Trustworthy Artificial Intelligence in Dentistry: Learnings from the EU AI Act

Artificial intelligence systems (AISs) gain relevance in dentistry, encompassing diagnostics, treatment planning, patient management, and therapy. However, questions about the generalizability, fairness, and transparency of these systems remain. Regulatory and governance bodies worldwide are aiming to address these questions using various frameworks. On March 13, 2024, members of the European Parliament approved the Artificial Intelligence Act (AIA), which emphasizes trustworthiness and human-centeredness as relevant aspects to regulate AISs beyond safety and efficacy. This review presents the AIA and similar regulatory and governance efforts in other jurisdictions and lays out that regulations such as the AIA are part of a complex ecosystem of interdependent and interwoven legal requirements and standards. Current efforts to regulate dental AISs require active input from the dental community, with participation of dental research, education, providers, and patients being relevant to shape the future of dental AISs.