News & Analysis as of

Department of Health and Human Services (HHS) Regulatory Reform

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

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Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more

McDermott+

McDermott+ Check-Up – July 25, 2025

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CBO releases final scores for OBBBA. The Congressional Budget Office (CBO) estimates that the One Big Beautiful Bill Act (OBBBA) will increase the uninsurance rate by 10 million individuals over 10 years. House Energy and...more

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

Quarles & Brady LLP on

On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more

Proskauer - Employee Benefits & Executive...

District Court Vacates HIPAA Reproductive Health Care Rule

Last month, a federal district court in Texas vacated portions of the HIPAA final rule that added heightened protections for reproductive health care information (the “Final Rule”). Purl, et al. v. U.S. Department of Health...more

Latham & Watkins LLP

Senators Introduce Legislation to Restrict Direct-to-Consumer Drug Advertising

Latham & Watkins LLP on

On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

BakerHostetler on

On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

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The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...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

Ballard Spahr LLP

Court Vacates HIPAA Reproductive Information Privacy Regulations

Ballard Spahr LLP on

A federal district court has vacated a federal regulation under HIPAA that provided special restrictions on the disclosure of reproductive health information....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

Epstein Becker & Green

Agencies’ Listening Sessions to Focus on Lowering Drug Prices Through Competition

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The Federal Trade Commission (FTC) and the Antitrust Division of the U.S. Department of Justice (DOJ), along with the U.S. Department of Commerce and the U.S. Department of Health and Human Services (collectively, “the...more

Morgan Lewis

On the Basis of Sex: HHS Rescinds Prior Section 1557 Guidance Interpreting Sex-Based Discrimination

Morgan Lewis on

The US Department of Health and Human Services (HHS) has rescinded several pieces of informal guidance, including its 2021 interpretation of Section 1557 of the Affordable Care Act (Section 1557), in response to executive...more

McDermott+

Health Information Technology Policy Under the Trump Administration

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Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....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

Mintz - Health Care Viewpoints

FDA in Flux — June 2025 Newsletter

Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Akin Gump Strauss Hauer & Feld LLP

Eliminating Waste, Fraud, and Abuse in Medicaid (Trump EO Tracker)

This memorandum directs the Secretary of Health and Human Services to take appropriate action to eliminate waste, fraud, and abuse in Medicaid, including by ensuring Medicaid payments rates are not higher than Medicare....more

Bergeson & Campbell, P.C.

President’s FY 2026 Budget Requests Would Eliminate CSB, Reorganize CPSC

President Trump’s fiscal year (FY) 2026 budget request for the Chemical Safety and Hazard Investigation Board (CSB) states that the President’s budget proposes to eliminate funding for CSB as part of the Trump...more

McDermott+

Filling in More Puzzle Pieces with HHS’s Newly Released Budget Documents

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McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. June 5, 2025 – On May 30, 2025, the US Department of Health and Human Services...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2025 #4

News Briefs - Judge Rules Against Administration's HHS Reorg, Reductions - California District Judge Susan Illston has granted a preliminary injunction against the Trump administration's recent reductions in force across...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

Akin Gump Strauss Hauer & Feld LLP

Five FDA Takeaways from the FY26 Budget

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

DLA Piper

Make Our Children Healthy Again Assessment: Unpacking the Report

DLA Piper on

The Trump Administration released its Make Our Children Healthy Again Assessment on May 22, 2025, documenting its rationale for future policy actions related to chronic disease in children. The report focuses on four key...more

Knobbe Martens

Executive Order 14297 and the Global Drug Market: Policy, Pricing, and Uncertainty

Knobbe Martens on

On May 12, 2025, President Trump issued Executive Order 14297 targeting prescription drug prices in America. The stated purpose of this order is to combat high drug prices in the United States, bringing the prices Americans...more

Mayer Brown

HHS and FDA Announce Plans to Phase out Synthetic Food Dyes

Mayer Brown on

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a series of steps intended to eliminate all petroleum-based synthetic dyes from the US food...more

McDermott+

First Steps in Implementing the Trump Administration’s Price Transparency Agenda

McDermott+ on

Recently, the Trump administration took steps toward implementing one of its major priorities: improving price transparency. As discussed in a previous Regs & Eggs blog post, President Trump signed an executive order (EO) on...more

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