ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
0.16.0 - CI Build
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.1.1.6.1"/>
<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>Maintain Evidence of Record Entry Output/Report Event</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>Evidence of Record Entry Output/Report Event includes key metadata, ensures health record integrity (and trust) and enables record audit.</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.1.1.6.1#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 audit each occurrence when an output (e.g., report, screen shot) is generated from Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#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 capture identity of the organization where output/report is generated from Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#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 capture identity of the patient who is subject of the Record Entry(ies) populating the output/report generated.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#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 capture identity of the user who generated the output/report of Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#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 capture identity of the system application from which the output/report is generated.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#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 capture the type of Record Event trigger (i.e., output/report).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#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 capture the date and time the output/report is generated.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#08</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD capture identity of the location (i.e., network address) where the output/report is generated.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#09</span>
</td>
<td style="padding-left: 4px;">
<span>MAY</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system MAY capture the rationale for generating the output/report.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#10</span>
</td>
<td style="padding-left: 4px;">
<span>MAY</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system MAY capture the data, document, or other identifier for the output/report generated.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#11</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 capture when a Record Entry content output/report occurrence is known to be a disclosure, according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6.1#12</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD capture known and applicable permissions regarding Record Entry content output/reported including confidentiality codes, patient consent authorizations, privacy policy pointers.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-RI.1.1.6.1"/>
<version value="0.16.0"/>
<name value="RI_1_1_6_1_Evidence_of_Record_Entry_Output_Report_Event"/>
<title
value="RI.1.1.6.1 Evidence of Record Entry Output/Report 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="Maintain Evidence of Record Entry Output/Report Event"/>
<purpose
value="Evidence of Record Entry Output/Report Event includes key metadata, ensures health record integrity (and trust) and enables record audit."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-01"/>
<label value="RI.1.1.6.1#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL audit each occurrence when an output (e.g., report, screen shot) is generated from Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-02"/>
<label value="RI.1.1.6.1#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the organization where output/report is generated from Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-03"/>
<label value="RI.1.1.6.1#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the patient who is subject of the Record Entry(ies) populating the output/report generated."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-04"/>
<label value="RI.1.1.6.1#04"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the user who generated the output/report of Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-05"/>
<label value="RI.1.1.6.1#05"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the system application from which the output/report is generated."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-06"/>
<label value="RI.1.1.6.1#06"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the type of Record Event trigger (i.e., output/report)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-07"/>
<label value="RI.1.1.6.1#07"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the date and time the output/report is generated."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-08"/>
<label value="RI.1.1.6.1#08"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD capture identity of the location (i.e., network address) where the output/report is generated."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-09"/>
<label value="RI.1.1.6.1#09"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY capture the rationale for generating the output/report."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-10"/>
<label value="RI.1.1.6.1#10"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY capture the data, document, or other identifier for the output/report generated."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-11"/>
<label value="RI.1.1.6.1#11"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture when a Record Entry content output/report occurrence is known to be a disclosure, according to scope of practice, organizational policy, and/or jurisdictional law."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6.1-12"/>
<label value="RI.1.1.6.1#12"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD capture known and applicable permissions regarding Record Entry content output/reported including confidentiality codes, patient consent authorizations, privacy policy pointers."/>
</statement>
</Requirements>