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
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
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 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
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more
8/24/2020
/ Anti-Kickback Statute ,
Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fines ,
Health Care Providers ,
Incentive Compensation ,
Life Sciences ,
Marketing ,
Novartis ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Popular ,
Qui Tam ,
Risk Assessment ,
Risk Mitigation ,
Salespersons ,
Settlement Agreements ,
Speaker Programs
As health organizations and governments around the world work to contain the coronavirus (COVID-19), businesses should be mindful of the various ways the virus may impact their operations and employees. The wide range of...more
3/5/2020
/ Acquisitions ,
Anti-Discrimination Policies ,
Business Interruption ,
Capital Markets ,
Centers for Disease Control and Prevention (CDC) ,
Commercial Contracts ,
Coronavirus/COVID-19 ,
Corporate Restructuring ,
Cybersecurity ,
Derivatives ,
Disclosure Requirements ,
Employment Policies ,
Equity Securities ,
Force Majeure Clause ,
Global Economy ,
Leveraged Finance ,
Life Sciences ,
Mergers ,
OSHA ,
Popular ,
Public Health ,
Public Safety ,
Publicly-Traded Companies ,
Securities and Exchange Commission (SEC) ,
Securities Litigation ,
Supply Chain ,
Virtual Meetings
In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many of these proposals are...more
1/18/2019
/ Affordable Care Act ,
Constitutional Challenges ,
Department of Justice (DOJ) ,
Deregulation ,
Digital Health ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Life Sciences ,
Popular ,
Tax Credits ,
Trump Administration ,
White Collar Crimes
On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more
12/14/2018
/ Adverse Events ,
Criminal Convictions ,
Criminal Forfeiture ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Failure to Report ,
Failure-to-File ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fines ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Interstate Commerce ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Misbranding ,
Patient Safety ,
Personal Liability ,
Plea Agreements ,
Popular ,
Warning Letters
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
12/13/2018
/ Anti-Bribery ,
Anti-Corruption ,
Anti-Kickback Statute ,
Bribery ,
Compliance ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Drug Pricing ,
Enforcement Actions ,
Ethical Standards ,
False Claims Act (FCA) ,
FDA Approval ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Internal Investigations ,
Kickbacks ,
Life Sciences ,
Materiality ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
PHRMA ,
Popular ,
Product Labels ,
Rebates ,
Safe Harbors ,
Securities and Exchange Commission (SEC) ,
Sunshine Act ,
Transparency ,
Universal Health Services Inc v United States ex rel Escobar ,
Whistleblowers
Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more
6/20/2018
/ 21st Century Cures Act ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health IT ,
Innovative Technology ,
Manufacturers ,
Medical Devices ,
OCR ,
Popular ,
Software Developers
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
3/30/2018
/ Acquisitions ,
Anti-Kickback Statute ,
Biotechnology ,
Charitable Donations ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Donations ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Life Sciences ,
Materiality ,
Medical Devices ,
Medicare ,
Off-Label Promotion ,
OIG ,
Park Doctrine ,
Patient Assistance Programs ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Promotional Items ,
Split of Authority ,
Universal Health Services Inc v United States ex rel Escobar ,
Warning Letters ,
Whistleblowers
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
12/5/2017
/ Anti-Kickback Statute ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Materiality ,
Medical Devices ,
Off-Label Promotion ,
OIG ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Popular ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more
9/29/2015
/ Advertising ,
Amarin ,
Caronia ,
Commercial Speech ,
Corporate Counsel ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Advertising ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Labeling ,
Medical Devices ,
Misleading Impressions ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Popular ,
Product Labels ,
Ripeness ,
Warning Letters