Bradley Merrill Thompson Quoted in “What the FDA Did in Digital Health in 2016”


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 MobiHealthNews, in “What the FDA Did in Digital Health in 2016,” by Jonah Comstock.

Following is an excerpt:

“From everything I’ve heard, Trump is very supportive of technology development, and very concerned about regulatory red tape. So I think we can feel confident that Trump will certainly not increase the regulation of digital health,” Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA, told MobiHealthNews in an email back in November. …

Thompson pointed out in a recent email to MobiHealthNews that the agency’s proposed list of guidances to publish in 2017 notably does not include draft guidance on clinical decision support software, which has appeared on the list the last two years.

“As I understand it, FDA removed it from the list because they plan to reevaluate the need for CDS guidance in connection with implementing the 21st Century Cures legislation,” Thompson wrote. “That legislation, in section 3060, adds the criterion that to be FDA regulated, CDS software must not be transparent. In this context, transparent means that the doctor user cannot see through the software to the underlying patient data and the clinical logic applied by the software, such that the physician is not required to rely on the software. ... My hope is that in connection with the legislation, FDA proceeds with the guidance. Indeed, the guidance is more important now than ever before.”

Thompson said the guidance is still needed for several reasons, including to address clinical decision support software that is not transparent and to provide guidance on how FDA will enforce transparency standards.