Consumer Mobile Health Application Functional Framework, Release 2, published by HL7 International / Mobile Health. This guide is not an authorized publication; it is the continuous build for version 2.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/cmhaff-ig/ and changes regularly. See the Directory of published versions

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: PDS.1 Regulatory Considerations (Header)

Page standards status: Informative

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<Requirements xmlns="http://hl7.org/fhir">
  <id value="CMHAFFR2-PDS.1"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en">
    
    
    
    
    <div id="requirements"><b>Criteria <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b></div>
    
    <table id="statements" class="grid dict">
        
        <tr>
            <td style="padding-left: 4px;">
            PDS.1#01
            </td>
            <td style="padding-left: 4px;">
            SHALL
            
            
            
            </td>
            <td style="padding-left: 4px;" class="requirement">
                <div><p>The app SHALL be analyzed to determine if regulatory approval (following Realm-specific regulatory rules) is needed before the app is used by the general public.</p>
</div>
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
            PDS.1#02
            </td>
            <td style="padding-left: 4px;">
            SHALL
            
            <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #f3e5ff;color: #7b1fa2;border: 1px solid #d1a3ff;">conditional</span>
            
            </td>
            <td style="padding-left: 4px;" class="requirement">
                <div><p>IF it is determined that realm-specific regulatory rule approval is required THEN the app SHALL not be presented for general public use until regulatory approval is obtained.</p>
</div>
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
            PDS.1#03
            </td>
            <td style="padding-left: 4px;">
            SHOULD
            
            
            
            </td>
            <td style="padding-left: 4px;" class="requirement">
                <div><p>The App SHOULD have measures to safeguard minors in accordance with applicable regulations.</p>
</div>
                
            </td>
        </tr>
        
    </table>
</div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="mobile"/>
  </extension>
  <url value="http://hl7.org/fhir/uv/cmhaffr2/Requirements/CMHAFFR2-PDS.1"/>
  <version value="2.0.1"/>
  <name value="PDS_1_Regulatory_Considerations"/>
  <title value="PDS.1 Regulatory Considerations (Header)"/>
  <status value="active"/>
  <date value="2026-03-20T11:58:09+00:00"/>
  <publisher value="HL7 International / Mobile Health"/>
  <contact>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/mobile"/>
    </telecom>
  </contact>
  <description
               value="This section is about the compliance of apps to applicable regulations for the domains (realms, locales,
environments) in which they are intended to be used. CMHAFF is designed as a framework that can be
further constrained (profiled) for these domains and does not require conformance to any specific
locale’s regulations."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <statement>
    <extension
               url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-PDS.1-01"/>
    <label value="PDS.1#01"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="The app SHALL be analyzed to determine if regulatory approval (following Realm-specific regulatory rules) is needed before the app is used by the general public."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-PDS.1-02"/>
    <label value="PDS.1#02"/>
    <conformance value="SHALL"/>
    <conditionality value="true"/>
    <requirement
                 value="IF it is determined that realm-specific regulatory rule approval is required THEN the app SHALL not be presented for general public use until regulatory approval is obtained."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-PDS.1-03"/>
    <label value="PDS.1#03"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The App SHOULD have measures to safeguard minors in accordance with applicable regulations."/>
  </statement>
</Requirements>