HL7 Personal Health Record System Functional Model, Release 2
2.0.1-ballot - Normative Ballot

HL7 Personal Health Record System Functional Model, Release 2, published by EHR WG. This guide is not an authorized publication; it is the continuous build for version 2.0.1-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/phrsfm-ig/ and changes regularly. See the Directory of published versions

: S.4.1.3 Manage PHR Account Holder Notification of Clinical Trials (Function) - XML Representation

Page standards status: Informative

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<Requirements xmlns="http://hl7.org/fhir">
  <id value="PHRSFMR2-S.4.1.3"/>
  <meta>
    <profile
             value="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/FMFunction"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
    <span id="description"><b>Statement <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b> <div><p>Support member notification of clinical trials or research.</p>
</div></span>

    
    <span id="purpose"><b>Description <a href="https://hl7.org/fhir/versions.html#std-process" title="Informative Content" class="informative-flag">I</a>:</b> <div><p>A PHR Account Holder should be notified of clinical trials in which they have an interest. The individual may obtain clinical trial information based on general description or specific description such as diagnosis or trial phase. A PHR Account Holder should be able to make their clinical and demographic data available for clinical trials and/or research matching.</p>
</div></span>
    

    
    
    

    
    <span id="requirements"><b>Criteria <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b></span>
    
    <table id="statements" class="grid dict">
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.3#01</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHOULD</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The system SHOULD provide the ability to capture the PHR Account Holder's enrollment for clinical trial notifications.</p>
</div></span>
                
                
                Satisfied by:<ol>
                
                    <li><a href="https://www.hl7.org/fhir/researchstudy.html">https://www.hl7.org/fhir/researchstudy.html</a></li>
                
                </ol>
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.3#02</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHOULD</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The system SHOULD provide the ability to capture the PHR Account Holder's consent to participate in a clinical trial.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.3#03</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHOULD</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The system SHOULD provide the ability to receive clinical trial notifications.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.3#04</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>MAY</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The system MAY provide the ability to export the data fields necessary to help qualify the PHR Account Holder as a clinical trial participant.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.3#05</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHOULD</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The system SHOULD provide the ability to capture and render information regarding multiple sources of clinical trial and research information (e.g., links to multiple clinical trial websites).</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.3#06</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHOULD</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The system SHOULD provide the ability to extract and determine a focused search of trials by one or more attributes.</p>
</div></span>
                
                
            </td>
        </tr>
        
    </table>
</div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="ehr"/>
  </extension>
  <url value="http://hl7.org/ehrs/uv/phrsfmr2/Requirements/PHRSFMR2-S.4.1.3"/>
  <version value="2.0.1-ballot"/>
  <name
        value="S_4_1_3_Manage_PHR_Account_Holder_Notification_of_Clinical_Trials"/>
  <title
         value="S.4.1.3 Manage PHR Account Holder Notification of Clinical Trials (Function)"/>
  <status value="active"/>
  <date value="2025-08-29T14:03:44+00:00"/>
  <publisher value="EHR WG"/>
  <contact>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/ehr"/>
    </telecom>
  </contact>
  <description
               value="Support member notification of clinical trials or research."/>
  <purpose
           value="A PHR Account Holder should be notified of clinical trials in which they have an interest. The individual may obtain clinical trial information based on general description or specific description such as diagnosis or trial phase. A PHR Account Holder should be able to make their clinical and demographic data available for clinical trials and/or research matching."/>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.3-01"/>
    <label value="S.4.1.3#01"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to capture the PHR Account Holder's enrollment for clinical trial notifications."/>
    <satisfiedBy value="https://www.hl7.org/fhir/researchstudy.html"/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.3-02"/>
    <label value="S.4.1.3#02"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to capture the PHR Account Holder's consent to participate in a clinical trial."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.3-03"/>
    <label value="S.4.1.3#03"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to receive clinical trial notifications."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.3-04"/>
    <label value="S.4.1.3#04"/>
    <conformance value="MAY"/>
    <conditionality value="false"/>
    <requirement
                 value="The system MAY provide the ability to export the data fields necessary to help qualify the PHR Account Holder as a clinical trial participant."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.3-05"/>
    <label value="S.4.1.3#05"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to capture and render information regarding multiple sources of clinical trial and research information (e.g., links to multiple clinical trial websites)."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.3-06"/>
    <label value="S.4.1.3#06"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to extract and determine a focused search of trials by one or more attributes."/>
  </statement>
</Requirements>