RopesTalk

On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray’s life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA’s revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." They address key changes from the FDA’s prior draft guidance, potential challenges in implementing the FDA’s recommendations, and how the new guidance fits within the FDA’s overall framework for medical product manufacturer communications. 

On this episode of Ropes & Gray’s podcast series, Controlling Opinions, hear from partners Brett Friedman, Andrew O’Connor, and Josh Oyster regarding recent developments related to the prescribing of controlled substances via telemedicine. They discuss the current DEA regulatory landscape related to prescriptions of controlled substances via telemedicine and explore the implications of a recently announced prosecution in which the Department of Justice alleged that executives at a digital health company wrongfully distributed controlled substances via telemedicine. 

On this episode of Ropes & Gray’s podcast series, Decoding Digital Health, Megan Baca, co-leader of the IP transactions and licensing practice and co-chair of the firm’s digital health initiative, is joined by IP transactions counsel Georgina Suzuki to explore the science behind AI. They discuss how AI works, including the different categories of AI and its evolution, while tackling tougher questions such as how to spot “snake oil” in the AI industry. Whether you're in the legal field, a business development professional, or just AI-curious, this podcast is for anyone wishing to raise their IQ on AI. 

On this episode of Ropes & Gray’s California Law for Asset Managers podcast series, asset management partner Catherine Skulan is joined by data, privacy & cybersecurity partner Ed McNicholas to discuss recent developments in California privacy law. California’s privacy laws can implicate a wide range of managers—from those based in the state to those that simply have California investors. Catherine and Ed delve into the implications for asset managers of the California Consumer Privacy Act (CCPA) of 2020 and its amending legislation, the California Privacy Rights Act (CPRA), which became enforceable for violations after July 1, 2023. 

On this episode of Culture & Compliance Chronicles, Amanda Raad and Nitish Upadhyaya from Ropes & Gray’s Insights Lab, and Richard Bistrong of Front-Line Anti-Bribery, delve into the intricacies of corporate culture and compliance with special guest Guillem Casoliva Cabana. A seasoned traveler and compliance manager at Booking.com, Guillem takes us on a journey through his academic and practical experiences. The conversation covers the importance of understanding team ethical culture, the role of direct managers in shaping it, and how ethics ambassadors can be used to support compliance programs by acting as a bridge between compliance teams and employees. 

The U.S. Supreme Court’s term has ended, with major implications for federal agencies and those that are regulated by them. What did the Court cover? And what remains unaddressed? Join litigation & enforcement partner Doug Hallward-Driemeier as he discusses the impact of Jarkesy and Loper Bright on federal agency authority, including the demise of the Chevron doctrine. Doug brings unique insight to the topic: he is head of Ropes & Gray’s appellate and Supreme Court practice, has argued 19 cases before the Supreme Court, and has filed more than 200 briefs there.

On this episode of Ropes & Gray’s podcast series, Decoding Digital Health, Christine Moundas, a health care partner and co-chair of the firm’s digital health initiative, is joined by Dr. Bernardo Bizzo, a senior director at Mass General Brigham AI and assistant professor of radiology in the Department of Radiology at Mass General Hospital. Dr. Bizzo discusses his work in the field of digital health and AI, including the development and clearance of AI products by the FDA. They also explore the promising aspects of AI in health care and the challenges involved in developing and deploying AI tools. 

Tune in to the latest episode of Ropes & Gray's podcast series, The Data Day, brought to you by the firm’s data, privacy & cybersecurity practice. This series focuses on the day-to-day effects that data has on all of our lives as well as other exciting and interesting legal and regulatory developments in the world of data, and features a range of guests, including clients, regulators and colleagues. On this episode, hosts Fran Faircloth, a partner in Washington, D.C., and Edward Machin, counsel in London, discuss the latest developments keeping the data team busy, including the drive to build AI governance programs in Europe and the U.S. and the launch of a new state privacy law microsite. The microsite features an interactive map of the U.S. that captures the rapidly developing privacy laws emerging from each state. 

On this episode of Ropes & Gray’s podcast series, Non-binding Guidance, counsel Steve Sencer moderates a discussion on how FDA regulatory issues may impact academic medical centers (AMCs), health systems, and universities/research institutions. Joined by partner David Peloquin, and counsel Sarah Blankstein and Beth Weinman, the episode explores the complexities of FDA regulation, the potential risks, and the best practices to mitigate them. The discussion also highlights the challenges and implications of using digital tools in research studies. 

On this podcast, Harvey Cotton, Bill Littell, and Darien Saft from Ropes & Gray’s benefits consulting group delve into the intricacies of the Lewandowski v. Johnson & Johnson ERISA class action lawsuit. They discuss the allegations of fiduciary breaches in the administration of J&J's pharmacy benefit and explore the potential implications of these alleged breaches for employers who provide self-insured medical and Rx benefits to their employees. The team also provides an overview and analysis of ERISA fiduciary duties as they relate to employer-sponsored health insurance plans, the role and complexities of pharmacy benefit managers (PBMs) within the health plan offering, and best practices for plan sponsors to ensure there are processes in place to benchmark and manage health plan costs effectively for their employees.