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
Overview -
- The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025.
- The...more
5/22/2025
/ Artificial Intelligence ,
Clinical Trials ,
EU ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector
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