Only about 0.1% of mHealth apps are FDA-approved

Of the nearly 100,000 mHealth apps available on the market, only 100 are approved by the U.S. Food and Drug Administration, according to a New England Journal of Medicine report.

The industry is debating the level of mHealth app regulation the FDA should exert. While one side sees FDA-approval as critical to maintaining clinical quality and patient safety standards, others see the regulatory process as a barrier to innovation.

The authors of the report — Nathan Cortez, associated dean of research at Southern Methodist University Dedman School of Law in Dallas, and I. Glenn Cohen, Harvard Law School professor and faculty director of the Petrie-Flom Center for Health Law, Policy, Biotechnology and Bioethics in Cambridge, Mass., and Aaron Kesselheim, MD, JD, associate professor of medicine at Brigham and Women's Hospital/Harvard Medical School in Boston — argue the FDA should increase oversight to ensure mHealth app safety.

"Increasing reliance on mHealth raises questions about compromised patient privacy, the cross-jurisdictional practice of medicine and legal liability for injuries," the authors wrote. "Serious mistakes with an mHealth product might affect thousands of patients at a time and often without ready mechanisms for detection and correction."

More articles on mHealth apps:

3 barriers to mHealth adoption
6 recently launched mHealth apps
FTC raises concerns over security of PHI collected by mobile apps

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