<?xml version="1.0" encoding="UTF-8"?>

<Device xmlns="http://hl7.org/fhir">
  <id value="dr-ai-device"/>
  <meta>
    <profile value="http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-device"/>
  </meta>
  <text>
    <status value="extensions"/><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>
</div></blockquote></div>
  </text>
  <extension url="http://example.org/fhir/trust-ai-transparency/StructureDefinition/third-country-data-transfer">
    <extension url="transferFlag">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension url="http://example.org/fhir/trust-ai-transparency/StructureDefinition/ext-model-card">
    <valueReference>
      <reference value="DocumentReference/dr-model-card"/>
    </valueReference>
  </extension>
  <extension url="http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-conformity-reference">
    <valueReference>
      <reference value="DocumentReference/eu-conformity-declaration-2"/>
    </valueReference>
  </extension>
  <identifier>
    <type>
      <coding>
        <system value="http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-identifier-type-cs"/>
        <code value="trust-ai-registration-number"/>
      </coding>
    </type>
    <system value="http://example.org/fhir/sid/trust-ai-database"/>
    <value value="trust-ai-DIAG-001"/>
  </identifier>
  <status value="active"/>
  <manufacturer value="Example AI Medical GmbH"/>
  <name>
    <value value="DiagnosticAssist AI"/>
    <type value="registered-name"/>
  </name>
  <version>
    <value value="1.0.0"/>
  </version>
  <conformsTo>
    <specification>
      <text value="Synthetic quality management certification"/>
    </specification>
  </conformsTo>
  <property>
    <type>
      <coding>
        <system value="http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs"/>
        <code value="ce-mark"/>
      </coding>
    </type>
    <valueBoolean value="true"/>
  </property>
  <property>
    <type>
      <coding>
        <system value="http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs"/>
        <code value="expected-lifetime"/>
      </coding>
    </type>
    <valueQuantity>
      <value value="5"/>
      <unit value="years"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="a"/>
    </valueQuantity>
  </property>
  <property>
    <type>
      <coding>
        <system value="http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs"/>
        <code value="intended-purpose"/>
      </coding>
    </type>
    <valueString value="Support diagnostic assessment from clinical findings"/>
  </property>
  <property>
    <type>
      <coding>
        <system value="http://example.org/fhir/trust-ai-transparency/CodeSystem/trust-ai-system-property-cs"/>
        <code value="target-population"/>
      </coding>
    </type>
    <valueCodeableConcept>
      <text value="Adult patients"/>
    </valueCodeableConcept>
  </property>
  <owner>
    <reference value="Organization/dr-organization"/>
  </owner>
  <contact>
    <system value="email"/>
    <value value="manufacturer@example-ai-medical.example"/>
  </contact>
  <contact>
    <system value="email"/>
    <value value="dpo@example-ai-medical.example"/>
  </contact>
  <note>
    <text value="Annual maintenance and validation required."/>
  </note>
</Device>