Navigating Health Tech: Regulations for AI/ML in Medical Devices and Software [Video] Navigating Health Tech: Regulations for AI/ML in Medical Devices and Software [Video] by: Benjamin M. Zegarelli, Pat G. Ouellette of Mintz - Viewpoints Tuesday, April 16, 2024 Related Practices & JurisdictionsHealth Law & Managed Care, Biotech, Food, Drug, Communications, Media & Internet, Administrative & RegulatoryAll Federal | Viewpoints Benjamin Zegarelli and Pat Ouellete discussed the health care regulations governing medical devices and software and shared how to stay informed and navigate the evolving landscape of health care regulations. This session explored: FDA’s current approach to regulating AI/ML devices, including recent marketing authorization decisions and enforcement actions Other health care applications of AI/ML and the accompanying regulatory landscape Potential pitfalls and emerging regulations New regulations for EMR developers Proposed non-discrimination requirements in connection with health care provider use of AI by the Office for Civil Rights The recent White House AI Executive Order and the sections relevant to use of AI in health care Recent proposed legislation at the state and federal levels Click here to see the slides from this presentation. ©1994-2024 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved. Current Legal Analysis Fortune 500 Terms of Use Utilize Varying Arbitration Providers by: Tyler J. Thompson OCR, CMS Issue New ACA Section 1557 Final Rule Prohibiting Discrimination Related to Use of Artificial Intelligence in Health Care by: Pat G. Ouellette Viking River Who? Another Cautionary Tale About Arbitration Agreement Drafting by: Jonathan P. Slowik , Michelle L. Lappen Expecting the Unexpected by: Jennifer B. Rubin Cancer Drugs: Strategies For Patenting Antibody-Drug Conjugate Inventions by: Oyvind Dahle Print