Is a mobile health app a medical device? Should an app that shows you how many steps you’ve taken be regulated exactly the same way as a blood glucose monitor? According to the FDA the answer is yes, and if pending legislation passes in the U.S. House of Representatives it could sound a death knell for innovation in the healthcare sector.
Here’s the issue. The U.S. Food and Drug Administration is tasked with monitoring the safety of all regulated medical devices. To gain approval from the FDA, new devices must undergo an arduous process to prove they are reasonably safe and effective for a particular use. This makes sense for things like Diabetes testing kits or imaging scans, but is it reasonable or necessary to put a weight loss app in the same category?
This year’s Digital Health Summit at CES signaled a burgeoning marketplace for health and wellness technology, featuring everything from digital scales and pedometers to heart rate apps and in-car technology for keeping wellness top-of-mind. While these apps may call for a new category of regulation, there is still a cautionary tale to be told, and that is claiming an app itself can reduce the risk of certain health conditions.
Is it time the FDA reevaluate its regulation process to adjust to these changing times? Similarly, how can tech entrepreneurs quickly get acquainted with regulation territory? What practical guidelines can be put in place to protect consumers without stifling innovation? Share your thoughts below.