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Source1

{
  "resourceType": "Requirements",
  "id": "CMHAFFR2-PDS.3",
  "meta": {
    "profile": [
      "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/FMHeader"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "mobile"
    }
  ],
  "url": "http://hl7.org/ehrs/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": "2026-08-27T10:32:57+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/ehrs/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), such as user types including those with motor disabilities, visual impairment, auditory disabilities, etc. [1]"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-02",
      "label": "PDS.3#02",
      "conformance": [
        "SHALL"
      ],
      "conditionality": true,
      "requirement": "IF intended users include those with motor disabilities THEN the app SHALL be assessed for usability by people with motor disabilities.[1]"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-03",
      "label": "PDS.3#03",
      "conformance": [
        "SHALL"
      ],
      "conditionality": true,
      "requirement": "IF intended users include those with visual disabilities THEN the app SHALL be assessed for usability by visually-impaired and/or color-blind people using a standard mobile screen reader."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-04",
      "label": "PDS.3#04",
      "conformance": [
        "SHALL"
      ],
      "conditionality": true,
      "requirement": "IF intended users include those with auditory disabilities THEN the app SHALL be assessed for usability by people with auditory disabilities."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-05",
      "label": "PDS.3#05",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The app SHALL be assessed for usability by a sample of intended users, drawing usability testing subjects from relevant populations if geared towards a certain age segment, people with a specific chronic health condition, or persons with disabilities other than those specified."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-06",
      "label": "PDS.3#06",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The app SHALL have a written usability assessment plan, including known problems with product usability and mitigation plan (where for U.S. Realm when an app is sponsored by a HIPAA entity, the force of this criteria is elevated to SHALL with the plan specifically addressing usability issues for people with visual and motor disabilities)."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-07",
      "label": "PDS.3#07",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The app SHALL follow design/style guide standards established by the platform provider(s) for the app (e.g., Android, iOS)."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-08",
      "label": "PDS.3#08",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The app SHALL avoid excessive data use, minimizing it as much as possible and warning users when high data usage occurs (e.g., downloads and updates).[2]"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-09",
      "label": "PDS.3#09",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The app SHALL describe the use cases (business scenarios) and intended users for the app's main functions.[3]"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-10",
      "label": "PDS.3#10",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The app SHALL permit flexibility (adaptation) to the user's specific abilities, needs, or requirements."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.3-11",
      "label": "PDS.3#11",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The app SHALL provide information about accessibility characteristics in the app description and in contextual assistance sections of the app."
    }
  ]
}