Remember when the Food and Drug Administration was going to regulate mobile health apps? The year was 2013.
There was even a bill from the congressman representing Silicon Valley that aimed to tame the “Wild West” of mobile and wireless health (Opens in a new window). The House Energy and Commerce Committee even held three rather fruitless days of hearings (Opens in a new window), lowlighted by an actual physician, Rep. Mike Burgess (R-Texas) asking then-national health IT coordinator Dr. Farzad Mostashari (Opens in a new window) to magically create interoperability.
Now, it sounds like the FDA might almost be ready to throw its hands up and walk away, something leadership may have been contemplating all along, given that in 2011, the agency circulated a draft guidance that really didn’t say much (Opens in a new window) anyway. The 2013 final version clarified policy a bit, stating that the FDA generally would focus only on mobile apps that serve as medical devices, and mostly stay away from regulating consumer technology.
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“It’ll be quite a few years before we have a handle on this technology and how it’s going to be regulated by the FDA, if at all,” Washington lawyer Jeffrey K. Shapiro said at a recent Food and Drug Law Institute (Opens in a new window) conference, according to Bloomberg BNA (Opens in a new window). “FDA doesn’t have a depth of experience here that necessarily justifies them heavily regulating this area,” he added.
Earlier this year (Opens in a new window), an FDA specialist in digital health told Bloomberg that the agency would be “almost hands-off” when it comes to consumer wellness and fitness gadgets. It seems as if little has changed.