Wellness Programs

News & Analysis as of

Getting The Best Medical Care: A Newsletter From Patrick Malone - March 2015

In This Issue: - Aging and Accidents - Heading for a Fall - Mind Your Meds - Exercise to Prevent Falls - Smart Home Design - Eating Right - Excerpt from Mind Your Meds: Discuss the risks...more

Five Health Care Developments Important to Employers

Perhaps never before have employers faced so many challenges when it comes to health care issues affecting their workforce. Congress may try to amend the Affordable Care Act (“ACA”). The Supreme Court of the United States is...more

ACA Countdown to Compliance - 52 Week Series For Employers

In this volume, we have collected the 52 weekly blog posts that comprise the series entitled, The Affordable Care Act—Countdown to Compliance for Employers. The series appeared in the Mintz Levin Employment Matters Blog...more

FDA Issues Draft Guidance on Medical Device Accessories

On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015)...more

FDA Regulatory and Compliance Monthly Recap - January 2015

In This Issue: - FDA’s CDER, CDRH and CBER put out 2015 guidance agendas - FDA to study limiting major risk statements in direct-toconsumer TV ads amid concern that information is getting lost on consumers...more

Employers Beware: Increased Attention to Workplace Harassment and Wellness Programs by the EEOC Coming in the New Year

Newly appointed U.S. Equal Employment Opportunity Commission (EEOC) Chair Jenny Yang recently offered some insight into the EEOC’s areas of focus for 2015, providing employers with a preview of some of the key regulatory and...more

Top 10 Topics for Directors in 2015: Explore New Trends in Reducing Corporate Health Care Costs

The increasing cost of healthcare is a significant concern for companies that provide health care benefits to their employees. With certain key provisions of the Patient Protection and Affordable Care Act, more commonly known...more

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On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more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

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