Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was cited in Healthcare IT News, in “CDS Coalition Requests FDA Rescind Final Decision Support Guidance,” by Andrea Fox.

Following is an excerpt:

The CDS Coalition is asking the U.S. Food and Drug Administration to pull back on its clinical decision support guidance in order to ensure that the agency better balances its regulatory oversight with the healthcare sector's need for innovation while comporting with the statutory language of the 21st Century Cures Act. 

'Flagrant' disregard for Congressional law and intent

The coalition's stakeholders – clinical decision support software developers, patient advocacy organizations, clinical societies, healthcare providers and healthcare payers – say FDA's guidance exceeds Congress’s statutory definitions of what is considered CDS and threatens to undermine lawmakers' goals.

"The Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services strongly believe that CDS software will help improve the quality of care, and that innovation must be encouraged in this space," the coalition said in its February 6 petition prepared by Epstein Becker & Green, P.C. 

"Congress expressed those same intentions when it carved out certain CDS functionality from FDA regulation as a medical device under the 21st Century Cures Act. FDA’s action in publishing the CDS Guidance is at odds with these other federal policies and congressional intent."

The coalition added that CMS made it clear long ago that CDS includes diagnostic support. The recipe for CDS, according to a 2014 CMS document the petition links to specifies the following the following construct:

  • The right information – including evidence-based guidance.
  • The right people – the entire care team and the patient.
  • On the right channels – EHR, patient portal, etc.
  • In the right format – dashboards, orders.
  • At the right points in the clinical workflow – optimizing decision-making or action. 
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