0.1.0 - ci-build
TrustAITransparencyIG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
{
"resourceType" : "Device",
"id" : "dr-ai-device",
"meta" : {
"profile" : [
🔗 "http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-device"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Device dr-ai-device</b></p><a name=\"dr-ai-device\"> </a><a name=\"hcdr-ai-device\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-trust-ai-device.html\">Trust AI System Device</a></p></div><blockquote><p><b>Third-Country Data Transfer</b></p><ul><li>transferFlag: false</li></ul></blockquote><p><b>Model Card Reference</b>: <a href=\"DocumentReference-dr-model-card.html\">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.</a></p><p><b>EU Conformity Declaration Reference</b>: <a href=\"DocumentReference-eu-conformity-declaration-2.html\">DocumentReference: status = current</a></p><p><b>identifier</b>: Trust AI Registration Number/trust-ai-DIAG-001</p><p><b>status</b>: Active</p><p><b>manufacturer</b>: Example AI Medical GmbH</p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Value</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>DiagnosticAssist AI</td><td>Registered name</td></tr></table><h3>Versions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Value</b></td></tr><tr><td style=\"display: none\">*</td><td>1.0.0</td></tr></table><h3>ConformsTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Specification</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Synthetic quality management certification</span></td></tr></table><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs ce-mark}\">CE Marking Status</span></p><p><b>value</b>: true</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs expected-lifetime}\">Expected Lifetime</span></p><p><b>value</b>: 5 years<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codea = 'a')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs intended-purpose}\">Intended Purpose</span></p><p><b>value</b>: Support diagnostic assessment from clinical findings</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs target-population}\">Target Population</span></p><p><b>value</b>: <span title=\"Codes:\">Adult patients</span></p></blockquote><p><b>owner</b>: <a href=\"Organization-dr-organization.html\">Organization Example Diagnostic Center</a></p><p><b>contact</b>: <a href=\"mailto:manufacturer@example-ai-medical.example\">manufacturer@example-ai-medical.example</a>, <a href=\"mailto:dpo@example-ai-medical.example\">dpo@example-ai-medical.example</a></p><p><b>note</b>: </p><blockquote><div><p>Annual maintenance and validation required.</p>\n</div></blockquote></div>"
},
"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."
}
]
}