The Final Rule: What Does It Mean for Health and Life Sciences Stakeholders?
Hosted by McDermott Will & Emery
Location, or Event type: Online
The Final Rule: What Does It Mean for Health and Life Sciences Stakeholders?
Webinar, Hosted By McDermott Will & Emery
Wednesday, March 1, 2017 - 6:00 AM
Please join us for a lunch hour webinar discussion on the recently published US Department of Health and Human Services (HHS) Final Common Rule. McDermott partners Bernadette Broccolo, Jiayan Chen and Jennifer Geetter will outline what this means for stakeholders now and in the future, including these notable changes:
-
Creation of biorepositories and other future research uses
-
Definition of “human subject” and agency policy position on identifiability of biospecimens and genomic data
-
Coordination and harmonization with the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
-
Jurisdictional scope and federal-wide assurances
-
Updates to exempt categories of research
-
Changes to scope of and approach to securing institutional review board (IRB) review