The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
6/20/2024
/ Artificial Intelligence ,
Biologics ,
Cannabis Products ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Marijuana ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology
In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services arrangement with referring...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA), the...more
10/23/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Reform ,
OIG ,
Regulatory Agenda ,
Regulatory Reform ,
Stark Law
In February 2022, US President Joseph Biden announced an overhaul of regulations affecting nursing homes. These reforms, aimed at enhancing the safety and quality of care for nursing-home residents, focus on improving...more
On April 20, 2023, the US Department of Health and Human Services (HHS) made ownership data of all Medicare-certified hospices and home health agencies publicly available for the first time. This move is consistent with the...more