Beyond Privacy Implications: Data Breaches in Clinical Trials

Healthcare attorney Dianne Bourque joined an episode of the American Health Law Association's (AHLA) Speaking of Health Law podcast for a conversation on the increasingly digital nature of clinical research and the legal and regulatory considerations implicated by this trend. Ms. Bourque, whose practice spans the Health Insurance Portability and Accountability Act (HIPAA), health information privacy and data security, and clinical research, talked about the regulatory framework surrounding clinical trials, including federal HIPAA rules on protected health information (PHI) and human subject protections, as well as ethical issues that arise when clinical data is compromised. She additionally touches on risk exposure and liability and how to respond to data breaches.

Duration: 43:53