10 threads from Congress’ hearings on FDA regulation of medical apps

By: Brian Dolan | Mar 21, 2013        

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Brian Dolan, Editor, MobiHealthNewsThis week the US House of Representatives’ Energy and Commerce Committee is hosting a three-day series of hearings focused mostly on the FDA regulation of mobile medical apps. As of this writing two hearings have taken place, one held by the Communications and Technology subcommittee on Tuesday and another held by the Health subcommittee on Wednesday, but what could be the main event is set to take place early Thursday morning as representatives from ONC and FDA face questions from Congress.

Wednesday evening the testimonies for both the FDA’s Director of the Office of Device Evaluation Center for Devices and Radiological Health, Christy Foreman and the ONC’s National Coordinator Dr. Farzad Mostashari are now posted on the committee’s site. Neither includes any real surprises, but Foreman’s reiterates much of the FDA’s draft guidance and includes a note that any questions about the medical device tax should be directed at the IRS. The real discussion will come when Foreman and Mostashari answer the representatives questions after they read their prepared remarks.

If you have been following our live blog coverage (day one and day two) of the past two days’ events, you understand how scattered some of the discussion has been so far. It is clear, however, that a number of threads have emerged during the course of the two days. Here’s hoping there are more answers than questions following Thursday’s hearing.

In no particular order, below are the top 10 ideas and questions that have come up (repeatedly usually) during the hearings so far:

1. Will the 2.3 percent tax on medical device revenue apply to mobile medical apps? This one has also been framed as “should” the device tax apply to mobile medical apps that the FDA deems are functioning as medical devices. The answers to this question have so far been very mixed. Some witnesses have suggested it should never apply to any mobile medical apps. Others said that the way the medical device tax is explained in the health reform legislation suggests that it will not apply to medical apps. Some legislators and witnesses said the FDA should not be given the authority to decide what gets taxed. A similar point that came up a few times was that the IRS retail exemption for medical devices would protect apps from the new tax, but not everyone agreed that was a sure bet.

2. The FDA has been slow to issue its final mobile medical app guidance. Everyone agrees the FDA should have published its final guidance for mobile medical apps by now. Draft guidance published in mid-2011. The most interesting comment on this probably came from mHealth Regulatory Coalition lead Bradley Merrill Thompson, who said the FDA may have had trouble publishing final guidance because the industry keeps changing and new innovations make it question whether its guidance is ready. That’s the first time I’ve heard Thompson offer an explanation for FDA’s extreme tardiness.

3. Should ONC or some other group take over for the FDA? We predicted this last week when we wrote about McKesson’s lobbying efforts to move some of FDA’s oversight of mobile medical apps to the ONC and into a similar framework as the certification process ONC uses for Meaningful Use. Perhaps even as part of that very same process. When asked about this some witness agreed the FDA was the best place for mobile medical app regulation while others favored a different approach. Some legislators asked whether the FDA should decide who should regulate mobile medical apps or whether Congress should decide who should regulate them?

4. The difference between devices and software, between health IT and medical devices. McKesson’s and the Republicans’ argument for moving regulation of mobile medical apps to the ONC or some other regulatory body largely rested on the distinction between health IT and medical devices. McKesson argued that software that relied on a healthcare provider as an intermediary, for example, should not be considered a medical device because the provider can ensure it is being used safely. Medical devices, on the other hand, perform some kind of function without the intermediation of a healthcare provider, and therefore require FDA oversight. An interesting tangent to this discussion came on Tuesday when one legislator asked Happtique CEO Ben Chodor if his company’s certification process could be used as something of a free market substitute for FDA regulation of mobile medical apps. Chodor said: Absolutely not.

5. Are these hearings just an attempt to take a few swipes at ObamaCare? Representative Henry Waxman (D-CA) suggested that his Republican colleagues were just using these hearings to scare people and to make disparaging remarks about the health reform legislation. There were quite a few references to the possibility of the FDA regulating smartphones and tablets as medical devices, but Waxman and others repeatedly described these kinds of claims as untrue and mythical.

6. A celebration of health IT adoption. On the other hand, a good amount of time was spent — especially on Wednesday — extolling the virtues of health IT and, especially, electronic health records. While at least one Republican took time to mention that the increasing adoption of EHRs and health IT in general is likely because it is being mandated, at significant costs (in some cases) to physician practices, everyone agreed that the trend was a positive one.

7. Clarity of FDA regulation vs. complexity of FDA regulation. A number of exchanges between legislators and witness were about particular types of mobile medical apps and whether they would be regulated as medical devices under the FDA’s draft guidance. One legislator wondered whether a Bluetooth-enabled weight scale was a medical device was upset to learn that the best answer was: It depends. It seemed like most of the legislators refused to believe or failed to grasp that at least in some cases FDA regulations must be complex and nuanced. If it couldn’t be easily explained, some argued, then clarity must be lacking.

8. The exportation of jobs threat. On Tuesday a popular thread of the discussion was the idea that the slow pace of regulatory clarity or the existence of regulations in the first place was leading to job exportation. If the FDA was quicker with its final guidance document, perhaps more jobs would have been created by developers working in mobile health.

9. Fewer investment dollars because of uncertainty. A similar thread to the one above was that regulatory uncertainty bred hesitance from investors. If the FDA had been quicker with its regulatory guidance, maybe more investors would be willing to fund startups working in mobile health. Instead, those investment dollars went into other sectors or, worse, to companies based in other countries.

10. Mobile developers have avoided healthcare. Another consequence of the regulatory environment — the existence of FDA regulation of mobile apps and/or the uncertainty surrounding it — might be that mobile developers have decided not to tackle health problems and decided to build another game or music app instead. While there was no data to back up this claim, it seemed to be a trend that some of the witnesses agreed was underway.

Thursday morning is the main event. Maybe ONC and FDA will shed some light on the current state of mobile medical app regulation. Better yet: Maybe the FDA will take the opportunity to publish its final guidance?