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.2.1.3"/>
<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 System 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>System Audit Triggers are designed to capture system related events, both routine and exceptional, including key metadata (who, what, when, where, why).</p>
</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.2.1.3#01</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to log system maintenance events for loading new versions of, or changes to, the clinical system.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1.3#02</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to store system maintenance events for loading new versions of codes and knowledge bases.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1.3#03</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to log system maintenance events for creating and restoring of backup.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1.3#04</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to audit events in the case of detection of corrupt or dirty data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1.3#05</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL provide the ability to audit the access and usage of systems, data, and organizational resources.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1.3#06</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL provide the ability to log system events at the hardware and software architecture level.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1.3#07</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL provide the ability to log system maintenance events for entry to, and exit from, the EHR system.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.2.1.3#08</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL provide the ability to log system maintenance events for remote access connections including those for system support and maintenance activities for security and access purposes.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.2.1.3"/>
<version value="2.1.0"/>
<name value="TI_2_1_3_System_Audit_Triggers"/>
<title value="TI.2.1.3 System 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 System 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="System Audit Triggers are designed to capture system related events, both routine and exceptional, including key metadata (who, what, when, where, why)."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1.3-01"/>
<label value="TI.2.1.3#01"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to log system maintenance events for loading new versions of, or changes to, the clinical system."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.2.2#16"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1.3-02"/>
<label value="TI.2.1.3#02"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to store system maintenance events for loading new versions of codes and knowledge bases."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.2.2#17"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1.3-03"/>
<label value="TI.2.1.3#03"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to log system maintenance events for creating and restoring of backup."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.2.2#19"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1.3-04"/>
<label value="TI.2.1.3#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to audit events in the case of detection of corrupt or dirty data."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1.3-05"/>
<label value="TI.2.1.3#05"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to audit the access and usage of systems, data, and organizational resources."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.2.2#1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1.3-06"/>
<label value="TI.2.1.3#06"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to log system events at the hardware and software architecture level."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.2.2#12"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1.3-07"/>
<label value="TI.2.1.3#07"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to log system maintenance events for entry to, and exit from, the EHR system."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.2.2#22"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.2.1.3-08"/>
<label value="TI.2.1.3#08"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to log system maintenance events for remote access connections including those for system support and maintenance activities for security and access purposes."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.2.2#23"/>
</statement>
</Requirements>