The American Medical Informatics Association (AMIA) recently released new recommendations focusing on AI-driven clinical decision support tools that adapt their algorithms as they're trained with new data to ensure their safety and efficacy.

Published in JAMIA, the organization’s scholarly journal, the position paper uses the term "adaptive CDS” in offering suggestions to the U.S. Food & Drug Administration while also articulating a new framework for non-regulatory oversight.

According to a statement, the organization explains that the new term describes “CDS that can learn and change its performance over time, incorporating new clinical evidence; new data types and data sources; and new methods for interpreting data. Adaptive CDS enables personalized decision support in a way that has not been possible previously because it has the capacity to learn from data and modify recommendations based on those data.”

According to the position paper’s authors, "Debates about the scope and force of oversight for the safety and effectiveness of CDS have tended to emphasize legal regulation, of which little exists, and institutional governance, which frequently is wholly lacking. Organizational leaders have recognized content creation, analytics and reporting, and governance and management as critical components in the development of CDS, but achieving all 3 in sufficient depth remains challenging for organizations.”

By centering the discussion around adaptive CDS, the organization says hopes “to engender a practical discussion of policies needed to ensure safe and effective use of AI-driven CDS for patient care,” while also facilitating a wider discussion of policies needed to build trust in the broader use of AI in healthcare.

“The current policy and oversight landscape for Adaptive CDS is inadequate,” said Joseph Kannry, MD, AMIA Policy Committee Chair and paper author. “Gaps in federal jurisdiction of Adaptive CDS have left patients subject to algorithmic bias and potentially exposed to patient safety issues. In this paper we present a policy framework that spans the design and development, implementation, evaluation, and on-going maintenance of Adaptive CDS.”

In particular, AMIA is focused on two use cases of adaptive CDS:

    •    Those tools sold to customers for use in a healthcare setting ("marketed ACDS").

    •    Those developed in-house by healthcare systems for their own use ("self-Developed ACDS”).

The paper notes that while FDA has oversight over most marketed adaptive CDS tools,"self-Developed ACDS is likely unregulated by any federal entity and is already used routinely without oversight by any authoritative body – public, private, or non-profit.”

Among other outcomes, the AMIA paper calls for creation of new bodies, groups, or departments that govern implementation and use of AI within an institution, as well as a system of oversight across institutions.