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
On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more
10/3/2023
/ Clinical Laboratory Testing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements
In this month’s Privacy & Cybersecurity Update, we examine Delaware’s new comprehensive data privacy law, a joint statement by 12 data protection authorities on data scraping and data protection, a district court ruling on a...more
10/3/2023
/ California Privacy Protection Agency (CPPA) ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Popular ,
Privacy Laws ,
Risk Assessment ,
Risk Management ,
State and Local Government ,
State Data Privacy Laws ,
State Privacy Laws ,
Web Scraping
In this month’s Privacy & Cybersecurity Update, we analyze the Biden administration’s proposed cybersecurity labeling program for smart devices, NIST’s extensive overhaul of its cybersecurity framework, and data privacy law...more
9/6/2023
/ Biden Administration ,
California ,
California Privacy Rights Act (CPRA) ,
Colorado ,
Compliance ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Labeling ,
NIST ,
Popular ,
Privacy Laws ,
Smart Devices ,
State Privacy Laws
In this month’s Privacy & Cybersecurity Update, we examine the newly established data privacy framework between the EU and U.S. and new consumer privacy laws in Oregon and Texas. We also review a court ruling that delayed...more
8/2/2023
/ Biometric Information Privacy Act ,
California ,
California Privacy Rights Act (CPRA) ,
Cyber Incident Reporting ,
Cybersecurity ,
Cybersecurity Framework ,
Data Privacy ,
Data Transfers ,
Disclosure ,
EU ,
European Commission ,
European Economic Area (EEA) ,
General Data Protection Regulation (GDPR) ,
NYDFS ,
Oregon ,
Popular ,
Privacy Laws ,
Proposed Amendments ,
Regulatory Requirements ,
Risk Management ,
Texas
In our June Privacy & Cybersecurity Update, we review new data privacy laws in Colorado, Connecticut, Florida and Montana; Verizon’s annual Data Breach Investigations Report; AM Best’s report on cyber insurance trends; and...more
7/6/2023
/ Biometric Information Privacy Act ,
Consumer Privacy Rights ,
Cyber Insurance ,
Cybersecurity ,
Data Breach ,
Data Collection ,
Data Processors ,
Data Protection ,
Employer Liability Issues ,
Employment Litigation ,
Enforcement ,
Investigations ,
Liability ,
Negligence ,
New Amendments ,
New Legislation ,
New Regulations ,
Opt-Outs ,
Popular ,
Privacy Laws ,
State and Local Government ,
State Privacy Laws ,
Technology Sector ,
Verizon
On June 1, 2023, the U.S. Supreme Court issued its highly anticipated decision in the consolidated cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc., Nos. 21-1326 &...more
6/12/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more
6/8/2023
/ Clawbacks ,
Compensation ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
New Regulations ,
OIG ,
Self-Disclosure Requirements
In this month’s Privacy & Cybersecurity Update, we review new consumer privacy laws in Tennessee and Indiana, three GDPR rulings by the Court of Justice of the European Union, updates regarding future California Privacy...more
6/5/2023
/ California Privacy Protection Agency (CPPA) ,
Cyber Insurance ,
Cybersecurity ,
EU ,
European Court of Justice (ECJ) ,
Fraud ,
General Data Protection Regulation (GDPR) ,
Hackers ,
Insureds ,
Liability ,
Privacy Laws ,
State Privacy Laws ,
Wire Fraud
In this month’s Privacy & Cybersecurity Update, we look at Washington state’s passage of the first-ever state-level health data privacy law and the finalized California Consumer Privacy Act regulations. We also examine a...more
5/2/2023
/ California Consumer Privacy Act (CCPA) ,
California Privacy Rights Act (CPRA) ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Fraudulent Wire Transfers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Insurance Industry ,
Medical Devices ,
Notice of Proposed Rulemaking (NOPR) ,
Popular ,
Privacy Laws ,
Reproductive Healthcare Issues ,
State Privacy Laws
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
In this month’s Privacy & Cybersecurity Update, we examine Iowa’s new data privacy law (the sixth state to enact a privacy law), the Biden administration’s new national cybersecurity strategy, the U.K. government’s revised...more
4/4/2023
/ Amended Regulation ,
Biden Administration ,
Consumer Privacy Rights ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Data Protection ,
National Security ,
Popular ,
Privacy Laws ,
State Privacy Laws ,
UK
In early March 2023, the Department of Justice (DOJ) released several important updates to its policies related to corporate crime enforcement and compliance programs. We discuss below the following key topics:
(i) The DOJ...more
3/13/2023
/ Corporate Crimes ,
Corporate Entities ,
Corporate Financing ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Employees ,
Executive Compensation ,
Financial Institutions ,
Instant Messaging Apps ,
Mobile Devices ,
Pilot Programs ,
White Collar Crimes
Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more
On January 17, 2023, the U.S. Department of Justice (DOJ) announced revisions to the Criminal Division’s Corporate Enforcement Policy. The revisions follow Deputy Attorney General (DAG) Lisa Monaco’s September 2022...more
1/24/2023
/ Anti-Corruption ,
Anti-Money Laundering ,
Commodities ,
Corporate Governance ,
Corporate Misconduct ,
Cross-Border ,
Department of Justice (DOJ) ,
Economic Sanctions ,
Enforcement Actions ,
False Claims Act (FCA) ,
Investigations ,
Securities and Exchange Commission (SEC) ,
Self-Reporting ,
White Collar Crimes
Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more
1/6/2023
/ Consolidated Appropriations Act (CAA) ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
HCEI ,
Information Sharing ,
Joe Biden ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry
In a speech on September 15, 2022, Deputy Attorney General (DAG) Lisa Monaco announced several important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. These...more
On August 7, 2022, the Senate passed the Inflation Reduction Act (the Act), which is expected to have a significant impact on climate, tax and health care policy in the United States. The result of intense negotiations among...more
On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more
In 2021, the Department of Health and Human Services Office of Inspector General (HHS-OIG) entered into 30 new corporate integrity agreements (CIAs) with companies and individuals to resolve exclusion authority arising out of...more
Takeaways - Despite predictions that the Biden administration would devote increased enforcement resources to the life sciences industry broadly, so far, the FDA and DOJ have focused their efforts on COVID-related...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 August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more
8/18/2021
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fifth Amendment ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Product Labels ,
Safe Harbors
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers About the Enforcement in Life Sciences Series Recent settlements between the U.S. Department of...more