AMIA Seeks Further Clarity on FDA Clinical Decision Support Guidance

January 13, 2020 - The American Medical Informatics Association (AMIA) has expressed its support for the FDA’s updated guidance for regulating clinical decision support (CDS) software, but experts are also calling for additional clarity around the use and development of these tools.

The updated draft guidance is part of the FDA’s implementation of the 21st Century Cures Act, as well as its Digital Health Innovation Action Plan that was launched in 2017.

In comments submitted to the FDA, AMIA noted that the FDA has made several important updates since issuing the first draft CDS guidance in 2017, including the discussion of regulatory controls and other adjustments.

“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“As the FDA refines this draft guidance and develops additional policies to ensure the safe and effective development of CDS and Software-as-a-Medical Device, AMIA and the informatics community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.”

While AMIA supports the FDA’s updates, the organization also stated that there could be potential confusion among clinicians and developers trying to determine which CDS software is subject to FDA oversight.

For example, AMIA pointed out a part of the guidance saying 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 that this was an improvement on the original language, it will likely raise follow-up questions about where in workflow this information should be made available and how the information should be presented.

In addition, AMIA expects that there will be confusion about the difference between software that “informs” and “drives” clinical management, as well as the concept of “independent review.” The organization recommended that FDA provide examples of each to better distinguish between those that “inform” and “drive.” “Independent review” could be made more understandable if FDA equates it to clear and transparent support for a clinical recommendation.

“AMIA recommends that FDA amend the guidance to clarify that ‘inform’ type CDS will not trigger automatically an immediate or near-term action. This insertion of ‘automatically’ will create more definition between “inform” and “drive” clinical management, while maintaining consistency with the International Medical Device Regulatory Forum framework,” AMIA wrote.

The group also called for more clarity around which CDS tools are currently being used and which are in development.

“We strongly recommend FDA take explicit steps to understand what kinds of CDS are used in production today and planned for development across healthcare delivery organizations. In addition to applications received for approval by commercial firms looking to market or sell CDS, the FDA should establish its regulatory parameters based on what CDS is in use today,” AMIA wrote.

AMIA suggested that FDA take explicit steps to understand what kinds of CDS are currently used and planned for development.

“In addition to applications received for approval by commercial firms looking to market or sell CDS, the FDA should establish its regulatory parameters based on what CDS is in use today. Our reading of the guidance portends an expansive regulatory purview for CDS, especially given FDA’s determination that all patient and caregiver-facing CDS is a medical device,” AMIA wrote.

With these recommendations, AMIA expects to provide the FDA with helpful feedback to further improve regulations around CDS software.

“Given our members’ longstanding work with decision support software development, implementation, and evaluation, AMIA stands ready to help FDA develop further thinking and potential guidance regarding this emerging and important area,” the organization concluded.