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recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA’s revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." They address key changes from the FDA’s prior draft guidance, potential challenges in implementing the FDA’s recommendations, and how the new guidance fits within the FDA’s overall framework for medical product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. 

Georgina Suzuki, an IP transactions counsel, and Andrew O’Brien, a technical advisor, dive into the intricate world of artificial intelligence. They decode how AI functions and evolve, shedding light on neural networks and their groundbreaking applications. The discussion takes a critical turn as they outline how to differentiate between genuine AI innovations and 'snake oil' products. Finally, they tackle the vital ethical and legal considerations surrounding AI, especially in the context of its regulation in business. A must-listen for those navigating the AI landscape!

Catherine Skulan, an asset management partner with expertise in California law, and Ed McNicholas, a data, privacy, and cybersecurity specialist, share insights on California's evolving privacy landscape. They discuss the impacts of the California Consumer Privacy Act and the California Privacy Rights Act on asset managers. The conversation highlights compliance challenges, implications for investor information, and the role of the California Privacy Protection Agency. Their insights are invaluable for navigating the complex regulations that affect asset management in California.

Guillem Casoliva Cabana, a compliance manager at Booking.com with a PhD on team ethical culture, shares his insights on corporate ethics. He discusses how team dynamics shape ethical behavior and the vital role managers play in this process. The podcast also examines the limitations of conventional compliance programs, emphasizing that true ethics require a cultural commitment, not just rules. Guillem highlights the importance of ethics ambassadors who act as links between compliance teams and employees, fostering a supportive ethical environment.

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 partners Doug Hallward-Driemeier and Jeremiah Williams as they discuss the impact of Jarkesy and Loper Bright on federal agency authority, including the demise of the Chevron doctrine. Doug and Jeremiah bring unique insight to the topic: Doug is head of Ropes & Gray’s appellate and Supreme Court practice; he has argued 19 cases before the Supreme Court and filed more than 200 briefs there. Jeremiah is a former SEC enforcement attorney who represents clients in government investigations and other regulatory matters. 

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. 

Discover the latest in AI governance, including the EU AI Act's impact on businesses. Explore the surge of state privacy laws in the U.S., focusing on Rhode Island's new disclosure act. Dive into the push for a federal privacy bill amidst evolving state regulations. Intriguing generational perspectives reveal how Gen Z views privacy differently, accepting smartphone tracking while older generations may resist. Stay updated with a new microsite featuring an interactive map of rapidly developing privacy laws across states.

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.