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 |
{
"resourceType" : "Requirements",
"id" : "CMHAFFR2-PDS.3",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"
]
},
"text" : {
"status" : "extensions",
"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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "mobile"
}
],
"url" : "http://hl7.org/fhir/uv/cmhaffr2/Requirements/CMHAFFR2-PDS.3",
"version" : "2.0.1",
"name" : "PDS_3_Usability_and_Accessibility_Assessment",
"title" : "PDS.3 Usability and Accessibility Assessment (Header)",
"status" : "active",
"date" : "2025-05-28T08:01:49+00:00",
"publisher" : "HL7 International / Mobile Health",
"contact" : [
{
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/mobile"
}
]
}
],
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"statement" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-01",
"label" : "PDS.3#01",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "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]"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-02",
"label" : "PDS.3#02",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "[Intended users include those with motor disabilities] Assess product for usability by people with motor disabilities.[1]"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-03",
"label" : "PDS.3#03",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "[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."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-04",
"label" : "PDS.3#04",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "[Intended users include those with auditory disabilities] Assess product for usability by people with auditory disabilities."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-05",
"label" : "PDS.3#05",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "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."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-06",
"label" : "PDS.3#06",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "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."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-07",
"label" : "PDS.3#07",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "Follow design/style guide standards established by the platform provider(s) for the app (e.g., Android, iOS)."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-08",
"label" : "PDS.3#08",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "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]"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-09",
"label" : "PDS.3#09",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "Describe the use cases (business scenarios) and intended users for the app’s main functions.[3]"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-10",
"label" : "PDS.3#10",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "Permit flexibility (adaptation) to the user’s specific abilities, needs, or requirements."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "CMHAFFR2-PDS.3-11",
"label" : "PDS.3#11",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "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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