As Trump administration directives emerge, it’s crucial for businesses and other stakeholders to stay informed and adapt their strategies accordingly. We will provide ongoing coverage of these developments and their potential...more
2/4/2025
/ Affirmative Action ,
Artificial Intelligence ,
Climate Change ,
Cybersecurity ,
Diversity and Inclusion Standards (D&I) ,
Energy Sector ,
Environmental Social & Governance (ESG) ,
Executive Orders ,
Federal Contractors ,
Financial Regulatory Reform ,
Healthcare ,
Intellectual Property Protection ,
International Litigation ,
International Trade ,
Legislative Agendas ,
Life Sciences ,
National Security ,
New Legislation ,
New Regulations ,
OECD ,
Privacy Laws ,
Regulatory Agenda ,
Technology Sector ,
Trade Policy ,
Trump Administration
Key Points -
- It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively.
- The Trump administration will likely focus on drug...more
1/21/2025
/ Affordable Care Act ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Secretary of HHS ,
Trump Administration
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
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 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 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
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
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