As technology quickly evolves in the healthcare industry, the distinctions between clinical research and innovative medical treatment may become blurred. Columbia partner Jennifer Mallory and Winston-Salem partner Carrie Hanger will discuss the reasons for the differences between these two as well as the risks of ignoring those differences at the HCCA Annual Compliance Institute, which will be held virtually on April 22.

Mallory and Hanger will cover humanitarian use devices, emergency use authorization, and emerging therapies, including those for COVID-19. Participants will learn how to use these distinctions to align their internal procedures and make sure they are mitigating risk.

Mallory holds graduate certificates in Pharmaceutical and Medical Device Law and Compliance: FDA Regulation and Liability as well as Clinical Research and the Law from Seton Hall University School of Law. Hanger focuses her practice on advising healthcare providers and entities engaged in clinical research.