Bradley Merrill Thompson and CDS Coalition Discuss the FDA’s Draft Guidance on Clinical Decision Support

Multiple Publications

Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in multiple publications on the topic of the FDA’s drafted regulatory guidelines on clinical decision support, in his work with the CDS Coalition.

Following is an excerpt from MobiHealthNews, “Clinical Decision Support Coalition Letter Criticizes FDA’s Stance on CDS,” by Laura Lovett.

Yesterday the Clinical Decision Support (CDS) Coalition released a comment broadly criticizing the FDA’s recent CDS draft guidance, noting that the draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market.

“The resulting overregulation would be to the detriment of patient care,” CDS Coalition Leader Bradley Merrill Thompson wrote in the comment that he penned on behalf of the organization.

The Clinical Decision Support Coalition is a recently-founded organization dedicated to ensuring clinical decision making software doesn’t become overregulated, while ensuring patient safety.

In December the FDA finally released the new CDS draft guidance, which outlined forms of CDS which won’t be regulated based on the degree of human involvement instead of based on risk. The draft says CDS software won’t be regulated if the physician can independently review and understand the basis of the software’s decision.

The coalition’s letter outlines three changes that it recommends to the CDS draft. First, it says the FDA should exempt low risk CDS software from FDA oversight and use the international criteria for stratifying risk of CDS software. Secondly, the organization urged the FDA to modify the draft to follow the Cures Act, which “allows for unregulated software that provides unique insights that the healthcare professional might not have come up with on his or her own, as long as the user has access to the factual basis for the insights.” Lastly, the organization said the FDA should include more examples of what is and isn’t going to be regulated.

Related reading:

Fierce Healthcare, “Health IT Stakeholders Want More from FDA’s Clinical Decision Support Guidance,” by Evan Sweeney.

POLITICO Morning eHealth, “FDA Gets Comments,” by Darius Tahir.

HealthDataManagement, “Groups Say FDA Draft Guidance on Decision Support Software Needs Work,” by Greg Slabodkin.

Healthcare IT News, “AMIA Wants More Specificity from FDA Decision Support Guidance,” by Mike Miliard.

Becker’s Hospital Review, “CDS Coalition: FDA’s Clinical Decision Support Guidance Would Be a ‘Detriment’ to Patient Care,” by Jessica Kim Cohen.