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.4.1.4 Manage PHR Account Holder Enrollment in Clinical Trials or Research (Function) - XML Representation

Page standards status: Informative

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<Requirements xmlns="http://hl7.org/fhir">
  <id value="PHRSFMR2-S.4.1.4"/>
  <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 enrollment in 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>The system should support a PHR Account Holder having the ability to enroll in clinical trials or research, The system should be able to capture administrative and consent requirements, trial or research questionnaires, data submissions and all alerts associated with a program. The PHR Account Holder should also have the ability to choose which programs they desire to participate in when notified of trial availability and high quality PHR Account Holder match.</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.4.1.4#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 manage a PHR Account Holder’s enrollment in a clinical trial or research program.</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.4.1.4#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 all administrative information about a clinical trial or research program.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.4#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 render clinical trial or research participation sorted by categories.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.4#04</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 alerts or notifications from the clinical trial program.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.4#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 render prompts to the PHR Account Holder regarding clinical trial requirements.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>S.4.1.4#06</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 render information regarding available health benefit plan clinical trial/research support.</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.4.1.4"/>
  <version value="2.0.1-ballot"/>
  <name
        value="S_4_1_4_Manage_PHR_Account_Holder_Enrollment_in_Clinical_Trials_or_Research"/>
  <title
         value="S.4.1.4 Manage PHR Account Holder Enrollment in Clinical Trials or Research (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 enrollment in clinical trials or research."/>
  <purpose
           value="The system should support a PHR Account Holder having the ability to enroll in clinical trials or research, The system should be able to capture administrative and consent requirements, trial or research questionnaires, data submissions and all alerts associated with a program. The PHR Account Holder should also have the ability to choose which programs they desire to participate in when notified of trial availability and high quality PHR Account Holder match."/>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.4-01"/>
    <label value="S.4.1.4#01"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to manage a PHR Account Holder’s enrollment in a clinical trial or research program."/>
    <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.4.1.4-02"/>
    <label value="S.4.1.4#02"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to capture all administrative information about a clinical trial or research program."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.4-03"/>
    <label value="S.4.1.4#03"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to render clinical trial or research participation sorted by categories."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.4-04"/>
    <label value="S.4.1.4#04"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to capture alerts or notifications from the clinical trial program."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.4-05"/>
    <label value="S.4.1.4#05"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to render prompts to the PHR Account Holder regarding clinical trial requirements."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="PHRSFMR2-S.4.1.4-06"/>
    <label value="S.4.1.4#06"/>
    <conformance value="MAY"/>
    <conditionality value="false"/>
    <requirement
                 value="The system MAY provide the ability to render information regarding available health benefit plan clinical trial/research support."/>
  </statement>
</Requirements>