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-RI.1.3.2"/>
<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>Manage Record Entries amended, corrected or augmented after finalization (or signature/attestation).</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>Clinicians need the ability to correct, amend or augment Record Entries once they have been completed. When an amendment, correction or augmentation has been made, principles for documentation practices require that the original documentation must be accessible, readable, and unobliterated. A user must have a clear indication that modifications have been made to an Record Entry. There is optionality in how a system may identify a Record Entry that has been corrected or amended – a flag or indicator could be displayed, the text could be in a different font, etc. The original Record Entry is not required to be displayed, but can be linked or traced back. The original Record Entry and each successive amendment, correction or augmentation should be retained for the legally prescribed timeframe as defined by scope of practice, organizational policy, and/or jurisdictional law.</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.1.3.2#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 a Record Entry for purposes of amendment, correction or augmentation, conforming to function [[RI.1.1.2]] (Amend Record Entry Content).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.3.2#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 provide the ability to tag a Record Entry as an amendment, a correction of erroneous information and the reason, or an augmentation to supplement content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.3.2#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, maintain and render the corresponding date, time, and user specifying when and by whom a Record Entry was amended, corrected, or augmented, conforming to function [[RI.1.1.2.1]] (Evidence of Record Entry Amendment Event).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.3.2#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 present the current version and provide a link or clear direction for accessing previous version(s) of the Record Entry.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.3.2#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 manage all versions of the Record Entry for the legal retention period, conforming to function [[RI.1.2.1]] (Manage Record Entries).</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-RI.1.3.2"/>
<version value="2.1.0"/>
<name
value="RI_1_3_2_Manage_Record_Entry_Amended__Corrected_and_Augmented_State"/>
<title
value="RI.1.3.2 Manage Record Entry Amended, Corrected and Augmented State (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 Record Entries amended, corrected or augmented after finalization (or signature/attestation)."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="Clinicians need the ability to correct, amend or augment Record Entries once they have been completed. When an amendment, correction or augmentation has been made, principles for documentation practices require that the original documentation must be accessible, readable, and unobliterated. A user must have a clear indication that modifications have been made to an Record Entry. There is optionality in how a system may identify a Record Entry that has been corrected or amended – a flag or indicator could be displayed, the text could be in a different font, etc. The original Record Entry is not required to be displayed, but can be linked or traced back. The original Record Entry and each successive amendment, correction or augmentation should be retained for the legally prescribed timeframe as defined by scope of practice, organizational policy, and/or jurisdictional law."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.3.2-01"/>
<label value="RI.1.3.2#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to update a Record Entry for purposes of amendment, correction or augmentation, conforming to function [[RI.1.1.2]] (Amend Record Entry Content)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.3.2-02"/>
<label value="RI.1.3.2#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to tag a Record Entry as an amendment, a correction of erroneous information and the reason, or an augmentation to supplement content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.3.2-03"/>
<label value="RI.1.3.2#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture, maintain and render the corresponding date, time, and user specifying when and by whom a Record Entry was amended, corrected, or augmented, conforming to function [[RI.1.1.2.1]] (Evidence of Record Entry Amendment Event)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.3.2-04"/>
<label value="RI.1.3.2#04"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL present the current version and provide a link or clear direction for accessing previous version(s) of the Record Entry."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.3.2-05"/>
<label value="RI.1.3.2#05"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL manage all versions of the Record Entry for the legal retention period, conforming to function [[RI.1.2.1]] (Manage Record Entries)."/>
</statement>
</Requirements>