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.1.3"/>
<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.1.3#39</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[App provides health recommendations] Disclose the scientific degree of evidence and the types and dates of sources used (e.g., clinical practice guidelines and protocols, peer-reviewed articles, professionals and organizations with their credentials) that guided the app content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.3#40</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[there is human[1] and/or automated interpretation of health-related content] The credentials of qualified health professionals are disclosed, and/or the algorithms and testing plans and reports are documented.[2]</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.3#41</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The app descriptions should identify the health professionals and credentials of those who worked on the app and/or at least the professional organization that made, reviewed, endorsed, or sponsored the app.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.3#42</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Show the date of the last update to the app and describe the changes from the previous release (e.g., revisions due to new scientific evidence).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.3#43</span>
</td>
<td style="padding-left: 4px;">
<span>MAY</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The app description may also include data related to app reliability and validity tests or population research results.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.3#44</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Declare the degree of admission of liability (publisher’s acceptance or disclaimer of responsibility) regarding the selection and use of the app’s content.[3]</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.1.3"/>
<version value="2.0.1"/>
<name value="PIM_1_3_Evidence_and_Credentials"/>
<title value="PIM.1.3 Evidence and Credentials (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.1.3-39"/>
<label value="PIM.1.3#39"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[App provides health recommendations] Disclose the scientific degree of evidence and the types and dates of sources used (e.g., clinical practice guidelines and protocols, peer-reviewed articles, professionals and organizations with their credentials) that guided the app content."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.3-40"/>
<label value="PIM.1.3#40"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[there is human[1] and/or automated interpretation of health-related content] The credentials of qualified health professionals are disclosed, and/or the algorithms and testing plans and reports are documented.[2]"/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.3-41"/>
<label value="PIM.1.3#41"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The app descriptions should identify the health professionals and credentials of those who worked on the app and/or at least the professional organization that made, reviewed, endorsed, or sponsored the app."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.3-42"/>
<label value="PIM.1.3#42"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Show the date of the last update to the app and describe the changes from the previous release (e.g., revisions due to new scientific evidence)."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.3-43"/>
<label value="PIM.1.3#43"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The app description may also include data related to app reliability and validity tests or population research results."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.3-44"/>
<label value="PIM.1.3#44"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Declare the degree of admission of liability (publisher’s acceptance or disclaimer of responsibility) regarding the selection and use of the app’s content.[3]"/>
</statement>
</Requirements>