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.

This audio conference covers:

• HIPAA changes, current risks and penalties
• How to get information from health care providers under HIPAA
• When you need a BAA
• Reasons to avoid a BAA unless absolutely necessary
• Effect under the security rule of working under a BAA

About the speaker:

Robert J. Klepinski is an Officer with Fredrikson & Byron and practices in the Food and Drug Administration, Health Care Fraud & Compliance and Intellectual Property service areas. He is also recognized as one of the leading FDA compliance attorneys. He counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy. Previously, he served as a regulatory attorney for Medtronic. While there, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.

Robert frequently speaks at local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools, including Northwestern University, Hamline University and William Mitchell College of Law. He is an adjunct professor at St. Thomas University Graduate School of Engineering and its MBA program.

Who should attend?

• Compliance officers
• Privacy officers
• Regulatory affairs professionals
• Clinical trial professionals