Protecting Patient Data in a Changing Regulatory Landscape
In this discussion, Edye Edens and Helen Maurer dive into the critical topic of data privacy and security in clinical research, particularly in light of potential federal oversight. Helen, an expert in compliance and quality assurance within oncology research, emphasizes the need for clinical trial sites—especially those at major academic medical centers—to understand whether their privacy regulations fall under state or federal jurisdiction. They explore hypothetical scenarios where federal ...