HL7 Personal Health Record System Functional Model, Release 2
2.0.1-ballot - Normative Ballot
HL7 Personal Health Record System Functional Model, Release 2
2.0.1-ballot - Normative Ballot
This page is part of the HL7 Personal Health Record System Functional Model, Release 2 (v2.0.1-ballot: Normative 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions
| Page standards status: Informative |
<Requirements xmlns="http://hl7.org/fhir">
<id value="PHRSFMR2-S.4.1.4"/>
<meta>
<profile
value="http://hl7.org/ehrs/uv/phrsfmr2/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>Support member enrollment in clinical trials or research.</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>The system should support a PHR Account Holder having the ability to enroll in clinical trials or research, The system should be able to capture administrative and consent requirements, trial or research questionnaires, data submissions and all alerts associated with a program. The PHR Account Holder should also have the ability to choose which programs they desire to participate in when notified of trial availability and high quality PHR Account Holder match.</p>
</div></span>
<span id="actors"><b>Actors:</b><br/> ehr</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>S.4.1.4#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 manage a PHR Account Holder’s enrollment in a clinical trial or research program.</p>
</div></span>
Satisfied by:<ol>
<li><a href="https://www.hl7.org/fhir/researchstudy.html">https://www.hl7.org/fhir/researchstudy.html</a></li>
</ol>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.4#02</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 capture all administrative information about a clinical trial or research program.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.4#03</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 clinical trial or research participation sorted by categories.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.4#04</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 capture alerts or notifications from the clinical trial program.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.4#05</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 prompts to the PHR Account Holder regarding clinical trial requirements.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.4#06</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 render information regarding available health benefit plan clinical trial/research support.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="ehr"/>
</extension>
<url value="http://hl7.org/ehrs/uv/phrsfmr2/Requirements/PHRSFMR2-S.4.1.4"/>
<version value="2.0.1-ballot"/>
<name
value="S_4_1_4_Manage_PHR_Account_Holder_Enrollment_in_Clinical_Trials_or_Research"/>
<title
value="S.4.1.4 Manage PHR Account Holder Enrollment in Clinical Trials or Research (Function)"/>
<status value="active"/>
<date value="2025-04-04T11:42:51+11:00"/>
<publisher value="EHR WG"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/ehr"/>
</telecom>
</contact>
<description
value="Support member enrollment in clinical trials or research."/>
<purpose
value="The system should support a PHR Account Holder having the ability to enroll in clinical trials or research, The system should be able to capture administrative and consent requirements, trial or research questionnaires, data submissions and all alerts associated with a program. The PHR Account Holder should also have the ability to choose which programs they desire to participate in when notified of trial availability and high quality PHR Account Holder match."/>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.4-01"/>
<label value="S.4.1.4#01"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to manage a PHR Account Holder’s enrollment in a clinical trial or research program."/>
<satisfiedBy value="https://www.hl7.org/fhir/researchstudy.html"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.4-02"/>
<label value="S.4.1.4#02"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture all administrative information about a clinical trial or research program."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.4-03"/>
<label value="S.4.1.4#03"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to render clinical trial or research participation sorted by categories."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.4-04"/>
<label value="S.4.1.4#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture alerts or notifications from the clinical trial program."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.4-05"/>
<label value="S.4.1.4#05"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to render prompts to the PHR Account Holder regarding clinical trial requirements."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.4-06"/>
<label value="S.4.1.4#06"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY provide the ability to render information regarding available health benefit plan clinical trial/research support."/>
</statement>
</Requirements>
IG © 2023 EHR WG. Package hl7.ehrs.uv.phrsfmr2#2.0.1-ballot based on FHIR 5.0.0. Generated 2025-04-04
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