On July 30, 2025, the U.S. Department of Justice (DOJ) announced that biotechnology company Illumina Inc. agreed to pay $9.8 million plus interest to resolve allegations of misrepresenting compliance with federal...more
8/6/2025
/ Biotechnology ,
Corporate Counsel ,
Cybersecurity ,
Cybersecurity Maturity Model Certification (CMMC) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
NIST ,
Popular ,
Whistleblowers
Private capital firms focused on investment and operations within the Life Science and Healthcare industries face complex compliance, operational, and business risks. To help clients navigate this evolving environment, White...more
8/5/2025
/ Acquisitions ,
Artificial Intelligence ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Life Sciences ,
Mergers ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Private Equity Firms
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
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