Consumer Mobile Health Application Functional Framework, Release 2
2.0.1 - CI build International flag

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

: PIM.1.1 General Information (Function) - XML Representation

Page standards status: Informative

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<Requirements xmlns="http://hl7.org/fhir">
  <id value="CMHAFFR2-PIM.1.1"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/cmhaffr2/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/></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>PIM.1.1#01</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHALL</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The description of an app includes the main functionality, the intended use, the intended (target) audience, and potential use of the user’s personal data by the app.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>PIM.1.1#02</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHALL</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>Screen shots of the app accurately depict the screens of the current version of the product.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>PIM.1.1#03</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHALL</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>Product information is provided before the app is used by the consumer, to help consumers decide whether the app is suitable.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>PIM.1.1#04</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHOULD</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The app description clearly states the human languages the app supports.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>PIM.1.1#05</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHOULD</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>Provide information about the app publisher (persons/organizations) and provide mechanisms to communicate with the publishers.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>PIM.1.1#06</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHOULD</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>Provide disclosure about sources of funding and possible conflicts of interest for the app (e.g., app use could incent user to buy products or services from app publisher).</p>
</div></span>
                
                
            </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-PIM.1.1"/>
  <version value="2.0.1"/>
  <name value="PIM_1_1_General_Information"/>
  <title value="PIM.1.1 General Information (Function)"/>
  <status value="active"/>
  <date value="2025-05-28T08:01:49+00:00"/>
  <publisher value="HL7 International / Mobile Health"/>
  <contact>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/mobile"/>
    </telecom>
  </contact>
  <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-PIM.1.1-01"/>
    <label value="PIM.1.1#01"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="The description of an app includes the main functionality, the intended use, the intended (target) audience, and potential use of the user’s personal data by the app."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-PIM.1.1-02"/>
    <label value="PIM.1.1#02"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="Screen shots of the app accurately depict the screens of the current version of the product."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-PIM.1.1-03"/>
    <label value="PIM.1.1#03"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="Product information is provided before the app is used by the consumer, to help consumers decide whether the app is suitable."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-PIM.1.1-04"/>
    <label value="PIM.1.1#04"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The app description clearly states the human languages the app supports."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-PIM.1.1-05"/>
    <label value="PIM.1.1#05"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="Provide information about the app publisher (persons/organizations) and provide mechanisms to communicate with the publishers."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-PIM.1.1-06"/>
    <label value="PIM.1.1#06"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="Provide disclosure about sources of funding and possible conflicts of interest for the app (e.g., app use could incent user to buy products or services from app publisher)."/>
  </statement>
</Requirements>