Foley & Lardner LLP Partner Kyle Faget is quoted in the GenomeWeb article, “Clinical Decision Support Guidance Suggest FDA Will Regulate Risk Scores, Treatment Recommendations,” discussing new guidance from the U.S. Food and Drug Administration (FDA) that regulates clinical support software.
Faget described how the new guidance goes further than the draft released in 2019, including the introduction of the idea of “time-critical decision-making.”
“Any time that the software functionality is going to be used with a certain level of software automation, and there’s a time-critical nature of the health care provider’s decision-making, the FDA is leaning on the concept of automation bias to make a determination that that should be regulated. That wasn’t even a concept that was raised in the 2019 draft guidance,” Faget said.
While some developers may take issue with their software being classified as medical devices, Faget noted the new clarity may actually provide some comfort, saying, “Clarity can, in the long run, actually lead to greater efficiencies, because at least you know where you stand.”
“Anything that is providing specific preventative diagnostic or treatment output or directives is going to be regulated. I think that it’s going to be more expensive for developers to go to market,” she added.