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Booming Mobile Health App Market Needs Robust FDA Oversight To Ensure Consumer Safety, Confidence

July 30, 2014
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SMU Dedman School of Law

Download .PDF of full article: Regulation of Mobile Health Technologies

Smart phones and mobile devices are on the cusp of revolutionizing health care, armed with mobile health (“mHealth”) apps capable of providing everything from cardiac measurements to sonograms.

While tremendous potential exists to broaden access to medical treatment and control costs, several health law experts say in a just-published New England Journal of Medicine (NEJM) report that more oversight is needed by the U.S. Food and Drug Administration (FDA) to ensure consumer confidence and safety. Out of some 100,000 mHealth apps on the market, only about 100 have been cleared by the FDA, while opponents see the FDA as deterrents to innovation — and profits.

“Consumers will be spending a lot of money on these products, and venture capital is flying into the industry,” says the article’s lead author, SMU Dedman School of Law Associate Dean of Research Nathan Cortez, adding that by 2017 mHealth apps are expected earn $26 billion— up from $2.4 billion in 2013.

The FDA needs “additional funding and in-house technical expertise to oversee the ongoing flood of mHealth products,” the authors note. An under-regulated mobile health industry could create “a Wild West” market, says Cortez, who has conducted extensive research into FDA regulation of mobile health technologies.

“Most consumers take mobile health app claims at face value, and think that because they’re available through a trusted retailer like the iTunes Store, they must have been reviewed by the FDA, which isn’t usually the case,” Cortez says.

Cortez, who also serves as an associate professor in SMU’s Dedman School of Law, co-wrote the NEJM article with Harvard Law School Professor I. Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics and author of Human Subjects Research Regulation: Perspectives on the Future (MIT Press, 2014) and Aaron S. Kesselheim, Associate Professor of Medicine at Brigham and Women’s Hospital/Harvard Medical School.

“Although the vast majority of mHealth products are very low-risk, some apps make promises they can’t fulfill, and others make errors that could harm patients,” Cortez notes, pointing out that life-threatening technical mistakes are not only possible – they also have occurred.

One of several examples cited in the study includes Sanofi Aventis’ 2012 recall of a diabetes app that miscalculated insulin dosages.

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Source: SMU Dedman School of Law



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