HL7 Personal Health Record System Functional Model, Release 2
2.0.1-ballot - Normative Ballot
HL7 Personal Health Record System Functional Model, Release 2, published by EHR WG. This guide is not an authorized publication; it is the continuous build for version 2.0.1-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/phrsfm-ig/ and changes regularly. See the Directory of published versions
Page standards status: Informative |
<Requirements xmlns="http://hl7.org/fhir">
<id value="PHRSFMR2-S.4.1.2"/>
<meta>
<profile
value="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/FMFunction"/>
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<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>Provide PHR Account Holder data in a manner that meets local requirements for de-identification.</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>When the PHR Account Holder desires to share his/her information in a de-identified state, the PHR Account Holder can export the data in a fashion that meets requirements for de-identification in that locale or realm.</p>
<p>Example(s): If a person wants to participate in a study that will utilize de-identified data, then the system should provide the ability to de-identify this data according to the requirements of the study.</p>
<p>In Germany, when a PHR Account Holder’s subscription is cancelled, the PHR data may be maintained. But if the data is maintained, it must be maintained in a de-identified state or be pseudonymized (similar to the limited data set in the U.S. Privacy Rule).</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>S.4.1.2#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 for the PHR Account Holder to de-identify his or her information as needed to meet the requirements of a study or other request.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.2#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 capture the source and date of a request for de-identified data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.2#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 capture the date of transmission, data transmitted, and the target of the de-identified data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.2#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 confirmation of the target’s receipt of the data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.2#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 the history of data transmissions.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>S.4.1.2#06</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to de-identify data according to organizational policy and/or jurisdictional law.</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.4.1.2"/>
<version value="2.0.1-ballot"/>
<name value="S_4_1_2_Manage_De_Identified_Data_Request_Process"/>
<title
value="S.4.1.2 Manage De-Identified Data Request Process (Function)"/>
<status value="active"/>
<date value="2025-08-29T14:03:44+00:00"/>
<publisher value="EHR WG"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/ehr"/>
</telecom>
</contact>
<description
value="Provide PHR Account Holder data in a manner that meets local requirements for de-identification."/>
<purpose
value="When the PHR Account Holder desires to share his/her information in a de-identified state, the PHR Account Holder can export the data in a fashion that meets requirements for de-identification in that locale or realm.
Example(s): If a person wants to participate in a study that will utilize de-identified data, then the system should provide the ability to de-identify this data according to the requirements of the study.
In Germany, when a PHR Account Holder’s subscription is cancelled, the PHR data may be maintained. But if the data is maintained, it must be maintained in a de-identified state or be pseudonymized (similar to the limited data set in the U.S. Privacy Rule)."/>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.2-01"/>
<label value="S.4.1.2#01"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability for the PHR Account Holder to de-identify his or her information as needed to meet the requirements of a study or other request."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.2-02"/>
<label value="S.4.1.2#02"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD capture the source and date of a request for de-identified data."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.2-03"/>
<label value="S.4.1.2#03"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture the date of transmission, data transmitted, and the target of the de-identified data."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.2-04"/>
<label value="S.4.1.2#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture confirmation of the target’s receipt of the data."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="PHRSFMR2-S.4.1.2-05"/>
<label value="S.4.1.2#05"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to render the history of data transmissions."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/uv/phrsfmr2/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="PHRSFMR2-S.4.1.2-06"/>
<label value="S.4.1.2#06"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to de-identify data according to organizational policy and/or jurisdictional law."/>
</statement>
</Requirements>