ACR DSI Chief Science Officer Dr. Keith Dreyer, ACR DSI Senior Scientist Dr. Bernardo Bizzo, and Dr. Vrushab Gowda published an opinion article in JACR responding to the Biden Administration’s new “Executive Order on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence” (AI EO), which is the most comprehensive domestic effort to regulate AI to date.
The AI EO’s scope is sweeping, “far exceeding the ambit of previous efforts to regulate AI at the federal level,” the authors said. They warn that while the AI EO marks little immediate change for radiology practice, significant regulatory shifts will happen over the next several months, with several federal agencies poised to take major enforcement action. It extends its reach to all software incorporating AI technology, which appears to include both computer-aided detection (CAD) systems as well as lower-tech AI products used in administrative, peer review, or other non-interpretive capacities.
Given their higher degree of patient risk exposure, the authors said computer-aided detection (CAD) systems will likely come under more intense scrutiny. CAD programs already go through FDA premarket review as medical devices, but will now face additional quality, equity, and output reproducibility requirements. However, the authors said rescinding FDA clearance from products which have already received authorization is unlikely.
The AI EO also places emphasis on regulatory compliance from AI developers, many of whom are also clinical radiologists. If developers pursue Medicare reimbursement for their AI products, they must incorporate security by design principles and proactively ensure that their tools are consonant with nondiscrimination laws. Academic radiology departments and large private practices would also be expected to share certain data with the National AI Research Resource (NAIRR) and make informed procurement decisions.
The authors emphasize that radiologists themselves can and should play a key role in policy creation at every level. Outside of formal avenues, radiologists as well as the ACR can provide active input during agency-led workshops, open conferences, and public comment periods.
The AI EO is not a “silver bullet,” and should be treated more as a set of mobilization orders for federal agencies rather than a substantive policy in its own right, the authors argued.
“On the one hand, it establishes a coherent platform and tasks specific agencies with applying existing law. On the other, lacks the independent binding force of new legislation, and does not create new obligations per se. AI EO, in other words, only applies to federal agencies to the extent they are applying existing law, and shapes the way they interpret said law. It nonetheless establishes the groundwork for future policy action undertaken by the current administration.”
To read the full opinion piece,
visit JACR.
