Abstract
As nations design regulatory frameworks for medical AI, research and pilot projects are urgently needed to harness AI as a tool to enhance today's regulatory and ethical oversight processes. Under pressure to regulate AI, policy makers may think it expedient to repurpose existing regulatory institutions to tackle the novel challenges AI presents. However, the profusion of new AI applications in biomedicine - combined with the scope, scale, complexity, and pace of innovation - threatens to overwhelm human regulators, diminishing public trust and inviting backlash. This article explores the challenge of protecting privacy while ensuring access to large, inclusive data resources to fuel safe, effective, and equitable medical AI. Informed consent for data use, as conceived in the 1970s, seems dead, and it cannot ensure strong privacy protection in today's large-scale data environments. Informed consent has an ongoing role but must evolve to nurture privacy, equity, and trust. It is crucial to develop and test alternative solutions, including those using AI itself, to help human regulators oversee safe, ethical use of biomedical AI and give people a voice in co-creating privacy standards that might make them comfortable contributing their data. Biomedical AI demands AI-powered oversight processes that let ethicists and regulators hear directly and at scale from the public they are trying to protect. Nations are not yet investing in AI tools to enhance human oversight of AI. Without such investments, there is a rush toward a future in which AI assists everyone except regulators and bioethicists, leaving them behind.