Digital Health Regulating Continuously Learning Digital Therapeutics: Closing Gaps in Premarket Approval, Surveillance, and Liability Yoo plus 2026-02-12 0 The rise of continuously learning digital therapeutics presents regulators, clinicians, and patients with a profound paradox: treatments... Read More Read more about Regulating Continuously Learning Digital Therapeutics: Closing Gaps in Premarket Approval, Surveillance, and Liability
Digital Health When SaMD Becomes the Trial Investigator: Regulating Autonomous Clinical-Decision Software in Decentralized Trials Yoo plus 2026-01-03 0 The rise of AI-enabled Software as a Medical Device (SaMD) that makes real‑time eligibility and dosing decisions... Read More Read more about When SaMD Becomes the Trial Investigator: Regulating Autonomous Clinical-Decision Software in Decentralized Trials