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.1.5"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"/>
</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.1.5#50</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[User can enter personal health information into the app] Clearly disclose whether or not data validity checking is done, and document or reference the evidence for such validity checking.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.5#51</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[App collects or receives quantitative data] The precision (accuracy, granularity) of measurements (e.g., physical activity, physiological data from connected devices) is documented and justified as appropriate for the intended use of the app.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.5#52</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[Personal health information is hosted] Backup and recovery procedures are documented and compliant with applicable regulatory requirements.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.5#53</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[Personal health data are imported or exported] Functions for data import or export are documented, including the ability to convert to standard formats.</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.1.5"/>
<version value="2.0.1"/>
<name value="PIM_1_5_Technical_Details"/>
<title value="PIM.1.5 Technical Details (Header)"/>
<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.1.5-50"/>
<label value="PIM.1.5#50"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[User can enter personal health information into the app] Clearly disclose whether or not data validity checking is done, and document or reference the evidence for such validity checking."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.5-51"/>
<label value="PIM.1.5#51"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[App collects or receives quantitative data] The precision (accuracy, granularity) of measurements (e.g., physical activity, physiological data from connected devices) is documented and justified as appropriate for the intended use of the app."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.5-52"/>
<label value="PIM.1.5#52"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[Personal health information is hosted] Backup and recovery procedures are documented and compliant with applicable regulatory requirements."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.5-53"/>
<label value="PIM.1.5#53"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[Personal health data are imported or exported] Functions for data import or export are documented, including the ability to convert to standard formats."/>
</statement>
</Requirements>