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Passage of the GENIUS Act: A Turning Point in Stablecoin and Digital Asset Regulation

President Donald J. Trump has signed into law the GENIUS Act (Guiding and Establishing National Innovation for U.S. Stablecoins of 2025 or the GENIUS Act of 2025), establishing the first comprehensive federal framework for...more

Stablecoins: Navigating the Money Transmitter Minefield & Forthcoming Federal Regulatory Frameworks

As digital assets gain traction across financial markets, stablecoins—cryptocurrencies pegged to fiat currencies like the U.S. dollar—are emerging as a practical medium for capital contributions, settlements, and liquidity...more

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Proposed Changes to the HIPAA Security Rule Will Have a Significant Impact on the Health Care Sector

A few days ago, the U.S. Department of Health and Human Services (“HHS”), through its Office for Civil Rights, issued the proposed rule HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health...more

Will The Standard of Liability Under The 60-Day Repayment Rule Change?

At the end of last year, the Centers for Medicare & Medicaid Services (CMS) proposed changes to the so-called 60-day repayment rule. The proposed changes include eliminating the current “reasonable diligence” standard that...more

New Jersey Health Care Entities Should Add New Employee Protections to Their Due Diligence Checklists

Healthcare entities, home healthcare agencies, and staffing registries considering a transaction in New Jersey must keep new obligations to certain employees in mind. On August 18, 2022, Governor Murphy signed into law New...more

New Protections for Employees of Certain New Jersey Health Care Entities

Health care entities, home health care agencies, and staffing registries considering a transaction in New Jersey will need to keep in mind new obligations to certain employees. On August 18, 2022, Governor Murphy signed into...more

Sham Transactions in Digital Health Industry

In its recently published Special Fraud Alert, the Office of Inspector General (“OIG”) presented a list of suspect characteristics related to arrangements with telehealth and telemedicine companies, which may help determine...more

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