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-PDS.1"/>
<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><p>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.</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>PDS.1#01</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><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></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.1#02</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><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></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.1#03</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The App SHOULD have measures to safeguard minors in accordance with applicable regulations.</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-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="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>
<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>