Digital Health Technology and Regulation Conference

Digital health tools and services enable industry to enhance care quality, provider efficiency, and patient access. Continued exponential growth in this sector challenges regulators to craft timely, relevant and adequate measures at the state and federal level to safeguard public interest. This conference explores current and prospective regulatory policy and legislation on prescription drug use-related software, laboratory-developed tests, quality management systems, predetermined change control plans, and generative AI safety, efficacy, and bias. Sessions will address pivotal concerns to the digital health community including FDA enforcement discretion policies and compliance with federal and state privacy laws.