Inside AI malpractice law: Why labeling and warnings matter for AI

Sara Gerke, associate professor of law at the University of Illinois, explains why clear labeling and disclosures for artificial intelligence (AI)-based medical devices are essential to improving transparency and safety — and how they could influence liability.

“There is a lack of labeling standards tailored to AI and machine learning-based medical devices,” Gerke says. “That really prevents users from receiving important information for their safe use.” Drawing inspiration from food labeling, her research in Emory Law Journal proposes a comprehensive labeling framework that includes both “AI facts” and front-of-package disclosures.

While such a system might not dramatically change the current liability landscape — where physicians and hospitals bear most of the risk under the “learned intermediary” doctrine — Gerke argues that better transparency could still strengthen accountability. “If a label is misleading or false,” she notes, “that could open the door to FDA enforcement actions for misbranded devices.”