FHIR IG analytics| Package | fhir.ig.trust.aitransparency |
| Resource Type | Device |
| Id | Device-dr-ai-device.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: Device dr-ai-device
Profile: Trust AI System Device
Third-Country Data Transfer
- transferFlag: false
EU Conformity Declaration Reference: DocumentReference: status = current
identifier: Trust AI Registration Number/trust-ai-DIAG-001
status: Active
manufacturer: Example AI Medical GmbH
| Value | Type |
| DiagnosticAssist AI | Registered name |
| Value |
| 1.0.0 |
| Specification |
| Synthetic quality management certification |
property
type: CE Marking Status
value: true
property
type: Expected Lifetime
value: 5 years (Details: UCUM codea = 'a')
property
type: Intended Purpose
value: Support diagnostic assessment from clinical findings
property
type: Target Population
value: Adult patients
owner: Organization Example Diagnostic Center
contact: manufacturer@example-ai-medical.example, dpo@example-ai-medical.example
note:
Annual maintenance and validation required.
{
"resourceType": "Device",
"id": "dr-ai-device",
"meta": {
"profile": [
"http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-device"
]
},
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"extension": [
{
"url": "transferFlag",
"valueBoolean": false
}
],
"url": "http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer"
},
{
"url": "http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card",
"valueReference": {
"reference": "DocumentReference/dr-model-card"
}
},
{
"url": "http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference",
"valueReference": {
"reference": "DocumentReference/eu-conformity-declaration-2"
}
}
],
"identifier": [
{
"type": {
"coding": [
{
"system": "http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-identifier-type-cs",
"code": "trust-ai-registration-number"
}
]
},
"system": "http://example.org/fhir/sid/trust-ai-database",
"value": "trust-ai-DIAG-001"
}
],
"status": "active",
"manufacturer": "Example AI Medical GmbH",
"name": [
{
"value": "DiagnosticAssist AI",
"type": "registered-name"
}
],
"version": [
{
"value": "1.0.0"
}
],
"conformsTo": [
{
"specification": {
"text": "Synthetic quality management certification"
}
}
],
"property": [
{
"type": {
"coding": [
{
"system": "http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs",
"code": "ce-mark"
}
]
},
"valueBoolean": true
},
{
"type": {
"coding": [
{
"system": "http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs",
"code": "expected-lifetime"
}
]
},
"valueQuantity": {
"value": 5,
"unit": "years",
"system": "http://unitsofmeasure.org",
"code": "a"
}
},
{
"type": {
"coding": [
{
"system": "http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs",
"code": "intended-purpose"
}
]
},
"valueString": "Support diagnostic assessment from clinical findings"
},
{
"type": {
"coding": [
{
"system": "http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs",
"code": "target-population"
}
]
},
"valueCodeableConcept": {
"text": "Adult patients"
}
}
],
"owner": {
"reference": "Organization/dr-organization"
},
"contact": [
{
"system": "email",
"value": "manufacturer@example-ai-medical.example"
},
{
"system": "email",
"value": "dpo@example-ai-medical.example"
}
],
"note": [
{
"text": "Annual maintenance and validation required."
}
]
}