obile apps are increasingly used in health care to promote wellness, treat and diagnose disease, aid clinical decision-making, and manage patient care in hospitals and homes.Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life. One factor that has been cited is uncertainty surrounding regulation that accompanies medical products, and how US Food and Drug Administration (FDA) regulations may apply to software platforms. There also are questions in the marketplace about the clinical validity and utility of certain mobile tools.Efficient regulation can help promote adoption of mobile medical apps. FDA determination that a product developer or manufacturer has met the high regulatory standard for demonstrating clinical benefit and safety (when agency clearance or approval of the app is required) can increase consumer confidence in that technology.1 In these cases, FDA regulation also can help patients, payers, and investors better understand the performance characteristics of high-quality software products, encouraging a race to the top in medical app development.Mobile medical apps may help overcome the siloed, episodic, reactive nature of US health care, whereby patients seek care only after potentially costly health complications occur, and physicians are only reimbursed for expensive in-person office visits that may not reflect the day-to-day reality of the patient experience of living with complex chronic conditions.

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