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-CPS.1.7.3"/>
<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>Create, maintain, and verify patient decisions (such as informed consent for treatment or disclosure).</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>Decisions are documented and include the extent of information, verification levels and exposition of treatment options. This documentation helps ensure that decisions made at the discretion of the patient, family, or other responsible party, govern the actual care that is delivered or withheld. There may be several documents active at any one time that may govern a patient's care. Both clinical and administrative consents and authorizations are considered part of this function. A consent or authorization includes patient authorization for re-disclosure of sensitive information to third parties. Consents/Authorizations for printing should include appropriate standardized forms for patients, guardians, or foster parents. The system must appropriately present forms for adolescents according to privacy rules.</p>
<p>Some jurisdictions may mandate assent. Assent is agreement by the patient to participate in services when they a legally unable to consent (e.g., an adolescent, an adult with early dementia).</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>CPS.1.7.3#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 and render an indication that a patient has completed a consent and authorization (e.g., the patient completes an eye surgery -related consent before receiving eye surgery).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#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 capture and render an indication that a patient has withdrawn applicable consents and authorizations.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#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 conform to function [[CPS.2.1]] (Support externally-sourced Clinical Documents).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#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 conform to function [[CPS.2.2]] (Support externally-sourced Clinical Data).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#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 scanned consent and authorization paper documents.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#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 present consent and authorization forms on-line.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#07</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<span>MAY</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system MAY provide the ability to enter consent and authorization forms on-line, with appropriate electronic signature, according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#08</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 printable consent and authorization forms/form templates.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#09</span>
</td>
<td style="padding-left: 4px;">
<span>MAY</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system MAY render the consents and authorizations as part of the patient's record during a specific clinical activity, (e.g., a treatment or a surgery).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#10</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 consents and authorizations chronologically, reverse chronologically, and by type of consent or authorization.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#11</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 an assent for patients who are legally unable to consent.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#12</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 source of each consent, such as the patient or the patient's personal representative if the patient is legally unable to provide it.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.7.3#13</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 information regarding the patient's personal representative, advocate, healthcare proxy, legal representative, financially responsible entity or other similar person or entity, including their level of authority to make medical or financial decisions on behalf of the patient.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CPS.1.7.3"/>
<version value="0.16.0"/>
<name value="CPS_1_7_3_Manage_Consents_and_Authorizations"/>
<title value="CPS.1.7.3 Manage Consents and Authorizations (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="Create, maintain, and verify patient decisions (such as informed consent for treatment or disclosure)."/>
<purpose
value="Decisions are documented and include the extent of information, verification levels and exposition of treatment options. This documentation helps ensure that decisions made at the discretion of the patient, family, or other responsible party, govern the actual care that is delivered or withheld. There may be several documents active at any one time that may govern a patient's care. Both clinical and administrative consents and authorizations are considered part of this function. A consent or authorization includes patient authorization for re-disclosure of sensitive information to third parties. Consents/Authorizations for printing should include appropriate standardized forms for patients, guardians, or foster parents. The system must appropriately present forms for adolescents according to privacy rules.
Some jurisdictions may mandate assent. Assent is agreement by the patient to participate in services when they a legally unable to consent (e.g., an adolescent, an adult with early dementia)."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-01"/>
<label value="CPS.1.7.3#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to capture and render an indication that a patient has completed a consent and authorization (e.g., the patient completes an eye surgery -related consent before receiving eye surgery)."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-02"/>
<label value="CPS.1.7.3#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to capture and render an indication that a patient has withdrawn applicable consents and authorizations."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#2"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-03"/>
<label value="CPS.1.7.3#03"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD conform to function [[CPS.2.1]] (Support externally-sourced Clinical Documents)."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#3"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-04"/>
<label value="CPS.1.7.3#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD conform to function [[CPS.2.2]] (Support externally-sourced Clinical Data)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-05"/>
<label value="CPS.1.7.3#05"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture scanned consent and authorization paper documents."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#3"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-06"/>
<label value="CPS.1.7.3#06"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY provide the ability to present consent and authorization forms on-line."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#4"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-07"/>
<label value="CPS.1.7.3#07"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY provide the ability to enter consent and authorization forms on-line, with appropriate electronic signature, 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-CPS.1.7.3-08"/>
<label value="CPS.1.7.3#08"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY provide the ability to render printable consent and authorization forms/form templates."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#5"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-09"/>
<label value="CPS.1.7.3#09"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY render the consents and authorizations as part of the patient's record during a specific clinical activity, (e.g., a treatment or a surgery)."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#6"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-10"/>
<label value="CPS.1.7.3#10"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY provide the ability to render consents and authorizations chronologically, reverse chronologically, and by type of consent or authorization."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#7"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-11"/>
<label value="CPS.1.7.3#11"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture an assent for patients who are legally unable to consent."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#8"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-12"/>
<label value="CPS.1.7.3#12"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to capture the source of each consent, such as the patient or the patient's personal representative if the patient is legally unable to provide it."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#9"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.7.3-13"/>
<label value="CPS.1.7.3#13"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to manage information regarding the patient's personal representative, advocate, healthcare proxy, legal representative, financially responsible entity or other similar person or entity, including their level of authority to make medical or financial decisions on behalf of the patient."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.3.3#10"/>
</statement>
</Requirements>