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. 

Unclear compliance obligations

In December, The HIMSS EHR Association sent a letter to the FDA that also expressed concern and focused on the highly intertwined nature of CDS with EHR technology.

“The FDA’s guidance does not appropriately reflect the reality that decision alerts are frequently created and configured by provider organizations and that for many health IT solutions, the developer asserts little or no control over CDS configuration,” the EHR Association said in its letter to FDA.

“It is unclear who ultimately has an obligation to enforce compliance when a provider is using the solution to deliver CDS they have developed themselves or purchased and implemented directly from a third party.”

With CDS sources from a number of places, compliance responsibility is murky and would be cumbersome, stymying innovation, the organization pointed out.

Unsustainable requirements and harming public health

The CDS Coalition, formed in 2012 after FDA announced its intention to develop CDS guidance, suggested that in the final guidance, FDA is compromising its own ability to enforce the law, harming public health and will be overwhelmed with submissions.

The coalition shared a summary of the following key points:

  • FDA’s own record in connection with CDS software shows that there is no public health problem to be solved.
  • FDA is harming, not helping, public health by dissuading innovators from evolving CDS software for the betterment of the public and imposing arbitrary rules on technology development that do not serve their intended purpose.
  • FDA is doing an end run around the process that Congress set up for the agency to expand its regulatory oversight in the event the agency identified a problem requiring it to do so.
  • FDA is improperly intruding into U.S. state jurisdiction over the practice of medicine and thus violating the Constitution.
  • FDA violated federal law by publishing the CDS Guidance without adequate notice that gave the public a legitimate opportunity to comment.
  • FDA violated federal law by disregarding the plain language of the Cures Act, and instead inventing its own interpretation that flies in the face of congressional intent.
  • FDA is taking on regulatory responsibilities that are not sustainable.

“Among other things, in the reproposed guidance FDA should clarify that CDS software can indeed recommend a single diagnosis or single treatment pathway,” the Coalition said.

Andrea Fox is senior editor of Healthcare IT News.
Email: [email protected]

Healthcare IT News is a HIMSS Media publication.

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