HL7 Electronic Health Record System Functional Model, Release 2.1.1
2.1.1-ballot - Normative Ballot

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## : TI.1.5 Non-Repudiation (Function) - XML Representation

Page standards status: Informative

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    <Requirements xmlns="http://hl7.org/fhir">
      <id value="EHRSFMR2-TI.1.5"/>
      <meta>
        <profile
                 value="http://hl7.org/ehrs/uv/ehrsfmr2/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="actors"><b>Actors:</b><br/> ehr</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 <a href="Requirements-EHRSFMR2-TI.2.html">TI.2</a> (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 <a href="Requirements-EHRSFMR2-RI.1.1.4.html">RI.1.1.4</a> (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>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="ehr"/>
      </extension>
      <url value="http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-TI.1.5"/>
      <version value="2.1.1-ballot"/>
      <name value="TI_1_5_Non_Repudiation"/>
      <title value="TI.1.5 Non-Repudiation (Function)"/>
      <status value="active"/>
      <date value="2025-04-04T11:04:36+11:00"/>
      <publisher value="HL7 International / Electronic Health Records"/>
      <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/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
        </extension>
        <key value="EHRSFMR2-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/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
        </extension>
        <key value="EHRSFMR2-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/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
        </extension>
        <key value="EHRSFMR2-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](Requirements-EHRSFMR2-TI.2.html) (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/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
        </extension>
        <key value="EHRSFMR2-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](Requirements-EHRSFMR2-RI.1.1.4.html) (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>