npj Digital Medicine · 2025 · 10 citations · 11 references
PharmacyHealth LawHealth PolicyArtificial IntelligenceRegulatory AffairsRegulatory ScienceArtificial Intelligence PolicyDrug ApprovalMarket Authorization ProceduresPrescription Drug PolicyPrescription RegulationRational PrescribingAi OversightFda Drug RegulationFda RegulationHealth Ai GovernanceHuman Oversight Of AiIndependent PrescribingOversightPrescriber Oversight
We live in interesting regulatory times. In January, a bill was introduced to the US Congress proposing that AI “can qualify as a practitioner eligible to prescribe drugs” if overseen by the States and FDA. This a bold and contentious move. Even proponents of AI’s swift integration into medicine must recognize the deep paradox: this proposal emerges even as the FDA’s world-leading infrastructure for AI oversight faces dismantling.
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Potential Liability for Physicians Using Artificial Intelligence
W. Nicholson Price, Sara Gerke, I. Glenn Cohen · JAMA · 2019 · 501 citations
Large language model AI chatbots require approval as medical devices
Stephen Gilbert, Hugh Harvey, Tom Melvin et al. · Nature Medicine · 2023 · 200 citations