Consumer Mobile Health Application Functional Framework, Release 2
2.0.1 - CI build International flag

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

Requirements: Product Development & Support

Official URL: http://hl7.org/fhir/uv/cmhaffr2/Requirements/CMHAFFR2-PDS Version: 2.0.1
Standards status: Informative Active as of 2026-03-20 Computable Name: Product_Development___Support

Prior to marketing a mobile app, the developer has a responsibility to ensure it meets Realm-specific rules and regulations. Although cMHAFF does not have guidelines for all aspects of the software product life cycle, cMHAFF still recommends that the product development life cycle, for new apps and for upgrades to apps, ensure that requirements for functionality, reliability, performance, scalability, safety, compatibility, portability, and maintainability have been addressed, as well as any requirements that relate to aspects that include these items previously described above:

  • Product Information for consumers (e.g., App Store descriptions, product disclosures)
  • Security
  • Privacy
  • Permission to use device features
  • Data Access
  • Data Sharing
  • Terms of Use, Conditions
  • Product Development, including risk management, user-centered design, compliance with applicable regulations, functions (product description), reliability, performance, scalability, safety, compatibility, and portability. The security and privacy of information used by the app needs to be considered throughout the development phases of the app. Functionality must support the intended use of the app for the target users and stakeholders. Thorough and iterative risk assessment and requirement analysis, testing, evidence collection, documentation, and configuration management ensures quality to satisfy the needs of the application’s various stakeholders 8 . Assessing the usability of the app helps ensure the app’s viability and adoption; testing must be population- relevant and demonstrate reasonable product usability (accessibility) by people with visual, auditory and motor disabilities within the intended target audience. Establishing a system of customer support enables product defects and usability issues to be surfaced in a systematic way and helps problems related to use of the app to be effectively resolved and the developer to continually deliver the intended use of the app.