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

HL7 Electronic Health Record System Functional Model, Release 2.1.1, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 2.1.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ehrsfm-ig/ and changes regularly. See the Directory of published versions

## : RI.1.2.1 Manage Record Entries (Function)

Page standards status: Normative

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    <Requirements xmlns="http://hl7.org/fhir">
      <id value="EHRSFMR2-RI.1.2.1"/>
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        <div id="description"><b>Description <a href="https://hl7.org/fhir/versions.html#std-process" title="Informative Content" class="informative-flag">I</a>:</b> <div><p>Occurs upon Record Entry origination/retention and thereafter on a continuous and uninterrupted basis for lifespan of each Record Entry.</p>
    <ul>
    <li>Ensures long-term retention and preservation of EHR Record Entries, without alteration.</li>
    </ul>
    <p>Reference: ISO 21089, Section 12.2.2</p>
    </div></div>

        <div id="requirements"><b>Criteria <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b></div>

        <table id="statements" class="grid dict">

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#01
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL manage each Record Entry as a persistent, indelible (unalterable) data object, including its revision history.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#02
                </td>
                <td style="padding-left: 4px;">
                SHALL

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL manage (persist) each Record Entry for its applicable retention period according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#03
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL manage (persist) the full set of identity, event and provenance Audit Metadata for each Record Entry, conforming to lifecycle events in function <a href="Requirements-EHRSFMR2-RI.1.1.html">RI.1.1</a> (Record Lifecycle) and metadata requirements in function <a href="Requirements-EHRSFMR2-TI.2.1.1.html">TI.2.1.1</a> (Record Entry Audit Triggers).</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#04
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL manage (persist) the attestation/signature event (e.g., digital signature) of each Record Entry conforming to function <a href="Requirements-EHRSFMR2-RI.1.1.4.html">RI.1.1.4</a> (Attest Record Entry Content).</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#05
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL manage Record Entries with data content in standard and non-standard formats.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#06
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL manage Record Entries containing both structured and unstructured data.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#07
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD manage Record Entry content with tagged or delimited elements including data formatted as text, documents, images, audio, waveforms, in ASCII, binary and other encodings.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#08
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD manage Record Entries in clinical and business contexts.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#09
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD provide the ability to manage sets of clinical and business context data, to be captured in or linked to Record Entries.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#10
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD provide the ability to extract all available elements included in the definition of a legal medical record (including Audit Log Entries and the decoded translation of anything stored only in code form) according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#11
                </td>
                <td style="padding-left: 4px;">
                MAY

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system MAY provide the ability to tag specific Record Entries for deletion according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#12
                </td>
                <td style="padding-left: 4px;">
                SHALL

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #f3e5ff;color: #7b1fa2;border: 1px solid #d1a3ff;">conditional</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>IF allowing tags for specific Record Entry deletion, THEN the system SHALL provide the ability to manage the set of tagged Entries, allowing review and confirmation before actual deletion occurs according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#13
                </td>
                <td style="padding-left: 4px;">
                SHALL

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #f3e5ff;color: #7b1fa2;border: 1px solid #d1a3ff;">conditional</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>IF allowing tags for specific Record Entry deletion, THEN the system SHALL provide the ability to delete Entries according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#14
                </td>
                <td style="padding-left: 4px;">
                SHALL

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #f3e5ff;color: #7b1fa2;border: 1px solid #d1a3ff;">conditional</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>IF allowing tags for specific Record Entry deletion, THEN the system SHALL provide the ability to render confirming notification that the destruction occurred according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#15
                </td>
                <td style="padding-left: 4px;">
                MAY

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system MAY provide the ability to maintain Record Entries by undeleting the Record Entries according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#16
                </td>
                <td style="padding-left: 4px;">
                MAY

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system MAY transmit record destruction date information along with existing data when transmitting Record Entries (or extracts) to another entity.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#17
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD manage health care information for organizations that have multiple facilities according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#18
                </td>
                <td style="padding-left: 4px;">
                MAY

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system MAY tag and render patient information that has been not been previously presented to the clinician.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                RI.1.2.1#19
                </td>
                <td style="padding-left: 4px;">
                MAY

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #f3e5ff;color: #7b1fa2;border: 1px solid #d1a3ff;">conditional</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>IF the system tags patient information from internal or external systems that has not been previously presented to the clinician, THEN the system MAY present a notification to that clinician in accordance with user role and according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

        </table>
    </div>
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        <valueCode value="normative"/>
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      <extension
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        <valueCode value="ehr"/>
      </extension>
      <url
           value="http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-RI.1.2.1"/>
      <version value="2.1.1"/>
      <name value="RI_1_2_1_Manage_Record_Entries"/>
      <title value="RI.1.2.1 Manage Record Entries (Function)"/>
      <status value="active"/>
      <date value="2025-12-13T09:06:06+00:00"/>
      <publisher value="HL7 International / Electronic Health Records"/>
      <contact>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/ehr"/>
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      <description value="Manage/Persist Record Entries (Multiple instances)"/>
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        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
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      <purpose
               value="Occurs upon Record Entry origination/retention and thereafter on a continuous and uninterrupted basis for lifespan of each Record Entry.
    - Ensures long-term retention and preservation of EHR Record Entries, without alteration.

    Reference: ISO 21089, Section 12.2.2"/>
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        <key value="EHRSFMR2-RI.1.2.1-01"/>
        <label value="RI.1.2.1#01"/>
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        <requirement
                     value="The system SHALL manage each Record Entry as a persistent, indelible (unalterable) data object, including its revision history."/>
      </statement>
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        <label value="RI.1.2.1#03"/>
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        <conditionality value="false"/>
        <requirement
                     value="The system SHALL manage (persist) the full set of identity, event and provenance Audit Metadata for each Record Entry, conforming to lifecycle events in function [RI.1.1](Requirements-EHRSFMR2-RI.1.1.html) (Record Lifecycle) and metadata requirements in function [TI.2.1.1](Requirements-EHRSFMR2-TI.2.1.1.html) (Record Entry Audit Triggers)."/>
      </statement>
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        <extension
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        <label value="RI.1.2.1#04"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL manage (persist) the attestation/signature event (e.g., digital signature) of each Record Entry conforming to function [RI.1.1.4](Requirements-EHRSFMR2-RI.1.1.4.html) (Attest Record Entry Content)."/>
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        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL manage Record Entries containing both structured and unstructured data."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.1#12"/>
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      <statement>
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        <label value="RI.1.2.1#07"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD manage Record Entry content with tagged or delimited elements including data formatted as text, documents, images, audio, waveforms, in ASCII, binary and other encodings."/>
      </statement>
      <statement>
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        <conditionality value="false"/>
        <requirement
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      </statement>
      <statement>
        <extension
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        <label value="RI.1.2.1#10"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD provide the ability to extract all available elements included in the definition of a legal medical record (including Audit Log Entries and the decoded translation of anything stored only in code form) according to scope of practice, organizational policy, and/or jurisdictional law."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
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        <label value="RI.1.2.1#11"/>
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        <conditionality value="false"/>
        <requirement
                     value="The system MAY provide the ability to tag specific Record Entries for deletion according to scope of practice, organizational policy, and/or jurisdictional law."/>
      </statement>
      <statement>
        <extension
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        <conformance value="SHALL"/>
        <conditionality value="true"/>
        <requirement
                     value="IF allowing tags for specific Record Entry deletion, THEN the system SHALL provide the ability to manage the set of tagged Entries, allowing review and confirmation before actual deletion occurs according to scope of practice, organizational policy, and/or jurisdictional law."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
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        <label value="RI.1.2.1#13"/>
        <conformance value="SHALL"/>
        <conditionality value="true"/>
        <requirement
                     value="IF allowing tags for specific Record Entry deletion, THEN the system SHALL provide the ability to delete Entries according to scope of practice, organizational policy, and/or jurisdictional law."/>
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      <statement>
        <extension
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        <label value="RI.1.2.1#14"/>
        <conformance value="SHALL"/>
        <conditionality value="true"/>
        <requirement
                     value="IF allowing tags for specific Record Entry deletion, THEN the system SHALL provide the ability to render confirming notification that the destruction occurred according to scope of practice, organizational policy, and/or jurisdictional law."/>
      </statement>
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        <conformance value="MAY"/>
        <conditionality value="false"/>
        <requirement
                     value="The system MAY provide the ability to maintain Record Entries by undeleting the Record Entries according to scope of practice, organizational policy, and/or jurisdictional law."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
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        <key value="EHRSFMR2-RI.1.2.1-16"/>
        <label value="RI.1.2.1#16"/>
        <conformance value="MAY"/>
        <conditionality value="false"/>
        <requirement
                     value="The system MAY transmit record destruction date information along with existing data when transmitting Record Entries (or extracts) to another entity."/>
        <derivedFrom value="EHR-S_FM_R1.1 IN.2.1#8"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
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        <label value="RI.1.2.1#17"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD manage health care information for organizations that have multiple facilities according to scope of practice, organizational policy, and/or jurisdictional law."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-RI.1.2.1-18"/>
        <label value="RI.1.2.1#18"/>
        <conformance value="MAY"/>
        <conditionality value="false"/>
        <requirement
                     value="The system MAY tag and render patient information that has been not been previously presented to the clinician."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
        </extension>
        <key value="EHRSFMR2-RI.1.2.1-19"/>
        <label value="RI.1.2.1#19"/>
        <conformance value="MAY"/>
        <conditionality value="true"/>
        <requirement
                     value="IF the system tags patient information from internal or external systems that has not been previously presented to the clinician, THEN the system MAY present a notification to that clinician in accordance with user role and according to scope of practice, organizational policy, and/or jurisdictional law."/>
      </statement>
    </Requirements>