December 4, 2024

Troutman Pepper is proud to sponsor the American Conference Institute’s Drug & Medical Device Litigation Conference, taking place December 3-4, 2024, at the Marriot Marquis, New York, NY.

Partners Brett A. Mason and Brent Hoard will be speaking on Wednesday, December 4.

Brett will be a panelist on the 11:00 a.m. session, “AI in Drug Development and Medical Devices: Unpacking Liability Risks in the Life Sciences.”

AI is revolutionizing drug development and diagnostics by predicting diseases and identifying therapies from large-scale biometric data. However, this invites increased risks and potential product liability. Join this breakout as our session leaders explore:

• Investigating the legal and regulatory landscape governing AI use in the pharmaceutical and medical device space

• Reviewing the recent guidance on AI/ML-Enabled Device Software Functions and the potential product liability risks

• Evaluating liability for AI-enabled drug development
  Calibrating the approach to implementing and monitoring healthcare AI tools based on a careful assessment of the liability risk of each tool

• Examining case law on physical injury caused by AI or the malfunctioning of software embedded in medical devices

• Understanding how companies can issue spot areas of potential product liability risk associated with the use of AI, and address the risks up front

And Brent will be a panelist on the 11:45 a.m. session, “Data Privacy Minefields: Mastering FDA Compliance and Privacy Standards for Drug and Devices Manufactures.”

Data privacy laws impact drug and medical device development, with pixel technology, biometric devices, and online portals posing major risks. Join this breakout to explore strategies for limiting litigation risk and preventing data breaches. Topics of discussion will include:

• Implementing encryption, access controls and other security measures to prevent unauthorized access to patient data

• Prioritizing data protection when choosing a vendor for FDA compliance assistance to meet standards effectively

• Managing compliance documentation and audit trails from risk assessments and internal audits

• Fortifying Data Security in the Supply Chain and in online portals

• Emerging legal issues with wearable and 3D printed devices

ACI’s Drug and Medical Device Litigation conference is the life sciences industry’s premier products liability conference, providing invaluable information on the potential impact of newly proposed MDL rule changes, overcoming the challenges of plaintiff census forms and registries, and how new Rule 702 amendments will impact future strategies for offering expert testimony.