ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
0.16.0 - CI Build
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
0.16.0 - CI Build
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| Active as of 2024-08-12 |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2.1-CP.2.5"/>
<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>Capture and explicitly label patient-originated data, link the data source with the data, and support provider authentication for inclusion in patient health record as well as subsequent rendering of the information as part of the health record.</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>It is critically important to be able to distinguish clinically authored and authenticated data from patient-originated data that is either provided by the patient for inclusion in the EHR or entered directly into the EHR by the patient from clinically authenticated data. Patients may provide data for entry into the health record or be given a mechanism for entering this data directly. Patient-originated data intended for use by providers will be available for their use.</p>
<p>Data about the patient may be appropriately provided by:</p>
<ul>
<li>the patient;</li>
<li>a surrogate (parent, spouse, guardian) or</li>
<li>an informant (teacher, lawyer, case worker)</li>
<li>devices (e.g., blood pressure/sugar monitors).</li>
</ul>
<p>An electronic health record may provide the ability for direct data entry by any of these. Patient-originated data may also be captured by devices and transmitted for inclusion into the electronic health record.</p>
<p>Data entered by any of these must be stored with source information. A provider must authenticate patient-originated data included in the patient's legal health record. A provider must be able to indicate they have verified the accuracy of patient-originated data (when appropriate and when a verification source is available) for inclusion in the patient record. Such verification does not have to occur at each individual data field and can be at a higher level of the data.</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>CP.2.5#01</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 patient- originated data and tag that data as such.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CP.2.5#02</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the system provides the ability for the patient to capture data directly, THEN the system SHALL tag the data as patient captured.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CP.2.5#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 render patient-originated data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CP.2.5#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 for an authorized user to annotate, but not alter, patient-originated data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CP.2.5#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 capture patient-originated annotations on provider-sourced data, and tag the annotations as patient-sourced.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CP.2.5#06</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the system conforms to function [[CPS.2.1]] (Support for externally-sourced Clinical documents), THEN the system SHALL provide the ability to render externally-sourced clinical documents.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CP.2.5"/>
<version value="0.16.0"/>
<name value="CP_2_5_Manage_Patient_Originated_Data"/>
<title value="CP.2.5 Manage Patient-Originated Data (Function)"/>
<status value="active"/>
<date value="2024-08-12T10:56:01+00:00"/>
<publisher value="EHR WG"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/ehr"/>
</telecom>
</contact>
<description
value="Capture and explicitly label patient-originated data, link the data source with the data, and support provider authentication for inclusion in patient health record as well as subsequent rendering of the information as part of the health record."/>
<purpose
value="It is critically important to be able to distinguish clinically authored and authenticated data from patient-originated data that is either provided by the patient for inclusion in the EHR or entered directly into the EHR by the patient from clinically authenticated data. Patients may provide data for entry into the health record or be given a mechanism for entering this data directly. Patient-originated data intended for use by providers will be available for their use.
Data about the patient may be appropriately provided by:
- the patient;
- a surrogate (parent, spouse, guardian) or
- an informant (teacher, lawyer, case worker)
- devices (e.g., blood pressure/sugar monitors).
An electronic health record may provide the ability for direct data entry by any of these. Patient-originated data may also be captured by devices and transmitted for inclusion into the electronic health record.
Data entered by any of these must be stored with source information. A provider must authenticate patient-originated data included in the patient's legal health record. A provider must be able to indicate they have verified the accuracy of patient-originated data (when appropriate and when a verification source is available) for inclusion in the patient record. Such verification does not have to occur at each individual data field and can be at a higher level of the data."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CP.2.5-01"/>
<label value="CP.2.5#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to capture patient- originated data and tag that data as such."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.3.2#1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CP.2.5-02"/>
<label value="CP.2.5#02"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF the system provides the ability for the patient to capture data directly, THEN the system SHALL tag the data as patient captured."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.3.2#2"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CP.2.5-03"/>
<label value="CP.2.5#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to render patient-originated data."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.3.2#4"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CP.2.5-04"/>
<label value="CP.2.5#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability for an authorized user to annotate, but not alter, patient-originated data."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.3.2#6"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CP.2.5-05"/>
<label value="CP.2.5#05"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture patient-originated annotations on provider-sourced data, and tag the annotations as patient-sourced."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CP.2.5-06"/>
<label value="CP.2.5#06"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF the system conforms to function [[CPS.2.1]] (Support for externally-sourced Clinical documents), THEN the system SHALL provide the ability to render externally-sourced clinical documents."/>
</statement>
</Requirements>