The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more
8/13/2025
/ Cybersecurity ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Popular ,
Whistleblowers
The risks associated with the growth of AI in the healthcare and life sciences industries, as well as recent federal and state activity and enforcement actions, emphasize the importance of understanding and implementing a...more
The US Departments of Justice and Health and Human Services recently issued a press release on the formation of a new False Claims Act Working Group, signaling to the healthcare industry an increased focus on anti-fraud...more
In United States ex rel. Cairns v. DS Medical LLC, the US Court of Appeals for the Eighth Circuit set a higher bar for proving causation in False Claims Act cases where plaintiffs seek to establish liability under the 2010...more
Last month we had an incredibly insightful Fast Break analyzing a significant HIPAA enforcement victory for The University of Texas MD Anderson Cancer Center (MD Anderson) in the US Court of Appeals for the Fifth Circuit. ...more
The US Court of Appeals for the Fifth Circuit issued its ruling in the landmark HIPAA case between The University of Texas MD Anderson Cancer Center (MD Anderson) and the US Department of Health and Human Services (HHS). The...more