FDA Won’t Say if Mobile Apps will be Taxed Under Obamacare
(CNSNews.com) – The House Energy and Commerce Committee is concerned medical “apps” on mobile devices will be taxed under Obamacare, but the Food and Drug Administration (FDA), which is in the process of establishing regulations for the applications, won't clearly say if taxes are forthcoming.
The Patient Protection and Affordable Care Act of 2010, better known as Obamacare, levels a 2.3 percent excise tax on the sales of medical device manufacturers and importers.
At the same time, the FDA is considering oversight of mobile medical applications for cell phones and other medical devices.
“Has the FDA discussed, prepared, or analyzed the effect of the medical device tax on smartphones (as well as tablets or similar devices) or creators or distributors of applications for these products?” asked a letter from Rep. Fred Upton (R-Mich.), the chairman of the House Energy and Commerce Committee, to FDA Commissioner Margaret A. Hamburg.
CNSNews.com asked the FDA if the coming regulation would mean taxes for medical apps on mobile devices. The FDA did not provide a clear answer.
“Regarding your inquiry, the FDA will respond directly to the members on this issue,” FDA spokeswoman Synim Rivers told CNSNews.com in an e-mail response. “This is all of the information I am able to provide at this time.”
The letter from Congress cited a USA Today report that about 40,000 medical applications are currently on the market for smartphone and tablets.
The Upton letter to the FDA commissioner was also signed by other Energy and Commerce committee members: vice chairwoman Rep. Marsha Blackburn (R- Tenn.); Chairman Emeritus Rep. Joe Barton (R- Texas); Rep. Tim Murphy (R- Pa.), the chairman of the Oversight and Investigations subcommittee; oversight subcommittee vice chairman Rep. Michael Burgess (R- Texas); and Rep. Greg Walden (R-Ore.), chairman of the subcommittee on Communications and Technology.
“With the growth of the smartphone and tablet market in the United States, the use of applications to monitor health information on those devices has also increased,” the letter said. “Some medical applications are used to monitor health information like diet and fitness data. Other applications can be used to monitor chronic conditions such as diabetes or high blood pressure.”
The FDA announced on July 19, 2011 it was seeking public comment on the regulation of mobile medical applications. The FDA said the oversight would affect a “small subset of mobile medical apps.”
This would include apps “used as an accessory to medical devices already regulated by the FDA,” and an app that “transform a mobile communications device into a regulation medical device by using attachments, sensors or other devices.”
In the 2011 announcement, the FDA cited a 2010 Research Guidance study that projected 500 million smartphone uses worldwide will use health apps by 2015