Reining in FDA regulation of mobile health apps

I’m watching with interest the legislative responses to the attempts by the Food and Drug Administration (FDA) to include mobile health apps within its jurisdiction of medical devices. There are more than 97,000 health apps listed in Apple’s apps store, and these applications are transforming consumer health. Together with wearable technology and direct-to-consumer laboratory and genetic testing, these apps are part of a general movement to empower individuals and enable them to make better choices about their own health.

In September, the FDA issued its guidance on mobile health apps, which could significantly expand its jurisdiction and limit individual access to personal health information. While the FDA has clearly defined jurisdiction over drugs and tangible devices, its claim of jurisdiction over mobile health apps is dubious. Moreover, FDA’s precautionary approach to regulation in this area would significantly limit innovation. It squanders FDA resources by focusing on low-risk information-based applications. And by inhibiting the free flow of health-related information, it puts FDA actions in tension with the First Amendment (see Sorrell v. IMS Health Inc., No. 10-779 131 S.Ct. 2653 (2011)).

Happily, both houses of Congress are moving to rein in the FDA.  The House has introduced the SOFTWARE Act, which would focus FDA authority over products that pose a potential risk to human health. In February, Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced a more direct and expansive approach in the Senate with ‘‘Preventing Regulatory Overreach To Enhance Care Technology Act of 2014’’ or the ‘‘PROTECT Act of 2014’’.

By amending Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)), it clarifies that the term “device” in the FD&CA does not include clinical software or health software and better ensures the free flow of information to consumers.

In a news release in February, Fischer said: “The PROTECT Act increases regulatory efficiency over health IT to promote innovation, expand consumer access to information, and improve patient safety. Current law is in desperate need of a make-over, and I’m pleased to work with Senator King on this commonsense solution.” I couldn’t agree more about the need for clarity in this important area, and I applaud these legislative attempts to bring regulatory restraint to mobile health applications.

Nita Farahany is Prof. of Law & Philosophy, Director of Science & Society, Director MA in Bioethics & Science Policy, Duke University; Member, President'l Comm'n for the Study of Bioethical Issues; Board Member, Internat'l Neuroethics Society; Co-Editor-in-Chief Journal of Law & the Biosciences; Editorial Board Member AJOB Neuroscience.
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