The American Hospital Association (AHA) recently sent a letter to the federal Food and Drug Administration (FDA) in which the association voiced strong support for the FDA’s efforts to enhance new treatments and drive innovative healthcare via statures such as the 21st Century Cures Act.  But in the letter the association also voiced its concern that specific FDA criteria might actually impede the release of new clinical decision support (CDS) algorithms.

As digital medicine has developed, the AHA explained, CDS systems have become increasingly important, and while the FDA recognized the importance of CDS tools in recent draft guidance to implement Section 3060(a) of the 21st Century Cures Act, the AHA has concerns that the FDA’s interpretation of various criteria could force existing CDS algorithms to go through the FDA’s approval process, which would slow the development of new software.

In particular, for example, the association recommended that “the FDA should clarify that once the data are created by an FDA-regulated device, any software that further collects, collates and analyzes the data ‘downstream’ to provide insights and recommendations to HCPs (healthcare professionals) would be exempt from FDA regulation under this criterion.”

The association also expressed concerns about the draft criterion that would exempt clinical decision support algorithms from FDA approval if they intend to support or provide recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition.

“While the AHA strongly agrees that any CDS algorithm that takes independent review and action out of the hands of the HCP should be regulated,” the letter said, “we are concerned that the FDA’s interpretation of this criterion 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.”

For example, the letter explained, the International Medical Device Regulators Forum (IMDRF) Framework states that tools that inform clinical management do not trigger an “immediate or near-term action.” 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.”

Finally, in the draft guidance, the FDA would require that exempt software functions be transparent and describe to HCPs the inputs used to generate the recommendation as well as the basis for rendering the specific recommendation.

The AHA supported this criterion but recommended the FDA should clarify that a CDS algorithm meet this requirement if the information is accessible regardless of if the HCP chooses to access the information.