0.1.0 - ci-build
EUAITransparencyIG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
<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 --> 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 = ,->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>