TrustAITransparencyIG, published by Selina Adlberger. 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/HL7Austria/AIST-TrustworthyAI-R5/ and changes regularly. See the Directory of published versions
Mappings for the trust-ai-device resource profile.
| Name | FiveWs Pattern Mapping | RIM Mapping | Interface Pattern | UDI Mapping |
 Device |
administrative.device |
|
Participant |
|
  Device / id |
|
|
|
|
  Device / meta |
|
|
|
|
  Device / implicitRules |
|
|
|
|
  Device / language |
|
|
|
|
  Device / text |
|
Act.text? |
|
|
  Device / contained |
|
N/A |
|
|
  Device / Slices for extension |
|
|
|
|
   Device / Slices for extension / extension:modelCard |
|
|
|
|
   Device / Slices for extension / extension:dataTransfer |
|
|
|
|
   Device / Slices for extension / extension:conformityDeclaration |
|
|
|
|
  Device / modifierExtension |
|
N/A |
|
|
  Device / Slices for identifier |
FiveWs.identifier |
.id |
Participant.identifier |
- The serial number which is a component of the production identifier (PI)
- a conditional
- variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
|
   Device / Slices for identifier / identifier:euDatabaseId |
FiveWs.identifier |
.id |
Participant.identifier |
- The serial number which is a component of the production identifier (PI)
- a conditional
- variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
|
    Device / Slices for identifier / identifier:euDatabaseId / id |
|
n/a |
|
|
    Device / Slices for identifier / identifier:euDatabaseId / extension |
|
n/a |
|
|
    Device / Slices for identifier / identifier:euDatabaseId / use |
|
Role.code or implied by context |
|
|
    Device / Slices for identifier / identifier:euDatabaseId / type |
|
Role.code or implied by context |
|
|
    Device / Slices for identifier / identifier:euDatabaseId / system |
|
II.root or Role.id.root |
|
|
    Device / Slices for identifier / identifier:euDatabaseId / value |
|
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
|
|
    Device / Slices for identifier / identifier:euDatabaseId / period |
|
Role.effectiveTime or implied by context |
|
|
    Device / Slices for identifier / identifier:euDatabaseId / assigner |
|
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper |
|
|
  Device / displayName |
|
|
|
|
  Device / definition |
|
|
|
|
  Device / udiCarrier |
FiveWs.identifier |
.id and .code |
|
|
   Device / udiCarrier / id |
|
n/a |
|
|
   Device / udiCarrier / extension |
|
n/a |
|
|
   Device / udiCarrier / modifierExtension |
|
N/A |
|
|
   Device / udiCarrier / deviceIdentifier |
FiveWs.what[x] |
Role.id.extension |
|
- The device identifier (DI)
- a mandatory
- fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
|
   Device / udiCarrier / issuer |
|
Role.id.root |
|
http://hl7.org/fhir/NamingSystem/gs1
HIBCC DIs:
http://hl7.org/fhir/NamingSystem/hibcc
ICCBBA DIs for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood
ICCBA DIs for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other |
   Device / udiCarrier / jurisdiction |
|
Role.scoper |
|
|
   Device / udiCarrier / carrierAIDC |
|
Role.id.extension |
|
A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology. |
   Device / udiCarrier / carrierHRF |
|
Role.id.extension |
|
A unique device identifier (UDI) on a device label in plain text |
   Device / udiCarrier / entryType |
|
NA |
|
|
  Device / status |
FiveWs.status |
.statusCode |
Participant.active |
|
  Device / availabilityStatus |
FiveWs.status |
|
|
|
  Device / biologicalSourceEvent |
FiveWs.what[x] |
|
|
|
  Device / manufacturer |
FiveWs.what[x] |
.playedRole[typeCode=MANU].scoper.name |
|
N/A |
  Device / manufactureDate |
FiveWs.what[x] |
.existenceTime.low |
|
- The date a specific device was manufactured - which is a component of the production identifier (PI)
- a conditional
- variable portion of a UDI. For FHIR
- MM:SS]. If hour is present
- the minutes and seconds should both be set to “00”.
|
  Device / expirationDate |
FiveWs.what[x] |
.expirationTime |
|
- the expiration date of a specific device - which is a component of the production identifier (PI)
- a conditional
- variable portion of a UDI. For FHIR
- MM:SS]. If hour is present
- the minutes and seconds should both be set to “00”.
|
  Device / lotNumber |
FiveWs.what[x] |
.lotNumberText |
|
- The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI)
- a conditional
- variable portion of a UDI.
|
  Device / serialNumber |
FiveWs.what[x] |
.playedRole[typeCode=MANU].id |
|
|
  Device / name |
|
|
Participant.name |
|
   Device / name / id |
|
n/a |
|
|
   Device / name / extension |
|
n/a |
|
|
   Device / name / modifierExtension |
|
N/A |
|
|
   Device / name / value |
|
|
|
|
   Device / name / type |
FiveWs.what[x] |
.playedRole[typeCode=MANU].code |
|
|
   Device / name / display |
FiveWs.status |
statusCode |
|
|
  Device / modelNumber |
FiveWs.what[x] |
.softwareName (included as part) |
|
|
  Device / partNumber |
FiveWs.what[x] |
.playedRole[typeCode=MANU].id |
|
|
  Device / category |
|
|
|
|
  Device / type |
|
|
|
|
  Device / version |
|
|
|
|
   Device / version / id |
|
n/a |
|
|
   Device / version / extension |
|
n/a |
|
|
   Device / version / modifierExtension |
|
N/A |
|
|
   Device / version / type |
|
|
|
|
   Device / version / component |
FiveWs.what[x] |
|
|
|
   Device / version / installDate |
FiveWs.what[x] |
|
|
|
   Device / version / value |
|
|
|
|
  Device / conformsTo |
|
|
|
|
   Device / conformsTo / id |
|
n/a |
|
|
   Device / conformsTo / extension |
|
n/a |
|
|
   Device / conformsTo / modifierExtension |
|
N/A |
|
|
   Device / conformsTo / category |
|
|
|
|
   Device / conformsTo / specification |
|
|
|
|
   Device / conformsTo / version |
|
|
|
|
  Device / Slices for property |
|
|
|
|
   Device / Slices for property / property:All Slices |
|
|
|
|
    Device / Slices for property / property:All Slices / id |
|
n/a |
|
|
    Device / Slices for property / property:All Slices / extension |
|
n/a |
|
|
    Device / Slices for property / property:All Slices / modifierExtension |
|
N/A |
|
|
    Device / Slices for property / property:All Slices / type |
|
|
|
|
    Device / Slices for property / property:All Slices / value[x] |
|
|
|
|
   Device / Slices for property / property:ceMark |
|
|
|
|
    Device / Slices for property / property:ceMark / id |
|
n/a |
|
|
    Device / Slices for property / property:ceMark / extension |
|
n/a |
|
|
    Device / Slices for property / property:ceMark / modifierExtension |
|
N/A |
|
|
    Device / Slices for property / property:ceMark / type |
|
|
|
|
    Device / Slices for property / property:ceMark / value[x] |
|
|
|
|
   Device / Slices for property / property:notifiedBody |
|
|
|
|
    Device / Slices for property / property:notifiedBody / id |
|
n/a |
|
|
    Device / Slices for property / property:notifiedBody / extension |
|
n/a |
|
|
    Device / Slices for property / property:notifiedBody / modifierExtension |
|
N/A |
|
|
    Device / Slices for property / property:notifiedBody / type |
|
|
|
|
    Device / Slices for property / property:notifiedBody / value[x] |
|
|
|
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   Device / Slices for property / property:expectedLifetime |
|
|
|
|
    Device / Slices for property / property:expectedLifetime / id |
|
n/a |
|
|
    Device / Slices for property / property:expectedLifetime / extension |
|
n/a |
|
|
    Device / Slices for property / property:expectedLifetime / modifierExtension |
|
N/A |
|
|
    Device / Slices for property / property:expectedLifetime / type |
|
|
|
|
    Device / Slices for property / property:expectedLifetime / value[x] |
|
|
|
|
   Device / Slices for property / property:intendedPurpose |
|
|
|
|
    Device / Slices for property / property:intendedPurpose / id |
|
n/a |
|
|
    Device / Slices for property / property:intendedPurpose / extension |
|
n/a |
|
|
    Device / Slices for property / property:intendedPurpose / modifierExtension |
|
N/A |
|
|
    Device / Slices for property / property:intendedPurpose / type |
|
|
|
|
    Device / Slices for property / property:intendedPurpose / value[x] |
|
|
|
|
   Device / Slices for property / property:targetPopulation |
|
|
|
|
    Device / Slices for property / property:targetPopulation / id |
|
n/a |
|
|
    Device / Slices for property / property:targetPopulation / extension |
|
n/a |
|
|
    Device / Slices for property / property:targetPopulation / modifierExtension |
|
N/A |
|
|
    Device / Slices for property / property:targetPopulation / type |
|
|
|
|
    Device / Slices for property / property:targetPopulation / value[x] |
|
|
|
|
  Device / mode |
|
|
|
|
  Device / cycle |
|
|
|
|
  Device / duration |
|
|
|
|
  Device / owner |
FiveWs.source |
.playedRole[typeCode=OWN].scoper |
|
|
  Device / contact |
FiveWs.source |
.scopedRole[typeCode=CON].player |
|
|
  Device / location |
FiveWs.where[x] |
.playedRole[typeCode=LOCE].scoper |
|
|
  Device / url |
FiveWs.where[x] |
.telecom |
|
|
  Device / endpoint |
|
n/a |
|
|
  Device / gateway |
|
|
|
|
  Device / note |
|
.text |
|
|
  Device / safety |
|
NA |
|
|
  Device / parent |
|
|
|
|
Documentation for this format |