In Securities and Exchange Commission v. Jarkesy, the U.S. Supreme Court held that “the Seventh Amendment entitles a defendant to a jury trial when the [Securities and Exchange Commission] seeks civil penalties against him...more
7/9/2024
/ Administrative Authority ,
Administrative Law Judge (ALJ) ,
Administrative Proceedings ,
Consumer Financial Products ,
Consumer Protection Laws ,
Enforcement Actions ,
SCOTUS ,
SEC v Jarkesy ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
Securities Litigation ,
Securities Regulation ,
Seventh Amendment
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
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
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
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
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
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
Despite the challenges posed by the COVID-19 public health emergency in 2020, the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) entered into the highest number of corporate integrity...more
On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more
11/25/2020
/ Coronavirus/COVID-19 ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fraud Alerts ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Speaker Programs
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
The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more
2/5/2019
/ Amended Rules ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Rebates ,
Safe Harbors
At the close of 2018, the Advanced Medical Technology Association (AdvaMed) released an updated version of its Code of Ethics governing medical technology manufacturers in their interactions with health care professionals...more
2/1/2019
/ AdvaMed ,
Consultants ,
Continuing Medical Education ,
Donations ,
Employee Training ,
Ethics ,
Good Clinical Practices ,
Grants ,
Health Care Providers ,
Health IT ,
Healthcare Workers ,
Meals-Gifts-and Entertainment Rules ,
Medical Devices ,
Off-Label Promotion ,
Sponsorship Agreements ,
Technology Sector ,
Traveling Employee
While the number of new corporate integrity agreements (CIAs) declined since last year, and was below the trailing five-year average, 2018 was an important year on the policy front for the Office of Inspector General (OIG),...more