Source

{
  "resourceType": "Requirements",
  "id": "CMHAFFR2-PIM.1.4",
  "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.1.4",
  "version": "2.0.1",
  "name": "PIM_1_4_Limitations_and_Warnings",
  "title": "PIM.1.4 Limitations and Warnings (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.1.4-45",
      "label": "PIM.1.4#45",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "[App provides health recommendations (e.g., general guidelines)] Disclose the potential risks to patient safety and their mitigations."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.4-46",
      "label": "PIM.1.4#46",
      "conformance": [
        "SHOULD"
      ],
      "conditionality": false,
      "requirement": "[App offers health advice (e.g., specific and personal health decision support)] State that the use of the app does not replace the provider-patient relationship or the recommendation, opinion, or diagnosis of a health professional."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.4-47",
      "label": "PIM.1.4#47",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "Document contraindications, potential risks and limitations of use. For example, environmental or patient conditions under which apps or connected devices may be unreliable (e.g., tattoos that impact optical sensors; avoid usage when pregnant; avoid usage outside a temperature range)."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.4-48",
      "label": "PIM.1.4#48",
      "conformance": [
        "SHOULD"
      ],
      "conditionality": false,
      "requirement": "Warn users of updates caused by possible errors in functionality, in health-related information, or in any other sensitive data."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PIM.1.4-49",
      "label": "PIM.1.4#49",
      "conformance": [
        "SHOULD"
      ],
      "conditionality": false,
      "requirement": "[App has collected personal health information] guarantee continuity of data use across different versions of the app."
    }
  ]
}