Beyond Privacy Implications: Data Breaches in Clinical Trials

• September 12, 2025

As clinical research becomes increasingly digital, the legal and compliance landscape is shifting. Hal Porter, Director of Consulting Services, Clearwater, speaks with Dianne Bourque, Partner, Holland & Knight LLP, about the legal, regulatory, and ethical considerations when clinical trial data is compromised. They discuss issues related to regulatory frameworks and legal obligations, risk exposure and liability, impacts of a breach that go beyond privacy, cross border data and transfer risks, and mitigating the risk and fallout of data breaches in clinical trials. Sponsored by Clearwater.