In 2022, the Department of Health and Human Services Office of Inspector General (OIG) entered into 31 new corporate integrity agreements (CIAs) with companies and individuals in lieu of exercising its permissive exclusion...more
Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more
9/9/2021
/ Criminal Investigations ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Falsified Documents ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Product Defects ,
Qui Tam ,
Whistleblowers
On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more
11/25/2020
/ Coronavirus/COVID-19 ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fraud Alerts ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Speaker Programs
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
7/15/2020
/ Coronavirus/COVID-19 ,
Domestic Corporations ,
Food and Drug Administration (FDA) ,
Foreign Corporations ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rating System ,
Re-Opening Guidelines ,
Risk Assessment ,
Safety Inspections ,
Tobacco Regulations
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
4/30/2020
/ Civil Monetary Penalty ,
Clinical Laboratory Testing ,
Compliance ,
Coronavirus/COVID-19 ,
Corporate Misconduct ,
Criminal Penalties ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Prosecutors ,
Health IT ,
Inducements ,
Kickbacks ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Off-Label Promotion ,
Patient Safety ,
Pharmaceutical Industry ,
Product Defects ,
Sunshine Act
Many countries around the world are being forced to watch as the only tool they have to suppress COVID-19 — social distancing — causes unprecedented damage to their economies. Because suppression measures may be required...more
4/10/2020
/ Contact Tracing ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Privacy ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Innovative Technology ,
Medical Devices ,
Mobile Apps ,
NHSX ,
Risk Assessment ,
Shelter-In-Place ,
Transparency ,
UK ,
Virus Testing