Resource Requirements/FHIR Server from package hl7.fhir.uv.cmhaffr2#current (47 ms)

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{
  "resourceType" : "Requirements",
  "id" : "CMHAFFR2-PIM.1.4",
  "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-PIM.1.4</b></p><a name=\"CMHAFFR2-PIM.1.4\"> </a><a name=\"hcCMHAFFR2-PIM.1.4\"> </a><a name=\"CMHAFFR2-PIM.1.4-en-US\"> </a><table class=\"grid\"><tr><td><b><a name=\"CMHAFFR2-PIM.1.4-45\"> </a></b>PIM.1.4#45</td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>[App provides health recommendations (e.g., general guidelines)] Disclose the potential risks to patient safety and their mitigations.</p>\n</div></td></tr><tr><td><b><a name=\"CMHAFFR2-PIM.1.4-46\"> </a></b>PIM.1.4#46</td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHOULD\">SHOULD</a></td><td><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></td></tr><tr><td><b><a name=\"CMHAFFR2-PIM.1.4-47\"> </a></b>PIM.1.4#47</td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><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></td></tr><tr><td><b><a name=\"CMHAFFR2-PIM.1.4-48\"> </a></b>PIM.1.4#48</td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHOULD\">SHOULD</a></td><td><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></td></tr><tr><td><b><a name=\"CMHAFFR2-PIM.1.4-49\"> </a></b>PIM.1.4#49</td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHOULD\">SHOULD</a></td><td><div><p>[App has collected personal health information] guarantee continuity of data use across different versions of the app.</p>\n</div></td></tr></table></div>"
  },
  "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" : "2025-01-30T10:38:20+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."
    }
  ]
}

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