ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
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: RI.1.1.1.1 Evidence of Record Entry Originate/Retain Event (Function) - XML Representation

Active as of 2024-11-26

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<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="2.1.0"/>
  <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="2024-11-26T16:30:50+00:00"/>
  <publisher value="EHR WG"/>
  <contact>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/ehr"/>
    </telecom>
  </contact>
  <description
               value="Maintain Evidence of Record Entry Originate/Retain Event"/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <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>