Our research focuses on the regulatory science of FDA-regulated products, those overseen by the Office of the National Coordinator for Health Information Technology (ONC), and advancements in artificial intelligence and machine learning. We conduct research that explores the development and evaluation of regulatory frameworks to ensure the safe and effective use of digital health technologies, including AI and machine learning-based tools. This includes studying the complexities of medical device approvals, assessing compliance with evolving ONC standards, and addressing the unique challenges posed by AI and machine learning in healthcare. Our goal is to advance regulatory science in a way that fosters innovation while maintaining a strong focus on patient safety and public trust.
Projects
The Pediatrics Therapeutics and Regulatory Science Initiative (PedRx) provides a forum for collaboration with academia, patients, policymakers, and industry.
CHIP has been instrumental in both the interoperability provisions in the 21st Century Cures Act as well as the final rule by the Office of the National Coordinator of Health Information Technology implementing API requirements.
