mHealth app market needs regulation for consumer safety and confidence


With mHealth apps popping up all around the place, some people started wondering whether some oversight is needed.

Several health law experts published a report in the New England Journal of Medicine (NEJM) that something like that should be put in place, and that FDA should step-in to regulate this market. At the moment, out of some 100,000 mHealth apps, only about 100 have been cleared by the FDA.

The FDA needs “additional funding and in-house technical expertise to oversee the ongoing flood of mHealth products,” the authors note. An under-regulated mHealth industry could create “a Wild West” market, says Nathan Cortez, SMU Dedman School of Law Associate Dean of Research.

“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,” he added.

Out of some 100,000 mHealth apps, only about 100 have been cleared by the FDA.“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 to Sanofi Aventis’ diabetes app that miscalculated insulin dosages. That app has been eventually recalled, but it’s possible that it caused some damage while it was available for download.

Several Congressional bills have been proposed to strengthen FDA jurisdiction over mHealth products, one of which even proposed the creation of a new Office of Wireless Health Technology within the administration. Meanwhile, more restrictive bills also have been introduced to keep the FDA from regulating “clinical software” or “applying a complex regulatory framework could inhibit future growth and innovation in this promising market.”

The authors suggest that some regulation is needed. “We’re trying to push lawmakers to empower the FDA, not hamstring it,” Cortez says. “Clarity will help the industry create products more helpful than harmful.”

Aside from Cortez, the report was co-authored by 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.