In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring...more
4/16/2025
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Clinical Laboratories ,
Food and Drug Administration (FDA) ,
Judicial Review ,
Laboratory Developed Tests ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Regulatory Authority ,
Statutory Interpretation
On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more
On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more
9/30/2024
/ Administrative Procedure Act ,
Class Action ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
PHI ,
Proposed Rules ,
Regulatory Requirements ,
Tracking Systems ,
Web Tracking