California’s Assembly Bill 489 (“AB 489”) signals more than just a tweak to existing healthcare law—it’s a glimpse into how the next generation of regulation may shape the future of AI development and deployment in healthcare.| www.healthlawadvisor.com
On July 17, 2025, the U.S. Court of Appeals for the Fourth Circuit held that a federal district court was “within bounds to order a do-over” in the case of Ron Elfenbein, a Maryland doctor who was found guilty of COVID-19-related health care fraud in 2023 in connection with upcoding and false documentation. Elfenbein was acquitted by the district court four months after his trial. The Fourth Circuit affirmed a contingent order of the U.S. District Court for the District of Maryland granti...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On July 17, 2025, Oregon Governor Tina Kotek signed SB 537, which adds to Oregon’s growing set of workplace violence prevention laws relating to health care. The bill passed the state Senate with an 18-11 vote on June 23, and the House, 37-12, on June 26, during the final days of the legislative session. The new provisions add detailed requirements for health care work sites.| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On July 29, 2025, Attorney General Pam Bondi issued a memorandum to all federal agencies providing guidance addressing “unlawful discrimination” on the basis of race, color, national origin, sex, religion, or other protected characteristics (the "July 29 Guidance"). According to the memorandum, the July 29 Guidance is intended to clarify “the application of federal antidiscrimination laws to programs or initiatives that may involve discriminatory practices, including those labeled [DEI]...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On August 1, 2025, the U.S. Department of Health and Human Services (“HHS”) Health Resources and Services Administration (“HRSA”) issued a call for applications for a 340B Rebate Model Pilot Program (the “Pilot Program”). The announcement of the Pilot Program signifies the intersection of several notable policy issues upon which stakeholders of the pharmaceutical supply chain have focused over the past few years, including drug manufacturer efforts to provide 340B discounts via re...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On July 10, 2025, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule to establish the Ambulatory Specialty Model (ASM)—a mandatory value-based payment model for specialists who treat patients with heart failure or low back pain. CMS selected heart failure and low back pain because these chronic conditions represent roughly 6% of total, annual spend for traditional Medicare. The model is scheduled to run from 2027 through 2031 and represents an expansion of CMS’s ...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging for” language in the Anti-Kickback Statute (“AKS”). The AO involves a proposed arrangement for a medical device company (the “Requestor”) to pay a third-party vendor to access an electronic billing portal operated by the vendor that is used by some of th...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
New from the Diagnosing Health Care Podcast: Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special guests Noah Voreades of OLIPOP and Ivan Wasserman of Amin Wasserman Gurnani join Epstein Becker Green attorneys Jessika Tuazon and Ada Peters to explore how food is being integrated into health care to prevent and manage chron...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On July 24, 2025, President Donald Trump issued Executive Order 14321, titled “Ending Crime and Disorder on America’s Streets” (“the E.O.”). Although the E.O. has a number of elements, the one most notable for behavioral health stakeholders is a policy to increase use of involuntary commitment for mental health and substance use disorder treatment. The introduction proclaimed: “Shifting homeless individuals into long-term institutional settings for humane treatment through the app...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On July 23, 2025, the president signed three AI-related Executive Orders (“E.O.s”) to accompany the recently released White House’s Artificial Intelligence (AI) Action Plan (“AI Action Plan”). These E.O.s seek to add clarity to, and drive forward, federal policy in the AI space. While they all relate to AI, the E.O.s otherwise vary considerably in subject matter: “Accelerating Federal Permitting of Data Center Infrastructure”; “Promoting the Export of the American AI Technolog...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
Last month, Judge Matthew Kaszmaryk of the U.S. District Court, Northern District of Texas, in Purl v. United States Department of Health and Human Services, No. 2:24-cv-00228-Z (N.D. Tex Jun. 18, 2025) struck down nearly all of the 2024 Reproductive Health Amendment to the HIPAA Privacy Rule.| www.healthlawadvisor.com
Delivers cutting-edge commentary on important legal issues affecting health care and life sciences institutions.| www.healthlawadvisor.com
On June 16, 2023, Nevada enacted Senate Bill 370 (“SB 370”), which imposes broad restrictions on the collection, use, and sale of consumer health data. This law is set to go into effect on March 31, 2024.| www.healthlawadvisor.com