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 "Next Up for Washington Attorney: Regulatory Clarity for Clinical Decision Support Tools."
Following is an excerpt:
Diverse interest groups are creating a new Clinical Decision Support Coalition to weigh in on FDA policies for clinical decision support software. Bradley Merrill Thompson is leading the coalition's efforts.
The Gray Sheet: "What is the primary mission of the coalition?"
Thompson: "In a nutshell, it's simply to try to ensure that decision support software doesn't get overregulated.
"There's a general understanding that some types of decision support software probably need FDA regulation. FDA has regulated certain types of decision support software for years. But I think what was heard in that September FDA hearing was a desire to re-examine the parameters of what they regulate and do away with some principles maybe that have been around for a while, like competent human intervention. The agency seemed to be drifting away from that concept as well as the concept that how the data gets entered matters."
Thompson hopes the coalition and FDA can find a way to balance industry best practices against what is legally and regulatorily necessary.
"Historically that made a big difference. If it was data automatically transferred from a medical device, they came at it from an accessory standpoint and said then the software is regulated. But they're moving away from some of those principles to a much broader set. ...
"I don't want to pre-judge where FDA is going; obviously, they're just brainstorming at this point. ...
"The group just wants to start brainstorming at the same time so that we can offer constructive ideas, kind of like the mHealth thing, where the agency and the industry were working in parallel. The industry was trying to be transparent throughout that. And by September, industry came up with a proposal that had a ton of input into it. ...
"You might find the same thing going on here. FDA obviously is internally thinking about these issues. The industry will come together and will be thinking about them and will try to be transparent so that FDA and everyone else in the health community knows what we're doing. And then hopefully they converge at some point, and what comes out of it is a combination of what the industry has identified as best practice and what FDA has identified as legally and regulatorily necessary."
