Source

{
  "resourceType": "Requirements",
  "id": "CMHAFFR2-PIM.1.3",
  "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-PIM.1.3",
  "version": "2.0.1",
  "name": "PIM_1_3_Evidence_and_Credentials",
  "title": "PIM.1.3 Evidence and Credentials (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-PIM.1.3-39",
      "label": "PIM.1.3#39",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "[App provides health recommendations] Disclose the scientific degree of evidence and the types and dates of sources used (e.g., clinical practice guidelines and protocols, peer-reviewed articles, professionals and organizations with their credentials) that guided the app content."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.3-40",
      "label": "PIM.1.3#40",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "[there is human[1] and/or automated interpretation of health-related content] The credentials of qualified health professionals are disclosed, and/or the algorithms and testing plans and reports are documented.[2]"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.3-41",
      "label": "PIM.1.3#41",
      "conformance": [
        "SHOULD"
      ],
      "conditionality": false,
      "requirement": "The app descriptions should identify the health professionals and credentials of those who worked on the app and/or at least the professional organization that made, reviewed, endorsed, or sponsored the app."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.3-42",
      "label": "PIM.1.3#42",
      "conformance": [
        "SHOULD"
      ],
      "conditionality": false,
      "requirement": "Show the date of the last update to the app and describe the changes from the previous release (e.g., revisions due to new scientific evidence)."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.3-43",
      "label": "PIM.1.3#43",
      "conformance": [
        "MAY"
      ],
      "conditionality": false,
      "requirement": "The app description may also include data related to app reliability and validity tests or population research results."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.3-44",
      "label": "PIM.1.3#44",
      "conformance": [
        "SHOULD"
      ],
      "conditionality": false,
      "requirement": "Declare the degree of admission of liability (publisher’s acceptance or disclaimer of responsibility) regarding the selection and use of the app’s content.[3]"
    }
  ]
}