The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more
8/13/2025
/ Cybersecurity ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Popular ,
Whistleblowers
The Agency shows no signs of slowing regulatory activity.
Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
9/1/2016
/ Advisory Committee ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Diagnostic Tests ,
Enforcement Actions ,
Final Guidance ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Investigational Device Exemptions ,
Medicaid ,
Medical Devices ,
Medicare ,
Patient-Specific ,
Provider Payments ,
Unique Device Identifiers ,
Validity
The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices.
In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more