Lina Genovesi, PhD, JD

As the pharmaceutical industry continues to face increasing cost of drug development, sample banking for future clinical research provides the pharmaceutical industry with new opportunities to obtain biological sample collections that will allow it to investigate safety and efficacy in future clinical research and answer regulatory authority questions related to safety and efficacy at the time of registration.

Sample banking for future clinical research provides the pharmaceutical industry with new opportunities to obtain biological sample collections.

The Omnibus Final Rule (Final Rule) entitled "Modifications of the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act" became effective on March 26, 2013.

On January 23, 2013, the Department of Health and Humans Services (HHS) published the Omnibus Final Rule (Final Rule) which modifies the "HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act and the Genetic Information Nondiscrimination Act of 2008."