{
  "resourceType" : "Requirements",
  "id" : "CMHAFFR2-PDS.1",
  "meta" : {
    "profile" : ["http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"]
  },
  "language" : "en",
  "text" : {
    "status" : "extensions",
    "div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">\n    \n    \n    \n    \n    <div id=\"requirements\"><b>Criteria <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b></div>\n    \n    <table id=\"statements\" class=\"grid dict\">\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            PDS.1#01\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHALL\n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <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>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            PDS.1#02\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHALL\n            \n            <span style=\"border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #f3e5ff;color: #7b1fa2;border: 1px solid #d1a3ff;\">conditional</span>\n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <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>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            PDS.1#03\n            </td>\n            <td style=\"padding-left: 4px;\">\n            SHOULD\n            \n            \n            \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                <div><p>The App SHOULD have measures to safeguard minors in accordance with applicable regulations.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n    </table>\n</div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "mobile"
  }],
  "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" : "2026-03-20T11:58:09+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."
  }]
}