Health Law Scan

California Governor Gavin Newsom recently signed two new bills into law that formalize restrictions on medical and dental practice management platforms operated by private equity groups and hedge funds and increase the state’s oversight of certain healthcare transactions. SB 351 and AB 1415 reflect California’s increasing attention on private equity and hedge fund participation in the healthcare industry. The changes to the law under each bill will go into effect on January 1, 2026.

Since its enactment in 2018, the Eliminating Kickbacks in Recovery Act (EKRA) has rapidly gained momentum as a powerful tool against healthcare kickbacks. By 2020, the US Department of Justice (DOJ) had already secured its first EKRA conviction. This relatively young law, aimed at curbing patient brokering in laboratories, recovery centers, and treatment facilities, carries hefty penalties and, unlike older statutes, applies even to services billed to private insurance.

In our latest Fast Break session and on the heels of recent announcements from the Biden-Harris administration and the US Food and Drug Administration’s (FDA’s) granting of full authorization for the Pfizer vaccine in August, we discussed how these updates may impact employers in the healthcare industry.

Our US Food and Drug Administration (FDA) team recently published a blog post discussing the FDA’s issuance of its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health databank. While the authority to issue such notices has existed since the 2007 passage of the Food and Drug Administration Amendments Act, this is the first time the FDA has exercised its clinicaltrials.gov enforcement authority.

Our FDA team recently published an Insight covering key considerations for artificial intelligence (AI) healthcare application developers and users, highlighting the FDA’s current regulatory scheme for AI/machine learning (ML)-based software, potential FDA enforcement discretion that may apply, and recent FDA developments impacting AI/ML technologies.