Bradley Merrill Thompson and Kim Tyrrell-Knott, Members of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, and San Diego offices, were featured in Mobi Health News, in “CDS Coalition Drops Voluntary Guidelines for Unregulated Clinical Decision Support Software,” by Jonah Comstock.

Following is an excerpt:

This week, the CDS Coalition, an industry group led by Bradley Merrill Thompson and Kim Tyrrell-Knott, members of the firm at Epstein Becker Green, has released the final draft of its voluntary industry guidelines for medium-risk clinical decision support software.

The guidelines seek to create another level of regulatory clarity, beyond what is found in the 21st Century Cures Act, which stipulates that the FDA will only regulate high-risk clinical decision support. In the introductory comments to the guidelines, the coalition explains the lines between those three risk categories:

“FDA will regulate high risk CDS software where, among other things, (1) the user does not have a reasonable opportunity to review the basis of a recommendation and (2) the software performs important functions where, should the software not work as intended, someone could get seriously hurt,” they write. “Further, in our judgment, low risk CDS software where the risk of injury is low regardless of whether there is reasonable opportunity to review the basis for the recommendation need not be burdened by these guidelines. Instead, these guidelines focus on what we call ‘medium risk clinical decision support’ software or ‘MRCDS,’ which naturally enough falls between those two other categories.”

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