Privacy has become a political hot potato in the healthcare industry as advances in technology have fueled fierce debate over medical record confidentiality. Earlier this year, after much political wrangling, a wide-ranging regulation to ensure confidentiality of personal health information was enacted. Even now huge differences in opinion exist, with some calling the regulation long overdue, while others consider it unworkable.
The Health Insurance Portability and Accountability Act (HIPAA) became law in August 1996. The primary intent of the legislation was to create portable health benefits — to protect individuals and family health benefits in the case of a job loss or change. HIPAA instructed Congress to enact legislation that would create standards protecting an individual’s personal health information.
On the surface, the privacy protection rule is a step forward in patient rights. The regulation, however, is expected to make the research of new medicines more complex. The rule will require an additional layer of administration during clinical trials, and its impact could reach even further since virtually all the research necessary to demonstrate safety and efficacy of new medicines depends on data obtained from patients and providers.
Almost from the start, the privacy provision was controversial. When Congress failed to enact legislation by the deadline, the Department of Health and Human Services was…
Protecting Patient’s Privacy
Experts on this topic
John Bentivoglio. Attorney, Arnold & Porter, Washington, D.C.; Arnold & Porter is a law firm
Bonnie Brescia. President, BBK Healthcare Inc., Newton, Mass.; BBK is a healthcare communications agency
Dr. Joe Fortuna. Medical director at Dorland Sweeney Jones, Philadelphia; Dorland Sweeney Jones is a healthcare communications agency
Jean Paul Gagnon, Ph.D. Director, public policy, Aventis Pharmaceuticals Inc., Bridgewater, N.J.; Aventis is a global pharmaceutical company
Natasha Leskovsek. Attorney, Heller Ehrman, Washington, D.C.; Heller Ehrman is a law firm
John Mack. President, Internet Healthcare Coalition, Washington, D.C.; the Internet Healthcare Coalition is an international, non-partisan, non-profit organization dedicated to identifying and promoting quality healthcare resources on the Internet
Dr. John Schrogie. VP, peri-approval research services, Omnicare Clinical Research, Fort Washington, Pa.; Omnicare Clinical Research is a contract research organization and a division of Omnicare Inc., Covington, K.Y.
Heidi Wagner. Director of government affairs, Genentech Inc., Washington, D.C.; Genentech is a biotechnology company with headquarters in South San Francisco, Calif.