Data Privacy Minefields: Mastering FDA Compliance and Privacy Standards for Drug and Device Manufacturers

Foley partner Aaron Tantleff is speaking in the American Conference Institute’s 29^th Annual Conference on Drug & Medical Device Litigation in a session titled “Data Privacy Minefields: Mastering FDA Compliance and Privacy Standards for Drug and Device Manufacturers.” Data privacy laws impact drug and medical device development, with pixel technology, biometric devices, and online portals posing major risks. This session will 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 U.S. Food and Drug Administration (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.

CLE

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation. Learn more here.