mHIMSS executives say FDA regulation won’t hold back app innovation
March 27, 2013 in Medical Technology
In the wake of last week’s House GOP-led hearings on mobile health app regulation, mHIMSS executives Tom Martin and David Collins say the future of healthcare apps couldn’t be brighter.
Both executives worked closely with leading industry mHealth experts to develop the mHIMSS Roadmap, a document that aggregates insights from the healthcare experts and other contributors, such as Verizon, ATT and PriceWaterhouse Coopers. The Roadmap offers mHealth implementation guidance to help health systems, hospitals and other healthcare organization leaders.
The hearings, held March 19-21, explored the balance between allowing innovation to flourish, versus regulating health apps for the sake of patient safety. Republican House Committee on Energy and Commerce subcommittee leaders aimed to expose the dangers of strict FDA oversight and the potential threat of Obamacare taxes on apps, with most witnesses dismissing these concerns.
Martin and Collins attended the hearings, and though unavailable for immediate phone interviews, they jointly answered email questions from Healthcare IT News.
Q: In HIMSS’ opinion, is the lack of FDA guidance posing a problem right now to app companies? If so, how?
A: Many developers continue to bring innovative products to market, and venture funding for healthcare startups is at an all time high. The average value of Rock Health startups has increased over the past few years so the argument of stifling innovation is circumspect. However, a few developers are waiting on the FDA’s final medical app guidance before submitting to app marketplaces. Most of these developers should recognize that they are missing the current opportunity to participate in the app marketplace, as they would be regulated only if the product was a medical device.
Q: Is the fear of taxation on apps affecting the app market right now?
A: Congressman Waxman read off a large segment of the app categories that would not be subjected to the medical device excise tax. Furthermore Ms. Christy Foreman from the FDA answered that there is no intent to broadly subject tablets and smartphones to the medical device excise tax. A very small segment of the app marketplace population could be subject to the excise tax on medical devices, if it meets the criteria for the IRS to do so, and is regulated by the FDA.