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

<Observation xmlns="http://hl7.org/fhir">
  <id value="sc-02-validation-ai-observation-risk-001"/>
  <meta>
    <profile value="http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-observation"/>
  </meta>
  <text>
    <status value="extensions"/><div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Observation sc-02-validation-ai-observation-risk-001</b></p><a name="sc-02-validation-ai-observation-risk-001"> </a><a name="hcsc-02-validation-ai-observation-risk-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-observation.html">EU AI Generated Observation</a></p></div><p><b>Case-Specific Indication</b>: <span title="Codes:{http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem prognosis}">Prognostic Prediction</span></p><p><b>Automated Decision-Making Flag</b>: false</p><p><b>status</b>: Final</p><p><b>code</b>: <span title="Codes:">AI-assisted early warning risk assessment</span></p><p><b>subject</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><p><b>effective</b>: 2026-03-01 10:15:03+0000</p><p><b>performer</b>: <a href="Organization-organization-examplehospital.html">Organization Example Hospital</a></p><p><b>value</b>: <span title="Codes:">high-risk</span></p><p><b>interpretation</b>: <span title="Codes:{http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem ai-generated}">AI Generated Result</span></p><p><b>note</b>: </p><blockquote><div><p>Urgent clinical review recommended</p>
</div></blockquote><p><b>device</b>: <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></p><blockquote><p><b>component</b></p><p><b>code</b>: <span title="Codes:">Confidence</span></p><p><b>value</b>: 0.86 1<span style="background: LightGoldenRodYellow"> (Details: UCUM  code1 = '1')</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: <span title="Codes:">Simplified score</span></p><p><b>value</b>: 9</p></blockquote></div>
  </text>
  <extension url="http://example.org/fhir/eu-ai-transparency/StructureDefinition/case-specific-indication">
    <valueCodeableConcept>
      <coding>
        <system value="http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"/>
        <code value="prognosis"/>
        <display value="Prognostic Prediction"/>
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension url="http://example.org/fhir/eu-ai-transparency/StructureDefinition/automated-decision-flag">
    <valueBoolean value="false"/>
  </extension>
  <status value="final"/>
  <code>
    <text value="AI-assisted early warning risk assessment"/>
  </code>
  <subject>
    <reference value="Patient/patient-001"/>
  </subject>
  <encounter>
    <reference value="Encounter/encounter-001"/>
  </encounter>
  <effectiveDateTime value="2026-03-01T10:15:03Z"/>
  <performer>
    <reference value="Organization/organization-examplehospital"/>
  </performer>
  <valueCodeableConcept>
    <text value="high-risk"/>
  </valueCodeableConcept>
  <interpretation>
    <coding>
      <system value="http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"/>
      <code value="ai-generated"/>
      <display value="AI Generated Result"/>
    </coding>
    <text value="AI Generated Result"/>
  </interpretation>
  <note>
    <text value="Urgent clinical review recommended"/>
  </note>
  <device>
    <reference value="Device/device-riskassist-ai"/>
  </device>
  <component>
    <code>
      <text value="Confidence"/>
    </code>
    <valueQuantity>
      <value value="0.86"/>
      <unit value="1"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="1"/>
    </valueQuantity>
  </component>
  <component>
    <code>
      <text value="Simplified score"/>
    </code>
    <valueInteger value="9"/>
  </component>
</Observation>