ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
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-CPS.2.8"/>
<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>Support collection and presentation of data captured from medical and medication monitoring devices.</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>Collection of medical device information is supported as appropriate to the care setting. Examples include: vital signs/pulse-oximeter, anesthesia machines, home diagnostic devices for chronic disease management, laboratory machines, bar coded artifacts (e.g., medicine, immunizations, demographics, history, and identification), transcranial magnetic stimulation systems, or medication reminder systems.</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.2.8#01</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL provide the ability to capture electronic data from medical devices according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.2.8#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 render information collected from medical devices as part of the medical record.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.2.8#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 and maintain the following information of a device when it is suspected as the cause of a Serious Adverse Event: brand name, common device name, manufacturer, model number, catalog number, serial number, lot number, expiration date, other number(s), operator of device, if implanted (date), if explanted (date), single or multiple use device indicator (i.e. if this is a single use device that was reprocessed and reused on a patient).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.2.8#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 present data captured from medical devices for verification by a provider according to scope of practice, organizational policy, and/or jurisdictional law, and present the identification of the relevant device.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.2.8#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 link data that was captured by a medical device to the originating device ID and device type.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.2.8#06</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/time from medical devices.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.2.8#07</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 user to capture data manually from medical devices.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CPS.2.8"/>
<version value="2.1.0"/>
<name value="CPS_2_8_Support_Medical_Device_Originated_Data"/>
<title value="CPS.2.8 Support Medical Device Originated Data (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>
</contact>
<description
value="Support collection and presentation of data captured from medical and medication monitoring devices."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="Collection of medical device information is supported as appropriate to the care setting. Examples include: vital signs/pulse-oximeter, anesthesia machines, home diagnostic devices for chronic disease management, laboratory machines, bar coded artifacts (e.g., medicine, immunizations, demographics, history, and identification), transcranial magnetic stimulation systems, or medication reminder systems."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-CPS.2.8-01"/>
<label value="CPS.2.8#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to capture electronic data from medical devices according to scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.3.2.5#1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.2.8-02"/>
<label value="CPS.2.8#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to render information collected from medical devices as part of the medical record."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.3.2.5#2"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.2.8-03"/>
<label value="CPS.2.8#03"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture and maintain the following information of a device when it is suspected as the cause of a Serious Adverse Event: brand name, common device name, manufacturer, model number, catalog number, serial number, lot number, expiration date, other number(s), operator of device, if implanted (date), if explanted (date), single or multiple use device indicator (i.e. if this is a single use device that was reprocessed and reused on a patient)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-CPS.2.8-04"/>
<label value="CPS.2.8#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to present data captured from medical devices for verification by a provider according to scope of practice, organizational policy, and/or jurisdictional law, and present the identification of the relevant device."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.2.8-05"/>
<label value="CPS.2.8#05"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD link data that was captured by a medical device to the originating device ID and device type."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.2.8-06"/>
<label value="CPS.2.8#06"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture the date/time from medical devices."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.2.8-07"/>
<label value="CPS.2.8#07"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability for the user to capture data manually from medical devices."/>
</statement>
</Requirements>