Abstract
HIPAA, the Health Insurance Portability and Accountability Act, is a federal law passed by US Congress in 1996 that requires the establishment of national standards for electronic transactions, privacy and security of healthcare information. This white paper highlights the impact of HIPAA on clinical research activities, how the HIPAA Privacy rule works in the course of conducting research, the HIPAA requirements from Business Associate perspective, transition provisions, and penalties for non-compliance and key monitoring agencies for HIPAA compliance.

The HIPAA Administrative Simplification-mandated regulations of DHHS do not apply directly to life science organizations (LSOs). Nevertheless, HIPAA’s privacy and security regulations will have a significant impact on the conduct of clinical trials by LSOs. The HIPAA Privacy Rule establishes the conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes. Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generali zable knowledge.

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