FHIR IG analytics| Package | fhir.ig.trust.aitransparency |
| Resource Type | Device |
| Id | Device-device-riskassist-ai.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: Device device-riskassist-ai
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-000123
status: Active
manufacturer: ExampleMed AI GmbH
| Value | Type | Display |
| RiskAssist AI | Registered name | true |
| Value |
| 1.0.0 |
| Category | Specification |
| quality-management-system | Synthetic QMS certification reference for PoC purposes. |
property
type: CE Marking Status
value: true
property
type: Notified Body Identifier
value: NB-0000
property
type: Expected Lifetime
value: 5 years (Details: UCUM codea = 'a')
property
type: Intended Purpose
value: Supportive risk stratification in acute care settings
property
type: Target Population
value: Adult patients with suspected infection in an acute care setting
owner: Organization Example Hospital
note: ,
Synthetic maintenance information for PoC purposes.
AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.
{
"resourceType": "Device",
"id": "device-riskassist-ai",
"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/modelcard-riskassist-ai"
}
},
{
"url": "http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference",
"valueReference": {
"reference": "DocumentReference/eu-conformity-declaration"
}
}
],
"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-000123"
}
],
"status": "active",
"manufacturer": "ExampleMed AI GmbH",
"name": [
{
"value": "RiskAssist AI",
"type": "registered-name",
"display": true
}
],
"version": [
{
"value": "1.0.0"
}
],
"conformsTo": [
{
"category": {
"text": "quality-management-system"
},
"specification": {
"text": "Synthetic QMS certification reference for PoC purposes."
}
}
],
"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": "notified-body-id"
}
]
},
"valueString": "NB-0000"
},
{
"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": "Supportive risk stratification in acute care settings"
},
{
"type": {
"coding": [
{
"system": "http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs",
"code": "target-population"
}
]
},
"valueCodeableConcept": {
"text": "Adult patients with suspected infection in an acute care setting"
}
}
],
"owner": {
"reference": "Organization/organization-examplehospital"
},
"note": [
{
"text": "Synthetic maintenance information for PoC purposes."
},
{
"text": "AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters."
}
]
}