Bradley Merrill Thompson Discusses the FDA’s Long Anticipated New Guidance on Digital Health Devices and Clinical Decision Support Guidelines

Multiple Publications

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 multiple publications on the topic of the FDA’s new regulatory guidelines, released on December 7, 2017, for digital health devices and clinical decision support.

Following is an excerpt from FierceHealthcare, “After A 6-Year Wait, FDA’s Clinical Decision Support Guidelines Get a Mixed Reaction,” by Evan Sweeney.

It’s been six years since the Food and Drug Administration said it would begin developing guidance for clinical decision support (CDS) software.

Now that the guidance is finally here, some industry experts are feeling slightly underwhelmed. For Bradley Merrill Thompson, a medical device attorney with Epstein Becker & Green in Washington, D.C., the FDA’s guidance “stopped at the edge” of the regulatory framework outlined in the 21st Century Cures Act, which carves out an oversight exemption for software that can be independently reviewed by physicians.

“I’m afraid I was expecting much more,” Thompson wrote in an email to FierceHealthcare. “I was expecting a guidance that focuses on risk, rather than simply explaining the statutory language in slightly greater detail.”

That reluctance to embrace a risk-based approach to CDS software is Thompson’s biggest complaint. He argues that software that predicts the likelihood of a migraine, for example, has a far lower risk to patient safety than a tool that recommends a specific chemotherapy treatment, which could be a life or death decision.

Instead, in its draft recommendations issued on Thursday, the agency fell in line with the approach outlined in Cures, devoting most of its focus to the transparency of CDS software and the ability for physicians and patients to understand the basis for the software’s recommendation.

“What I think many of us in industry were hoping for was an effort by FDA to distinguish high from low risk as a basis for regulation,” he wrote. “We didn’t get that. Worse, it appears based on the guidance that FDA is not interested in drawing that line.”

Related reading:

HealthcareDive, "FDA Debuts New Clinical Support Software Draft Guide, Backs Off Certain Regulations," by David Lim.

Politico Morning, "FDA Digital Health Guidance Aftermath," by Darius Tahir.

MobiHealthNews, "FDA Issues Three Guidances, Including Long-Awaited CDS Guidelines," by Jonah Comstock.

Health Data Management, “FDA Issues Draft Guidance on Clinical Decision Support Software,” by Greg Slabodkin.

CNBC, “The Feds Just Cleared a Major Roadblock for Digital Health,” by Christina Farr.

Bloomberg BNA Medical Devices Law & Industry Report, “FDA Plans to Exempt Some Health Software from Device Rules,” by James Swann. (Read the full version – subscription required.)

Inside Health Policy, “FDA OKs First Medical Device For Use With Apple Watch After 19-Month Review,” by Nicholas Florko. (Read the full version – subscription required.)

Medtech Insight, "Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work," by Ferdous Al-Faruque. (Read the full version - subscription required.)

MedCityNews, “FDA Digital Health Draft Guidance Scales Back Regulation of Certain Types of Software,” by Stephanie Baum.

Rodexo, “FDA Guidance on Clinical Decision Support Clears Digital Health Block.”