Update on the EU-U.S. Data Privacy Framework

Since our previous post discussing plans for the European Union-U.S. Trans-Atlantic Data Privacy Framework, the United States has taken a significant step toward setting this new framework into action. On Oct. 7, 2022, President Joe Biden signed an “Executive Order on Enhancing Safeguards for United States Signals Intelligence Activities,” which lays out steps the U.S.…

New Changes to the European Union’s Medical Device and In Vitro Diagnostic Device Regulations

On May 26, 2020, the European Union enacted new regulations concerning medical and in vitro diagnostic devices—a move that should cause manufacturers, clinical trial sponsors, investigators, and other regulated parties involved in medical device development, manufacture, and distribution in the EU to take notice. These new regulations replace existing directives and bring about many changes,…

EU’s New Whistleblower Directive & Impacts on RIM

Whistleblower Directive Quick Overview The EU recently approved a new Whistleblower Directive promoting common minimum standards designed to enhance protections for Whistleblowers and prevent retaliation for participation in whistleblowing activities. The directive allows for reporting of breaches of law both internally within companies, and externally, directly to national and EU authorities, and requires the creation…