Consumer Mobile Health Application Functional Framework, Release 2
2.0.1 - CI build
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
Page standards status: Informative |
<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>