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Source1

{
  "resourceType": "Requirements",
  "id": "CMHAFFR2-PDS.1",
  "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.1",
  "version": "2.0.1",
  "name": "PDS_1_Regulatory_Considerations",
  "title": "PDS.1 Regulatory Considerations (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"
        }
      ]
    }
  ],
  "description": "This section is about the compliance of apps to applicable regulations for the domains (realms, locales,\nenvironments) in which they are intended to be used. CMHAFF is designed as a framework that can be\nfurther constrained (profiled) for these domains and does not require conformance to any specific\nlocale’s regulations.",
  "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.1-01",
      "label": "PDS.1#01",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The app SHALL be analyzed to determine if regulatory approval (following Realm-specific regulatory rules) is needed before the app is used by the general public."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.1-02",
      "label": "PDS.1#02",
      "conformance": [
        "SHALL"
      ],
      "conditionality": true,
      "requirement": "IF it is determined that realm-specific regulatory rule approval is required THEN the app SHALL NOT be presented for general public use until regulatory approval is obtained."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-PDS.1-03",
      "label": "PDS.1#03",
      "conformance": [
        "SHOULD"
      ],
      "conditionality": false,
      "requirement": "The app SHOULD have measures to safeguard minors in accordance with applicable regulations."
    }
  ]
}