Congress called upon the FDA this week to clarify its regulation of mobile medical apps. In a bipartisan note, 6 U.S. senators said they wanted to ensure that agency oversight of mobile medical apps was current with the latest techonology, MobiHealth News reported. Senators who signed the letter include Michael Bennet (D-CO), Orrin Hatch (R-UT), Tom Harkin (D-IA), Lamar Alexander (R-TN), Mark Warner (D-VA) and Richard Burr (R-NC). The letter stated that "more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated.
In other words, Congress wants answers.
The letter went on to list 9 questions, including inquiries about how many emails the agency has received to date regarding mobile medical apps, and how quickly regulators respond to messages. Senators also asked the FDA how it regulates an app with an unclassified or complex function.
This isn't the first time Congress has checked in with the agency about its regulation of mobile apps: In October 2013, a Tennessee congresswoman filed a bipartisan bill that asked the agency to clarify which mobile medical apps fell under regulatory discretion. As the Memphis Business Journal reported, the bill (H.R. 3303) would distinguish a higher-risk mobile app from a lower-risk one. Pacemakers and other implanted devices would be classified as high-risk, while apps that tracked blood pressure, calories or other benign medical data would qualify as low-risk.
The bill was meant to facilitate innovation, as not all mobile medical app makers would have to go through the regulatory process, lead sponsor Rep. Marsha Blackburn (R-Brentwood) told the newspaper. Only those companies with devices marked as high-risk or invasive would need to submit their product for approval.
Congress's latest letter also follows the FDA's release of final rules for developing mobile medical apps. In September 2013, the agency said it would exert control over apps that worked as a regulated medical device or that turned a smartphone/tablet into a de facto medical device. The new guidance focused on an app's function and risk rather than its platform, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, told Reuters.
Perhaps it's no happy coincidence that in three weeks, the FDA and HHS will likely present a report to Congress with a working group's suggestions for regulating health IT, MobiHealthNews reported. Until then, the Senate will wait for an official response to its laundry list of questions--the letter's co-signers requested a response within three weeks of FDA receipt.
- here's the MobiHealthNews story
- read the letter text