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

## : CP.1.9 Manage Adverse Events (Function)

Page standards status: Normative

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    <Requirements xmlns="http://hl7.org/fhir">
      <id value="EHRSFMR2-CP.1.9"/>
      <meta>
        <profile
                 value="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/FMFunction"/>
      </meta>
      <language value="en"/>
      <text>
        <status value="extensions"/>
        <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en">

        <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>This function is focused on the capture and maintenance of adverse events that have occurred to the patient. The system should capture discrete information about the adverse event to enable the rendering Serious Adverse Event (SAE) reports according to organizational policy, and or jurisdictional law. Reporting may conform to the HL7 Individual Case Safety Reporting (ICSR).</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;">
                CP.1.9#01
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL provide the ability to manage adverse events associated with a patient.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CP.1.9#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 capture and maintain as discrete data an adverse event. For example:a) Patient identificationb) Event date/timec) Event descriptiond) Event severitye) Event category (e.g., medication error, fall)f) Care providers associated with the eventaccording to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CP.1.9#03
                </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 provide the ability to capture and render a Serious Adverse Event (SAE) report according to organizational policy, and/or jurisditional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CP.1.9#04
                </td>
                <td style="padding-left: 4px;">
                MAY

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system MAY provide the ability to render a set of Serious Adverse Event (SAE) data as modeled by the current release of HL7 ICSR (Individual Case Safety Reporting).</p>
    </div>

                </td>
            </tr>

        </table>
    </div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="normative"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="ehr"/>
      </extension>
      <url value="http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CP.1.9"/>
      <version value="2.1.1"/>
      <name value="CP_1_9_Manage_Adverse_Events"/>
      <title value="CP.1.9 Manage Adverse Events (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"/>
        </telecom>
      </contact>
      <description value="Capture and maintain adverse events."/>
      <jurisdiction>
        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
        </coding>
      </jurisdiction>
      <purpose
               value="This function is focused on the capture and maintenance of adverse events that have occurred to the patient. The system should capture discrete information about the adverse event to enable the rendering Serious Adverse Event (SAE) reports according to organizational policy, and or jurisdictional law. Reporting may conform to the HL7 Individual Case Safety Reporting (ICSR)."/>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CP.1.9-01"/>
        <label value="CP.1.9#01"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to manage adverse events associated with a patient."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.1.3.1#1"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
        </extension>
        <key value="EHRSFMR2-CP.1.9-02"/>
        <label value="CP.1.9#02"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL capture and maintain as discrete data an adverse event. For example:a) Patient identificationb) Event date/timec) Event descriptiond) Event severitye) Event category (e.g., medication error, fall)f) Care providers associated with the eventaccording to scope of practice, organizational policy, and/or jurisdictional law."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.1.3.1#2"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
        </extension>
        <key value="EHRSFMR2-CP.1.9-03"/>
        <label value="CP.1.9#03"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to capture and render a Serious Adverse Event (SAE) report according to organizational policy, and/or jurisditional law."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.1.3.1#2"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CP.1.9-04"/>
        <label value="CP.1.9#04"/>
        <conformance value="MAY"/>
        <conditionality value="false"/>
        <requirement
                     value="The system MAY provide the ability to render a set of Serious Adverse Event (SAE) data as modeled by the current release of HL7 ICSR (Individual Case Safety Reporting)."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.1.3.1#3"/>
      </statement>
    </Requirements>