HIPAA AND PRIVACY ISSUES

The Health Insurance Portability and Accountability Act, or HIPAA, has far-reaching effects on pharmaceutical and medical device companies. Some companies are considered “covered entities” under HIPAA, subject to a wide range of requirements. Others are considered “business associates” and will need to negotiate business associate contracts with covered entities. Even if a pharmaceutical or medical device company is neither a “covered entity” nor “business associate,” HIPAA issues will arise in the context of sponsoring clinical research and engaging in direct-to-consumer marketing. In addition, the FTC and the States are becoming increasingly active in regulating privacy issues and this activity will impact pharmaceutical and medical device companies in various ways. KKB advises its clients on the privacy implications of their activities and works with clients to meet their research and marketing objectives while minimizing regulatory risk.