Bradley Merrill Thompson Quoted in “Debate Over FDA Oversight of Apps Continues”

Government Health IT

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Debate Over FDA Oversight of Apps Continues."

Following is an excerpt:

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. ?...

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."

"What we need is a more refined approach that distinguishes high-risk apps from low-risk and allows the FDA to continue its role with high-risk apps," Thompson said. "No one yet has come up with the right conceptual approach for distinguishing clinical decision support apps based on risk, and in my opinion we ought to continue to work with the experts at the agency to develop that more nuanced parsing. It is not the right time for legislation." ?...

"The biggest issue with both the SOFTWARE Act and the PROTECT Act is that it would deregulate certain stand-alone software used for such things as guiding therapeutic decision-making," he said. "For example, under both acts, a radiation dosage calculator would be removed from FDA regulation even though there is considerable risk in using such a program."