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

<AuditEvent xmlns="http://hl7.org/fhir">
  <id value="sc-02-validation-audit-event-ai-execution-001"/>
  <meta>
    <profile value="http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-machine-execution-audit-event"/>
  </meta>
  <text>
    <status value="extensions"/><div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: AuditEvent sc-02-validation-audit-event-ai-execution-001</b></p><a name="sc-02-validation-audit-event-ai-execution-001"> </a><a name="hcsc-02-validation-audit-event-ai-execution-001"> </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-eu-ai-machine-execution-audit-event.html">EU AI Execution Audit Event</a></p></div><p><b>EU AI Act Log Integrity Signature</b>: No display for Signature  (type: Verification Signature (ASTM Signature Type Codes#1.2.840.10065.1.12.1.5); when: 2026-03-01 10:15:04+0000; who: -&gt;Device: extension = ,-&gt;DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; description = Synthetic model card for a deterministic AI-output simulation component used in the PoC.; identifier = EU AI Database Identifier: EU-AI-000123; status = active; manufacturer = ExampleMed AI GmbH; contact = contact@examplemed.example(Work),dpo@examplemed.example(Work); note = Synthetic maintenance information for PoC purposes.,AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.; sigFormat: text/plain; data: c2hhMjU2LTIzNGY0MmQxMzQyN2YyMzRiOWU3YTg5NTJjMGU1ZjA1MmRkZDNiNTBkMWMxMGZjY2Q0OWNjN2EwMWM5OWQ0NjA=)</p><p><b>code</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/audit-event-type rest}">RESTful Operation</span></p><p><b>action</b>: Create</p><p><b>occurred</b>: 2026-03-01 10:15:00+0000 --&gt; 2026-03-01 10:15:03+0000</p><p><b>recorded</b>: 2026-03-01 10:15:04+0000</p><p><b>authorization</b>: <span title="Codes:">Document simulated AI execution for PoC traceability.</span></p><p><b>patient</b>: <a href="Patient-patient-001.html">Anonymous Patient Female, DoB: 1959-04-12</a></p><p><b>encounter</b>: <a href="Encounter-encounter-001.html">Encounter: status = completed; class = ambulatory; actualPeriod = 2026-03-01 10:00:00+0000 --&gt; 2026-03-01 10:30:00+0000</a></p><h3>Agents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Who</b></td><td><b>Requestor</b></td></tr><tr><td style="display: none">*</td><td><a href="Device-device-riskassist-ai.html">Device: extension = ,-&gt;DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; description = Synthetic model card for a deterministic AI-output simulation component used in the PoC.; identifier = EU AI Database Identifier: EU-AI-000123; status = active; manufacturer = ExampleMed AI GmbH; contact = contact@examplemed.example(Work),dpo@examplemed.example(Work); note = Synthetic maintenance information for PoC purposes.,AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.</a></td><td>false</td></tr></table><h3>Sources</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Observer</b></td></tr><tr><td style="display: none">*</td><td><a href="Device-device-riskassist-ai.html">Device: extension = ,-&gt;DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; description = Synthetic model card for a deterministic AI-output simulation component used in the PoC.; identifier = EU AI Database Identifier: EU-AI-000123; status = active; manufacturer = ExampleMed AI GmbH; contact = contact@examplemed.example(Work),dpo@examplemed.example(Work); note = Synthetic maintenance information for PoC purposes.,AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.</a></td></tr></table><blockquote><p><b>entity</b></p><p><b>what</b>: <a href="Observation-sc-02-validation-observation-temperature-001.html">Observation </a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/object-role 4}">Domain Resource</span></p></blockquote><blockquote><p><b>entity</b></p><p><b>what</b>: <a href="Observation-sc-02-validation-observation-heart-rate-001.html">Observation Heart rate</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/object-role 4}">Domain Resource</span></p></blockquote><blockquote><p><b>entity</b></p><p><b>what</b>: <a href="Observation-sc-02-validation-observation-respiratory-rate-001.html">Observation Respiratory rate</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/object-role 4}">Domain Resource</span></p></blockquote><blockquote><p><b>entity</b></p><p><b>what</b>: <a href="Observation-sc-02-validation-observation-blood-pressure-001.html">Observation </a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/object-role 4}">Domain Resource</span></p></blockquote><blockquote><p><b>entity</b></p><p><b>what</b>: <a href="Observation-sc-02-validation-observation-oxygen-saturation-001.html">Observation Oxygen saturation in Arterial blood</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/object-role 4}">Domain Resource</span></p></blockquote><blockquote><p><b>entity</b></p><p><b>what</b>: <a href="Observation-sc-02-validation-observation-consciousness-status-001.html">Observation </a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/object-role 4}">Domain Resource</span></p></blockquote><blockquote><p><b>entity</b></p><p><b>what</b>: <a href="Observation-sc-02-validation-ai-observation-risk-001.html">Observation </a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/object-role 3}">Report</span></p></blockquote></div>
  </text>
  <extension url="http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-log-integrity">
    <valueSignature>
      <type>
        <system value="urn:iso-astm:E1762-95:2013"/>
        <code value="1.2.840.10065.1.12.1.5"/>
        <display value="Verification Signature"/>
      </type>
      <when value="2026-03-01T10:15:04Z"/>
      <who>
        <reference value="Device/device-riskassist-ai"/>
      </who>
      <sigFormat value="text/plain"/>
      <data value="c2hhMjU2LTIzNGY0MmQxMzQyN2YyMzRiOWU3YTg5NTJjMGU1ZjA1MmRkZDNiNTBkMWMxMGZjY2Q0OWNjN2EwMWM5OWQ0NjA="/>
    </valueSignature>
  </extension>
  <code>
    <coding>
      <system value="http://terminology.hl7.org/CodeSystem/audit-event-type"/>
      <code value="rest"/>
      <display value="RESTful Operation"/>
    </coding>
    <text value="RESTful Operation"/>
  </code>
  <action value="C"/>
  <occurredPeriod>
    <start value="2026-03-01T10:15:00Z"/>
    <end value="2026-03-01T10:15:03Z"/>
  </occurredPeriod>
  <recorded value="2026-03-01T10:15:04Z"/>
  <authorization>
    <text value="Document simulated AI execution for PoC traceability."/>
  </authorization>
  <patient>
    <reference value="Patient/patient-001"/>
  </patient>
  <encounter>
    <reference value="Encounter/encounter-001"/>
  </encounter>
  <agent>
    <who>
      <reference value="Device/device-riskassist-ai"/>
    </who>
    <requestor value="false"/>
  </agent>
  <source>
    <observer>
      <reference value="Device/device-riskassist-ai"/>
    </observer>
  </source>
  <entity>
    <what>
      <reference value="Observation/sc-02-validation-observation-temperature-001"/>
    </what>
    <role>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/object-role"/>
        <code value="4"/>
        <display value="Domain Resource"/>
      </coding>
      <text value="Domain Resource"/>
    </role>
  </entity>
  <entity>
    <what>
      <reference value="Observation/sc-02-validation-observation-heart-rate-001"/>
    </what>
    <role>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/object-role"/>
        <code value="4"/>
        <display value="Domain Resource"/>
      </coding>
      <text value="Domain Resource"/>
    </role>
  </entity>
  <entity>
    <what>
      <reference value="Observation/sc-02-validation-observation-respiratory-rate-001"/>
    </what>
    <role>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/object-role"/>
        <code value="4"/>
        <display value="Domain Resource"/>
      </coding>
      <text value="Domain Resource"/>
    </role>
  </entity>
  <entity>
    <what>
      <reference value="Observation/sc-02-validation-observation-blood-pressure-001"/>
    </what>
    <role>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/object-role"/>
        <code value="4"/>
        <display value="Domain Resource"/>
      </coding>
      <text value="Domain Resource"/>
    </role>
  </entity>
  <entity>
    <what>
      <reference value="Observation/sc-02-validation-observation-oxygen-saturation-001"/>
    </what>
    <role>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/object-role"/>
        <code value="4"/>
        <display value="Domain Resource"/>
      </coding>
      <text value="Domain Resource"/>
    </role>
  </entity>
  <entity>
    <what>
      <reference value="Observation/sc-02-validation-observation-consciousness-status-001"/>
    </what>
    <role>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/object-role"/>
        <code value="4"/>
        <display value="Domain Resource"/>
      </coding>
      <text value="Domain Resource"/>
    </role>
  </entity>
  <entity>
    <what>
      <reference value="Observation/sc-02-validation-ai-observation-risk-001"/>
    </what>
    <role>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/object-role"/>
        <code value="3"/>
        <display value="Report"/>
      </coding>
      <text value="Report"/>
    </role>
  </entity>
</AuditEvent>