Research Compliance Q&A: Focus on HIPAA

March 16, 2006 Published Work
Association of Healthcare Internal Auditors, New Perspectives, Winter 2006

Institutions and investigators that conduct clinical research need to be aware of how the HIPAA Privacy Rule applies to the use and disclosure of protected health information ("PHI") in the research context. Instititutions engaged in research often raise questions concerning the impact of HIPAA on subject recruitment activities, the use of PHI in research databases or for future studies, and whether a HIPAA authorization is required in certain circumstances unique to the research arena. The following questions and answers address these and other issues that affect covered entities involved in clinical research.