HIPAA Compliance in Clinical Research

The passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) has generated widespread concern that clinical research may be increasingly difficult to conduct. Certainly, those involved in clinical research may feel frustrated or confused by HIPAA’s requirements, particularly when the media report that investigators have been denied access to patient records or that patient enrollment in studies has dramatically decreased. Innovative drugs and devices that improve and save lives would not be possible without the contributions of clinical research and human subject volunteers.