FDA regulation of medical apps

Proposed Office of Mobile Health to certify mobile medical apps

With more than 40,000 medical mobile apps available for download, it’s hard for the average consumer to know which apps are of high quality and reliable for health information. The U.S. Food and Drug Administration (FDA) hopes to start reviewing medical apps in order to protect patient health and privacy.

As of now, the FDA has cleared a few apps for distribution as medical devices, but it doesn’t have any mobile app guidelines in place for developers. Many health apps are in violation of FDA regulation as it stands; however, the FDA hasn’t investigated them because it doesn’t want to stall innovation.

Later this month, the Healthcare Innovation and Marketplace Technologies Act (HIMTA) will be introduced in the U.S. House of Representatives and could establish an Office of Mobile Health within the FDA. This office would help the FDA with the clearance of medical apps and set up resources for developers so they can comply with privacy regulations and standards.

Some developers fear that the FDA won’t be able to keep up with the creation of mobile apps and that it will take too long for apps to be approved, while others would prefer the office to help them navigate the dense rules and regulations of the FDA.

“Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry,” said Rep. Mike Honda, D-California. “Why have the principles of Silicon Valley, which I represent – competition, innovation, and entrepreneurship – not fully manifested themselves in the healthcare information technology space? This bill gets us closer to that space.”

Would you be more likely to recommend apps to patients if they are regulated by the FDA?