{ "resourceType" : "Device", "id" : "dr-ai-device", "meta" : { "profile" : ["http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-device"] }, "text" : { "status" : "extensions", "div" : "

Generated Narrative: Device dr-ai-device

Profile: Trust AI System Device

Third-Country Data Transfer

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 an AI system generating diagnostic reports from structured clinical input.

EU Conformity Declaration Reference: DocumentReference: status = current

identifier: Trust AI Registration Number/trust-ai-DIAG-001

status: Active

manufacturer: Example AI Medical GmbH

Names

-ValueType
*DiagnosticAssist AIRegistered name

Versions

-Value
*1.0.0

ConformsTos

-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.

\n
" }, "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." }] }