News & Analysis as of

Regulatory Requirements Final Rules Department of Health and Human Services (HHS)

Ropes & Gray LLP

U.S. District Court Ruling Vacates HIPAA Final Rule that Strengthened Privacy Protections for Reproductive Health Information

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On June 18, 2025, the United States District Court for the Northern District of Texas Amarillo Division issued an opinion, Purl v. Department of Health and Human Services, declaring the U.S. Department of Health and Human...more

Neal, Gerber & Eisenberg LLP

Parity on Ice: MHPAEA’s 2024 Final Rule Heads to the Penalty Box

Federal regulators have paused enforcement of the 2024 Mental Health Parity and Addiction Equity Act (“MHPAEA”) Final Rule (the “2024 Final Rule”, published September 23, 2024) while they reconsider the rule and defend...more

Quarles & Brady LLP

HIPAA Reproductive Health Rule Vacated Nationally

Quarles & Brady LLP on

A federal judge in Texas has vacated almost all of the 2024 HIPAA Rule to Support Reproductive Health Care Privacy that created special protections for reproductive health care information, finding that the U.S. Department of...more

Seyfarth Shaw LLP

Time to Revisit Your HIPAA Documents After Reproductive Health Privacy Rule Vacated

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In the wake of a recent federal District Court decision, the reproductive health care HIPAA Privacy rules finalized during the Biden Administration have been vacated and plan sponsors should re-evaluate the language included...more

Ropes & Gray LLP

With Implementation Deadline Looming, ORI Releases Sample Research Misconduct Policies and Procedures

Ropes & Gray LLP on

On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align...more

Snell & Wilmer

Limited Mental Health Parity Relief for Plan Sponsors

Snell & Wilmer on

On January 17, 2025, the ERISA Industry Committee (“ERIC”) filed suit in the U.S. Court of Appeals for the D.C. Circuit asking the court to hold various key provisions under the 2024 Mental Health Parity Addiction Equity Act...more

Groom Law Group, Chartered

Departments Pause Enforcement of MHPAEA Final Rule and Reconsider MHPAEA Enforcement Program

In a widely anticipated and welcome move, the Departments of Health and Human Services (“HHS”), the Treasury, and Labor (“DOL”) (collectively, the “Departments”), sought an abeyance of a lawsuit challenging the Mental Health...more

Bond Schoeneck & King PLLC

Administration Grants Welcome Reprieve From Certain NQTL Requirements

Administration Grants Welcome Reprieve From Certain NQTL Requirements - Earlier this month, the Departments of Labor, Health and Human Services and Treasury (the “Departments”) announced that for the foreseeable future...more

Warner Norcross + Judd

Delayed Enforcement of Mental Health Parity NQTL Comparative Analysis Final Regulations

Warner Norcross + Judd on

Under the Mental Health Parity and Addiction Equity Act (MHPAEA), as amended by the Consolidated Appropriations Act (CAA), 2021, group health plans and health insurance issuers must conduct comparative analyses to show that...more

Foley & Lardner LLP

Mental Health Parity Alert - Non-Enforcement of Final Rules

Foley & Lardner LLP on

The Mental Health Parity and Addiction Equity Act (MHPAEA), and its implementing regulations and guidance, prohibits health insurance policies and group health plans that cover mental health and substance use disorder...more

Woodruff Sawyer

​​​​​​Agencies Push Pause Button on Enforcement of MHPAEA 2024 Final Rule

Woodruff Sawyer on

On May 15, 2025, the Department of Labor, Department of Health and Human Services, and the Treasury Department (collectively, the “Agencies”) released a statement regarding the Agencies’ recent request for abeyance of a...more

Quarles & Brady LLP

Departments Will Not Enforce 2024 Final Rule under MHPAEA

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The Trump Administration has just announced that it will pause enforcement of the September 2024 final rule (“Final Rule”) under the Mental Health Parity and Addiction Equity Act (“MHPAEA”)....more

Epstein Becker & Green

The Final Rule on Research Misconduct Regulations: What Institutions Need to Know as Implementation Looms

Epstein Becker & Green on

When the current federal administration took office, it issued a memorandum requiring, among other things, that federal agencies delay the issuance of new or proposed rules to the Office of the Federal Register until further...more

Seyfarth Shaw LLP

Parity in Peril? Plan Sponsors Breathe Easier As Trump Administration Hits Pause on Enforcement of Mental Health Parity Final Rule

Seyfarth Shaw LLP on

On May 15, 2025 the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) announced they will temporarily not enforce their new standards published under the mental health parity Final Rule last...more

Morgan Lewis - ML Benefits

Mental Health Parity Non-Enforcement Statement Released

The US Departments of Labor, Health and Human Services, and the Treasury (the Departments) announced their non-enforcement policy on May 15, 2025, indicating they will not enforce any new requirements imposed by the...more

Morgan Lewis - ML Benefits

US District Court Grants Freeze on Mental Health Parity Enforcement

The US Departments of Health and Human Services, Labor, and the Treasury (together, the Departments) filed a motion to suspend the litigation proceedings in The ERISA Industry Committee vs. HHS et al. on May 9, 2025 while the...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more

Husch Blackwell LLP

Litigation Looms: ERIC Seeks Stay on 2024 Mental Health Parity Rule Enforcement

Husch Blackwell LLP on

On February 20, 2025, the ERISA Industry Committee (ERIC) announced that its legal counsel submitted a letter to the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury, requesting a stay of...more

Foley & Lardner LLP

DEA Buprenorphine Rule Delayed to December 31, 2025

Foley & Lardner LLP on

The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

MoFo Life Sciences on

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

DLA Piper

Food and Beverage News and Trends - March 2025 #2

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Secretary Kennedy takes first steps to eliminate GRAS exception. Health and...more

Jones Day

FDA Directed to Explore Elimination of Food Additive "Loophole"

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Secretary Kennedy seeks to enhance FDA's oversight of food additives by eliminating a pathway that allows new ingredients to be introduced into the U.S. food supply without premarket notification to or approval by FDA....more

ArentFox Schiff

RFK Jr. Takes Aim at GRAS Self-Affirmation Process

ArentFox Schiff on

On March 10, the US Department of Health and Human Services (HHS) announced that newly confirmed HHS Secretary Robert F. Kennedy Jr. has directed acting US Food and Drug Administration (FDA) Commissioner Dr. Sara Brenner to...more

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