Overview
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:
🔷 Overlapping regulatory frameworks — HIPAA, the Common Rule, FDA, and GDPR — and how they collide in clinical research
🔷 Sponsor liability, CRO responsibilities, and the contractual gaps that create exposure
🔷 How breaches can jeopardize trial integrity, delay FDA submissions, and erode patient trust
🔷 Practical strategies to reduce risk, from indemnity provisions and insurance to robust incident response planning
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Featured Experts
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Hal Porter, Director of Consulting Services Clearwater
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Dianne Bourque, Partner, Holland & Knight LLP
