Consumer Mobile Health Application Functional Framework, Release 2
2.0.1 - CI build
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.3"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"/>
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<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>PDS.3#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 assessed against an industry-validated usability assessment tool, using subjects who are demographically-similar to intended users (target audience). For example, user types may include those with motor disabilities, visual impairment, auditory disabilities, etc. [1]</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#02</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[Intended users include those with motor disabilities] Assess product for usability by people with motor disabilities.[1]</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#03</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[Intended users include those with visual disabilities] Assess product for usability by visually-impaired and/or color-blind people using a standard mobile screen reader.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#04</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[Intended users include those with auditory disabilities] Assess product for usability by people with auditory disabilities.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#05</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Assess product for usability by a sample of intended users. If geared towards a certain age segment or to people with a specific chronic health condition, or to persons with disabilities other than those specified above, usability testing subjects are drawn from these populations.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#06</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Create a written usability assessment plan, including known problems with product usability and mitigation plan. NOTE: for U.S. Realm when an app is sponsored by a HIPAA entity, the force of this criteria is elevated to “SHALL†with plan specifically addressing usability issues for people with visual and motor disabilities.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#07</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Follow design/style guide standards established by the platform provider(s) for the app (e.g., Android, iOS).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#08</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Avoid excessive data use by the app, minimizing it as much as possible warning users when high data usage occurs (e.g., downloads and updates).[2]</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#09</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Describe the use cases (business scenarios) and intended users for the app’s main functions.[3]</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#10</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Permit flexibility (adaptation) to the user’s specific abilities, needs, or requirements.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PDS.3#11</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Provide information about accessibility characteristics in the app description and in contextual assistance sections of the app.</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.3"/>
<version value="2.0.1"/>
<name value="PDS_3_Usability_and_Accessibility_Assessment"/>
<title value="PDS.3 Usability and Accessibility Assessment (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-PDS.3-01"/>
<label value="PDS.3#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The App SHALL be assessed against an industry-validated usability assessment tool, using subjects who are demographically-similar to intended users (target audience). For example, user types may include those with motor disabilities, visual impairment, auditory disabilities, etc. [1]"/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-02"/>
<label value="PDS.3#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[Intended users include those with motor disabilities] Assess product for usability by people with motor disabilities.[1]"/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-03"/>
<label value="PDS.3#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[Intended users include those with visual disabilities] Assess product for usability by visually-impaired and/or color-blind people using a standard mobile screen reader."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-04"/>
<label value="PDS.3#04"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[Intended users include those with auditory disabilities] Assess product for usability by people with auditory disabilities."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-05"/>
<label value="PDS.3#05"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Assess product for usability by a sample of intended users. If geared towards a certain age segment or to people with a specific chronic health condition, or to persons with disabilities other than those specified above, usability testing subjects are drawn from these populations."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-06"/>
<label value="PDS.3#06"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Create a written usability assessment plan, including known problems with product usability and mitigation plan. NOTE: for U.S. Realm when an app is sponsored by a HIPAA entity, the force of this criteria is elevated to “SHALL†with plan specifically addressing usability issues for people with visual and motor disabilities."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-07"/>
<label value="PDS.3#07"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Follow design/style guide standards established by the platform provider(s) for the app (e.g., Android, iOS)."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-08"/>
<label value="PDS.3#08"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Avoid excessive data use by the app, minimizing it as much as possible warning users when high data usage occurs (e.g., downloads and updates).[2]"/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-09"/>
<label value="PDS.3#09"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Describe the use cases (business scenarios) and intended users for the app’s main functions.[3]"/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-10"/>
<label value="PDS.3#10"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Permit flexibility (adaptation) to the user’s specific abilities, needs, or requirements."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PDS.3-11"/>
<label value="PDS.3#11"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Provide information about accessibility characteristics in the app description and in contextual assistance sections of the app."/>
</statement>
</Requirements>
IG © 2025 HL7 International / Mobile Health. Package hl7.fhir.uv.cmhaffr2#2.0.1 based on FHIR 5.0.0. Generated 2025-05-28
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