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.1.1"/>
<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 a single logical record for each patient.</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>A single record is needed for legal purposes, as well as to organize it unambiguously for the provider. Health information is captured and linked to the patient record. Static data elements as well as data elements that will change over time are maintained. The patient is uniquely identified, after which the record is tied to that patient. Combining information on the same patient, or separating information where it was inadvertently captured for the wrong patient, helps maintain health information for a single patient. In the process of creating a patient record, it is at times advantageous to replicate identical information across multiple records, so that such data does not have to be re-entered. For example, when a parent registers children as new patients, the address, guarantor, and insurance data may be propagated in the children's records without having to re-enter them.</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.1.1#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 manage a single logical record for each patient.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#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 determine the unique identity of a patient and link the record to a single patient.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#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 manage a record for a patient when the identity of the patient is unknown.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#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 a record when the identity of the patient is unknown according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#05</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 more than one patient identifier for each patient record.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#06</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 link key patient identifier information (e.g., system ID, medical record number) to each patient record according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#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 to determine and render a patient by an alias and link the record to a single patient.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#08</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, through a controlled method, to integrate or link information for an individual patient upon recognizing the identity of the patient (e.g., if portions of a record were not yet integrated or linked because the patient's identity was not yet known, or a temporary identity (an alias) was being used, or there were duplicate records).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#09</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 tag the information as erroneous in the record of the patient in which it was mistakenly associated and render that information as erroneous in all renderings (i.e., outputs) containing that information.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#10</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF health information was mistakenly associated with a patient, THEN the system SHALL provide the ability to link the health information with the correct patient and tag that health information as erroneous in the mistakenly associated patient's record.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#11</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL render appropriate health information that has been tagged as erroneous in a patient's record (e.g., identify as erroneous when rendering or render in audit logs only).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#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 render parts of a single patient's record using a primary identifier (e.g., Unique patient identifier, encounter number), secondary identifiers (e.g., Social Security Number), or other information, or combination of information, which are not identifiers, but could be used to help identify the patient (e.g., name or Date of Birth).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#13</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 tag as obsolete, inactivated or nullified, to store in archives and to remove a patient's record in accordance with local policies and procedures, as well as applicable laws and regulation.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#14</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 auto-populate identical data to all records of related patients.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#15</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 anonymized patient registration.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#16</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 link the mother's and neonate's medical record numbers.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#17</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 records based on previous names.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.1.1#18</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 link several patients that have some common demographics.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CPS.1.1"/>
<version value="2.1.0"/>
<name value="CPS_1_1_Manage_a_Patient_Record"/>
<title value="CPS.1.1 Manage a Patient Record (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="Manage a single logical record for each patient."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="A single record is needed for legal purposes, as well as to organize it unambiguously for the provider. Health information is captured and linked to the patient record. Static data elements as well as data elements that will change over time are maintained. The patient is uniquely identified, after which the record is tied to that patient. Combining information on the same patient, or separating information where it was inadvertently captured for the wrong patient, helps maintain health information for a single patient. In the process of creating a patient record, it is at times advantageous to replicate identical information across multiple records, so that such data does not have to be re-entered. For example, when a parent registers children as new patients, the address, guarantor, and insurance data may be propagated in the children's records without having to re-enter them."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-01"/>
<label value="CPS.1.1#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL manage a single logical record for each patient."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-02"/>
<label value="CPS.1.1#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to determine the unique identity of a patient and link the record to a single patient."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#5"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-03"/>
<label value="CPS.1.1#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to manage a record for a patient when the identity of the patient is unknown."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#2"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-04"/>
<label value="CPS.1.1#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to tag a record when the identity of the patient is unknown 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.1.1-05"/>
<label value="CPS.1.1#05"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to manage more than one patient identifier for each patient record."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#3"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-06"/>
<label value="CPS.1.1#06"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL link key patient identifier information (e.g., system ID, medical record number) to each patient record according to scope of practice, organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#4"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-07"/>
<label value="CPS.1.1#07"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to determine and render a patient by an alias and link the record to a single patient."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-08"/>
<label value="CPS.1.1#08"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability, through a controlled method, to integrate or link information for an individual patient upon recognizing the identity of the patient (e.g., if portions of a record were not yet integrated or linked because the patient's identity was not yet known, or a temporary identity (an alias) was being used, or there were duplicate records)."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#6"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-09"/>
<label value="CPS.1.1#09"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to tag the information as erroneous in the record of the patient in which it was mistakenly associated and render that information as erroneous in all renderings (i.e., outputs) containing that information."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#7"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-10"/>
<label value="CPS.1.1#10"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="IF health information was mistakenly associated with a patient, THEN the system SHALL provide the ability to link the health information with the correct patient and tag that health information as erroneous in the mistakenly associated patient's record."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#8"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-11"/>
<label value="CPS.1.1#11"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL render appropriate health information that has been tagged as erroneous in a patient's record (e.g., identify as erroneous when rendering or render in audit logs only)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-12"/>
<label value="CPS.1.1#12"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to render parts of a single patient's record using a primary identifier (e.g., Unique patient identifier, encounter number), secondary identifiers (e.g., Social Security Number), or other information, or combination of information, which are not identifiers, but could be used to help identify the patient (e.g., name or Date of Birth)."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#9"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-13"/>
<label value="CPS.1.1#13"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to tag as obsolete, inactivated or nullified, to store in archives and to remove a patient's record in accordance with local policies and procedures, as well as applicable laws and regulation."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#10"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-14"/>
<label value="CPS.1.1#14"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY provide the ability to auto-populate identical data to all records of related patients."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.1.1#11"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-15"/>
<label value="CPS.1.1#15"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture anonymized patient registration."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-16"/>
<label value="CPS.1.1#16"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to link the mother's and neonate's medical record numbers."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-17"/>
<label value="CPS.1.1#17"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to render patient records based on previous names."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.1.1-18"/>
<label value="CPS.1.1#18"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to link several patients that have some common demographics."/>
</statement>
</Requirements>