FDA and digital health = FUD?

Categories: Latest News.

Over at his blog, Dana Blankenhorn of ZDNet has a wonderful acronym for the feelings stirred by FDA’s recent blanket declaration that health IT (HIT) software is a medical device and under regulation: Fear, Uncertainty and Doubt. (Just what we need!) It isn’t a matter of ‘should’, it’s what types will be regulated, and how. This has been building since February with healthcare reform and the ‘meaningful use’ of EMRs [TA, 20 April, ‘Nowhere to hide…’]
Devices that involve patient contact are regulated.  But will it affect devices that simply report or transmit the data at a distance from the patient (like a smartphone app)?  If regulation (pre-market clearance) is mandated, it will triple development costs–a real damper on innovation. How will it affect EMR implementation with primary care physicians which is being aggressively rolled out on a 2-3 year track?  FDA seems to be moving to a ‘lite’ version for software which is tracking and QSR for good manufacturing practices…but then there’s the Senate, and Senators who like headlines…..Dana Blankenhorn, ZDNet (sort of for regulation, with caveats) How will the FDA regulate health IT?.   Amednews.com (AMA), FDA oversight may extend through health IT .