Mobile Medical Applications: Innovation vs. Regulation

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Mobile apps are absolutely exploding on the marketplace. It seems like so many business entrepreneurs are focusing on creating new apps that fit various needs such as games, music, organizational purposes and the list goes on. I recently read an article that discussed creating a Mobile Health office within the FDA. Specifically focusing on health alone, there are thousands of mobile apps that focus on counting calories, recording miles walked, and monitoring blood sugar levels.

Although it seems as if the gateway to entering the mobile health app marketplace is pretty wide open, users should be wary of how valid these applications are. The reason for this is because what regulations are behind the claims of these different applications?

It has not been until recently that the FDA has started regulating and approving different medical apps. Guidelines that specifically focus on when mobile app developers need to apply to the FDA for approval to sell because of the medical claims they are making are still in their draft forms.

However what would it mean for the innovation and speed to market of medical mobile apps if they had to go through an approval process similar to other regulated sectors such as devices? Where is the line drawn between innovation and regulation in this case?

This is an interesting situation because unlike medical devices in which the care that is provided is focused on the treatment and technology delivered, for apps it is more about the information and algorithm behind the claims that are being made. Because of this the apps aren’t necessarily “life sustaining” which gives the appearance of them being less harmful if something were to go wrong.

The Healthcare Innovation and Marketplace Technologies Act (HIMTA) is the act that introduces the new office. Opinions right now are fairly split on whether or not this department should be created. Small business mobile app developers are mostly in support of the act because it helps create a clearer regulatory pathway for them which they have not ventured down before. For larger companies that have the manpower and regulatory expertise they view this part of the new act as decreasing the amount of innovation in mobile apps.

So what do you think? Will a new department focusing on medical mobile apps be helpful or hurtful to innovation?

--Jillian F. Walker