March 27th, 2014
Posted by Stephanie Kreml, M.D.
In my post for InformationWeek Healthcare (available here), I discussed the implications of the U.S. Food and Drug Administration’s (FDA) final guidance for medical apps. While the September 2013 guidance specified that it would require clearance of any app intended to diagnose, treat, mitigate or prevent a disease, it left an open door to exercise “enforcement discretion” if an app meets the technical definition of a medical device but poses a low risk to the patient.
In this post, I will discuss the practical challenges resulting from this guidance, and how the evolving environment of app regulations should be folded into your business strategy.