ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
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| Active as of 2024-11-26 |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2.1-RI.1.1.6"/>
<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>Report (Output) Record Entries (1 or more instances)</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 produce and deliver record entry content in a particular form and manner.</p>
<p>Reference: ISO 21089-2018, Section 15.6.</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.1.1.6#01</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 render Record Entry content (e.g., as a report) retaining original, unaltered content and signature bindings, Action and Record Entry provenance and metadata.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6#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 provide the ability to render Record Entry extracts, including content, context, provenance and metadata.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6#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 provide the ability to capture the identity of the patient or the individual subject who is the target of Record Entry content that is presented/reported.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6#04</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<i>conditional</i>
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the identity of a specific recipient has been stored, THEN the system SHOULD render protected Record Entry content based on established permissions and according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6#05</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 known and explicit as to Record Entry content being output/reported, THEN the system SHOULD transmit corresponding authorizations and patient consent permissions.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6#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 conform to function [[TI.1.6]] (Secure Data Exchange).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6#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 extract Record Entry content prior to output/report, conforming to function [[RI.1.1.13]] (Extract Record Entry Content).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6#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 provide the ability to de-identify Record Entry content prior to output/report, conforming to function [[RI.1.1.10]] (De-Identify Record Entries).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>RI.1.1.6#09</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 provide the ability to render updates (new versions) of Record Entry Content to known recipients of prior versions of that Record Entry Content according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-RI.1.1.6"/>
<version value="2.1.0"/>
<name value="RI_1_1_6_Report__Output__Record_Lifecycle_Event"/>
<title value="RI.1.1.6 Report (Output) Record Lifecycle 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="Report (Output) Record Entries (1 or more instances)"/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="Occurs when an agent causes the system to produce and deliver record entry content in a particular form and manner.
Reference: ISO 21089-2018, Section 15.6."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6-01"/>
<label value="RI.1.1.6#01"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to render Record Entry content (e.g., as a report) retaining original, unaltered content and signature bindings, Action and Record Entry provenance and metadata."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6-02"/>
<label value="RI.1.1.6#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to render Record Entry extracts, including content, context, provenance and metadata."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6-03"/>
<label value="RI.1.1.6#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to capture the identity of the patient or the individual subject who is the target of Record Entry content that is presented/reported."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6-04"/>
<label value="RI.1.1.6#04"/>
<conformance value="SHOULD"/>
<conditionality value="true"/>
<requirement
value="IF the identity of a specific recipient has been stored, THEN the system SHOULD render protected Record Entry content based on established permissions and according to scope of practice, organizational policy, and/or jurisdictional law."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6-05"/>
<label value="RI.1.1.6#05"/>
<conformance value="SHOULD"/>
<conditionality value="true"/>
<requirement
value="IF known and explicit as to Record Entry content being output/reported, THEN the system SHOULD transmit corresponding authorizations and patient consent permissions."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6-06"/>
<label value="RI.1.1.6#06"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [[TI.1.6]] (Secure Data Exchange)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6-07"/>
<label value="RI.1.1.6#07"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to extract Record Entry content prior to output/report, conforming to function [[RI.1.1.13]] (Extract Record Entry Content)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6-08"/>
<label value="RI.1.1.6#08"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to de-identify Record Entry content prior to output/report, conforming to function [[RI.1.1.10]] (De-Identify Record Entries)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-RI.1.1.6-09"/>
<label value="RI.1.1.6#09"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to render updates (new versions) of Record Entry Content to known recipients of prior versions of that Record Entry Content according to scope of practice, organizational policy, and/or jurisdictional law."/>
</statement>
</Requirements>