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
Last week, TZP Management Associates, LLC (TZP), a New York-based private equity investment adviser, agreed to pay more than $680,000 in monetary relief to settle charges brought by the Securities and Exchange Commission...more
On June 16, 2025, the New York Attorney General announced it had entered into a stipulated final judgment to settle its suit against a non-bank money transfer provider over alleged violations of federal and state consumer...more
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
On February 25, 2025, the Commodity Futures Trading Commission (CFTC or Commission) Division of Enforcement (Division) issued an Advisory on how to evaluate a firm’s self-reporting, cooperation, and remediation (referred to...more
How did federal racketeering and conspiracy charges against a politician and a 501(c)(4) organization controlled by him lead to another company’s alleged securities law violations? According to this SEC Order against...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
On December 20, 2024, the Securities and Exchange Commission (“SEC”) announced charges against two private companies and a registered investment advisor for failure to file a Form D in connection with exempt offerings under...more
Compliance with AB 1305, the Voluntary Carbon Market Disclosures Act (Health & Safety Code sections 44475 – 44475.3), is mandatory for certain entities, but there is still no official date for initial disclosures under AB...more
In a significant development for the investment management industry, a large adviser agreed to pay a hefty $17.5 million civil penalty to settle charges with the SEC over misleading statements about its Environmental, Social,...more
Continuing its controversial and aggressive approaches to cybersecurity, the U.S. Securities and Exchange Commission (SEC) recently charged four current and former public companies for purportedly “materially misleading...more
The SEC on Oct. 22, 2024, announced charges against four companies for allegedly making materially misleading disclosures concerning the impact of cybersecurity incidents associated with the compromised SolarWinds' Orion...more
On October 22, 2024, the SEC charged two current reporting companies, Unisys Corp. and Check Point Software Technologies, and two former public companies, Mimecast Limited and Avaya Holdings Corp., with making materially...more
This week, the Securities and Exchange Commission (SEC) charged four public companies for alleged deceptive cyber disclosures: Unisys Corp., Avaya Holdings Corp., Check Point Software Technologies Ltd., and Mimecast Limited....more
On October 22, 2024, the Securities and Exchange Commission charged four companies with making materially misleading disclosures about their cybersecurity risks. Each of the companies—Unisys Corp., Avaya Holdings Corp., Check...more
On October 16, 2024, the Federal Trade Commission announced a final “click-to-cancel” rule that will require sellers to make it as easy for consumers to cancel their enrollment as it was to sign-up. Most of the final rule’s...more
This is part four of our examination of the European Union’s new artificial intelligence law, the (“EU AI Act”). In part one, we introduced the scope of the EU AI Act and discussed what types of AI systems are outright...more
Recently, the SEC announced settled charges against a former chairman/CEO and director of Church & Dwight Co. Inc., for violating proxy disclosure rules by standing for election as an independent director without informing...more
As previously blogged about here, following notices of proposed rulemaking in 2022 and 2023, on August 22, 2024 the Federal Trade Commission finalized a rule that will impose monetary civil penalties false and misleading...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 September 10, 2024, the SEC announced that it had charged Keurig Dr. Pepper for making incomplete, and therefore inaccurate, statements regarding the recyclability of its popular K-cup pods....more
While the Securities and Exchange Commission’s (SEC) new climate-related disclosure rules remain stayed, the SEC has not abandoned its focus on sustainability-related issues. On September 10, 2024, the SEC charged Keurig Dr...more
On August, 19, 2024, the SEC announced settled charges against Carl C. Icahn and his publicly traded company, Icahn Enterprises L.P. (IEP), for failing to disclose information relating to Icahn’s pledges of IEP securities –...more
The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...more
With the voluntary carbon offset market being unregulated in the United States, California Assembly Bill No. 1305 (AB 1305) was enacted to confirm the authenticity of claimed emissions offsets, emphasizing the need to ensure...more