ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
0.16.0 - CI Build
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Active as of 2024-08-12 |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2.1-RI.1.1.2"/>
<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>Amend (Update) Record Entry (1 instance)</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>Occurs when an agent makes any change to record entry content currently residing in storage considered permanent (persistent).</p>
<p>Reference: ISO 21089-2018, Section 15.2.</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>RI.1.1.2#01</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 update (amend) Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.2#02</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL maintain the original and all previously amended versions of the Record Entry, retaining each version instance without alteration.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.2#03</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 a new uniquely identifiable version of the Record Entry, incorporating amended content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.2#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 signature event (e.g., digital signature) of the amendment Author, binding signature to Record Entry content.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-RI.1.1.2"/>
<version value="0.16.0"/>
<name value="RI_1_1_2_Amend__Update__Record_Lifecycle_Event"/>
<title value="RI.1.1.2 Amend (Update) Record Lifecycle Event (Function)"/>
<status value="active"/>
<date value="2024-08-12T10:56:01+00:00"/>
<publisher value="EHR WG"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/ehr"/>
</telecom>
</contact>
<description value="Amend (Update) Record Entry (1 instance)"/>
<purpose
value="Occurs when an agent makes any change to record entry content currently residing in storage considered permanent (persistent).
Reference: ISO 21089-2018, Section 15.2."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.2-01"/>
<label value="RI.1.1.2#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to update (amend) Record Entry content."/>
<derivedFrom value="EHR-LM_R1 14.2.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.2-02"/>
<label value="RI.1.1.2#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL maintain the original and all previously amended versions of the Record Entry, retaining each version instance without alteration."/>
<derivedFrom value="EHR-LM_R1 14.2.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.2-03"/>
<label value="RI.1.1.2#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture a new uniquely identifiable version of the Record Entry, incorporating amended content."/>
<derivedFrom value="EHR-LM_R1 14.2.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.2-04"/>
<label value="RI.1.1.2#04"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the signature event (e.g., digital signature) of the amendment Author, binding signature to Record Entry content."/>
<derivedFrom value="EHR-LM_R1 14.2.1"/>
</statement>
</Requirements>