FDA regulating medical apps–or not? The Hearings. (US)

Much coverage of this past Tuesday-Thursday’s US House of Representatives Energy and Commerce Committee hearings on how the Food and Drug Administration (FDA) should be regulating developing mobile health technologies.  Some key issues are if the 2.3 percent Obamacare medical device tax will apply to apps (after chilling development on surgical devices–see day 1 hearings), whether FDA will ever get around to publishing a final guidance (end of year), will FDA consider smartphones medical devices (no) and if FDA should share some of the responsibility with–or give it over entirely to–the Office of the National Coordinator for Health Information (ONC) under Health and Human Services (HHS). Can FDA even keep up at this stage? (it takes them about three months on average review) and How much will regulation add to the price? are major questions. The representatives have heard from numerous leaders in the field: Tuesday, Happtique’s CEO Ben Chodor and the mHealth Regulatory Coalition’s Bradley Merrill Thompson; Wednesday, West Wireless Institute’s chief medical officer Joseph Smith; Thursday, Dr. Farzad Mostashari, National Coordinator, Health Information Technology, HHS and Ms. Christy Foreman of FDA. Mobihealthnews’ Brian Dolan live blogged from the hearings; there are also testimony statements. From these reports, the hearings have decided exactly nothing and revealed little about FDA’s inaction, but at least the issues have received some fresh air from those in the industry.

An overview of the articles/blogs to date.  Updated 23 March  (more…)

FDA regulating medical apps–or not? (US)

The long-drawn out drama on the FDA’s endlessly pending (July 2011) final regulations on the approval procedure of mobile health apps seems to be coming to a crescendo with next week’s US House of Representatives Energy and Commerce Committee hearings. There are missed deadlines, unanswered questions, reports due, an apparent repositioning of mobile apps as ‘health IT’, the involvement of an alphabet soup of agencies–Health and Human Services (HHS), the Federal Communications Commission (FCC) and, most importantly the Office of the National Coordinator for Health Information (ONC) under HHS, which seems to be breaking away and asserting control in the FDA vacuum. Cheering on ONC for dominance are health IT companies such as McKesson and perhaps some members of the Committee. This apparent lassitude on FDA’s part is certainly odd, as according to Mobihealthnews, the FDA has already approved 75 mobile medical apps. Brian Dolan over there has done fine work on sorting out this ‘who’s on first?‘–and why–situation in two articles, Republicans, EHR vendors want ONC to take over medical app regulation (14 Mar) and Congress asks FDA if “actual use” is factor in medical app regulation (6 Mar).

Related TTA: The mHealth road map, as drawn by the FCC and Adding another chef to the government regulation kitchen