Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more
7/23/2025
/ AI Act ,
Artificial Intelligence ,
Compliance ,
EU ,
European Commission ,
Healthcare ,
Liability ,
Manufacturers ,
Medical Devices ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Management
On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more
7/21/2025
/ Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Legislative Agendas ,
Life Sciences ,
Medicare ,
Medicare Advantage ,
Popular ,
Regulatory Agenda ,
Risk Management ,
Trump Administration ,
Whistleblowers
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
5/6/2025
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Popular ,
Private Equity ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Tariffs ,
Technology ,
Trump Administration