{
  "resourceType" : "Requirements",
  "id" : "CMHAFFR2-PIM.1.4",
  "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            PIM.1.4#45\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>[App provides health recommendations (e.g., general guidelines)] Disclose the potential risks to patient safety and their mitigations.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            PIM.1.4#46\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>[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.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            PIM.1.4#47\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>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).</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            PIM.1.4#48\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>Warn users of updates caused by possible errors in functionality, in health-related information, or in any other sensitive data.</p>\n</div>\n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n            PIM.1.4#49\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>[App has collected personal health information] guarantee continuity of data use across different versions of the app.</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-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" : "2026-03-20T11:58:09+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."
  }]
}