Stakeholders Concerned About FDA's Regulation of Mobile Medical Apps


Health care stakeholders are debating how much FDA should regulate mobile medical applications, Kaiser Health News/USA Today reports (Gold, Kaiser Health News/USA Today, 6/22).


Last week, the House passed legislation (S 3187) to reauthorize and modify FDA's prescription drug and medical device user-fee programs (Burton, Wall Street Journal, 6/20).

The measure also would require HHS -- with input from FDA and other stakeholders -- to publish a report on an "appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications that promotes innovation, protects patient safety and avoids regulator duplication."

Under the bill, FDA could move forward on issuing guidelines on mobile medical apps while HHS prepares the report (iHealthBeat, 6/20).

The Senate is expected to approve the bill this week (Wall Street Journal, 6/20).

Concerns About FDA Regulation

Some developers say that FDA's plan to regulate mobile medical apps is vague and could stifle innovation (Kaiser Health News/USA Today, 6/22).

Dirk Hobbs, CEO of Medical Voyce Sciences and Multimedia, said, "This is just going to slam the brakes on an innovative sector that includes tons of small businesses."

Liz Boehm -- a director at ExperiaHealth, a consulting firm -- said FDA's approval process "adds months, if not years, and potentially millions of dollars to what it takes to bring a solution to the market." Boehm added that the FDA approval process could put many medical app companies out of business.

Support for FDA To Move Forward

Meanwhile, other health care stakeholders say they have been expecting FDA to regulate mobile medical apps and are eager for the agency to get started.

Bradley Thompson, general counsel for the mHealth Regulatory Coalition, said, "We started telling the FDA that they're going to stifle innovation if they don't start clarifying where the lines will be drawn."

The West Wireless Health Institute and the Application Developers Alliance have taken similar positions, according to the Washington Post.

Lisa Suennen -- cofounder of Psilos Group, a venture capital firm -- said that although FDA regulation "puts an extra burden on young companies, those that can get through it will have a huge competitive advantage" (ElBoghdady, Washington Post, 6/22).

to share your thoughts on this article.