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 

The detailsFive things we learned from the FDA’s medical app testimony,  Liveblog: Day 3 Congressional hearing on FDA regulating apps (8 pages), 10 threads from Congress’ hearings on FDA regulation of medical appsLiveblog Day 2: Congressional hearing on FDA regulating appsLiveblog: Day 1 Congressional hearings on FDA regulating apps (Mobihealthnews)  New FDA: No ‘iPhone tax’ from health law (The Hill)

Summaries of each dayNew FDA to Congress: Final mobile medical app guidance coming by end of fiscal year (Day 3), Capitol Hill: Call for new reg framework for apps (Day 2) and On Capitol Hill: FDA urged to clarify oversight of medical apps (Day 1)  (Clinical Innovation & Technology)

Company testimony: Happtique/Ben Chodor: Release, Testimony; West Wireless Institute/Joseph Smith: Testimony

OpinionNew Where is the ‘fine line’ between safety and free rein for mobile development? (HealthcareITNews) New 25 March FDA regulation is the way to go for apps that are used to diagnose (MedCityNews)

Related: WWI released its study that device interoperability–a wide variety of devices communicating seamlessly with health care systems–could save up to $30 billion per year and improve patient care. The study also includes case studies developed with the Medical Device Interoperability Coordination Council (MDICC). Release, study (PDF, 45 pages)  And in the try, try again department, Senators Thune and Klobuchar have introduced, for the fifth time since 2005, the Fostering Independence Through Technology (FITT) Act. S.596 would require HHS to launch a remote monitoring pilot with home health agencies for Medicare beneficiaries. Announcement

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