<?xml version="1.0" encoding="UTF-8"?>

<Requirements xmlns="http://hl7.org/fhir">
  <id value="CMHAFFR2-APU.10"/>
  <meta>
    <profile value="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="extensions"/><div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en">
    
    
    
    
    <div id="requirements"><b>Criteria <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b></div>
    
    <table id="statements" class="grid dict">
        
        <tr>
            <td style="padding-left: 4px;">
            APU.10#111
            </td>
            <td style="padding-left: 4px;">
            SHALL
            
            
            
            </td>
            <td style="padding-left: 4px;" class="requirement">
                <div><p>[User authentication is required to access app] User authentication attempts, both successful and unsuccessful, generate an audit record.</p>
</div>
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
            APU.10#112
            </td>
            <td style="padding-left: 4px;">
            SHALL
            
            
            
            </td>
            <td style="padding-left: 4px;" class="requirement">
                <div><p>User permissions to access, or the revocation of access, regarding smartphone/tablet device capabilities for use by the app (e.g., use of camera, location services) generate an audit record.</p>
</div>
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
            APU.10#113
            </td>
            <td style="padding-left: 4px;">
            SHALL
            
            
            
            </td>
            <td style="padding-left: 4px;" class="requirement">
                <div><p>[App uses external devices or data sources for data collection] Pairing a device or data repository external to the app, which supplies data used by the app, generates an audit record.</p>
</div>
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
            APU.10#114
            </td>
            <td style="padding-left: 4px;">
            SHALL
            
            
            
            </td>
            <td style="padding-left: 4px;" class="requirement">
                <div><p>[App allows for the export of data to a data repository external to the app] Any export of data from the app generates an audit record.</p>
</div>
                
            </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-APU.10"/>
  <version value="2.0.1"/>
  <name value="APU_10_Audit"/>
  <title value="APU.10 Audit (Header)"/>
  <status value="active"/>
  <date value="2026-03-20T11:58:09+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 category is about auditing, which is a mechanism for user and system accountability. Important events, such as logins and access to&#xA;particular functions and data, are recorded and can be used to detect instances of non-compliant behavior and to facilitate detection of improper&#xA;creation, access, modification, and deletion of personal health information. Any information technology including consumer health apps should follow&#xA;best practices in managing an audit trail. The audit trail should maintain a record of users who have accessed what data, from where, and when. Audit&#xA;logs should also record any attempts to access the system from an unauthorized terminal; expired usernames or passwords that try to access the&#xA;system, unusual numbers of authentication attempts, and violations of an organizations security policy."/>
  <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-APU.10-111"/>
    <label value="APU.10#111"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement value="[User authentication is required to access app] User authentication attempts, both successful and unsuccessful, generate an audit record."/>
  </statement>
  <statement>
    <extension url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-APU.10-112"/>
    <label value="APU.10#112"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement value="User permissions to access, or the revocation of access, regarding smartphone/tablet device capabilities for use by the app (e.g., use of camera, location services) generate an audit record."/>
  </statement>
  <statement>
    <extension url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-APU.10-113"/>
    <label value="APU.10#113"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement value="[App uses external devices or data sources for data collection] Pairing a device or data repository external to the app, which supplies data used by the app, generates an audit record."/>
  </statement>
  <statement>
    <extension url="http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="CMHAFFR2-APU.10-114"/>
    <label value="APU.10#114"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement value="[App allows for the export of data to a data repository external to the app] Any export of data from the app generates an audit record."/>
  </statement>
</Requirements>