Privacy and Confidentiality in Clinical Research

Summary

This practice note discusses the statutes and regulations governing privacy and confidentiality of patient information in clinical trials involving drugs, medical devices, and other life sciences products. In particular, this practice note explains the Health Insurance Portability and Accountability Act (HIPAA), federal Common Rule, and Food and Drug Administration (FDA) regulations, which set the standards for maintaining the privacy and confidentiality of data obtained from participants in clinical trials. It also highlights key compliance issues that arise in the context of advising life sciences companies about privacy and confidentiality in clinical trials settings.