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-PIM.1.4"/>
<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.1.4#45</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 (e.g., general guidelines)] Disclose the potential risks to patient safety and their mitigations.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.4#46</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[App offers health advice (e.g., specific and personal health decision support)] State that the use of the app does not replace the provider-patient relationship or the recommendation, opinion, or diagnosis of a health professional.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.4#47</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Document contraindications, potential risks and limitations of use. For example, environmental or patient conditions under which apps or connected devices may be unreliable (e.g., tattoos that impact optical sensors; avoid usage when pregnant; avoid usage outside a temperature range).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.4#48</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>Warn users of updates caused by possible errors in functionality, in health-related information, or in any other sensitive data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>PIM.1.4#49</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>[App has collected personal health information] guarantee continuity of data use across different versions 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-PIM.1.4"/>
<version value="2.0.1"/>
<name value="PIM_1_4_Limitations_and_Warnings"/>
<title value="PIM.1.4 Limitations and Warnings (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.1.4-45"/>
<label value="PIM.1.4#45"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="[App provides health recommendations (e.g., general guidelines)] Disclose the potential risks to patient safety and their mitigations."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.4-46"/>
<label value="PIM.1.4#46"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="[App offers health advice (e.g., specific and personal health decision support)] State that the use of the app does not replace the provider-patient relationship or the recommendation, opinion, or diagnosis of a health professional."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.4-47"/>
<label value="PIM.1.4#47"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="Document contraindications, potential risks and limitations of use. For example, environmental or patient conditions under which apps or connected devices may be unreliable (e.g., tattoos that impact optical sensors; avoid usage when pregnant; avoid usage outside a temperature range)."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.4-48"/>
<label value="PIM.1.4#48"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="Warn users of updates caused by possible errors in functionality, in health-related information, or in any other sensitive data."/>
</statement>
<statement>
<extension
url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="CMHAFFR2-PIM.1.4-49"/>
<label value="PIM.1.4#49"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="[App has collected personal health information] guarantee continuity of data use across different versions 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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