{ "resourceType" : "Requirements", "id" : "CMHAFFR2-PDS.3", "meta" : { "profile" : ["http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"] }, "language" : "en", "text" : { "status" : "extensions", "div" : "
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Criteria N:
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\n PDS.3#01\n \n SHALL\n \n \n \n \n

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]

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\n PDS.3#02\n \n SHALL\n \n \n \n \n

[Intended users include those with motor disabilities] Assess product for usability by people with motor disabilities.[1]

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\n PDS.3#03\n \n SHALL\n \n \n \n \n

[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.

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\n PDS.3#04\n \n SHALL\n \n \n \n \n

[Intended users include those with auditory disabilities] Assess product for usability by people with auditory disabilities.

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\n PDS.3#05\n \n SHOULD\n \n \n \n \n

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.

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\n PDS.3#06\n \n SHOULD\n \n \n \n \n

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.

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\n PDS.3#07\n \n SHOULD\n \n \n \n \n

Follow design/style guide standards established by the platform provider(s) for the app (e.g., Android, iOS).

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\n PDS.3#08\n \n SHOULD\n \n \n \n \n

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]

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\n PDS.3#09\n \n SHOULD\n \n \n \n \n

Describe the use cases (business scenarios) and intended users for the app’s main functions.[3]

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\n PDS.3#10\n \n SHOULD\n \n \n \n \n

Permit flexibility (adaptation) to the user’s specific abilities, needs, or requirements.

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\n PDS.3#11\n \n SHOULD\n \n \n \n \n

Provide information about accessibility characteristics in the app description and in contextual assistance sections of the app.

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" }, "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" : "2026-03-20T11:58:09+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." }] }