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.

Because health data on patients are among the most sensitive types of personal information, protecting the confidentiality of personally identifiable health data is critical. Insufficient protections leading to unauthorized use and disclosures of data may subject individuals to adverse consequences such as loss of personal privacy and social stigma, as well as damaged financial standing, employability, and insurability.

Although a September 2004 US Government Accountability Office report found that organizations believe that HIPAA implementation went more smoothly than expected, the report also found that organizations continue to face many challenges involving access to health information for public health monitoring, research, and patient advocacy.7 By understanding what is required of those involved in clinical research, HIPAA compliance may become less challenging. This chapter highlights the HIPAA requirements for those involved in clinical research and illustrates how and why HIPAA's Privacy Rule protects identifiable health information.

From: Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition Edited by: K. M. Becker and J. J. Whyte © Humana Press Inc., Totowa, NJ

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