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.1.5"/>
<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>Limit an EHR-S user's ability to deny (repudiate) data origination, transmission or receipt by that user.</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>An EHR-S allows data entry to a patient's electronic health record and it can be a sender or receiver of healthcare information. Non-repudiation is a way to guarantee that the source of the data/record cannot later deny that fact; and that the sender of a message cannot later deny having sent the message; and that the recipient cannot deny having received the message. Components of non-repudiation can include:</p>
<ul>
<li>Digital signature, which serves as a unique identifier for an individual (much like a written signature);</li>
<li>Confirmation service, which utilizes a message transfer agent to create a digital receipt (providing confirmation that a message was sent, and/or received);</li>
<li>Timestamp, which proves that a document existed at a certain date and time;</li>
<li>The use of standardized timekeeping protocols (e.g., the Integrating the Healthcare Enterprise (IHE) Consistent Time Profile).</li>
</ul>
</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.1.5#01</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 the identity of the entity taking the action according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.5#02</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 time stamp of the initial entry, modification and exchange of data according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.5#03</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 conform to function [[TI.2]] (Audit) to prevent repudiation of data origination, transmission and receipt according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.5#04</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD conform to function [[RI.1.1.4]] (Attest Record Entry Content) to ensure integrity of data and data exchange and thus prevent repudiation of data origination, transmission or receipt according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.1.5"/>
<version value="2.1.0"/>
<name value="TI_1_5_Non_Repudiation"/>
<title value="TI.1.5 Non-Repudiation (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="Limit an EHR-S user's ability to deny (repudiate) data origination, transmission or receipt by that user."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="An EHR-S allows data entry to a patient's electronic health record and it can be a sender or receiver of healthcare information. Non-repudiation is a way to guarantee that the source of the data/record cannot later deny that fact; and that the sender of a message cannot later deny having sent the message; and that the recipient cannot deny having received the message. Components of non-repudiation can include:
- Digital signature, which serves as a unique identifier for an individual (much like a written signature);
- Confirmation service, which utilizes a message transfer agent to create a digital receipt (providing confirmation that a message was sent, and/or received);
- Timestamp, which proves that a document existed at a certain date and time;
- The use of standardized timekeeping protocols (e.g., the Integrating the Healthcare Enterprise (IHE) Consistent Time Profile)."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.5-01"/>
<label value="TI.1.5#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture the identity of the entity taking the action according to scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.5#1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.5-02"/>
<label value="TI.1.5#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL capture time stamp of the initial entry, modification and exchange of data according to scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.5#2"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.5-03"/>
<label value="TI.1.5#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [[TI.2]] (Audit) to prevent repudiation of data origination, transmission and receipt according to scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.5#3"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.5-04"/>
<label value="TI.1.5#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD conform to function [[RI.1.1.4]] (Attest Record Entry Content) to ensure integrity of data and data exchange and thus prevent repudiation of data origination, transmission or receipt according to scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.5#4"/>
</statement>
</Requirements>