Source

{
  "resourceType": "Requirements",
  "id": "CMHAFFR2-PIM.1.5",
  "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.1.5",
  "version": "2.0.1",
  "name": "PIM_1_5_Technical_Details",
  "title": "PIM.1.5 Technical Details (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.1.5-50",
      "label": "PIM.1.5#50",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "[User can enter personal health information into the app] Clearly disclose whether or not data validity checking is done, and document or reference the evidence for such validity checking."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.5-51",
      "label": "PIM.1.5#51",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "[App collects or receives quantitative data] The precision (accuracy, granularity) of measurements (e.g., physical activity, physiological data from connected devices) is documented and justified as appropriate for the intended use of the app."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.5-52",
      "label": "PIM.1.5#52",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "[Personal health information is hosted] Backup and recovery procedures are documented and compliant with applicable regulatory requirements."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.5-53",
      "label": "PIM.1.5#53",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "[Personal health data are imported or exported] Functions for data import or export are documented, including the ability to convert to standard formats."
    }
  ]
}