EHRS-FM IG

ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
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: RI.1.1.1 Originate/Retain Record Lifecycle Event (Function) - XML Representation

Active as of 2024-08-12

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<Requirements xmlns="http://hl7.org/fhir">
  <id value="EHRSFMR2.1-RI.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>Originate and Retain Record Entry (1 instance)</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>Occurs when an agent causes the system to: a) initiate capture of potential record content, and b) incorporate that content into the storage considered a permanent part of the health record.</p>
<p>Reference: ISO 21089-2018, Section 15.1.</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#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 provide the ability to capture (originate) a Record Entry instance corresponding to an Action instance and context.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.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 a unique instance identifier for each Record Entry.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.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 the signature event (e.g., digital signature) of the origination entry Author, binding signature to Record Entry content.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.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 provide the ability to capture both structured and unstructured content in Record Entries.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.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 provide the ability to capture Record Entries from information recorded during system downtime.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.1.1.1#06</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>SHOULD</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The system SHOULD provide the ability to integrate Record Entries from Information recorded during system downtime.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.1.1.1#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 provide the ability to capture the date/time an Action was taken or data was collected if different than date/time of the Record Entry.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.1.1.1#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 metadata that identifies the source of non-originated Record Entry (e.g., templated, copied, duplicated, or boilerplate information).</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.1.1.1#09</span>
                
            </td>
            <td style="padding-left: 4px;">
                
                
                
                <span>MAY</span>
                
            </td>
            <td style="padding-left: 4px;" class="requirement">
                
                <span><div><p>The system MAY provide the ability to tag unstructured Record Entry content to organize it according to need, for example, in a time-related fashion or by application-specific groups (such as photographs, handwritten notes, or auditory sounds), or by order of relative importance.</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.1.1.1#10</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 and maintain a Record Entry encoded as a standards-based data object (e.g., HL7 Continuity of Care, other HL7 CDA R2 Document, ISO 13606 artifact).</p>
</div></span>
                
                
            </td>
        </tr>
        
        <tr>
            <td style="padding-left: 4px;">
                
                <span>RI.1.1.1#11</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 and maintain a standards-based data object to mirror (be duplicate and synchronous with) internal Record Entry representation.</p>
</div></span>
                
                
            </td>
        </tr>
        
    </table>
</div>
  </text>
  <url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-RI.1.1.1"/>
  <version value="0.16.0"/>
  <name value="RI_1_1_1_Originate_Retain_Record_Lifecycle_Event"/>
  <title value="RI.1.1.1 Originate/Retain Record Lifecycle 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="Originate and Retain Record Entry (1 instance)"/>
  <purpose
           value="Occurs when an agent causes the system to: a) initiate capture of potential record content, and b) incorporate that content into the storage considered a permanent part of the health record. 

Reference: ISO 21089-2018, Section 15.1."/>
  <statement>
    <extension
               url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="EHRSFMR2.1-RI.1.1.1-01"/>
    <label value="RI.1.1.1#01"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHALL provide the ability to capture (originate) a Record Entry instance corresponding to an Action instance and context."/>
    <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.1.1.1-02"/>
    <label value="RI.1.1.1#02"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHALL capture a unique instance identifier for each Record Entry."/>
    <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.1.1.1-03"/>
    <label value="RI.1.1.1#03"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHALL capture the signature event (e.g., digital signature) of the origination entry Author, binding signature to 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.1.1.1-04"/>
    <label value="RI.1.1.1#04"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHALL provide the ability to capture both structured and unstructured content in Record Entries."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="EHRSFMR2.1-RI.1.1.1-05"/>
    <label value="RI.1.1.1#05"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHALL provide the ability to capture Record Entries from information recorded during system downtime."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="EHRSFMR2.1-RI.1.1.1-06"/>
    <label value="RI.1.1.1#06"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD provide the ability to integrate Record Entries from Information recorded during system downtime."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="EHRSFMR2.1-RI.1.1.1-07"/>
    <label value="RI.1.1.1#07"/>
    <conformance value="SHALL"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHALL provide the ability to capture the date/time an Action was taken or data was collected if different than date/time of the Record Entry."/>
    <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.1.1.1-08"/>
    <label value="RI.1.1.1#08"/>
    <conformance value="SHOULD"/>
    <conditionality value="false"/>
    <requirement
                 value="The system SHOULD capture metadata that identifies the source of non-originated Record Entry (e.g., templated, copied, duplicated, or boilerplate information)."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="EHRSFMR2.1-RI.1.1.1-09"/>
    <label value="RI.1.1.1#09"/>
    <conformance value="MAY"/>
    <conditionality value="false"/>
    <requirement
                 value="The system MAY provide the ability to tag unstructured Record Entry content to organize it according to need, for example, in a time-related fashion or by application-specific groups (such as photographs, handwritten notes, or auditory sounds), or by order of relative importance."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="EHRSFMR2.1-RI.1.1.1-10"/>
    <label value="RI.1.1.1#10"/>
    <conformance value="MAY"/>
    <conditionality value="false"/>
    <requirement
                 value="The system MAY capture and maintain a Record Entry encoded as a standards-based data object (e.g., HL7 Continuity of Care, other HL7 CDA R2 Document, ISO 13606 artifact)."/>
  </statement>
  <statement>
    <extension
               url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
      <valueBoolean value="false"/>
    </extension>
    <key value="EHRSFMR2.1-RI.1.1.1-11"/>
    <label value="RI.1.1.1#11"/>
    <conformance value="MAY"/>
    <conditionality value="false"/>
    <requirement
                 value="The system MAY capture and maintain a standards-based data object to mirror (be duplicate and synchronous with) internal Record Entry representation."/>
  </statement>
</Requirements>