Washington’s My Health My Data Act (“MHMDA”) and Nevada’s SB 370 (“NV CHD Law”) (collectively, “CHD Laws”) went into effect at the end of last month, on March 31, 2024 (as many know, MHMDA’s geofencing prohibition went into effect last summer). Unlike the Health Insurance Portability and Accountability Act (“HIPAA”), a federal law which governs privacy and security in traditional healthcare settings, CHD Laws regulate “consumer health data” or “CHD”– a very broadly defined term – collected by companies in a broad swath of health and non-health related industries alike. Even anci ..read more

The US Department of Health and Human Services, Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration issued a Final Rule modifying the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations under 42 C.F.R. Part 2 (Part 2), applicable to certain federally assisted SUD treatment programs (Part 2 Programs), and to SUD patient records (Part 2 Records). The effective date of the Final Rule is April 16, 2024, and entities have until February 16, 2026, to comply. The Final Rule includes several changes to align Part 2 more closely with t ..read more

On February 28, 2024, President Biden issued a groundbreaking executive order (EO) establishing the framework for new restrictions on transactions involving US persons’ sensitive personal data and “countries of concern,” including China, or related parties. The EO and forthcoming regulations will impact the use of genomic data, biometric data, personal health care data, geolocation data, financial data and some other types of personally identifiable information. The administration is taking this extraordinary step in response to the national security risks posed by access to US pers ..read more

Members of our Government Investigations & White Collar team recently presented a timely webinar on the new Foreign Extortion Prevention Act (FEPA).  The Act, which has been referred to as  “the most consequential anti-foreign-bribery law passed in almost 50 years,” allows the DOJ to prosecute foreign officials who demand or accept a bribe from a U.S. citizen or company. Understanding FEPA is critical for US companies with international business interactions and other companies whose business subjects them to US jurisdiction. Read on at the link below for an outline of FEPA ..read more

Fishermen in the small town of Cape May, New Jersey, are at the epicenter of a legal challenge that could reshape the landscape of agency authority. The fishermen are challenging the entrenched “Chevron” doctrine, which for years has afforded deference to government agencies with respect to reasonable interpretation of ambiguous statutes. Once again, the US Supreme Court is in the spotlight as it hears pivotal cases – Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo, which may presage the dismantling of “Chevron”. Squire Patton Boggs attorneys Keith Bradley, Peter ..read more

Federal appropriations provide annual discretionary funding for our government to carry out its mission and, in turn, spur various healthcare organizations towards efficiencies and achievements. Whether you serve an entity interested in the government’s work in disease research or a nonprofit hospital requesting community project funding for infrastructure needs, it is important for those seeking funding provided through Congress’ annual appropriations cycle to understand the process and current legislative landscape. This year more than most, the process is complex – with timelines that abut ..read more

On Tuesday January 30, we hope you will join a seasoned team of former Department of Justice (DOJ) prosecutors for what will certainly be a robust a discussion on “the most consequential anti-foreign-bribery law passed in almost 50 years”: the Foreign Extortion Prevention Act (FEPA). Passed as part of the National Defense Authorization Act (NDAA), FEPA allows the DOJ to prosecute foreign officials who demand or accept a bribe from a U.S. citizen or company.   For any entity doing business abroad, understanding FEPA is critical. Tom Firestone, a key player in drafting the legislation ..read more

On December 18, 2023, the US Department of Justice (DOJ) and Federal Trade Commission (FTC) (collectively, the “government”) released the final 2023 Merger Guidelines (the “Guidelines”) which set forth factors and frameworks the government will use when assessing mergers and acquisitions. While the Guidelines are not legally binding, they provide important guidance on how the government may view certain transactions, including those involving healthcare entities. The Guidelines also reflect the Biden Administration’s aggressive stance on merger enforcement. Squire Patton Boggs attorneys Barry ..read more

In 2022, the state of California passed into law the California Health Care Quality and Affordability Act which requires that health care entities give the state 90-day notice of certain mergers, acquisitions, or other transactions projected to close on or after April 1, 2024.  Review of these transactions began on January 1, 2024.  Health care entities subject to this obligation include payers, fully integrated delivery systems, and providers, including large physician organizations, that meet certain thresholds.  Captured transactions are those that involve the sale of a mater ..read more

Courts around the country continue to disagree on the causation standard to be applied in False Claims Act cases based on alleged Anti-Kickback Statute violations.  Two recent federal district court decisions out of the District of Massachusetts, United States v. Regeneron Pharms., Inc., No. 20-11217-FDS, 2023 WL 7016900 (D. Mass. Oct. 25, 2023) and United States v. Teva Pharmaceuticals USA, Inc., No. 20-11548-NMG, 2023 WL 4565105 (D. Mass. July 14, 2023), add to differing conclusions on what the causation standard should be, i.e., “but-for,” “exposure,” or some other, less demanding stan ..read more