Resource Requirements/FHIR Server from package hl7.fhir.uv.cmhaffr2#current (31 ms)

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{
  "resourceType" : "Requirements",
  "id" : "CMHAFFR2-PDS.1",
  "meta" : {
    "profile" : [
      "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Requirements CMHAFFR2-PDS.1</b></p><a name=\"CMHAFFR2-PDS.1\"> </a><a name=\"hcCMHAFFR2-PDS.1\"> </a><a name=\"CMHAFFR2-PDS.1-en-US\"> </a><table class=\"grid\"><tr><td><b><a name=\"CMHAFFR2-PDS.1-01\"> </a></b>PDS.1#01</td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>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.</p>\n</div></td></tr><tr><td><b><a name=\"CMHAFFR2-PDS.1-02\"> </a></b>PDS.1#02</td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>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.</p>\n</div></td></tr><tr><td><b><a name=\"CMHAFFR2-PDS.1-03\"> </a></b>PDS.1#03</td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHOULD\">SHOULD</a></td><td><div><p>The App SHOULD have measures to safeguard minors in accordance with applicable regulations.</p>\n</div></td></tr></table></div>"
  },
  "url" : "http://hl7.org/fhir/uv/cmhaffr2/Requirements/CMHAFFR2-PDS.1",
  "version" : "2.0.1",
  "name" : "PDS_1_Regulatory_Considerations",
  "title" : "PDS.1 Regulatory Considerations (Header)",
  "status" : "active",
  "date" : "2025-01-30T10:38:20+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/fhir/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/fhir/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/fhir/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."
    }
  ]
}

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