AMIA Supports Updated FDA CDS Draft Guidance, but Seeks Additional Clarity

Thursday, January 9, 2020

Nation’s clinical informatics experts urge FDA to take further steps to understand what kinds of CDS are currently used and planned for development across healthcare delivery organizations.

On December 26, AMIA offered comments on the U.S. Food and Drug Administration’s (FDA) second iteration of its guidance for regulating clinical decision support (CDS) software intended for healthcare professionals, patients, and caregivers. While AMIA applauded several updates, it also sought additional clarity for developers and clinicians trying to determine whether specific decision support software is, or is not, subject to FDA regulatory oversight.

The long-awaited update to this guidance is part of FDA’s implementation of the 21st Century Cures Act, as well as its Digital Health Innovation Action Plan it unveiled in 2017. AMIA applauded the updated guidance, noting that several important and substantive updates had been made since FDA issued the first draft CDS guidance in 2017. These updates included AMIA recommendations to include discussion of regulatory controls, such as the International Medical Device Regulatory Forum (IMDRF) risk stratification model for Software-as-a-Medical Device (SaMD), and more explicit examples based on the guidance decision logic.

While AMIA supported the update, it also cautioned FDA about potential confusion among developers and clinicians trying to determine which CDS software is subject to FDA oversight. For example, AMIA pointed to a provision in the statute that “the software developer should describe the underlying data used to develop the algorithm and should include plain language descriptions of the logic or rationale used by an algorithm to render a recommendation.” While the group said this was a helpful improvement upon the initial language, it nonetheless raised follow-on questions about where in the workflow this information should be made available and through what means such information should be presented.

AMIA additionally expects there to be concerns raised by industry over the difference between software that “informs” and “drives” clinical management, as well as the concept of “independent review.” AMIA wrote that the distinction between “inform” and “drive” could be made stronger with examples for each. And “independent review” could be made more relatable and understandable a concept by equating it to clear and transparent support for a clinical recommendation.

Lastly, AMIA recommended that FDA take explicit steps to understand what kinds of CDS are used in production today and planned for development across healthcare delivery organizations. Although FDA’s purview is limited to products marketed and sold as medical devices, it must be aware of what kinds of CDS and Software-as-a-Medical Device are in use or being planned for deployment in health systems today and it should establish its regulatory parameters based on these findings.

“AMIA’s members have longstanding experience with decision support software development, implementation, and evaluation,” said AMIA Vice President of Public Policy, Jeffery Smith, MPP. “As the FDA refines this draft guidance and develops additional policies to ensure the safe and effective development of CDS and Software-as-a-Medical Device, AMIA and the informatics community stands ready to help.”

AMIA’s full comments can be found here.