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…)