Health Law Advisor

The federal government is pursuing restrictions on gender-affirming care through a coordinated, multifaceted enforcement strategy.

For health care providers, understanding both the tools being deployed and the methods providers are using to respond is essential to compliance planning.

Jennifer Nelson Carney, Member of the Firm, examines the federal enforcement mechanisms and discusses how health care organizations are responding to coordinated federal challenges.

The first half of 2026 has seen active U.S. Food and Drug Administration (FDA) enforcement across multiple regulatory domains. For regulated companies, monitoring the FDA’s enforcement priorities is critical to compliance and audit readiness.

Megan Robertson, Member of the Firm, examines the FDA’s recent enforcement actions, identifies six trends in the agency’s regulatory approach, and offers practical guidance for in-house counsel.

Key Takeaways

• The FDA is monitoring websites, social media, podcasts, and online storefronts for marketing claims that may be inappropriate based on a company’s regulatory status.
• The most prominent trend is continued enforcement against online telehealth platforms offering compounded GLP-1s. Companies must clearly distinguish health care services from drugs being compounded and sold by pharmacies.
• The Center for Drug Evaluation and Research is actively enforcing current Good Manufacturing Practice compliance. Recalls alone do not satisfy the FDA’s remediation expectations; companies must demonstrate comprehensive, root-cause corrections.
• Food facilities face enforcement action for inadequate Foreign Supplier Verification Programs on imported products, including produce, rice, matcha powder, and green tea.
• Form 483 responses are receiving heightened FDA scrutiny. Medical device manufacturers should prepare for potential increased Quality Management System Regulation enforcement as the year progresses.
• These warning letters were issued under the former FDA commissioner. In-house counsel should monitor for potential shifts in enforcement priorities under new leadership as the year progresses.

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 regulatory scrutiny is far from over.

In this episode, Epstein Becker Green attorneys E. John Steren and David J. Clark discuss the FTC’s concerns for health care employers, offer guidance on revising non-compete agreements to withstand legal challenges, and explore alternative strategies to protect business interests.

From our Thought Leaders in Health Law video series: On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs).

The court’s judgment vacates the agency’s controversial final rule of May 6, 2024 (the “Final Rule”), regulating LDTs as medical devices, just weeks before the Final Rule’s initial implementation deadline and remands the issue back to the FDA for further consideration.

From our Thought Leaders in Health Law video series: In today's complex and rapidly evolving health care landscape, navigating the path of expanding or selling a business requires a nuanced understanding of the intricate state and federal regulatory frameworks.

With states increasingly imposing legislative oversight to safeguard competition, care access, and quality, it's crucial for health care providers, private equity firms, and management organizations to have a strategic partner adept at handling these challenges.

States are imposing prior approval or prior review legislation to allow for more visibility regarding proposed transactions. Much of the legislation seeks to increase oversight of health care entity relationships with management companies and private equity firms.

What does this mean for you?

From our Thought Leaders in Health Law video series: The U.S. Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country.

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights published a final rule entitled the “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” (the “Final Rule”).

The Final Rule—amending the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009—strengthens privacy protections related to the use and disclosure of reproductive health care information. HIPAA’s Privacy Rule limits the disclosure of protected health information (PHI) and is part of HHS’s efforts to ensure that patients will not be afraid to seek health care from, or share important information with, health care providers.

What are the key takeaways from the Final Rule?

From our Thought Leaders in Health Law video series: Braidwood v. Becerra represents a significant legal challenge to the Affordable Care Act’s (ACA’s) preventive services coverage provision, which requires private health insurance to cover various clinical preventive services, including immunizations; services rated A or B by the U.S. Preventive Services Task Force; and women's preventive services, such as contraceptives.

Employer plaintiffs have contested the law on moral and religious grounds, particularly objecting to coverage for HIV prevention medication ...

From our Thought Leaders in Health Law video series: The Inflation Reduction Act (IRA) introduces significant changes in prescription drug pricing, including the establishment of the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program to control drug prices.

The IRA includes a redesign of the Medicare Part D benefit, which began with the announcement of 10 Medicare Part D drugs open for negotiation. This video highlights the challenges and complexities during the multi-year IRA implementation and emphasizes the penalties for ...

As featured in #WorkforceWednesday: The Centers for Medicare & Medicaid Services (CMS) issued an interim final rule outlining vaccine requirements for staff at Medicare- and Medicaid-certified providers and suppliers.

Attorney Frank Morris discusses the next steps for health care providers. In addition, covered employers should continue to monitor the recent litigation filed in the Eastern District of Missouri and the Western District of Louisiana seeking to permanently enjoin the CMS interim final rule.

See below for the video and podcast links. Visit ...

Employment Law This Week (Episode 88: Week of September 25, 2017) has released bonus footage of its interview with Michael McGahan, a Member of the Firm at Epstein Becker Green.

As Mike discusses, New York home care agencies typically pay sleep-in home health aides for 13 hours per day, relying on a 2010 opinion from the state Department of Labor. Two home health attendants who claimed they did not “live in” the homes of their clients filed suit against their employers, claiming that their patients’ need for 24-hour ...

Two stories on the new episode of Employment Law This Week will be of particular interest to our readers in the health care industry:

California Health Care Workers Can Waive Breaks

California health care workers can still waive some breaks. In February 2015, a California appeals court invalidated an order from the Industrial Welfare Commission (IWC) that allowed health care workers to waive certain meal breaks. The court found the order, which allowed the workers to miss one of their two meal periods when working over eight hours, was in direct conflict with the California Labor Code ...

The new episode of Employment Law This Week offers a year-end roundup of the biggest employment, workforce, and management issues in 2016:

• Impact of the Defend Trade Secrets Act
• States Called to Ban Non-Compete Agreements
• Paid Sick Leave Laws Expand
• Transgender Employment Law
• Uncertainty Over the DOL’s Overtime Rule and Salary Thresholds
• NLRB Addresses Joint Employment
• NLRB Rules on Union Organizing

Watch the episode below and read EBG’s Take 5 newsletter, "Top Five Employment, Labor & Workforce Management Issues of 2016."

Featured on Employment Law This Week: The Occupational Safety and Health Administration (OSHA) has issued a final rule for handling retaliation under the Affordable Care Act (ACA).

The ACA prohibits employers from retaliating against employees for receiving Marketplace financial assistance when purchasing health insurance through an Exchange. The ACA also protects employees from retaliation for raising concerns regarding conduct that they believe violates the consumer protections and health insurance reforms in the ACA. OSHA’s new final rule establishes procedures ...

Featured on Employment Law This Week:  The Equal Employment Opportunity Commission (EEOC) has issued new guidance on workplace retaliation.

The EEOC’s final guidance on retaliation includes concrete examples of retaliation issues that the courts have largely agreed upon, as well as expanded definitions of “adverse action” and “causal connection.” The guidance also describes “promising practices” for reducing the possibility of retaliation, including anti-retaliation training and proactive follow-up with potential targets. Retaliation has become the ...

The top story on Employment Law This Week is the unfolding Zika virus crisis.

For the fourth time in history, the World Health Organization has declared a global public health emergency, following the spread of the Zika virus throughout Latin America and the Caribbean. The disease can have harmful effects on fetuses, and the CDC has warned against travel for pregnant women and their partners. The Zika crisis has important implications for employers. Workers who travel for their jobs may request accommodations, and employers should make them aware of the risks if they aren’t ...

One of the featured stories on Employment Law This Week is the EEOC's recent release of two different guides on the rights of HIV-positive employees.

The first guide outlines employees’ rights under the ADA. The second guide is for health care providers with HIV-positive patients. It encourages them to advocate for their patients' rights in the workplace. These documents are also valuable resources employers. Among other takeaways, they break down the process involved in a request for reasonable accommodation from an HIV positive employee.

View the episode below or read more ...

A recent survey conducted by the Robert Graham Center, the American Academy of Family Physicians, and Anthem caught my attention. The survey was conducted to gauge the attitudes of primary care physicians regarding telehealth.  And the results make for interesting reading— providing great insight into how certain providers view and use telehealth. What struck me most is that while great progress has been made in the rate of telehealth adoption among providers, we still have a way to go. According to the survey report, state legal and regulatory issues, reimbursement, and provider ...