News & Analysis as of

Wellness Programs

Gardner Law

FDA’s 2026 CDS and General Wellness Guidance Updates

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For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates provide important clarification on how certain products may fall within, or outside, FDA oversight....more

Jones Day

A Relaxing 2026? FDA Updates General Wellness and Clinical Decision Support Software Guidance

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The U.S. Food and Drug Administration ("FDA") recently issued updated final guidance documents on general wellness products and clinical decision support ("CDS") software, reflecting a pro-innovation and risk-based regulatory...more

Baker Donelson

BakerWell Corner: The Gift I Never Asked For

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I'm just going to come right out with it. Something no psychologist, psychiatrist, researcher, professor, author, or speaker ever says. Something many behavioral-health specialists dance around. It's simple, really. I didn't...more

King & Spalding

FDA Updates General Wellness and Clinical Decision Support Guidance Documents

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On January 6, 2026, the Food and Drug Administration (FDA) published revised, final versions of its guidance documents on general wellness products and clinical decision support (CDS) software, superseding the prior versions...more

Foley & Lardner LLP

Episode 37: Chanda Center for Health: Reimagining Access to and Delivery of Long-term Disability Care

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In this episode, Lauren Carboni, co-chair of Foley’s Health Care Litigation Area of Focus, is joined by Chanda Hinton, Founder and Executive Director of The Chanda Center for Health, a pioneering nonprofit dedicated to...more

Ropes & Gray LLP

[Podcast] Culture & Compliance Chronicles: From Formula 1 to Resilient Leadership – Health, Identity & Success with Annastiina...

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On this episode of Culture & Compliance Chronicles, Amanda Raad and Nitish Upadhyaya from Ropes & Gray’s Insights Lab welcome Annastiina Hintsa, CEO of Hintsa Performance. The conversation examines the relationship between...more

Morgan Lewis - ML Benefits

Clearing the Smoke: Insights from the Williams v. Bally’s Tobacco Use Surcharge Dismissal

In Williams v. Bally Management Group, LLC, the US District Court for the District of Rhode Island became the first court to grant a motion to dismiss in a class action challenging Bally Management Group’s (Bally) tobacco...more

Ice Miller

Tobacco Surcharge Litigation Update

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Last year, we notified employers about recently filed class action lawsuits related to wellness programs that impose a “smoker’s surcharge” on employee health plan premiums. We are now revisiting that litigation ahead of 2026...more

Bradley Arant Boult Cummings LLP

Gratitude: Continuing the Conversation

Last week’s post gave me an opportunity to share my thoughts on how choosing to lead a business with a gratitude mindset can have a remarkably positive impact on the company’s performance, as well as on the people who work...more

ArentFox Schiff

Class Action Challenges ERISA Compliance of Tobacco Cessation Program

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Generally, the Employee Retirement Income Security Act of 1974 (ERISA) prohibits discrimination based on a plan participant’s health status-related factor, such as a medical condition, medical history, or genetic information....more

Holland & Knight LLP

District of Rhode Island Dismisses ERISA Class Action Challenging Tobacco Surcharges

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As discussed in a previous Holland & Knight alert, there has been a recent uptick in Employee Retirement Income Security Act of 1974 (ERISA) class actions challenging employers' tobacco-free wellness programs. Plaintiffs in...more

Law School Toolbox

Law School Toolbox Podcast Episode 529: Last-Minute Law School Exam Prep: Triage Tips for Success

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Welcome back to the Law School Toolbox podcast! Today we're discussing how you can regroup, triage, and get the most out of the final weeks before law school exams.   In this episode we discuss: >Preparing outlines and...more

Keating Muething & Klekamp PLL

Benefits Monthly Minute - October 2025

Trick or Treat? Court Finds ERISA Fiduciary Breach in ESG Investing Case, But Says No to Monetary Damages- A Texas district court recently ruled in Spence v. American Airlines that American Airlines’ focus on environmental,...more

Society54

The Unspoken and Hidden Challenges of Leadership

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Being a leader is hard. We talk about it often, yet many leaders find themselves isolated and burning out before they even recognize it. Day-to-day challenges like managing competing deadlines, navigating different...more

Loeb & Loeb LLP

FTC Scrutiny of Automatic Renewals: What Health & Wellness Companies Should Know

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Earlier this summer, the Federal Trade Commission’s (FTC’s) “click-to-cancel” rule was overturned by the U.S. Court of Appeals for the Eighth Circuit, just days before the new rule was set to go into effect. According to the...more

Vedder

Health Plan Tobacco Surcharge Litigation

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Employers are facing a surge in class action lawsuits challenging health plan premium surcharges imposed on smokers and other tobacco users, commonly referred to as “smoker surcharges.” Earlier this year Bass Pro Shops agreed...more

Williams Mullen

[Hybrid Event] 2025 Benefits Forum: Benefit Trends for a Resilient Workforce - September 25th, Richmond, VA

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Join Williams Mullen for our hybrid 2025 Benefits Forum, where our attorneys will examine how emerging trends and recent legislative developments have created new opportunities for employers to design benefits that meet the...more

Proskauer - Law and the Workplace

Four Things You May Not Know About …. The Genetic Information Nondiscrimination Act

Genetic information may not be the first thing that comes to mind when employers think about workplace discrimination.  However, federal law provides protections for employees based on their genetic information and that of...more

Wilson Sonsini Goodrich & Rosati

The FDA and WHOOP Debate Challenges the Line Between Wellness Products and Medical Devices

In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc. (WHOOP), asserting that the company is marketing its wearable blood pressure product, or Blood Pressure Insights (BPI), in the...more

McGuireWoods LLP

Frontiers in Women’s Health: Where Investor Opportunities Meet Unmet Need

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For years, women’s health was often siloed into OB/GYN care and absent from mainstream investment theses, but that landscape is changing. New platforms and care models are addressing women’s health in a more comprehensive...more

K&L Gates LLP

Client Conversations With Craig Budner: Interview With Patrick Krill, Lawyer, Addiction Counselor, and Researcher

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Patrick Krill is a lawyer, addiction counselor, and founder of Krill Strategies—a consulting firm dedicated to improving mental health and well-being in the legal profession. Patrick is widely recognized as a leading...more

Bricker Graydon Wyatt LLP

Can you Charge Smokers More for Your Health Plan?  

Several new lawsuits have been filed recently alleging that employers violated HIPAA’s non-discrimination rule by charging higher health insurance premiums to employees who use tobacco products. ...more

Husch Blackwell LLP

Employers Continue to Face ERISA Tobacco Surcharge Lawsuits, With Mixed Results

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Recently, companies have seen a spate of class action lawsuits challenging the legality of tobacco cessation wellness programs and related tobacco surcharges imposed by their employer-sponsored health benefit plans....more

Gallagher

Health, Wellness, and Workers' Comp: A Promising Cost-Saving Connection

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Employee health and wellness directly influence workers’ compensation costs, especially when comorbid conditions are involved. Implementing targeted wellness programs can help HR leaders reduce these costs and improve overall...more

Mintz - Health Care Viewpoints

FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more

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