This standard establishes a framework and criteria for assessing medical mobile health applications (apps), defined as those mobile device applications that are seeking regulatory review and approval, prescribed by a clinician, and/or seeking payor reimbursement. The standard applies exclusively to software-based medical apps used for diagnostic, monitoring, decision-support, and therapeutic purposes, as well as remote services that power these apps (e.g., application servers and content delivery networks). The standard excludes general wellness or lifestyle apps, as well as hardware sensors or companion platforms (e.g., glucose monitors, smart watches, or fall detectors). The criteria span multiple domains including clinical evidence and efficacy, privacy and data protection, usability and accessibility, technical reliability, implementation readiness, and ethical considerations.
- Standard Committee
- EMB/Stds Com - Standards Committee
- Status
- Active PAR
- PAR Approval
- 2026-02-12
Working Group Details
- Society
- IEEE Engineering in Medicine and Biology Society
- Standard Committee
- EMB/Stds Com - Standards Committee
- Working Group
-
CAFMMH - Criteria Assessment Framework for Medical Mobile Health Applications
- IEEE Program Manager
- Christian Orlando
Contact Christian Orlando - Working Group Chair
- Colby Holliday
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