Consumer Mobile Health Application Functional Framework, Release 2
2.0.1 - CI build
Consumer Mobile Health Application Functional Framework, Release 2
2.0.1 - CI build
Consumer Mobile Health Application Functional Framework, Release 2, published by HL7 International / Mobile Health. This guide is not an authorized publication; it is the continuous build for version 2.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/cmhaff-ig/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@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 "CMHAFFR2-PDS.3"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader> ] )
] ; #
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/></span>\n\n \n\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>PDS.3#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 App SHALL be assessed against an industry-validated usability assessment tool, using subjects who are demographically-similar to intended users (target audience). For example, user types may include those with motor disabilities, visual impairment, auditory disabilities, etc. [1]</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#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>[Intended users include those with motor disabilities] Assess product for usability by people with motor disabilities.[1]</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#03</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>[Intended users include those with visual disabilities] Assess product for usability by visually-impaired and/or color-blind people using a standard mobile screen reader.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#04</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>[Intended users include those with auditory disabilities] Assess product for usability by people with auditory disabilities.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#05</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>Assess product for usability by a sample of intended users. If geared towards a certain age segment or to people with a specific chronic health condition, or to persons with disabilities other than those specified above, usability testing subjects are drawn from these populations.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#06</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>Create a written usability assessment plan, including known problems with product usability and mitigation plan. NOTE: for U.S. Realm when an app is sponsored by a HIPAA entity, the force of this criteria is elevated to “SHALL†with plan specifically addressing usability issues for people with visual and motor disabilities.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#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>Follow design/style guide standards established by the platform provider(s) for the app (e.g., Android, iOS).</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#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>Avoid excessive data use by the app, minimizing it as much as possible warning users when high data usage occurs (e.g., downloads and updates).[2]</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#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>Describe the use cases (business scenarios) and intended users for the app’s main functions.[3]</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#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>Permit flexibility (adaptation) to the user’s specific abilities, needs, or requirements.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PDS.3#11</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>Provide information about accessibility characteristics in the app description and in contextual assistance sections of the app.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n </table>\n</div>"^^rdf:XMLLiteral
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "mobile" ]
] ) ; #
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/Requirements/CMHAFFR2-PDS.3"^^xsd:anyURI] ; #
fhir:version [ fhir:v "2.0.1"] ; #
fhir:name [ fhir:v "PDS_3_Usability_and_Accessibility_Assessment"] ; #
fhir:title [ fhir:v "PDS.3 Usability and Accessibility Assessment (Header)"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:date [ fhir:v "2025-05-28T08:01:49+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International / Mobile Health"] ; #
fhir:contact ( [
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/mobile" ] ] )
] ) ; #
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:statement ( [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-01" ] ;
fhir:label [ fhir:v "PDS.3#01" ] ;
( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "The App SHALL be assessed against an industry-validated usability assessment tool, using subjects who are demographically-similar to intended users (target audience). For example, user types may include those with motor disabilities, visual impairment, auditory disabilities, etc. [1]" ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-02" ] ;
fhir:label [ fhir:v "PDS.3#02" ] ;
( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "[Intended users include those with motor disabilities] Assess product for usability by people with motor disabilities.[1]" ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-03" ] ;
fhir:label [ fhir:v "PDS.3#03" ] ;
( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "[Intended users include those with visual disabilities] Assess product for usability by visually-impaired and/or color-blind people using a standard mobile screen reader." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-04" ] ;
fhir:label [ fhir:v "PDS.3#04" ] ;
( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "[Intended users include those with auditory disabilities] Assess product for usability by people with auditory disabilities." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-05" ] ;
fhir:label [ fhir:v "PDS.3#05" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "Assess product for usability by a sample of intended users. If geared towards a certain age segment or to people with a specific chronic health condition, or to persons with disabilities other than those specified above, usability testing subjects are drawn from these populations." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-06" ] ;
fhir:label [ fhir:v "PDS.3#06" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "Create a written usability assessment plan, including known problems with product usability and mitigation plan. NOTE: for U.S. Realm when an app is sponsored by a HIPAA entity, the force of this criteria is elevated to “SHALL†with plan specifically addressing usability issues for people with visual and motor disabilities." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-07" ] ;
fhir:label [ fhir:v "PDS.3#07" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "Follow design/style guide standards established by the platform provider(s) for the app (e.g., Android, iOS)." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-08" ] ;
fhir:label [ fhir:v "PDS.3#08" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "Avoid excessive data use by the app, minimizing it as much as possible warning users when high data usage occurs (e.g., downloads and updates).[2]" ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-09" ] ;
fhir:label [ fhir:v "PDS.3#09" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "Describe the use cases (business scenarios) and intended users for the app’s main functions.[3]" ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-10" ] ;
fhir:label [ fhir:v "PDS.3#10" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "Permit flexibility (adaptation) to the user’s specific abilities, needs, or requirements." ]
] [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PDS.3-11" ] ;
fhir:label [ fhir:v "PDS.3#11" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "Provide information about accessibility characteristics in the app description and in contextual assistance sections of the app." ]
] ) . #
IG © 2025 HL7 International / Mobile Health. Package hl7.fhir.uv.cmhaffr2#2.0.1 based on FHIR 5.0.0. Generated 2025-05-28
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