Source

{
  "resourceType": "Requirements",
  "id": "CMHAFFR2-PDS.3",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/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/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."
    }
  ]
}