Certificates of Confidentiality: Mind the Gap

Certificates of Confidentiality (“Certificates”) are a federal mechanism designed to protect sensitive, identifiable research data from compelled disclosure in any legal proceeding. The 21st Century Cures Act revised the authorizing statute to address criticisms raised about the Certificates’ coverage and protections. Despite many changes that expanded the scope and reinforced the protection of Certificates, questions remain concerning the robustness of the protection Certificates afford. Here, we briefly review the legal evolution of Certificates and then examine the gaps in protections that remain and their implications.

We conclude with recommendations for areas of clarification and future research.