Key Points -
- The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more
7/8/2025
/ Advisory Opinions ,
Anti-Kickback Statute ,
Compliance ,
Enforcement Actions ,
Healthcare ,
Healthcare Facilities ,
Healthcare Fraud ,
Hospitals ,
Manufacturers ,
Medical Devices ,
OIG
Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more
On April 15, 2025, President Trump issued the executive order “Lowering Drug Prices by Once Again Putting Americans First,” aimed at lowering the prices of prescription drugs and biologics, encouraging competition in the drug...more
Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more
3/27/2025
/ Department of Government Efficiency (DOGE) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Pharmaceutical Industry ,
Prescription Drugs ,
Presidential Appointments ,
Public Health ,
Regulatory Agenda ,
Regulatory Reform ,
Trump Administration
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more
2/13/2025
/ Alternative Medicine ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Healthcare ,
Healthcare Reform ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Popular ,
Regulatory Agenda ,
Regulatory Reform ,
Research and Development ,
Trump Administration ,
Vaccinations
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
In his first week in office, President Donald Trump issued executive orders and took other actions with significant implications for the life sciences and health care industries that mark substantial departures from the...more
1/30/2025
/ Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Medicare ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Trump Administration ,
Withdrawal ,
World Health Organization
Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more
1/23/2025
/ Department of Health and Human Services (HHS) ,
Drug Safety ,
Food and Drug Administration (FDA) ,
GRAS ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Reform ,
Regulatory Requirements ,
Trump Administration ,
User Fees
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
What Are GLP-1s? Glucagon-like peptide-1 receptor agonists, also known as GLP-1 drugs, are a class of medications that mimic the action of the glucagon-like peptide-1 hormone, which is involved in the regulation of blood...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
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
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 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 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 July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
7/15/2020
/ Coronavirus/COVID-19 ,
Domestic Corporations ,
Food and Drug Administration (FDA) ,
Foreign Corporations ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rating System ,
Re-Opening Guidelines ,
Risk Assessment ,
Safety Inspections ,
Tobacco Regulations