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
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