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FHIR IG analytics

Packagefhir.ig.trust.aitransparency
Resource TypeDevice
IdDevice-device-riskassist-ai.json
FHIR VersionR5

Resources that use this resource

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Resources that this resource uses

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: Device device-riskassist-ai

Third-Country Data Transfer

  • transferFlag: false

Model Card Reference: DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; date = 2026-03-01 10:00:00+0000; description = Synthetic model card for a deterministic AI-output simulation component used in the PoC.

EU Conformity Declaration Reference: DocumentReference: status = current

identifier: Trust AI Registration Number/trust-ai-000123

status: Active

manufacturer: ExampleMed AI GmbH

Names

-ValueTypeDisplay
*RiskAssist AIRegistered nametrue

Versions

-Value
*1.0.0

ConformsTos

-CategorySpecification
*quality-management-systemSynthetic 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.


Source1

{
  "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."
    }
  ]
}