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.1.1.1.1"/>
<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 Originate/Retain 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 Originate/Retain 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.1.1.1.1#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 a Record Entry is originated and retained.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#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 Record Entry content is originated.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#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 Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#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 individual(s) who performed the Action documented in Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#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 user who entered/authored Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#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 identity of the system application which originated Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#07</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 source of Record Entry content is a device, THEN the system SHALL capture identity of the device.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#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 capture the Action as evidenced by Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#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 capture the type of Record Event trigger (i.e., originate/retain).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#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 capture the date and time of Action occurrence as evidenced by Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#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 capture the date and time Record Entry content is originated.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#12</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 duration of the Action evidenced by Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#13</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 physical location of the Action evidenced by Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#14</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 Record Entry content is originated.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#15</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 the Action evidenced by Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#16</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 originating Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.1.1#17</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF Record Entry content includes templates (boilerplate information) or copied (duplicated) information, THEN the system SHOULD capture the source of such content.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-RI.1.1.1.1"/>
<version value="0.16.0"/>
<name value="RI_1_1_1_1_Evidence_of_Record_Entry_Originate_Retain_Event"/>
<title
value="RI.1.1.1.1 Evidence of Record Entry Originate/Retain 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 Originate/Retain Event"/>
<purpose
value="Evidence of Record Entry Originate/Retain 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.1.1.1.1-01"/>
<label value="RI.1.1.1.1#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL audit each occurrence when a Record Entry is originated and retained."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-02"/>
<label value="RI.1.1.1.1#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the organization where Record Entry content is originated."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-03"/>
<label value="RI.1.1.1.1#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the patient who is subject of Record Entry content."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-04"/>
<label value="RI.1.1.1.1#04"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the individual(s) who performed the Action documented in Record Entry content."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-05"/>
<label value="RI.1.1.1.1#05"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the user who entered/authored Record Entry content."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-06"/>
<label value="RI.1.1.1.1#06"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the system application which originated Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-07"/>
<label value="RI.1.1.1.1#07"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF the source of Record Entry content is a device, THEN the system SHALL capture identity of the device."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-08"/>
<label value="RI.1.1.1.1#08"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the Action as evidenced by Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-09"/>
<label value="RI.1.1.1.1#09"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the type of Record Event trigger (i.e., originate/retain)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-10"/>
<label value="RI.1.1.1.1#10"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the date and time of Action occurrence as evidenced by Record Entry content."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-11"/>
<label value="RI.1.1.1.1#11"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the date and time Record Entry content is originated."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-12"/>
<label value="RI.1.1.1.1#12"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY capture the duration of the Action evidenced by Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-13"/>
<label value="RI.1.1.1.1#13"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY capture the physical location of the Action evidenced by Record Entry content."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-14"/>
<label value="RI.1.1.1.1#14"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD capture identity of the location (i.e., network address) where Record Entry content is originated."/>
<derivedFrom value="EHR-LM_R1 14.1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-15"/>
<label value="RI.1.1.1.1#15"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY capture the rationale for the Action evidenced by Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-16"/>
<label value="RI.1.1.1.1#16"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY capture the rationale for originating Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.1.1-17"/>
<label value="RI.1.1.1.1#17"/>
<conformance value="SHOULD"/>
<conditionality value="true"/>
<requirement
value="IF Record Entry content includes templates (boilerplate information) or copied (duplicated) information, THEN the system SHOULD capture the source of such content."/>
</statement>
</Requirements>