R6 Ballot (2nd Draft)

Publish-box (todo)

Example ClinicalUseDefinition/example-indication (XML)

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

Raw XML (canonical form + also see XML Format Specification)

Indication example (id = "example-indication")

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

<ClinicalUseDefinition xmlns="http://hl7.org/fhir">
  <id value="example-indication"/> 
  <contained> 
    <Group> 
      <id value="group"/> 
      <type value="person"/> 
      <membership value="definitional"/> 
      <characteristic> 
        <code> 
          <coding> 
            <system value="http://ema.europa.eu/example/characteristic"/> 
            <code value="age-range"/> 
          </coding> 
        </code> 
        <valueRange> 
          <low> 
            <value value="18"/> 
            <unit value="a"/> 
          </low> 
        </valueRange> 
        <exclude value="false"/> 
      </characteristic> 
    </Group> 
  </contained> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/> 
  </extension> 
  <type value="indication"/> 
  <subject> 
    <reference value="MedicinalProductDefinition/example"/> 
  </subject> 
  <!--   example product is indicated for Prevention of venous thromboembolic events 
    -->
  <indication> 
    <diseaseSymptomProcedure> 
      <concept> 
        <coding> 
          <system value="http://ema.europa.eu/example/indicationasdisease-symptom-procedure"/> 
          <code value="Pulmonary-embolism-and-thrombosis-example-code"/> 
        </coding> 
        <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone
         elective hip or knee replacement surgery. Prevention of stroke and systemic embolism
         in adult patients with non-valvular atrial fibrillation (NVAF), with one or more
         risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75
         years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥
         II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention
         of recurrent DVT and PE in adults."/> 
      </concept> 
    </diseaseSymptomProcedure> 
    <diseaseStatus> 
      <concept> 
        <coding> 
          <system value="http://ema.europa.eu/example/diseasestatus"/> 
          <code value="Recurrent"/> 
        </coding> 
      </concept> 
    </diseaseStatus> 
    <intendedEffect> 
      <concept> 
        <coding> 
          <system value="http://ema.europa.eu/example/intendedeffect"/> 
          <code value="PRYLX"/> 
        </coding> 
      </concept> 
    </intendedEffect> 
  </indication> 
  <population> 
    <reference value="#group"/> 
  </population> 
</ClinicalUseDefinition> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.