News & Analysis as of

New Regulations Department of Health and Human Services (HHS)

Alston & Bird

Health Care Week in Review | Senate Parliamentarian Issues Rulings on Budget Reconciliation Provisions; Supreme Court Upholds the...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott+

Health Plans’ Commitment to Prior Authorization Improvements: What’s New Versus What’s Already Required

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Health plan members of AHIP and the Blue Cross and Blue Shield Association made news earlier this week when they announced a series of steps that a broad swath of health insurers will take to improve the prior authorization...more

Morrison & Foerster LLP

FDA Publishes Post-Market Assessment Tool to Rank Chemicals in Food Supply

On June 18, 2025, FDA published a proposed “Post-Market Assessment Prioritization Tool” to guide how the agency plans to rank and prioritize food chemicals under its enhanced post-market review process. FDA’s unveiling of...more

Ropes & Gray LLP

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

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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

Cozen O'Connor

FDA’s New Measures to Eliminate All Petroleum-Based Synthetic Dyes from Food

Cozen O'Connor on

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a plan to phase out all petroleum-based synthetic dyes from the nation’s food supply. The plan is...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Holland & Knight LLP

Holland & Knight Health Dose: June 3, 2025

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Looking Ahead: Fiscal Year 2026 Appropriations - This week, the U.S. House of Representatives and U.S. Senate return to Capitol Hill following the Memorial Day recess. The Senate is expected to begin work behind the scenes on...more

Epstein Becker & Green

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

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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

Jackson Lewis P.C.

UPDATE – Departments issue nonenforcement policy statement!

Jackson Lewis P.C. on

On May 15, 2025, the Departments of Labor, Treasury, and Health and Human Services issued their anticipated nonenforcement policy regarding the 2024 Mental Health Parity regulations. As expected, nonenforcement is applicable...more

ArentFox Schiff

RFK Jr. Sets Sights on Currently Authorized Synthetic Food Dyes

ArentFox Schiff on

On April 22, at the direction of US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., both the US Food and Drug Administration (FDA) and HHS published identical statements announcing the...more

Hogan Lovells

HHS & FDA Request Public Comment to Inform Agency’s Infant Formula Nutrient Review

Hogan Lovells on

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) are requesting public comment on nutrient requirements for infant formulas intended for healthy, full-term infants. FDA’s...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Holland & Knight LLP

Implementing NIH's New Grant Requirements

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The National Institutes of Health (NIH) on April 21, 2025, published a notice (the NIH Notice) updating the civil rights provisions of the NIH Grants Policy Statement and creating new requirements that federally funded...more

DLA Piper

Food and Beverage News and Trends - May 2025

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On April 22, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced coming FDA actions aiming “to phase out all petroleum-based synthetic dyes from the nation’s food supply” and to prompt the food industry...more

Ropes & Gray LLP

Food Policy Update: FDA’s Focus on Regulating What’s In Our Food

Ropes & Gray LLP on

Since their U.S. Senate confirmations, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary have focused significant attention on one of the administration’s key policy priorities: improving the safety of...more

Hogan Lovells

HHS and FDA Announce Plans to Phase Out Certified Colors

Hogan Lovells on

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced a series of measures to phase out all certified colors from the nation’s food supply by the end...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - April 2025

The U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) have announced actions to phase out petroleum-based synthetic dyes from foods in the U.S. food supply. In a news release, FDA said...more

Venable LLP

FDA to Phase Out Eight Artificial Dyes by 2026

Venable LLP on

On April 22, 2025, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration announced a series of new measures to quickly phase out all petroleum-based synthetic dyes from the nation’s food...more

Venable LLP

Food Industry Braces Itself as FDA Announces Plan to Ban Artificial Dyes

Venable LLP on

On April 21, 2025, it was reported that the U.S. Department of Health and Human Services (HHS) has released a media advisory describing the Food and Drug Administration’s (FDA) intention to remove petroleum-based synthetic...more

DLA Piper

President Trump Signs Executive Order to Lower Prescription Drug Costs

DLA Piper on

President Donald Trump recently signed an Executive Order (EO) aimed at lowering the cost of prescription drugs, titled, “Lowering Drug Prices by Once Again Putting Americans First.” On April 15, 2025, through this EO, 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

McCarter & English, LLP

Federal Telehealth Update

Congress has extended telehealth flexibilities through its recent federal spending bill, H.R. 1968, titled “Full-Year Continuing Appropriations and Extensions Act, 2025” (the Act). Notably for health care providers, among...more

Alston & Bird

Health Care Week in Review | Oz Confirmed as CMS Administrator; CMS finalizes CY 2026 MA/Part D Final Rule

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Second Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Alston & Bird

Health Care Week in Review | HHS Announces Significant Workforce Reductions and Reorganization; FDA and NIH Nominees are Confirmed

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

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