How does HIPAA work under Version 3.0?

Version 3.0 of the SMART IRB Reliance Agreement places the Relying Institution that is a HIPAA Covered Entity in the driver seat for all HIPAA-related matters, including waiver/alterations, HIPAA authorization language, and HIPAA compliance. Please note that like V2.0, the Agreement continues to allow for flexibility for HIPAA items, e.g. institutions may opt to use flexible provisions to enable the Reviewing IRB to utilize their HIPAA language or have the Reviewing IRB make HIPAA determinations (e.g. waiver or alteration of authorization) on behalf of a relying institution.