On March 19, 20 and 21, 2013, the Energy and Commerce Committee of the U.S. House of Representatives will hold a series of three hearings on “Health Information Technology to Explore Potential Regulations and Taxes on Smartphones, Tablets, and Mobile Apps.”
The hearings will take place in three different Energy and Commerce subcommittees and will focus on the following topics:
- How FDA regulations and taxes could affect innovation in mobile applications and devices;
- How technological advancements benefit patients and ways to ensure that innovation continues; and
- The Obama Administration’s perspective and future plans with regard to regulation of medical apps.
The hearing announcement comes less than two weeks after six Members of the Committee sent a letter to FDA expressing concern that the agency, in draft guidance, has taken too broad an approach to regulating mobile medical apps, which would slow growth and innovation in the industry. Specifically, the Members expressed concern that the FDA would examine an item’s “actual use” in determining whether it is a medical device subject to regulation, thereby subjecting a wide swath of of apps and hardware to regulation and the excise tax on medical devices required by the Affordable Care Act. (We previously reported on the congressional letter here). In the letter, the Committee Members asked for a written response by March 15, 2013.
The letter and the hearing are in response to July 2011 guidance issued by FDA in which the agency announced plans to regulate mobile medical applications that both meet the definition of a medical device and (1) are used as an accessory to a “regulated medical device” or (2) transform a mobile platform into a “regulated medical device.” We previously discussed the guidance here.
The recent congressional interest in FDA regulatory action over mobile apps comes as the industry continues to expand. According to a recent survey reported in the Washington Post, the market for mobile medical applications will reach $26 billion by 2017, compared to $718 million in 2011.
We will report on these hearings in a future post.