Into the fog: FDA and smartphone apps regulation

Categories: Latest News.

Scientific American jumps into the fogbank of FDA regulation of smartphones as medical devices.  The FDA is considering various degrees of oversight of health information technology (HIT), which includes apps and other digital systems such as electronic health record software. Regulation could be mild, focusing on postmarket safety via an electronic registry, which is what Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, is maintaining–for now.  Reference applications will also likely be outside regulation (as print references are).  Will innovation slow down?  Will the FDA be able to handle it?  With questions already arising on accuracy of applications, the FDA action already taken against one image viewer, Mobile MIM [Telecare Aware 31 March] and the general tendencies of the present US administration–if you see red lights in the fog, it’s a traffic jam.   Summary at FierceMobileHealthcare.