ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
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| Active as of 2024-11-26 |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2.1-TI.2.1"/>
<meta>
<profile value="http://hl7.org/ehrs/StructureDefinition/FMFunction"/>
</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>Manage Audit Triggers</p>
</div></span>
<span id="purpose"><b>Description <a href="https://hl7.org/fhir/versions.html#std-process" title="Informative Content" class="informative-flag">I</a>:</b> <div><p>EHR Systems have built in audit triggers to capture key events in real-time. Audit triggers signal key:</p>
<ul>
<li>Record management and lifecycle events;</li>
<li>Security events related to system and data safeguards, both routine and exceptional;</li>
<li>System events related to performance and operations, both routine and exceptional.</li>
<li>Clinical events with special log requirements.</li>
</ul>
</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>TI.2.1#01</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL audit key events, as specified in function [[TI.2.1]] (Audit Triggers) and child functions, according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1#02</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL capture key Audit Metadata at each Audit Trigger, as specified in [[TI.2.1]] (Audit Triggers) and child functions, according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1#03</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL capture an Audit Log Entry at each Audit Trigger as specified in [[TI.2.1]] (Audit Triggers) according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1#04</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL capture the current master clock time to establish valid record date and time metadata.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1#05</span>
</td>
<td style="padding-left: 4px;">
<span>MAY</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system MAY manage Audit Trigger logging using a common audit engine (e.g., using schema and transports such as specified in the Audit Log specification of IHE Audit Trails and Node Authentication (ATNA) Profile).</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.2.1"/>
<version value="2.1.0"/>
<name value="TI_2_1_Audit_Triggers"/>
<title value="TI.2.1 Audit Triggers (Function)"/>
<status value="active"/>
<date value="2024-11-26T16:30:50+00:00"/>
<publisher value="EHR WG"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/ehr"/>
</telecom>
</contact>
<description value="Manage Audit Triggers"/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="EHR Systems have built in audit triggers to capture key events in real-time. Audit triggers signal key:
- Record management and lifecycle events;
- Security events related to system and data safeguards, both routine and exceptional;
- System events related to performance and operations, both routine and exceptional.
- Clinical events with special log requirements."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1-01"/>
<label value="TI.2.1#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL audit key events, as specified in function [[TI.2.1]] (Audit Triggers) and child functions, according to scope of practice, organizational policy, and/or jurisdictional law."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1-02"/>
<label value="TI.2.1#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture key Audit Metadata at each Audit Trigger, as specified in [[TI.2.1]] (Audit Triggers) and child functions, according to scope of practice, organizational policy, and/or jurisdictional law."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1-03"/>
<label value="TI.2.1#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture an Audit Log Entry at each Audit Trigger as specified in [[TI.2.1]] (Audit Triggers) according to scope of practice, organizational policy, and/or jurisdictional law."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1-04"/>
<label value="TI.2.1#04"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the current master clock time to establish valid record date and time metadata."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.2.2#18"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1-05"/>
<label value="TI.2.1#05"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY manage Audit Trigger logging using a common audit engine (e.g., using schema and transports such as specified in the Audit Log specification of IHE Audit Trails and Node Authentication (ATNA) Profile)."/>
</statement>
</Requirements>