HIPAA (Health Insurance Portability and Accountability Act of 1996) required the creation of a Privacy Rule for identifiable health information. The resultant Privacy Rule, finalized in August 2002, took effect on April 14, 2003. While the main impact of the Privacy Rule is on the provision of care (treatment, payment and operations), the Rule also affects the conduct and oversight of research.

To understand more about how the HIPPA act impacts clinical research, read more: http://healthcare.partners.org/phsirb/hrchipaa.htm