CMHAFF Normalization (PSS-2642)

Project Name
CMHAFF Normalization (PSS-2642)

Project Number
1981

Project Type

Product Family

Products

Project Intent

Ballot Type

Project Need

The HL7 Consumer Mobile Health Application Functional Framework (CMHAFF) has advanced significantly through its successive Standard for Trial Use (STU) iterations—STU1 and STU2—demonstrating increasing alignment with industry needs, stakeholder feedback, and real-world implementation experience. These versions have helped validate the relevance, feasibility, and utility of CMHAFF in guiding the development and evaluation of consumer mobile health applications, particularly with respect to privacy, security, data governance, and interoperability.

Throughout STU1, the foundational structure of the framework was established, offering a comprehensive set of functional criteria for mobile health apps. STU2 introduced refined criteria, greater alignment with regulatory and policy environments (e.g., GDPR, HIPAA, 21st Century Cures Act), and incorporated implementer feedback from public comment periods and working group collaborations. This iterative development process has ensured that CMHAFF is not only technically sound, but also practical and actionable for developers, evaluators, and regulators.

Now, with a growing ecosystem of mobile health applications and increasing regulatory focus on app transparency and accountability, it is both timely and necessary to move CMHAFF STU2 to normative status. Normalization will formalize its role as a stable, consensus-based standard suitable for reference in procurement, certification, and compliance processes. The transition to normative ensures that the framework can be confidently adopted by the broader standards community as a mature and authoritative resource to promote trust, quality, and interoperability in consumer health technologies.

Objectives and Deliverables

Project Document Repository
https://build.fhir.org/ig/HL7/cmhaff-ig/

Collaboration Efforts

Dependencies
N/a

Stakeholders

Implementers
Health eServices, Inc., HRSA HITEQ Center, CEN-ISO/TS 82304-2

External Drivers
1. Proliferation of Consumer Health Apps • Over 350,000 digital health apps are currently available, with thousands added yearly. • Many lack standard practices for security, privacy, consent, or clinical data quality. • A normative CMHAFF provides an industry-aligned, standards-based benchmark to distinguish trustworthy apps from low-quality or unsafe ones. 2. Regulatory Pressures and Policy Mandates • ONC Cures Act Final Rule: Requires app access to patient data via standardized APIs and promotes patient-directed data exchange. • HIPAA Right of Access and 42 CFR Part 2: Highlight the need for apps to properly handle sensitive health data. • GDPR and California Consumer Privacy Act (CCPA): Impose obligations on data transparency, consent, and deletion—all addressed within CMHAFF. • CMHAFF directly supports compliance with these and other data stewardship laws. 3. Cybersecurity and Trust Concerns • Ongoing data breaches and misuse of personal health information (PHI) in mobile apps have eroded consumer trust. • CMHAFF defines criteria for encryption, secure transmission, access controls, and third-party data sharing—critical for strengthening cybersecurity posture and restoring user confidence. 4. Need for Evaluative Tools and Procurement Criteria • Governments, payers, and health systems increasingly need standardized criteria to evaluate apps for inclusion in: • Digital formularies • Remote monitoring programs • Population health platforms • CMHAFF provides a common language and checklist for procurement, accreditation, and certification efforts. 5. Rise of Patient Empowerment and Digital Health Equity • Patients are demanding greater control over their data and transparency around how it’s used. • CMHAFF supports patient-centered design principles such as consent, data portability, and plain-language disclosures. • Normative status enhances its credibility for use by advocacy groups and communities working to address digital divide and health equity issues. 6. Interoperability and Standards Alignment • Aligns with FHIR, SMART on FHIR, and other HL7 standards supporting data exchange. • Facilitates consistent functionality across health apps that integrate with EHRs, HIEs, or wearable platforms. • A normative CMHAFF will support end-to-end app interoperability across diverse healthcare ecosystems. 7. Global Demand for Harmonized App Standards • Nations and standards bodies (e.g., ISO/IEC, WHO) are calling for harmonized app quality frameworks to support cross-border health innovation.

Common Names
cMHAFF

Lineage

External Vocabularies

Backwards Compatibility
Yes

Joint Copyright