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 |
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:Requirements ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "EHRSFMR2.1-CPS.3.5"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/ehrs/StructureDefinition/FMFunction"^^xsd:anyURI ;
fhir:link <http://hl7.org/ehrs/StructureDefinition/FMFunction> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <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>Provide support for the management of patients enrolled in research protocols.</p>\n</div></span>\n\n \n <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>The clinician is presented with appropriate protocols for patients participating in research studies, and is supported in the management and tracking of study participants.</p>\n</div></span>\n \n\n \n\n \n <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>\n \n <table id=\"statements\" class=\"grid dict\">\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#01</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL provide the ability to present protocols for patients enrolled in research studies.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#02</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL provide the ability to capture, maintain and render research study protocols.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#03</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD conform to function [[AS.9.1]] (Support Financial Plan Enrollment), to enable participation in research studies.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#04</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD provide the ability to analyze and maintain patients participating in research studies.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#05</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>MAY</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system MAY provide the ability to capture and maintain appropriate details of patient condition and response to treatment as required for patients enrolled in research studies.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#06</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL conform to function [[CP.3.3]] (Manage Clinical Documents and Notes) to capture patient condition and response to treatment.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#07</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD capture, maintain and render research subject disposition information including date/time and trial phase/cycle of study completion/discontinuation as discrete elements.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#08</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#09</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD present information notifying staff of patient's eligibility for known active clinical research protocols as defined by inclusion and exclusion criteria.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.3.5#10</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n </table>\n</div>"
] ; #
fhir:url [ fhir:v "http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CPS.3.5"^^xsd:anyURI] ; #
fhir:version [ fhir:v "2.1.0"] ; #
fhir:name [ fhir:v "CPS_3_5_Support_for_Research_Protocols_Relative_to_Individual_Patient_Care"] ; #
fhir:title [ fhir:v "CPS.3.5 Support for Research Protocols Relative to Individual Patient Care (Function)"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:date [ fhir:v "2024-11-26T16:30:50+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "EHR WG"] ; #
fhir:contact ( [
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/ehr" ] ] )
] ) ; #
fhir:description [ fhir:v "Provide support for the management of patients enrolled in research protocols."] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ] ] )
] ) ; #
fhir:purpose [ fhir:v "The clinician is presented with appropriate protocols for patients participating in research studies, and is supported in the management and tracking of study participants."] ; #
fhir:statement ( [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-01" ] ;
fhir:label [ fhir:v "CPS.3.5#01" ] ;
( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system SHALL provide the ability to present protocols for patients enrolled in research studies." ] ;
fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#1" ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-02" ] ;
fhir:label [ fhir:v "CPS.3.5#02" ] ;
( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system SHALL provide the ability to capture, maintain and render research study protocols." ] ;
fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#2" ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-03" ] ;
fhir:label [ fhir:v "CPS.3.5#03" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system SHOULD conform to function [[AS.9.1]] (Support Financial Plan Enrollment), to enable participation in research studies." ] ;
fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#3" ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-04" ] ;
fhir:label [ fhir:v "CPS.3.5#04" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system SHOULD provide the ability to analyze and maintain patients participating in research studies." ] ;
fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#4" ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-05" ] ;
fhir:label [ fhir:v "CPS.3.5#05" ] ;
( fhir:conformance [ fhir:v "MAY" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system MAY provide the ability to capture and maintain appropriate details of patient condition and response to treatment as required for patients enrolled in research studies." ] ;
fhir:derivedFrom [ fhir:v "EHR-S_FM_R1.1 DC.2.2.3#5" ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-06" ] ;
fhir:label [ fhir:v "CPS.3.5#06" ] ;
( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system SHALL conform to function [[CP.3.3]] (Manage Clinical Documents and Notes) to capture patient condition and response to treatment." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-07" ] ;
fhir:label [ fhir:v "CPS.3.5#07" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system SHOULD capture, maintain and render research subject disposition information including date/time and trial phase/cycle of study completion/discontinuation as discrete elements." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-08" ] ;
fhir:label [ fhir:v "CPS.3.5#08" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-09" ] ;
fhir:label [ fhir:v "CPS.3.5#09" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system SHOULD present information notifying staff of patient's eligibility for known active clinical research protocols as defined by inclusion and exclusion criteria." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/ehrs/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ;
fhir:key [ fhir:v "EHRSFMR2.1-CPS.3.5-10" ] ;
fhir:label [ fhir:v "CPS.3.5#10" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v "false"^^xsd:boolean ] ;
fhir:requirement [ fhir:v "The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation." ]
] ) . #
IG © 2024 EHR WG. Package hl7.ehrs.ehrsfmr21#2.1.0 based on FHIR 5.0.0. Generated 2024-11-26
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