is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, July 1st, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
Manufacturers of medical devices and drugs had enough exemptions in the HIPAA privacy regulation that they could obtain most needed information in spite of the stringent controls on privacy rights. Occasionally such manufacturers needed to work under a Business Associate Agreement (BAA). However, the new statutory changes, including the privacy provisions of the HITECH Act, greatly increase the risk to manufacturers who work under BAAs. They are now directly liable under the HIPAA security regulations.
In this audio conference, FDA compliance attorney Bob Klepinski discusses the implications of this latest round of changes, how drug and device companies are expected to conduct themselves within this new HIPAA world, and the perils of failing to do so.
