Bradley Merrill Thompson Quoted in Article, “HIT Study to Assert FDA Regulates Clinical Software, Guidance Will Follow”

FDA Week

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 "HIT Study to Assert FDA Regulates Clinical Software, Guidance Will Follow."

Following is an excerpt:

FDA device center chief Jeff Shuren told mobile health stakeholders this week that a report due to Congress early next year laying out a tri-agency framework for health IT, while primarily focusing on health IT products that fall outside of FDA's authority, will reassert FDA's plan to regulate clinical decision support software. But he added that FDA will hold off issuing draft clinical decision support software guidance until stakeholders have an opportunity to comment on that section of the report. ?...

The FDA Safety and Innovation Act requires FDA, along with the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology, to submit recommendations for the development of a risk-based health IT regulatory framework. ?...

An industry attorney said he found it "concerning" that FDA would wait so long to issue guidance and provide much needed clarity on its clinical decision support software regulation. The big implication is that FDA is going to reexamine the line it has drawn on CDS regulation and regulate only some of the software, but it is unclear where it is going to draw that line, said Bradley Merrill Thompson, an attorney with Epstein, Becker & Green.

The agency's proposed deadline of next summer to issue the guidance seems like too long to wait for clarification on the issue, said Thompson, who is also general counsel for the Clinical Decision Support Coalition. The group formed two years ago in an effort to help FDA develop CDS regulations.

"I talked to (Shuren) out in the hall and said that's kind of concerning that you're going to wait that long," he said during the mHealth Summit. "And he said maybe end of summer would be a reasonable time to see those guidances, including the CDS guidance. So we'll see. That seems like a long time."