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

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="eu-ai-clinical-validation-status-cs"/>
  <text>
    <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem eu-ai-clinical-validation-status-cs</b></p><a name="eu-ai-clinical-validation-status-cs"> </a><a name="hceu-ai-clinical-validation-status-cs"> </a><p>This case-sensitive code system <code>http://example.org/fhir/eu-ai-transparency/CodeSystem/eu-ai-clinical-validation-status-cs</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">clinically-validated<a name="eu-ai-clinical-validation-status-cs-clinically-validated"> </a></td><td>Clinically Validated</td><td>Clinical validation for the documented intended use has been completed.</td></tr><tr><td style="white-space:nowrap">not-clinically-validated<a name="eu-ai-clinical-validation-status-cs-not-clinically-validated"> </a></td><td>Not Clinically Validated</td><td>Clinical validation for the documented intended use has not been completed.</td></tr><tr><td style="white-space:nowrap">validation-in-progress<a name="eu-ai-clinical-validation-status-cs-validation-in-progress"> </a></td><td>Validation In Progress</td><td>Clinical validation is ongoing and no final validation conclusion has yet been documented.</td></tr><tr><td style="white-space:nowrap">technical-validation-only<a name="eu-ai-clinical-validation-status-cs-technical-validation-only"> </a></td><td>Technical Validation Only</td><td>Technical verification or validation has been performed, but clinical validation for the intended use has not been completed.</td></tr></table></div>
  </text>
  <url value="http://example.org/fhir/eu-ai-transparency/CodeSystem/eu-ai-clinical-validation-status-cs"/>
  <version value="0.1.0"/>
  <name value="EUAIClinicalValidationStatusCodeSystem"/>
  <title value="EU AI Clinical Validation Status Code System"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-07-31T11:07:29+00:00"/>
  <publisher value="Selina Adlberger"/>
  <description value="Codes indicating the documented clinical validation status of an AI system for its intended clinical use."/>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="4"/>
  <concept>
    <code value="clinically-validated"/>
    <display value="Clinically Validated"/>
    <definition value="Clinical validation for the documented intended use has been completed."/>
  </concept>
  <concept>
    <code value="not-clinically-validated"/>
    <display value="Not Clinically Validated"/>
    <definition value="Clinical validation for the documented intended use has not been completed."/>
  </concept>
  <concept>
    <code value="validation-in-progress"/>
    <display value="Validation In Progress"/>
    <definition value="Clinical validation is ongoing and no final validation conclusion has yet been documented."/>
  </concept>
  <concept>
    <code value="technical-validation-only"/>
    <display value="Technical Validation Only"/>
    <definition value="Technical verification or validation has been performed, but clinical validation for the intended use has not been completed."/>
  </concept>
</CodeSystem>