The U.S. government’s recent complaint in a relator-filed case under the False Claims Act (FCA):
- Marks the first FCA suit in which the Department of Justice (DOJ) has intervened since launching its ongoing Civil...more
Two recent settlements under the False Claims Act (FCA):
- Signal enhanced risk around cybersecurity for recipients of federal funds.
- Underscore the need to assess compliance with cybersecurity requirements and...more
Circuit Split Widens Over AKS-Based FCA Causation Element -
The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more
3/25/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Life Sciences ,
OIG ,
Personal Information ,
Pharmaceutical Industry ,
Regulatory Reform
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
11/3/2023
/ Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
OCR ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Telehealth ,
Tracking Systems
Circuits Split Over Whether Targeting Is Necessary for Seller Liability -
Key Points -
- While courts have long held that solicitations must be tailored to a particular audience to precipitate statutory seller liability,...more
3/16/2023
/ Acquisitions ,
Bitcoin ,
Business Model ,
Cannabis Products ,
Class Action ,
Cryptocurrency ,
Cybersecurity ,
Department of Labor (DOL) ,
Disclosure ,
Dismissals ,
Entertainment Industry ,
Failure To Disclose ,
FinTech ,
Gambling ,
Healthcare ,
Investigations ,
Investors ,
Life Sciences ,
Media ,
Mergers ,
Online Platforms ,
Popular ,
Section 12 ,
Securities Act of 1933 ,
Securities and Exchange Commission (SEC) ,
Securities Litigation ,
Sellers ,
Social Media ,
Special Purpose Acquisition Companies (SPACs) ,
Telecommunications ,
Unregistered Securities ,
Whistleblower Protection Policies ,
Whistleblowers
Cornerstone Research reports that during the first six months of 2022, plaintiffs filed 110 securities class actions, a pace that is generally in line — 2.8% higher — with what we saw in the second half of 2021. Looking...more
12/5/2022
/ Class Action ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Corporate Sales Transactions ,
Cybersecurity ,
Enforcement Actions ,
FinTech ,
Futures ,
Healthcare ,
Initial Public Offering (IPO) ,
Life Sciences ,
Popular ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
Securities Litigation ,
Stock Options
The Chinese regulatory authorities have published several new regulations and proposals in the past two months seeking to clarify the requirements of the Chinese Personal Information Protection Law (the PIPL) that came into...more
Two new Chinese laws dealing with data security and privacy came into force in the fall of 2021 that are likely to have an impact on many multinational companies operating in China or whose operations touch China. These two...more
11/4/2021
/ Algorithms ,
Artificial Intelligence ,
China ,
Corporate Counsel ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
International Data Transfers ,
Personal Information ,
Personal Information Protection Law (PIPL)
Addressing the Evolving Risks -
Warren Buffett said that “only when the tide goes out do you discover who’s been swimming naked.” Buffett was not talking about compliance programs in a time of crisis, but his wisdom applies...more
5/2/2020
/ Anti-Corruption ,
Anti-Money Laundering ,
BSA/AML ,
Compliance ,
Coronavirus/COVID-19 ,
Corporate Misconduct ,
Cybersecurity ,
Disclosure Requirements ,
Economic Sanctions ,
Enforcement Actions ,
FFIEC ,
Financial Distress ,
Financial Fraud ,
FinCEN ,
Foreign Corrupt Practices Act (FCPA) ,
Market Manipulation ,
Office of Foreign Assets Control (OFAC) ,
Popular ,
Public Health Emergency ,
Publicly-Traded Companies ,
Risk Assessment ,
Risk Mitigation ,
Sanction Violations ,
Securities and Exchange Commission (SEC)
This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more
10/3/2019
/ Anti-Money Laundering ,
Appeals ,
Blocking Statutes ,
Bribery ,
CFTC ,
China ,
CLOUD Act ,
Communication Restrictions ,
Compliance ,
Conspiracies ,
Cooperation Agreement ,
Crime (Overseas Production Orders) Act 2019 (the COPO Act) ,
Criminal Prosecution ,
Cross-Border Transactions ,
Cryptocurrency ,
Cybersecurity ,
Deferred Prosecution Agreements ,
Denial of Certiorari ,
Department of Justice (DOJ) ,
Deutsche Bank ,
Disclosure ,
Dodd-Frank ,
Economic Sanctions ,
Enforcement Actions ,
EU ,
EURIBOR ,
Exports ,
Extradition ,
Extraterritoriality Rules ,
Financial Conduct Authority (FCA) ,
Financial Records ,
Foreign Corrupt Practices Act (FCPA) ,
Foreign Exchanges ,
France ,
Fraud ,
General Data Protection Regulation (GDPR) ,
Government Investigations ,
Hackers ,
Hungary ,
Imports ,
India ,
Indictments ,
Information Sharing ,
Iran Sanctions ,
Israel ,
Lithuania ,
Money Laundering ,
Morrison v National Australia Bank ,
Multinationals ,
Office of Foreign Assets Control (OFAC) ,
Opioid ,
Pharmaceutical Industry ,
Popular ,
Rate-Rigging ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Serious Fraud Office (SFO) ,
Spoofing ,
Subpoenas ,
Swiss Supreme Court ,
Switzerland ,
Tax Crimes ,
Tax Evasion ,
Tax Treaty ,
Turkey ,
UK ,
United States ,
Venezuela ,
Wal-Mart
This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including DOJ guidance on the use of corporate monitors in criminal...more
1/7/2019
/ Anti-Bribery ,
Anti-Corruption ,
Anti-Money Laundering ,
Appeals ,
Attorney-Client Privilege ,
Brazil ,
Bribery ,
BSA/AML ,
China ,
Corporate Counsel ,
Criminal Conspiracy ,
Criminal Convictions ,
Criminal Investigations ,
Cross-Border ,
Cryptocurrency ,
Cyber Attacks ,
Cybersecurity ,
Data Privacy ,
Data Protection Acts ,
Department of Justice (DOJ) ,
Enforcement Actions ,
EU ,
Exports ,
Extraterritoriality Rules ,
FATCA ,
Financial Crimes ,
Foreign Corrupt Practices Act (FCPA) ,
Forex ,
France ,
Government Investigations ,
Guilty Pleas ,
Hackers ,
Imports ,
International Litigation ,
Iran ,
Legal Professional Privilege ,
Libor ,
Litigation Privilege ,
Market Manipulation ,
Money Laundering ,
Multi-Jurisdictional Litigation ,
Multinationals ,
NYDFS ,
Privileged Communication ,
Russia ,
Sanction Violations ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
SFO ,
Spoofing ,
Tax Fraud ,
Traders ,
UK ,
Unexplained Wealth Orders (UWOs) ,
United Arab Emirates (UAE) ,
Yates Memorandum
This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including the use of legal holds in cross-border investigations,...more
8/29/2018
/ China ,
Civil Monetary Penalty ,
Cooperation ,
Criminal Investigations ,
Cross-Border Transactions ,
Cryptocurrency ,
Cybersecurity ,
Data Breach ,
Data Protection ,
Department of Justice (DOJ) ,
Enforcement Actions ,
EU ,
Fee Reductions ,
General Data Protection Regulation (GDPR) ,
Initial Coin Offering (ICOs) ,
Personal Liability ,
Popular ,
Privileged Communication ,
Serious Fraud Office (SFO) ,
Settlement ,
Trump Administration ,
UK
On September 20, 2016, the Bureau of Industry and Security (BIS) of the U.S. Commerce Department amended the Export Administration Regulations (EAR) and the list of goods, software and technology that are controlled under the...more
9/30/2016
/ Arms Export Control Act ,
Bureau of Industry and Security (BIS) ,
CCATS ,
Commerce Control List ,
Cybersecurity ,
Dual Use Goods ,
ECCNs ,
Encryption ,
Exceptions ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
Licensing Rules ,
Software ,
Technology ,
U.S. Commerce Department