Source

{
  "resourceType" : "Requirements",
  "id" : "CMHAFFR2-PIM.1.1",
  "meta" : {
    "profile" : [
      "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMFunction"
    ]
  },
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n    <span id=\"description\"><b>Statement <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b> <div/></span>\n\n    \n\n    \n    \n    \n\n    \n    <span id=\"requirements\"><b>Criteria <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b></span>\n    \n    <table id=\"statements\" class=\"grid dict\">\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>PIM.1.1#01</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\">\n                \n                \n                \n                <span>SHALL</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                \n                <span><div><p>The description of an app includes the main functionality, the intended use, the intended (target) audience, and potential use of the user’s personal data by the app.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>PIM.1.1#02</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\">\n                \n                \n                \n                <span>SHALL</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                \n                <span><div><p>Screen shots of the app accurately depict the screens of the current version of the product.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>PIM.1.1#03</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\">\n                \n                \n                \n                <span>SHALL</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                \n                <span><div><p>Product information is provided before the app is used by the consumer, to help consumers decide whether the app is suitable.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>PIM.1.1#04</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\">\n                \n                \n                \n                <span>SHOULD</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                \n                <span><div><p>The app description clearly states the human languages the app supports.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>PIM.1.1#05</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\">\n                \n                \n                \n                <span>SHOULD</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                \n                <span><div><p>Provide information about the app publisher (persons/organizations) and provide mechanisms to communicate with the publishers.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>PIM.1.1#06</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\">\n                \n                \n                \n                <span>SHOULD</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\" class=\"requirement\">\n                \n                <span><div><p>Provide disclosure about sources of funding and possible conflicts of interest for the app (e.g., app use could incent user to buy products or services from app publisher).</p>\n</div></span>\n                \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-PIM.1.1",
  "version" : "2.0.1",
  "name" : "PIM_1_1_General_Information",
  "title" : "PIM.1.1 General Information (Function)",
  "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.1.1-01",
      "label" : "PIM.1.1#01",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "The description of an app includes the main functionality, the intended use, the intended (target) audience, and potential use of the user’s personal data by the app."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "CMHAFFR2-PIM.1.1-02",
      "label" : "PIM.1.1#02",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "Screen shots of the app accurately depict the screens of the current version of the product."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "CMHAFFR2-PIM.1.1-03",
      "label" : "PIM.1.1#03",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "Product information is provided before the app is used by the consumer, to help consumers decide whether the app is suitable."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "CMHAFFR2-PIM.1.1-04",
      "label" : "PIM.1.1#04",
      "conformance" : [
        "SHOULD"
      ],
      "conditionality" : false,
      "requirement" : "The app description clearly states the human languages the app supports."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "CMHAFFR2-PIM.1.1-05",
      "label" : "PIM.1.1#05",
      "conformance" : [
        "SHOULD"
      ],
      "conditionality" : false,
      "requirement" : "Provide information about the app publisher (persons/organizations) and provide mechanisms to communicate with the publishers."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "CMHAFFR2-PIM.1.1-06",
      "label" : "PIM.1.1#06",
      "conformance" : [
        "SHOULD"
      ],
      "conditionality" : false,
      "requirement" : "Provide disclosure about sources of funding and possible conflicts of interest for the app (e.g., app use could incent user to buy products or services from app publisher)."
    }
  ]
}

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