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 Healthcare Dive, in “Coalition Issues Final Guidelines on CDS Software Design,” by Meg Bryant.

Following is an excerpt:

An industry coalition has finalized guidelines on the design and development of medium-risk clinical decision support software that aren’t subject to Food and Drug Administration review.

The aim of the Clinical Decision Support Coalition’s voluntary guideline is to encourage software designs that allow clinicians to independently review the basis for a CDS product’s recommendations. It also provides a framework for software developers to determine if additional validation is needed. …

The 21st Century Cures Act, passed late last year, removes clinical decision support software and certain other categories of software from FDA regulation. That helps manufacturers in planning their strategies, Bradley Merrill Thompson, a partner at Epstein Becker Green, told Healthcare Dive last December.

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