What the Biden administration’s artificial intelligence executive order means for radiology

Gowda and co-authors do not believe the order will result in immediate change for the regular practice of radiology. However, they see “significant” regulatory shifts on the horizon, including several government agencies taking “major enforcement action.” The order applies to both computer-aided detection systems that help radiologists in clinical work, along with AI for noninterpretative uses such as administrative tasks and peer review.

“Understandably, given their higher degree of patient risk exposure, the former will likely come under more intense scrutiny,” the authors advised. “CAD programs (such as those identifying subtle pulmonary nodules) are already subject to FDA premarket review as medical devices. This class of programs will now face additional quality, equity and output reproducibility requirements, although rescinding FDA clearance from products which have already received authorization is unlikely.”

The administration plans to deploy Health and Human Services in some fashion to oversee data input into AI algorithms. This could include the mandated disclosure of training datasets used in development.  Clinical radiologists and other AI developers seeking Medicare reimbursement for these products will likely need to incorporate “security by design principles” and ensure they comply with nondiscrimination laws, Gowda et al. noted. The feds also will expect academic radiology departments and large private practices  to share data with the National AI Research Resource and “make informed procurement decisions.”

All of this is to be determined, as October’s executive order does not spell the specific parameters and regulatory framework to begin increasing AI oversight. It’s far from a “silver bullet” to cure what ails artificial intelligence, the authors noted, rather the order serves as a “set of mobilization orders for federal agencies.”

“Radiologists themselves can and should play a key role in policy creation at every level,” they wrote. “The EO does not specify the composition of the HHS AI Task Force, which may very well include members of the public in the vein of FDA advisory committees. Outside of formal platforms, individual radiologists as well as the ACR as a body can provide active input during agency-led workshops, open conferences, and public comment periods. On a finer level, they are well positioned to influence institution- and enterprise-wide best practices, quality systems and data stewardship guidelines.”

Read much more at the link below. Mass General radiologists Keith Dreyer, DO, PhD, and Bernardo Bizzo, MD, PhD, also co-authored the opinion piece.