Consumer Mobile Health Application Functional Framework, Release 2
2.0.1 - CI build
Consumer Mobile Health Application Functional Framework, Release 2
2.0.1 - CI build
Consumer Mobile Health Application Functional Framework, Release 2, published by HL7 International / Mobile Health. This guide is not an authorized publication; it is the continuous build for version 2.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/cmhaff-ig/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
{
"resourceType" : "Requirements",
"id" : "CMHAFFR2-PIM.1.4",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"
]
},
"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.1.4#45</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>[App provides health recommendations (e.g., general guidelines)] Disclose the potential risks to patient safety and their mitigations.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PIM.1.4#46</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>[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></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PIM.1.4#47</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>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></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PIM.1.4#48</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>Warn users of updates caused by possible errors in functionality, in health-related information, or in any other sensitive data.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>PIM.1.4#49</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>[App has collected personal health information] guarantee continuity of data use across different versions of the app.</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.1.4",
"version" : "2.0.1",
"name" : "PIM_1_4_Limitations_and_Warnings",
"title" : "PIM.1.4 Limitations and Warnings (Header)",
"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.1.4-45",
"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."
}
]
}
IG © 2025 HL7 International / Mobile Health. Package hl7.fhir.uv.cmhaffr2#2.0.1 based on FHIR 5.0.0. Generated 2025-05-28
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