Vates Jennifer R, Hetrick Jennifer L Ridge, Lavin Kelly L, Sharma Giriraj K, Wagner Robin L, Johnson Jonas T
Department of Otolaryngology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Laryngoscope. 2005 Mar;115(3):441-4. doi: 10.1097/01.mlg.0000157829.00509.e9.
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was enacted with the long-term goal of improving the efficiency and effectiveness of health care. It has created sweeping changes for clinical medicine and research. Generally, the standards for privacy of individual, identifiable health information (the privacy rule) require patient consent before their protected health information (PHI) can be employed in clinical research. This rule requires that all patients sign an IRB approved informed consent before their identifiable clinical information can be aggregated with the information from other patients. This rule has been applied to ensure the privacy of health care data accrued previously. Accordingly, investigators have been blocked from using the aggregate data from prior clinical records and registries until consent is obtained from living, former patients. At the University of Pittsburgh Department of Otolaryngology, a clinical tumor registry was established in 1982. These data have served as the basis for over 200 publications reflecting practice-based learning. The present study quantifies the cost of HIPAA compliance to maintain access to our faculty's career-long clinical activities and to stress to all physicians the importance of research registries as a means of protecting their own career's work.
RESULTS/CONCLUSIONS: Compliance with the privacy rule required that written, informed consents be mailed to 14,330 former patients. This resulted in direct costs of more than $30,888. The practical and financial impact of HIPAA on clinical research and our departmental solutions to these challenges are discussed.
