HL7 Electronic Health Record System Functional Model, Release 2.1.1
2.1.1-ballot - Normative Ballot
HL7 Electronic Health Record System Functional Model, Release 2.1.1
2.1.1-ballot - Normative Ballot
HL7 Electronic Health Record System Functional Model, Release 2.1.1, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 2.1.1-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ehrsfm-ig/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2-OV.1"/>
<meta>
<profile
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<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>Overarching criteria are those that apply to all EHR Systems.</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>The Overarching Section contains Conformance Criteria that apply to all EHR Systems and consequently must be included in all EHR-S FM compliant profiles. These criteria are grouped under a single Function.</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>OV.1#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 conform to function <a href="Requirements-EHRSFMR2-CP.9.1.html">CP.9.1</a> (Produce a Summary Record of Care).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#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 conform to function <a href="Requirements-EHRSFMR2-CPS.9.3.html">CPS.9.3</a> (Health Record Output).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#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 conform to function <a href="Requirements-EHRSFMR2-CPS.9.4.html">CPS.9.4</a> (Standard Report Generation).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.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 conform to function <a href="Requirements-EHRSFMR2-RI.1.1.html">RI.1.1</a> (Record Lifecycle) and all child functions.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#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 conform to function <a href="Requirements-EHRSFMR2-RI.1.2.html">RI.1.2</a> (Record Lifespan) and all child functions.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#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 conform to function <a href="Requirements-EHRSFMR2-RI.2.html">RI.2</a> (Record Synchronization).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#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 conform to function <a href="Requirements-EHRSFMR2-RI.3.html">RI.3</a> (Record Archive and Restore).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#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 conform to function <a href="Requirements-EHRSFMR2-TI.1.1.html">TI.1.1</a> (Entity Authentication).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#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 conform to function <a href="Requirements-EHRSFMR2-TI.1.2.html">TI.1.2</a> (Entity Authorization) .</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#10</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.1.3.html">TI.1.3</a> (Entity Access Control).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#11</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.1.4.html">TI.1.4</a> (Patient Access Management).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#12</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.1.5.html">TI.1.5</a> (Non-Repudiation).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#13</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the system transmits data to or receives data from a system outside of a secure network, THEN the system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.1.6.html">TI.1.6</a> (Secure Data Exchange), to ensure that the data are protected.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#14</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the system transmits data to or receives data from a system outside of a secure network, THEN the system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.1.7.html">TI.1.7</a> (Secure Data Routing), to ensure that the exchange occurs only among authorized senders and receivers.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#15</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.1.8.html">TI.1.8</a> (Patient Privacy and Confidentiality).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#16</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.2.html">TI.2</a> (Audit) and all child functions.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#17</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD conform to function <a href="Requirements-EHRSFMR2-TI.3.html">TI.3</a> (Registry and Directory Services).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#18</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.4.html">TI.4</a> (Standard Terminology and Terminology Services).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#19</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the system manages data for which standard terminologies have been established, THEN the system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.4.1.html">TI.4.1</a> (Standard Terminologies and Terminology Models) to support semantic interoperability.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#20</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the system manages data for which standard terminologies have been established, THEN the system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.4.2.html">TI.4.2</a> (Maintenance and Versioning of Standard Terminologies) to preserve the semantics of coded data over time.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#21</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF terminology mapping is implemented within the system, THEN the system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.4.3.html">TI.4.3</a> (Terminology Mapping).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#22</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the system receives or transmits data for which jurisdictionally established interchange standards exist, THEN the system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.5.1.html">TI.5.1</a> (Application and Structured-Document Interchange Standards) and all child functions to support interoperability.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#23</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the system receives and transmits data for which generally accepted interchange standards have been established, THEN the system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.5.2.html">TI.5.2</a> (Interchange Standards Versioning and Maintenance), to accommodate the inevitable evolution of interchange standards.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#24</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD conform to function <a href="Requirements-EHRSFMR2-TI.5.3.html">TI.5.3</a> (Standards-based Application Integration).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#25</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the system receives and transmits data with other systems outside itself, THEN the system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.5.4.html">TI.5.4</a> (Interchange Agreements), to define how the sender and receiver will exchange data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#26</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD conform to function <a href="Requirements-EHRSFMR2-TI.6.html">TI.6</a> (Business Rules Management).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#27</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD conform to function <a href="Requirements-EHRSFMR2-TI.7.html">TI.7</a> (Workflow Management).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#28</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.8.html">TI.8</a> (Database Backup and Recovery).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#29</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-CPS.10.html">CPS.10</a> (Manage User Help).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>OV.1#30</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function <a href="Requirements-EHRSFMR2-TI.9.html">TI.9</a> (System Management Operations and Performance).</p>
</div></span>
</td>
</tr>
</table>
</div>
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<extension
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<requirement
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<extension
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<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
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<statement>
<extension
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<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
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<statement>
<extension
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<conditionality value="false"/>
<requirement
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<statement>
<extension
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<statement>
<extension
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<conditionality value="false"/>
<requirement
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<extension
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<requirement
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<extension
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<statement>
<extension
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<conditionality value="false"/>
<requirement
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<statement>
<extension
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</extension>
<key value="EHRSFMR2-OV.1-16"/>
<label value="OV.1#16"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [TI.2](Requirements-EHRSFMR2-TI.2.html) (Audit) and all child functions."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-17"/>
<label value="OV.1#17"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD conform to function [TI.3](Requirements-EHRSFMR2-TI.3.html) (Registry and Directory Services)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-18"/>
<label value="OV.1#18"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [TI.4](Requirements-EHRSFMR2-TI.4.html) (Standard Terminology and Terminology Services)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-19"/>
<label value="OV.1#19"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF the system manages data for which standard terminologies have been established, THEN the system SHALL conform to function [TI.4.1](Requirements-EHRSFMR2-TI.4.1.html) (Standard Terminologies and Terminology Models) to support semantic interoperability."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-20"/>
<label value="OV.1#20"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF the system manages data for which standard terminologies have been established, THEN the system SHALL conform to function [TI.4.2](Requirements-EHRSFMR2-TI.4.2.html) (Maintenance and Versioning of Standard Terminologies) to preserve the semantics of coded data over time."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-21"/>
<label value="OV.1#21"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF terminology mapping is implemented within the system, THEN the system SHALL conform to function [TI.4.3](Requirements-EHRSFMR2-TI.4.3.html) (Terminology Mapping)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-22"/>
<label value="OV.1#22"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF the system receives or transmits data for which jurisdictionally established interchange standards exist, THEN the system SHALL conform to function [TI.5.1](Requirements-EHRSFMR2-TI.5.1.html) (Application and Structured-Document Interchange Standards) and all child functions to support interoperability."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-23"/>
<label value="OV.1#23"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF the system receives and transmits data for which generally accepted interchange standards have been established, THEN the system SHALL conform to function [TI.5.2](Requirements-EHRSFMR2-TI.5.2.html) (Interchange Standards Versioning and Maintenance), to accommodate the inevitable evolution of interchange standards."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-24"/>
<label value="OV.1#24"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD conform to function [TI.5.3](Requirements-EHRSFMR2-TI.5.3.html) (Standards-based Application Integration)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-25"/>
<label value="OV.1#25"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF the system receives and transmits data with other systems outside itself, THEN the system SHALL conform to function [TI.5.4](Requirements-EHRSFMR2-TI.5.4.html) (Interchange Agreements), to define how the sender and receiver will exchange data."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-26"/>
<label value="OV.1#26"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD conform to function [TI.6](Requirements-EHRSFMR2-TI.6.html) (Business Rules Management)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-27"/>
<label value="OV.1#27"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD conform to function [TI.7](Requirements-EHRSFMR2-TI.7.html) (Workflow Management)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-28"/>
<label value="OV.1#28"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [TI.8](Requirements-EHRSFMR2-TI.8.html) (Database Backup and Recovery)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-29"/>
<label value="OV.1#29"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [CPS.10](Requirements-EHRSFMR2-CPS.10.html) (Manage User Help)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2-OV.1-30"/>
<label value="OV.1#30"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [TI.9](Requirements-EHRSFMR2-TI.9.html) (System Management Operations and Performance)."/>
</statement>
</Requirements>
IG © 2025 HL7 International / Electronic Health Records. Package hl7.ehrs.uv.ehrsfmr2#2.1.1-ballot based on FHIR 5.0.0. Generated 2025-08-29
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