FDA Takes Aim At Medical Apps

Growth may be slowed by a longer regulatory process, which can take several years to approve new products.

Growth may be slowed by a longer regulatory process, which can take several years to approve new products.

Smart phones have become a big part of our everyday lives. The phones have applications for just about everything, and that includes apps that deal with your health.

As these mobile medical apps increase in popularity, the Food and Drug Administration (FDA) has decided to explore the possibility of regulating them. While the FDA argues that this would insure that all medical apps are kept honest and safe for users, the makers of the apps argue that this could be disastrous for the mobile medical app market.

If the FDA decides to treat these apps like they treat other medical devices, the apps will have to endure the three-year wait period that typically accompanies the approval of medical devices. In addition, the apps will be subjected to a 2.3 percent medical device tax, which would end up raising the prices of the apps, effectively eliminating the possibility of free mobile medical apps.

The Future of Mobile Medical Applications 
While it’s true that there are already mobile medical applications that must pass FDA approval, such as blood sugar apps that work in conjunction with a medical device, experts argue that if this regulation passes, it could be the death of many mobile medical applications.

However, the FDA argues that as long as the applications are up to code and safe for users, the market has nothing to fear. In fact, the FDA has explicitly stated that they intend to only regulate apps that offer specific medical advice or are intended to help a user with their health (such as the blood sugar app mentioned earlier). Apps that are purely informational and apps that do not offer specific medical advice would be exempt.

Effects on Growth of the App Market
Estimates predict that the number of smartphone users who utilize mobile medical apps could jump to as much as 500 million by 2015.

But opponents to the regulation argue that this number could shrink significantly if the FDA were to get involved and that makers of mobile medical apps may opt to develop apps in a field that doesn’t have as many regulatory obstacles.

Proponents of the regulation argue that the regulation would insure that it would keep apps safe, and would insure the apps stay up to date. For example, when the latest iteration of a smartphone is released, apps must adjust to ensure that they will work on the new operating systems. Without regulation, it would be possible for apps to fall behind, which could conceivably put users who rely upon the apps in danger.

While the debate about government app regulations continues to heat up, users will just have to stay patient and see how this ends up. If this regulation were to pass, it could change the face of the application market forever.