Debate Over FDA Oversight Of Apps Continues

Eric Wicklund | Government Health IT | February 18, 2014

A new bill aimed at calling off the FDA on over-regulation of medical apps is taking some heat. It seems some industry experts feel the bill won’t accomplish what drafters of the bill intended.

The Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014, introduced earlier this month by Sens. Angus King (I-Maine) and Deb Fischer (R-Nebraska), seeks to clarify the extent to which the U.S. Food and Drug Administration can regulate health IT. Its sponsors say the bill would prioritize the FDA's attention to technologies that pose the greatest health risk, rather than giving the agency broad authority over "low-risk health IT" and thus hindering innovation.

But Bradley Merrill Thompson, a Washington, D.C.-based attorney who advises the mHealth Regulatory Coalition, calls the proposed bill a "meat cleaver" that would, if passed into law, do a lot of damage, particularly to clinical decision support apps.

"The PROTECT Act (would declare) all such mobile apps unregulated regardless of risk," he said in an e-mail exchange with mHealth News. "That is a colossally bad idea, both for patients who would be put at risk, but also for (an) industry that would be dragged down by apps that don't work and destroy the credibility for the industry."