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-TI.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>Manage the ability to create, update, delete, view, and version business rules including institutional preferences. Apply business rules from necessary points within an EHR-S to control system behavior. An EHR-S audits changes made to business rules, as well as compliance to and overrides of applied business rules.</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>EHR-S business rule implementation functions include decision support, diagnostic support, workflow control, and access privileges, as well as system and user defaults and preferences. An EHR-S supports the ability of providers and institutions to customize decision support components such as triggers, rules, or algorithms, as well as the wording of alerts and advice to meet realm specific requirements and preferences.
Example:
Examples of applied business rules include:</p>
<ul>
<li>Suggesting diagnosis based on the combination of symptoms (flu-like symptoms combined with widened mediastinum suggesting anthrax);</li>
<li>Classifying a pregnant patient as high risk due to factors such as age, health status, and prior pregnancy outcomes;</li>
<li>Sending an update to an immunization registry when a vaccination is administered or when immunization information is added to patient record;</li>
<li>Limiting access to mental health information to authorized providers;</li>
<li>Establishing system level defaults such as for vocabulary data sets to be implemented; and</li>
<li>Establishing user level preferences such as allowing the use of health information for research purposes.$EX$</li>
</ul>
</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>TI.6#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 manage business rules.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.6#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 enter, import, or receive business rules to guide system behavior.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.6#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 maintain business rules and their components.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.6#04</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 tag decision support rules as inactive / obsolete or to remove them according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.6#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 business rules.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.6#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 manage diagnostic decision support rules that guide system behavior according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.6#07</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 manage workflow control rules that guide system behavior according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.6#08</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 manage access privilege rules that guide system behavior according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.6#09</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 manage other rules (for example, monitoring rules, user defaults rules and preferences rule) that guide system behavior according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.6#10</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 determine system behavior based upon defined business rules.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.6"/>
<version value="2.1.0"/>
<name value="TI_6_Business_Rules_Management"/>
<title value="TI.6 Business Rules Management (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>
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<description
value="Manage the ability to create, update, delete, view, and version business rules including institutional preferences. Apply business rules from necessary points within an EHR-S to control system behavior. An EHR-S audits changes made to business rules, as well as compliance to and overrides of applied business rules."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="EHR-S business rule implementation functions include decision support, diagnostic support, workflow control, and access privileges, as well as system and user defaults and preferences. An EHR-S supports the ability of providers and institutions to customize decision support components such as triggers, rules, or algorithms, as well as the wording of alerts and advice to meet realm specific requirements and preferences.
Example:
Examples of applied business rules include:
- Suggesting diagnosis based on the combination of symptoms (flu-like symptoms combined with widened mediastinum suggesting anthrax);
- Classifying a pregnant patient as high risk due to factors such as age, health status, and prior pregnancy outcomes;
- Sending an update to an immunization registry when a vaccination is administered or when immunization information is added to patient record;
- Limiting access to mental health information to authorized providers;
- Establishing system level defaults such as for vocabulary data sets to be implemented; and
- Establishing user level preferences such as allowing the use of health information for research purposes.$EX$"/>
<statement>
<extension
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<valueBoolean value="false"/>
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<key value="EHRSFMR2.1-TI.6-01"/>
<label value="TI.6#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to manage business rules."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.6#1"/>
</statement>
<statement>
<extension
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<valueBoolean value="false"/>
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<key value="EHRSFMR2.1-TI.6-02"/>
<label value="TI.6#02"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
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<derivedFrom value="EHR-S_FM_R1.1 IN.6#2"/>
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<statement>
<extension
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<key value="EHRSFMR2.1-TI.6-03"/>
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<conformance value="SHOULD"/>
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<requirement
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<derivedFrom value="EHR-S_FM_R1.1 IN.6#3"/>
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<statement>
<extension
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<valueBoolean value="true"/>
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<key value="EHRSFMR2.1-TI.6-04"/>
<label value="TI.6#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
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<derivedFrom value="EHR-S_FM_R1.1 IN.6#5"/>
</statement>
<statement>
<extension
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<valueBoolean value="false"/>
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<key value="EHRSFMR2.1-TI.6-05"/>
<label value="TI.6#05"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
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<derivedFrom value="EHR-S_FM_R1.1 IN.6#23"/>
</statement>
<statement>
<extension
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<valueBoolean value="true"/>
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<key value="EHRSFMR2.1-TI.6-06"/>
<label value="TI.6#06"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to manage diagnostic decision support rules that guide system behavior according to scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.6#7"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.6-07"/>
<label value="TI.6#07"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to manage workflow control rules that guide system behavior according to scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.6#12"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.6-08"/>
<label value="TI.6#08"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to manage access privilege rules that guide system behavior according to scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.6#17"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.6-09"/>
<label value="TI.6#09"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to manage other rules (for example, monitoring rules, user defaults rules and preferences rule) that guide system behavior 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-TI.6-10"/>
<label value="TI.6#10"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to determine system behavior based upon defined business rules."/>
</statement>
</Requirements>