What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more
5/9/2025
/ Biologics ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Regulatory Reform ,
Research and Development ,
Risk Assessment ,
Risk Management ,
Supply Chain
On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. ยง 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more
1/24/2025
/ Artificial Intelligence ,
Automation Systems ,
Covered Entities ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
OCR ,
Regulatory Requirements ,
Risk Management ,
Section 1557