AHA voices concerns about FDA guidance on clinical decision support

The American Hospital Association is concerned that if the Food and Drug Administration’s draft guidance on clinical decision support software is implemented it could hinder innovation.

According to the FDA, its draft guidance—released in September for public comment—is a proposed approach for regulating CDS software that not only fulfills the provisions of the 21st Century Cures Act, but also strikes the right balance between ensuring patient safety and promoting innovation.

However, in a letter last week to the FDA, the AHA charged that the regulatory agency’s “interpretation of certain criteria could result in many existing CDS algorithms being subject to the FDA approval process and ultimately slow the pace of innovation and development of new software tools to support better patient care and outcomes.”


In particular, AHA notes that the FDA proposes to focus its regulatory oversight on CDS functions that are intended to help a healthcare professional inform their clinical management for serious or critical conditions and that are not intended for professionals to independently evaluate the basis of the software’s recommendations.

Although the AHA strongly agrees that any CDS algorithm that takes independent review and action out of the hands of a healthcare professional should be regulated, the hospital group is concerned that FDA’s draft guidance as currently written “could apply an arbitrary distinction between ‘informing clinical management’ and ‘driving clinical management’ that is not directly supported by the statute and does not accurately reflect how CDS is used in a patient care environment.”

AHA points out that the FDA proposes to define software functions intended to “support or provide recommendations” as those that align with the International Medical Device Regulators Forum (IMDRF) Framework category of functions that “inform clinical management” and that CDS that falls under the additional two categories of the IMDRF Framework—“drive clinical management” and “treat or diagnose”—would, in turn, be subject to FDA regulation.

“The IMDRF Framework describes the ‘inform’ function as information ‘not triggering an immediate or near-term action,’” states AHA’s letter. “However, according to our members, almost all CDS output is intended to do just that—be one of several sources of information that support an HCP’s decision of whether to take action—action that could be time-sensitive and critical to achieving a positive health outcome for a patient.”

According to AHA, this example highlights a compelling case for decision support that creates inputs for the healthcare professional to independently consider when determining diagnosis and treatment. As a result, the hospital group is urging the FDA to “reconsider applying this arbitrary distinction of ‘informing’ vs. ‘driving’ clinical management” and instead “propose policy that is consistent with the statute’s focus on supporting or providing recommendations about prevention, diagnosis or treatment."