Regulating Mobile Health Apps under a 38-Year-Old Law: It’s Time for Congress to Act

1976: The United States celebrated the bicentennial of our independence; Jimmy Carter was elected president; young men wore bell bottoms and middle-aged ones wore leisure suits; advertising encouraged women to smoke Kool cigarettes. And the Food and Drug Administration (FDA) first regulated medical devices.

Although we fantasized about having Captain Kirk’s communicator or Dr. McCoy’s tricorder, nobody would have known what to do with an actual smartphone or tablet, had they existed in those days. Today, increasing numbers of us use them to keep track of medical information, to remind us to take our meds or do countless other tasks important to our health. In 2013, the Apple app store had 97,000 mobile health apps, and over 60 percent of physicians were using tablets.

And yet, the FDA is still regulating these 21st century technologies under legislation passed when Wings’ Silly Love Songs topped the pop music charts. It’s past time for Congress to amend the Food, Drug and Cosmetic Act to clarify the FDA’s regulatory authority over these new tools for our health.

According to the 1976 amendments, a medical device is an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory…” [21 U.S.C. 321(h)]. That does not really give the FDA much direction with respect to apps, smartphones and tablets, does it?

The final guidance was published in September 2013, at which time the FDA noted, “The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.”

While comforting to developers, this language fairly screams for Congressional action. If the FDA is using its own, self-perceived “enforcement discretion” to withhold regulation of apps, smartphones, tablets and the like, a future FDA can turn that on its head. In the final guidance, the FDA has had to define for itself the terms “mobile app” and “mobile medical app.” The American people should demand that Congress define the technologies subject to FDA regulation, not allow the regulator to define for itself that which it regulates.

Although the panel and audience agreed that the FDA is very open and a developer can “give them a phone call” to discuss whether his new app will be regulated or not, the audience noted that the answer might depend on which staffer answered the phone. A couple of entrepreneurs in the audience reported contradictory responses from within the FDA. The FDA cannot be expected to generate fully consistent regulatory standards, ex nihilo, without appropriate legislation. Fortunately, this may be resolved in the next Congress.

The MEDTECH Act, introduced by Senator Hatch (R-Utah) and Senator Bennet (D-Colo.), would legislate that electronic health records (EHRs) and other technologies that only store and communicate information are exempt from FDA regulation. Currently, this exemption exists only in the FDA’s own guidance.

The SOFTWARE Act, first introduced in October 2013 by Representative Marsha Blackburn (R-Tenn.) and a bipartisan group of co-sponsors, would define the term “medical software” as software distributed directly to consumers and not integrated with a drug or device but which includes the use of a drug or device. Such software would be subject to FDA regulation.

These bills are four and five pages long ― marvels in this age of thousand-plus pages of incomprehensible legislative jargon. Further, there is not much daylight between that which the FDA is regulating now and that which these bills seek to define as regulated versus not regulated. These bills would not disrupt the way things are working today. Instead, they would give developers and patients confidence that the FDA’s regulatory powers over 21st century medical technology are limited and well-defined.

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