Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FierceHealthcare, in “Industry Coalition Finalizes Clinical Decision Support Guidelines Aimed at Self-Regulation,” by Evan Sweeney.
Following is an excerpt:
Under the 21st Century Cures Act, CDS software falls outside of the FDA’s jurisdiction. The agency plans to release draft guidance that delineates the types of CDS software that falls outside its regulatory scope. Thompson believes it’s up to the industry to self-regulate machine learning software to ensure it remains outside of FDA oversight.
“The legislation provides an avenue for FDA to clawback into regulated territory any software the Agency finds may lead to serious injury or death in patients,” Thompson wrote in a LinkedIn post. “If industry does an adequate job of self-regulating and therefore avoiding patient injury, we can reduce the likelihood that FDA will need to expand the scope of its regulation.”
Thompson added that the CDS Coalition was only a temporary holdover, and the group is actively seeking out an organization that can regularly update the guidelines moving forward.
