FDA revises final guidance for mobile medical apps

FDA revises final guidance for mobile medical apps and the new final, final guidance is just one sentence SOURCE: MobiHealthNews, 4/1/2014, by Aditi Pai The FDA rescinded then re-released its (now final) final guidance for mobile medical apps (MMA) today and promised that this will be the final time the FDA will amend the document. The new, new guidance differs from the document released in September 2013 in two important ways. The first is that all founders and C-level executives of companies developing mobile medical apps are now required to attend medical school before marketing medical apps. The second change to the original final guidelines is that, in an effort to provide maximum clarity, the FDA has erased all of its other MMA guidelines. “The agency is sick and tired of being hauled in front of Congress to explain that sometimes software behaves like a medical device,” an FDA spokeswoman said in a statement. “Frankly, we just couldn’t take it anymore. The FDA has never regulated the practice of medicine — that’s between a patient and their provider. With these new, new MMA guidelines, the FDA can take a backseat, encourage doctors to use their free time to run health startups, and finally let innovation flourish.” The FDA suggests that founders and executives at mobile medical app companies take an accelerated program (just seven years!) at a local medical school or hand the company over to someone who is already a physician. When news of the final, final guidelines was leaked two weeks ago, there was an initial uproar from entrepreneurs in the digital health world, but now the health startup founders have either resigned themselves to their MCAT prep books or gone back to developing ecommerce apps.