On May 19, 2025, the U.S. Deputy Attorney General issued a memorandum (the “Memo”) announcing a Civil Rights Fraud Initiative (the “Initiative”) and instructing the U.S. Department of Justice (“DOJ”) to pursue False Claims...more
5/22/2025
/ Affirmative Action ,
Department of Justice (DOJ) ,
Diversity and Inclusion Standards (D&I) ,
Employment Discrimination ,
Enforcement Actions ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Contractors ,
Universities ,
Whistleblowers ,
White Collar Crimes
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more
This year, at the Federal Bar Association’s (FBA) annual Qui Tam Conference, United States Department of Justice (DOJ) leadership confirmed that DOJ will remain committed to aggressive enforcement of the False Claims Act...more
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the eighth episode of When Your Life Sciences Are on the...more
2/25/2025
/ Department of Justice (DOJ) ,
Enforcement Actions ,
Fraud ,
Insider Trading ,
Internal Controls ,
Life Sciences ,
Mergers ,
Risk Management ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
Securities Regulation ,
Thought Leadership ,
White Collar Crimes
The 119th Congress is underway, and Republicans control both chambers. With President Trump in the White House, both the House and the Senate will focus more of their oversight on the private sector. Continuing a trend over...more
2/5/2025
/ Artificial Intelligence ,
Banking Sector ,
China ,
Congressional Investigations & Hearings ,
Corporate Counsel ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Data Privacy ,
Data Protection ,
Data Security ,
Diversity and Inclusion Standards (D&I) ,
Environmental Social & Governance (ESG) ,
Federal Trade Commission (FTC) ,
Financial Services Industry ,
Pharmacy Benefit Manager (PBM) ,
Regulatory Agenda ,
Technology Sector
In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more
1/28/2025
/ Compliance ,
Cybersecurity ,
Data Privacy ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
NASA ,
Personally Identifiable Information ,
Private Equity ,
Qui Tam ,
Trump Administration ,
Venture Capital ,
Voluntary Disclosure ,
Whistleblowers
The Department of Justice published its False Claims Act (FCA) statistics for Fiscal Year 2024 this month, revealing a nearly 40% increase in whistleblower filings, increased recoveries year over year, and a near record...more
1/22/2025
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Healthcare Fraud ,
Medicaid ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
Settlement ,
State Attorneys General ,
Whistleblowers
On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more
1/22/2025
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Genetic Testing ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Manufacturers ,
OIG ,
Pharmaceutical Industry
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the seventh episode of When Your Life Sciences Are on...more
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the sixth episode of When Your Life Sciences Are on the...more
On April 9, 2024, the United States Department of Justice (DOJ) released a report on the COVID-19 Fraud Enforcement Task Force (“Task Force”), by far DOJ’s most comprehensive review of the Task Force since its creation in...more
4/25/2024
/ Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Economic Injury Disaster Loans ,
Enforcement ,
False Claims Act (FCA) ,
FBI ,
Fraud ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Paycheck Protection Program (PPP) ,
Qui Tam
Artificial Intelligence (AI), specifically generative AI technologies, hold significant promise for improving the healthcare industry by streamlining clinical operations, freeing service providers from mundane tasks, and...more
3/4/2024
/ Algorithms ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Information Technologies ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Popular ,
Prior Authorization
On February 14, 2024, Deputy Attorney General Lisa Monaco announced two important developments related to the advent of artificial intelligence (AI) as it relates to the work of the U.S. Department of Justice (DOJ). First,...more
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more
1/10/2024
/ Anti-Kickback Statute ,
Antitrust Violations ,
Artificial Intelligence ,
CDRH ,
Cyber Attacks ,
Cybersecurity ,
Data Security ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
OPDP ,
Popular ,
Ransomware ,
Securities and Exchange Commission (SEC)
On March 28, 2023, the U.S. Court of Appeals for the Sixth Circuit issued a decision in U.S. ex rel. Martin v. Hathaway limiting the scope of liability under the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) in...more
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more
11/16/2022
/ Biotechnology ,
Clinical Trials ,
Criminal Investigations ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Data ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences
On September 28, 2022, the Assistant Attorney General for the Criminal Division of the United States Department of Justice (DOJ) joined the Inspector General for the United States Department of Health and Human Services...more