Imagine going online to chat with someone and finding an account with a profile photo, a description of where the person lives, and a job title . . . indicating she is a therapist. You begin chatting and discuss the highs and lows of your day among other intimate details about your life because the conversation flows easily. Only the “person” with whom you are chatting is not a person at all; it is a “companion AI.” Recent statistics indicate a dramatic rise in adoption of these c...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
In September 2025, the U.S. Attorneys’ Office for the Eastern District of Pennsylvania (EDPA) announced that it would be implementing a White-Collar Justice Program to strengthen its white- collar enforcement framework. Among other things, the program will “empower Assistant United States Attorneys to aggressively pursue complex investigations and significant new matters on their own initiative.” This announcement demonstrates another step in federal districts ramping up their white-col...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On October 11, California Governor Gavin Newsom signed AB 1415, which regulates private equity and hedge fund activity by expanding the Office of Health Care Affordability’s (OHCA) jurisdiction and notice requirements.| www.healthlawadvisor.com
Well before the latest government shutdown, the U.S. Department of Justice’s National Security Division (DOJ NSD) issued a final rule at 28 CFR Part 202 (“2025 Final Rule” or “Rule”) to help prevent “countries of concern” or “covered persons” from accessing U.S. government-related data and Americans’ bulk sensitive personal data. The 2025 Final Rule took effect in April—and after a 90-day safe harbor period, the DOJ began enforcement on July 8. Six months after implement...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On October 6, 2025, California Governor Gavin Newsom signed SB 351, aimed at limiting the involvement of private equity groups and hedge funds in health care practices. While the new law does create new statutory requirements governing hedge fund and private equity group involvement in the management of physician and dental practices, those requirements largely reflect existing California case law and Medical Board of California guidance. Specifically, the new law: prohibits a private equity ...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
In the latest in a series of recent cases involving the “but-for” causation standard for Anti-Kickback Statute (“AKS”) claims, Judge Waverly D. Crenshaw in the U.S. District Court for the Middle District of Tennessee has dismissed United States, et al., ex rel. Nolan, et al. v. HCA Healthcare, Inc., 2025 WL 2713747 (M.D. Tenn. Sept. 22, 2025) pursuant to Rules 12(b)(6) and 9(b). Judge Crenshaw weighed in Nolan whether the relators, co-owners of Pathologists Laboratory P.C. (“PLPC”...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
In the wake of a lawsuit filed in federal district court in California in August—alleging that an artificial intelligence (AI) chatbot encouraged a 16-year-old boy to commit suicide—a similar suit filed in September is now claiming that an AI chatbot is responsible for death of a 13-year-old girl. It’s the latest development illustrating a growing tension between AI’s promise to improve access to mental health support and the alleged perils of unhealthy reliance on AI chatbots by vuln...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On September 25, 2025, the Department of Justice announced a new office within the Civil Division—the Enforcement & Affirmative Litigation Branch—“dedicated to safeguarding public health and safety through proactive enforcement and high-impact affirmative litigation.” The creation of this new office restructures and consolidates affirmative litigation into a specialized branch to “hold powerful actors accountable, protect public health and safety, and enforce critical national polic...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
The telehealth cliff that we warned you about on March 3 and March 25, 2025, is now more fact than fiction—and we need a parachute. Current Medicare telehealth flexibilities expired on September 30, 2025. This expiration has come to be called a “cliff,” since millions of beneficiaries who have used telehealth as a means for receiving health care services since the COVID-19 pandemic could lose coverage for this benefit. Now, they may have to travel to a health care provider’s office or...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
As featured in #WorkforceWednesday®: This week, we examine the Federal Trade Commission’s (FTC’s) decisions to drop its appeal of a federal court ruling striking down its proposed non-compete ban and to issue warnings to health care employers about using unreasonable restrictive covenants in employment agreements. Although the FTC’s decision to abandon its non-compete ban appeal may appear to favor employers, its recent warning letters to health care organizations make clear that regu...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On September 16, 2025, the U.S. Food and Drug Administration (FDA) released more than 60 warning letters sent to specific pharmaceutical manufacturers, alleging misbranding of a particular drug through direct-to-consumer (DTC) advertisements in violation of the federal Food, Drug, and Cosmetic Act (FDCA).| www.healthlawadvisor.com
On September 12, 2025, the United States Court of Appeals for the Fifth Circuit, in AbbVie v. Fitch, Case No. 24-60375, (5th Cir. 2025), affirmed a federal District Court’s denial of a preliminary injunction sought by the pharmaceutical manufacturer AbbVie.| www.healthlawadvisor.com
The DOJ has made clear that it will use “every available tool” to pursue both companies and individuals in connection with potential trade violations, meaning effective compliance programs and self-disclosure mechanisms will play a critical role in mitigating risk.| www.healthlawadvisor.com
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
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
