and time of expiry of this device (if applicable) | |||||
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0..1 | string | Lot number of manufacture | |||||
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0..1 | string | Serial number assigned by the manufacturer | |||||
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S | 0..* | BackboneElement | The name of the device as given by the manufacturer | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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1..1 | string | The name of the device | |||||
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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. | |||||
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S | 0..1 | string | The model number for the device | ||||
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0..1 | string | The part number of the device | |||||
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1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. Required Pattern: At least the following | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS | |||||
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0..1 | string | Version of the system - if relevant | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: Artificial-Intelligence | |||||
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0..1 | string | Representation defined by the system | |||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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1..1 | CodeableConcept | The standard that is used to operate and communicate | |||||
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0..1 | string | The version of the standard that is used to operate and communicate | |||||
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S | 0..* | BackboneElement | The actual design of the device or software version running on the device | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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0..1 | CodeableConcept | The type of the device version | |||||
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0..1 | Identifier | A single component of the device version | |||||
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1..1 | string | The version text | |||||
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0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
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0..* | Quantity | Property value as a quantity | |||||
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0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
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0..1 | Reference(Patient) | Patient to whom Device is affixed | |||||
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S | 0..1 | Reference(Organization) | Organization responsible for device | ||||
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S | 0..* | ContactPoint | Details for human/organization for support | ||||
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0..1 | Reference(Location) | Where the device is found | |||||
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S | 0..1 | uri | Network address to contact device | ||||
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S | 0..* | Annotation | Device notes and comments | ||||
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SΣ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||
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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: 11 elements
Extensions
This structure refers to these extensions:
Maturity: 0
Other representations of profile: CSV, Excel, Schematron