Wellness Programs

News & Analysis as of

FDA Policy On Wellness Products Is Healthy For Industry

On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more

Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents

Background - On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more

FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT

On January 20, 2015, the United States Food and Drug Administration (FDA) issued two new draft guidance documents, announcing the agency’s plans not to regulate “general wellness products” (including certain software...more

FDA Issues Guidance for Low-Risk General Wellness Products

On January 20, 2015, the FDA issued draft guidelines designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as...more

Life Sciences Alert FDA Issues Draft Guidance on General Wellness Products

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more

FDA Proposes Additional Flexibility for Mobile Health Products

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

Labor & Employment E-Note - January 2015

In This Issue: - Purple Communications Inc. Update - NLRB Issues Key Changes To Election Rules *Effective April 14, 2015* - Making Headlines - Excerpt from NLRB Issues Key Changes To Election...more

Is An Injury Sustained by an Employee While Participating in a Workplace Wellness Program Compensable Under the Workers'...

With the new year upon us, chances are that your employees are making those age old resolutions to lose weight, get fit, and exercise more. And, if you sponsor or offer an employee wellness program, your employees might be...more

Employment Flash - December 2014

In This Issue: - Supreme Court Rejects Security Screening Time Pay - NLRB Finalizes Union Election Rule - NLRB Reverses Employers’ Ability To Ban Employee Nonwork Email Use - EEOC Challenges Employer...more

2014 EEOC Year In Review: Lots Of Action, Mixed Results

2014 has been a notable year for the U.S. Equal Employment Opportunity Commission. The agency has initiated historic litigation, issued significant new guidance and signaled increased scrutiny of background checks and...more

EEOC's Regulatory Agenda Anticipates Wellness Program Rules in February

Last month, federal agencies released their semiannual regulatory agendas. The agendas list the rules in progress for the various agencies, along with anticipated dates of issuance. New additions or shortened timeframes can...more

Gavel to Gavel: What's in store for employers?

In 2014, the government’s employment agencies were aggressive and active in terms of investigations and lawsuits. Employers should expect this to continue in the new year and pay particular attention to the...more

ACA Liabilities: Workplace Wellness Programs in Crosshairs of EEOC

Employers implementing new voluntary workplace wellness programs that are otherwise compliant with regulations under the Affordable Care Act (ACA) are nevertheless finding themselves in the crosshairs of the Equal Employment...more

EEOC to Issue Proposed Regulations for Wellness Programs

The Equal Employment Opportunity Commission (EEOC) announced recently that it intends to issue proposed regulations in the next 60 days to clarify its enforcement authority under the Americans with Disabilities Act (ADA) with...more

Grand Theft PHI – Are Vendors Putting You at Risk for a HIPAA Breach?

Your vendor’s employee goes home after a long day of collecting wellness questionnaires and biometric screening results only to wake up the next day to discover that her car has been stolen from her driveway. As you can...more

EEOC Casts Uncertainty on Popular Wellness Programs

Action Item: Employers with wellness programs that involve higher premiums or other increased cost-sharing for employees who do not participate should contact us immediately to discuss their wellness strategies and to assess...more

Wellness Watch

According to reports, more than half of all businesses with over 200 employees ask employees to participate in biometric screening, and nearly 10% of them provide a financial incentive for employees to participate. As a part...more

EEOC Challenges Honeywell’s Wellness Program

The EEOC recently sued Honeywell International, Inc., claiming that Honeywell’s wellness program violated the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA). Although the EEOC...more

Quirky Question #247, An Update on Wellness Programs

Question: Our company has been considering implementing financial incentives for employees to participate in biometric screening as part of an employee wellness program. Are there legal issues we should be...more

The Affordable Care Act—Countdown to Compliance for Employers, Week 4: EEOC v. Honeywell and the Future of Wellness Programs

While my entries have focused principally on the employer shared responsibility rules of the Affordable Care Act (ACA), every once in a while an item comes along that nevertheless grabs my attention. The treatment of wellness...more

Employment Law - November 2014 #2

EEOC’s Wellness Challenge Feeling Under the Weather - Why it matters: The Equal Employment Opportunity Commission’s (EEOC) efforts to challenge employer wellness programs hit a snag when a federal court judge in...more

EEOC Promises Guidance On Wellness Programs In February

Good news! The Equal Employment Opportunity Commission recently announced in its 2015 regulatory agenda that it will be issuing proposed regulations on the impact of the Americans with Disabilities Act and the Genetic...more

EEOC Wellness Program Suits Highlight Need for Agency Guidance

The EEOC has been pursuing litigation against wellness programs of late, arguing that certain health plan penalties render participation in wellness program health screens ”involuntary” and thus violate Americans with...more

Mainstream Wellness Program Challenged in EEOC v. Honeywell

Despite promulgating a paucity of guidance on what constitutes a “voluntary medical exam” under the Americans with Disabilities Act (“ADA”), on October 27, 2014, the U.S. Equal Employment Opportunity Commission (“EEOC”)...more

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