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Section 2: Clinical and Administrative Domains
Section 4: Rules and References

HL7 Consumer Mobile Health Application Functional Framework (cMHAFF), Release 1

DESCRIPTION

The Consumer Mobile Health Application Functional Framework is an HL7 Standard for Trial Use (STU). The primary goals of the Consumer Mobile Health Functional Framework ( cMHAFF ) are to provide a standard against which a mobile app’s foundational characteristics -- including but not limited to security, privacy, data access, data export, and transparency/disclosure of conditions -- can be assessed.

This is not a Functional Model, but is a Frameworks which includes functions and non-functional criteria and guidance that can be used to derive Implementation Conformance Criteria profile and certification conformity assessment.

ALTERNATIVE NAMES

HL7 Consumer Mobile Health Application Functional Framework (cMHAFF), Release 1 may also go by the following names or acronyms:

"HL7 MHaFF: Consumer Mobile Health App Functional Framework, R1",cMHAFF

TARGETS

  • Quality Reporting Agencies
  • Regulatory Agency
  • Standards Development Organizations (SDOs) 
  • Mobile Health App Developers
  • EHR, PHR Vendors
  • Health Care IT Vendors
  • Local and State Departments of Health
  • Healthcare Institutions (hospitals, long term care, home care, mental health)

BENEFITS

  • Provides Health App developers and vendors with a best practices standard for the development of consumer/patient targeted health and wellness apps
  • Provides a path to assessments that can span a range including self-attestation, testing, endorsement, and/or certification (voluntary or regulatory)
  • Promotes opportunity for certified apps to claim their conformance, and as a consequence, consumers who use the apps, and providers who recommend them, can be more confident of an app’s rigor in enforcing basic security, its respect for the privacy of individuals, and the usefulness of data for improving and maintaining a better state of health

IMPLEMENTATIONS/CASE STUDIES

  • Childrens Hospital of Philadelphia
  • HRSA HITEQ Center project
  • CEN/ISO TS: IEC 82304-2: Health Software

DEVELOPMENT BACKGROUND

The primary goals of cMHAFF are to provide a standard against which a mobile app’s foundational characteristics -- including but not limited to security, privacy, data access, data export, and transparency/disclosure of conditions -- can be assessed. The framework is based on the lifecycle of an app, as experienced by an individual consumer, from first deciding to download an app, to determining what happens with consumer data after the app has been deleted from a smartphone. It is important to note that the Framework does not speak directly to the specific health or clinical functionality of an app but can be extended to do so through the use of profiles (with constraints and/or extensions) developed on top of cMHAFF.

The decision to create a standard focused on a smaller set of criteria was made so that the standard is both developer-friendly and easy to update on a frequent basis. CMHAFF challenges market assumptions concerning safe and acceptable use of personal information and may in some circumstances increase coding complexity and decrease the efficiency of data transmission. As such, there is no expectation that most consumer health apps will choose to follow this standard. Yet, for apps which conform, cMHAFF can potentially provide a path to assessments that can span a range including self-attestation, testing, endorsement2, and/or certification (voluntary or regulatory). CMHAFF is independent of the method of assessment but aims to be suitable for use for types of assessments up to and including certification. Certified apps can promote their conformance, and as a consequence, consumers who use the apps, and providers who recommend them, can be more confident of an app’s rigor in enforcing basic security, its respect for the privacy of individuals, and the usefulness of data for improving and maintaining a better state of health.

 

 

RELATED DOCUMENTS

HL7 Consumer Mobile Health Application Functional Framework (cMHAFF), Release 1

STU DOCUMENTS

HL7 Consumer Mobile Health Application Functional Framework (cMHAFF), Release 1, STU Release 2 (Submit Feedback on STU)

(Download)

HL7 Consumer Mobile Health Application Functional Framework (cMHAFF), Release 1, STU Release 1 Expiration Jun 2022

(Download) (1.94 MB)

TOPIC

  • Security and Privacy

BALLOT TYPE

  • STU

STATUS DATE

2018-06-26

RESPONSIBLE WORK GROUP

Mobile Health

PRODUCT TYPE

  • Functional Profile

STAKEHOLDERS

  • EHR, PHR Vendors
  • Health Care IT Vendors
  • Healthcare Institutions
  • HIS Vendors
  • Local and State Departments of Health
  • Quality Reporting Agencies
  • Regulatory Agency
  • Standards Development Organizations (SDOs)

CURRENT STATE

  • Active

REALM

  • Universal