On Monday, President Obama signed into law an FDA user-fee bill (S 3187) that includes provisions designed to help the agency move forward on its plan to regulate mobile health applications, FierceMobileHealthcare reports (Bowman, FierceMobileHealthcare, 7/10).
The legislation, which Congress passed last month, reauthorizes and modifies FDA's prescription drug and medical device user-fee programs.
The measure also requires 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, 6/25). By the end of this year, FDA hopes to clarify how it will handle the regulation of mobile health apps (Stein, "Shots," NPR, 7/10).
Reaction to the New Law
Joseph Smith -- chief medical officer of West Wireless Health Institute -- in a joint statement with life sciences advocacy groups BIOCOM and CONNECT praised the new FDA user fee law.
Smith said, "The entire mobile health ecosystem is developing inherently low-risk technologies to extend care beyond offices and hospitals, and these novel, low-risk devices and integrated solutions can be expedited via these changes to the FDA's de novo pathway" (West Wireless Health Institute release, 7/9).
Concerns Over Mobile Health App Regulation
However, some mobile health app developers and advocates have expressed concern that FDA regulation will restrain innovation.
Scott Gottlieb of the American Enterprise Institute said, "If FDA steps into this field, it's going to create so much uncertainty for product developers that it's going to discourage a lot of investment and it's going to discourage a lot of programmers from getting into this space" ("Shots," NPR, 7/10).