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
: PIM.1.4 Limitations and Warnings (Header)
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:Requirements ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "CMHAFFR2-PIM.1.4"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader> ] )
] ; #
fhir:language [ fhir:v "en"] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
] ; #
fhir:extension ( [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-wg> ] ;
fhir:value [
a fhir:Code ;
fhir:v "mobile" ]
] ) ; #
fhir:url [
fhir:v "http://hl7.org/fhir/uv/cmhaffr2/Requirements/CMHAFFR2-PIM.1.4"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/cmhaffr2/Requirements/CMHAFFR2-PIM.1.4>
] ; #
fhir:version [ fhir:v "2.0.1"] ; #
fhir:name [ fhir:v "PIM_1_4_Limitations_and_Warnings"] ; #
fhir:title [ fhir:v "PIM.1.4 Limitations and Warnings (Header)"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:date [ fhir:v "2026-03-20T11:58:09+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International / Mobile Health"] ; #
fhir:contact ( [
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/mobile" ] ] )
] ) ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [
fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm> ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ] ] )
] ) ; #
fhir:statement ( [
( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent> ] ;
fhir:value [
a fhir:Boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PIM.1.4-45" ] ;
fhir:label [ fhir:v "PIM.1.4#45" ] ;
( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "[App provides health recommendations (e.g., general guidelines)] Disclose the potential risks to patient safety and their mitigations." ]
] [
( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent> ] ;
fhir:value [
a fhir:Boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PIM.1.4-46" ] ;
fhir:label [ fhir:v "PIM.1.4#46" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "[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." ]
] [
( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent> ] ;
fhir:value [
a fhir:Boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PIM.1.4-47" ] ;
fhir:label [ fhir:v "PIM.1.4#47" ] ;
( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "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)." ]
] [
( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent> ] ;
fhir:value [
a fhir:Boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PIM.1.4-48" ] ;
fhir:label [ fhir:v "PIM.1.4#48" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "Warn users of updates caused by possible errors in functionality, in health-related information, or in any other sensitive data." ]
] [
( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/requirements-dependent> ] ;
fhir:value [
a fhir:Boolean ;
fhir:v false ] ] ) ;
fhir:key [ fhir:v "CMHAFFR2-PIM.1.4-49" ] ;
fhir:label [ fhir:v "PIM.1.4#49" ] ;
( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:conditionality [ fhir:v false ] ;
fhir:requirement [ fhir:v "[App has collected personal health information] guarantee continuity of data use across different versions of the app." ]
] ) . #
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