Health Care AI Rapidly Evolving Regulatory and Payment Environment: What Every Clinician Should Know

An exclusive foundational webinar diving into the regulatory and payment landscape of healthcare AI systems. Gain valuable insights into its implications for clinicians and other end-users, and understand the evolving dynamics, with a special focus on the recent federal regulatory activity by the FDA, HHS OCR, Office of the National Coordinator for Health IT, White House Executive Order on AI, CMS, and more. Stay informed in this rapidly evolving space!

Presenters:

David Vidal, JD, is an attorney and FDA quality/regulatory expert focused on Software as a Medical Device (SaMD). As Vice Chair of SaMD Regulation in Mayo Clinic Center for Digital Health, he is leading the development of enterprise-wide infrastructure to enable safe, effective, and ethical realization of FDA-regulated software. David is also part of the leadership council for the Health AI Partnership, a multi-stakeholder collaborative with the mission to empower healthcare organizations to use AI safely, effectively, and equitably. David previously held the position of General Counsel and Senior VP of Quality Assurance & Regulatory Affairs at IDx Technologies Inc., where he played an instrumental role in the clearance and deployment of IDx-DR, the first autonomous AI diagnostic authorized by the FDA.  

Cybil Roehrenbeck, JD, is a partner with Hogan Lovells where she provides counsel on federal legislative and regulatory opportunities, often focusing on healthcare reimbursement and emerging sectors such as digital health, artificial intelligence (AI), and value-based care. Cybil also serves as Executive Director of the AI Healthcare Coalition, which advocates on behalf of healthcare AI innovators. Cybil serves on the American Bar Association (ABA) Standing Committee on Governmental Affairs, and as Chair of the ABA Health Law and Policy Committee. Cybil is an Adjunct Associate Professor at American University Washington College of Law, where she teaches health law and policy, and a frequent speaker at national health law conferences.