Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
The Offence and Penalty - On 8 May 2025, the UK’s Office of Financial Sanctions Implementation (OFSI) published its 11 April 2025 notice of its first-ever monetary penalty for an information offence relating to financial...more
The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
California’s Safe and Secure Innovation for Frontier Artificial Intelligence Models Act is one of the first significant regulations of artificial intelligence in the United States that, if signed, would place liability on the...more
On October 30, 2023, the US Securities and Exchange Commission ("SEC") announced that it filed charges against SolarWinds Corp. ("SolarWinds" or the "Company") and its Chief Information Security Officer ("CISO") in connection...more
The Corporate Transparency Act requires a broad range of entities to file a report with the U.S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN) identifying those who own, control and formed the...more
On December 15, 2022, the Financial Crimes Enforcement Network (“FinCEN”) issued a Notice of Proposed Rulemaking (the “NPRM”) that would implement provisions of the Corporate Transparency Act (the “CTA”) regarding access to...more
The 112th General Assembly adjourned sine die on April 28th, 2022, but many of the successful measures will become effective on July 1st. Public Chapter 1087 – one of the most weighty and intricate bills – made changes to...more
In This Issue. The Financial Crimes Enforcement Network (FinCEN) issued a proposed rule about the establishment of a limited-duration pilot program for sharing suspicious activity reports (SARs); FinCEN published the final...more
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more
The U.S. Securities and Exchange Commission (SEC) has launched a stunning salvo across the bows of public companies with its announcement of civil monetary penalties and a cease-and-desist order against First American...more
Under the Federal Civil Monetary Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Inflation Adjustment Act), the US Department of Labor (DOL) increased the penalties for specified violations of the Employee...more
Non-Enforcement Cybersecurity Is At the Top of SEC Examination Concerns In a recent SEC “risk alert” for registered broker-dealers and investment advisers, the SEC’s Office of Compliance Inspections and Examinations (OCIE)...more
At the very beginning of this year, we wrote that we expected the CPSC to remain active in bringing enforcement actions against companies for violations of the Consumer Product Safety Act (CPSA). About one month later, CPSC...more
Two recent enforcement actions by the Department of Justice and the Federal Trade Commission (the “FTC”) confirm that there is continuing attention in the United States on compliance by investors with the reporting...more