Vrushab Gowda, Keith Dreyer, Bernardo Bizzo
J Am Coll Radiol . 2024 Oct;21(10):1686-1688. doi: 10.1016/j.jacr.2024.04.007. Epub 2024 Apr 26.
On October 30, 2023, the Biden Administration issued the “Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence” (AI EO), marking the most comprehensive domestic effort to regulate artificial intelligence (AI) technologies to date [1]. Questions around AI regulation have swirled in the recent past, in particular given the absence of purpose-built oversight frameworks at the federal level; as yet, there remains no purpose-built pathway for AI products seeking FDA premarket review. This has engendered significant uncertainty not only among radiologists—with unanswered questions of workflow integration and remuneration—but also to developers, payors, and health care institutions. The AI EO aims to coordinate the federal government’s currently disparate approach to AI regulation and lend clarity to a space hitherto lacking in concrete guidelines.