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.4.2"/>
<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>Enable version control according to scope of practice, organizational policy, and/or jurisdictional law to ensure maintenance of utilized standard terminologies.</p>
<p>This includes the ability to accommodate changes to terminology sets as the source terminology undergoes its natural update process (new codes, retired codes, redirected codes). Such changes need to be cascaded to clinical content embedded in templates, custom formularies, etc., as determined by existing policy.</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>Version control allows for multiple sets or versions of the same terminology to exist and be distinctly recognized over time. Standard terminologies are usually periodically updated, and concurrent use of different versions may be required. Ideally, the meaning of a concept never changes over time, but a concept can be deprecated, and replaced with a new concept in a new version. However, in some terminologies, the meaning of a concept can change over time. In any case, it is important that retrospective analysis and research maintains the ability to relate to the appropriate conceptual meaning. If the terminology encoding for a concept changes over time, it is also important that for legal health records, as well as for retrospective analysis and research, the different encodings can be correlated to ensure the permanence of the concept as originally captured. This does not necessarily imply that complete older versions of the terminology be kept in the EHR-S, only access to the changes needs to be maintained.</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.4.2#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 manage data using different versions of standard terminologies.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.4.2#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 update standard terminologies.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.4.2#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 maintain relationships among versions of a standard terminology to allow preservation of interpretation over time.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.4.2#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 receive and harmonize data from and transmit data to other systems that use known different versions of a terminology standard while preserving the meaning of that data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.4.2#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 provide the ability to update terminologies to a deprecated status.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.4.2#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 update individual codes within a terminology to a deprecated status.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.4.2#07</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 provide the ability to update terms with their equivalent when terminology is changed, where coded terminology content is embedded in clinical models (e.g., templates and custom formularies), when the terminology changes can be accomplished unambiguously, and if consistent with scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.4.2#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 update standard terminologies used to enter clinical content (via templates, custom formularies, etc.)</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.4.2#09</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 an audit log or a change history of code system to the individual code level, for versions used, dates implemented and updated to enable correct interpretation of historical data over time.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.4.2"/>
<version value="2.1.0"/>
<name value="TI_4_2_Maintenance_and_Versioning_of_Standard_Terminologies"/>
<title
value="TI.4.2 Maintenance and Versioning of Standard Terminologies (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="Enable version control according to scope of practice, organizational policy, and/or jurisdictional law to ensure maintenance of utilized standard terminologies.
This includes the ability to accommodate changes to terminology sets as the source terminology undergoes its natural update process (new codes, retired codes, redirected codes). Such changes need to be cascaded to clinical content embedded in templates, custom formularies, etc., as determined by existing policy."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="Version control allows for multiple sets or versions of the same terminology to exist and be distinctly recognized over time. Standard terminologies are usually periodically updated, and concurrent use of different versions may be required. Ideally, the meaning of a concept never changes over time, but a concept can be deprecated, and replaced with a new concept in a new version. However, in some terminologies, the meaning of a concept can change over time. In any case, it is important that retrospective analysis and research maintains the ability to relate to the appropriate conceptual meaning. If the terminology encoding for a concept changes over time, it is also important that for legal health records, as well as for retrospective analysis and research, the different encodings can be correlated to ensure the permanence of the concept as originally captured. This does not necessarily imply that complete older versions of the terminology be kept in the EHR-S, only access to the changes needs to be maintained."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.4.2-01"/>
<label value="TI.4.2#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to manage data using different versions of standard terminologies."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.4.2#1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.4.2-02"/>
<label value="TI.4.2#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to update standard terminologies."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.4.2#2"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.4.2-03"/>
<label value="TI.4.2#03"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD maintain relationships among versions of a standard terminology to allow preservation of interpretation over time."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.4.2#3"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.4.2-04"/>
<label value="TI.4.2#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to receive and harmonize data from and transmit data to other systems that use known different versions of a terminology standard while preserving the meaning of that data."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.4.2#4"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.4.2-05"/>
<label value="TI.4.2#05"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to update terminologies to a deprecated status."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.4.2#5"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.4.2-06"/>
<label value="TI.4.2#06"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to update individual codes within a terminology to a deprecated status."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.4.2#6"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.4.2-07"/>
<label value="TI.4.2#07"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to update terms with their equivalent when terminology is changed, where coded terminology content is embedded in clinical models (e.g., templates and custom formularies), when the terminology changes can be accomplished unambiguously, and if consistent with scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.4.2#7"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.4.2-08"/>
<label value="TI.4.2#08"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to update standard terminologies used to enter clinical content (via templates, custom formularies, etc.)"/>
<derivedFrom value="EHR-S_FM_R1.1 IN.4.2#8"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.4.2-09"/>
<label value="TI.4.2#09"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL maintain an audit log or a change history of code system to the individual code level, for versions used, dates implemented and updated to enable correct interpretation of historical data over time."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.4.2#9"/>
</statement>
</Requirements>