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 |
This section is about the compliance of apps to applicable regulations for the domains (realms, locales, environments) in which they are intended to be used. CMHAFF is designed as a framework that can be further constrained (profiled) for these domains and does not require conformance to any specific locale’s regulations.
PDS.1#01 | SHALL |
The app SHALL be analyzed to determine if regulatory approval (following Realm-specific regulatory rules) is needed before the app is used by the general public. |
PDS.1#02 | conditional SHALL |
IF it is determined that realm-specific regulatory rule approval is required THEN the app SHALL not be presented for general public use until regulatory approval is obtained. |
PDS.1#03 | SHOULD |
The App SHOULD have measures to safeguard minors in accordance with applicable regulations. |
The documents listed below are overviews of the regulatory landscape, rather than specific regulations governing mobile health apps. Specific references are listed either following the conformance tables, or in the Appendix.
Commission Staff Working Document on the existing EU legal framework applicable to lifestyle and wellbeing apps. This broad guidance for the European Union, analogous to the USA FTC document. It is complemented by country-specific guidelines. In the EU, some mHealth apps may fall under the definition of a medical device and therefore may have to comply with the safety and performance requirements of Council Directive 93/42/EEC concerning medical devices.
For the European Union, the figure below summarizes relevant guidance and regulations for Mobile Health. There are three principal EU regulatory areas impacting mHealth apps:
Shades of blue indicate directives and regulations. Red indicates voluntary codes/guidelines. Yellow indicates possible other actions with uncertain timing.
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