ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - CI Build
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - CI Build
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| Active as of 2024-11-23 |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2.1-RI.1.1.27.1"/>
<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 Decryption 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 Decryption 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.1.1.27.1#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 Record Entry content is decrypted.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#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 decrypted.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#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 decrypted Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#04</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF a user initiated a Record Entry content decryption, THEN the system SHALL capture identity of the user initiating Record Entry content decryption.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#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 which decrypted Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#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., decryption).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#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 Record Entry content is decrypted.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#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 Record Entry content is decrypted.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#09</span>
</td>
<td style="padding-left: 4px;">
<span>MAY</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF a user initiated a Record Entry decryption, THEN the system MAY capture the rationale for decrypting Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#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 a sequence identifier for decrypted Record Entry content.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#11</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 the identifier and version of decryption Tools used for each decrypted Record Entry.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.27.1#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 a reference (e.g., link, pointer) to pre-decrypted data for each Record Entry decryption.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-RI.1.1.27.1"/>
<version value="2.1.0"/>
<name value="RI_1_1_27_1_Evidence_of_Record_Entry_Decryption_Event"/>
<title
value="RI.1.1.27.1 Evidence of Record Entry Decryption Event (Function)"/>
<status value="active"/>
<date value="2024-11-23T08:20:40+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 Decryption Event"/>
<purpose
value="Evidence of Record Entry Decryption 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.1.1.27.1-01"/>
<label value="RI.1.1.27.1#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL audit each occurrence when Record Entry content is decrypted."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-02"/>
<label value="RI.1.1.27.1#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the organization where Record Entry content is decrypted."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-03"/>
<label value="RI.1.1.27.1#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the patient who is subject of decrypted Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-04"/>
<label value="RI.1.1.27.1#04"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="IF a user initiated a Record Entry content decryption, THEN the system SHALL capture identity of the user initiating Record Entry content decryption."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-05"/>
<label value="RI.1.1.27.1#05"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture identity of the system application which decrypted Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-06"/>
<label value="RI.1.1.27.1#06"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the type of Record Event trigger (i.e., decryption)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-07"/>
<label value="RI.1.1.27.1#07"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the date and time Record Entry content is decrypted."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-08"/>
<label value="RI.1.1.27.1#08"/>
<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 decrypted."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-09"/>
<label value="RI.1.1.27.1#09"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="IF a user initiated a Record Entry decryption, THEN the system MAY capture the rationale for decrypting Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-10"/>
<label value="RI.1.1.27.1#10"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture a sequence identifier for decrypted Record Entry content."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-11"/>
<label value="RI.1.1.27.1#11"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD capture the identifier and version of decryption Tools used for each decrypted Record Entry."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.27.1-12"/>
<label value="RI.1.1.27.1#12"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD capture a reference (e.g., link, pointer) to pre-decrypted data for each Record Entry decryption."/>
</statement>
</Requirements>