Mobile health care is one of the most booming industries worldwide, with a strong potential for growth and an excellent financial prognosis. No wonder the industry attracted $900 million in venture capital funding in the year 2012 alone, notes author Greg Slabodkin in his article “Regulatory Front is Biggest Potential Drag on mHealth.” According to the market report on mHealth published by the mobile research firm research2guidance, even with such high financial prospects, the industry could face a serious setback due to regulatory uncertainty—missing regulations and lack of clear guidance from the FDA. The industry’s main concern is that if the mobile apps are treated like regular medical devices requiring market approval through a similar regulatory pathway, the industry’s future is seriously doomed. Frankly, it appears that even the FDA is overwhelmed and uncertain about the regulatory pathway for this new wave of medical device technology. Two years back, in July 2011, the FDA issued a draft guidance discussing the kind of mobile applications it considered medical devices regulated by the FDA. In the same guidance, the FDA also reflected upon regulatory requirements for mobile medical apps and the FDA’s expectations from app developers and distributors. I encourage health and medical app developers to review this guidance to get some sense of the regulatory arena for software applications. More clear-cut apps might even find a regulatory direction in this guidance. The general perception, however, is that the guidance raised more questions than it answered. The FDA received 130 comments to the draft guidance, and a final guidance is still pending.
The lack of clarity in the guidance concerned the U.S. House of Representatives’ House Energy and Commerce Committee. As a result, in March 2013, the Energy and Commerce Committee hosted a three-day series of hearings focused mostly on the FDA regulation of mobile medical apps.
The committee’s main concerns were the effect of the FDA’s regulatory proposal on innovation in technology, its burden on app developers who operate under low profit margins, and the applicability of Obamacare’s 2.3 percent medical device tax on mobile apps. While the FDA deferred the device tax question to the IRS, it shed some light on what it does not propose to regulate under the current proposal. Ms. Christy Foreman, director of the Office of Device Evaluation, Center for Devices and Radiological Health at the FDA, stated in her testimony at the hearing that the agency:
[W]ould not regulate the sale or general consumer use of smartphones or tablets. It would not consider entities that exclusively distribute mobile medical apps, such as the iTunes App store or the Android market, to be medical device manufacturers. It would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA. It would not require mobile medical app developers to seek agency re-evaluation for minor, iterative product changes. And, it would not apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system.
The FDA also promised a final guidance in the area by December 2013.
Overall, the FDA’s stand at the meeting did not present immediate regulatory threat to mobile app developers, most of whom operate unregulated. Perhaps, based on the discussions at the committee hearing, some developers might have even doubted the FDA’s ability to regulate mobile medical apps in a systematic manner anytime soon. But within two months of the meeting, the FDA slapped enforcement on a mobile app manufacturer. In May 2013, the FDA issued a letter to Biosense Technologies Private Limited, a manufacturer of a mobile app, uChek, that allows a mobile phone to function as a dipstick reader for urine analysis. In the letter, the FDA declared uChek app to be a medical device regulated by the FDA and required its manufacturer to obtain clearance from the FDA before marketing the device in the United States. Mind you, the market clearance for a medical device can be a time- and cost-intensive process that could take several months to years. Stay tuned for my next discussion on what a market clearance could entail for a medical app developer, and note that selling a medical device that requires prior approval/clearance from the FDA without obtaining such approval/clearance is a punishable offense. If the FDA continues to hold its opinion regarding the regulatory status of uChek, its manufacturer/developer will have to discontinue its marketing in the United States.
Although it is uncertain how many enforcement actions similar to uChek’s are forthcoming, the FDA’s action against the manufacturer/developer of uChek might not be an isolated one. It should alert app developers into some regulatory planning. At the very least, the app developers should proactively begin evaluating the health/medical claims of their technology and understand which side of the line they might fall should systematic enforcement become a reality.