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Regulatory Requirements Department of Health and Human Services (HHS) Regulatory Agenda

Dickinson Wright

Breaking: FDA, HHS Seek Public Input on Cutting Rules

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On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary...more

Clark Hill PLC

Right To Know - May 2025, Vol. 29 | News & Events

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Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Virginia Governor Signs Bill Restricting Minor’s Use of Social...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA at the Start of the Trump Administration: A Cheat Sheet

There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...more

Holland & Knight LLP

Holland & Knight Health Dose: March 25, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Morgan Lewis - Well Done

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...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

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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

Mintz - Health Care Viewpoints

CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more

ArentFox Schiff

Five Key Topics for Beverage and Food Companies in 2025

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2025 will be a transformational year for the beverage and food industry, which has already been dramatically impacted by shifting market trends and profound policy changes. Here are the top five topics influencing the...more

Holland & Knight LLP

Holland & Knight Health Dose: March 19, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Bradley Arant Boult Cummings LLP

Top 10 takeaways from the new HIPAA security rule NPRM

On Jan. 6, 2025, the U.S. Department of Health and Human Services (HHS) proposed new regulations to enhance cybersecurity protections for electronic protected health information (ePHI) under the Health Insurance Portability...more

Akerman LLP - Health Law Rx

No (Public) Comment: HHS Rescinds Policy on Public Participation in Rulemaking

The Department of Health and Human Services (HHS) recently rescinded its policy dating back to 1971 to now allow its agencies and offices to quickly alter certain rules and regulations without public notice and comment. The...more

McDermott+

Trump Administration Executive Order Tracker

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Alston & Bird

Trump Administration Changes Seek to Avoid Notice and Comment Hurdles

Alston & Bird on

Our Health Care and Health Care Litigation Groups examine a policy move by the Department of Health and Human Services (HHS) that will allow the department to forgo notice and comment procedures for many of its regulations....more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott Will & Emery

This Week in 340B: February 18 – 24, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Holland & Knight LLP

Holland & Knight Health Dose: February 25, 2025

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Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Foley & Lardner LLP

Make Food “Healthy” Again: FDA’s Resolution for a Healthier 2025

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more

Cozen O'Connor

Republican AGs Have Beef with Nutritional Standards Report

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Twenty-three Republican AGs submitted a comment letter to HHS and Department of Agriculture officials opposing aspects of the Scientific Report of the 2025 Dietary Guidelines Advisory Committee; the Dietary Guidelines are...more

Holland & Knight LLP

Holland & Knight Health Dose: February 11, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Bradley Arant Boult Cummings LLP

HHS Security Rule NPRM Proposes Makeover for Administrative Safeguard Compliance for Regulated Entities

In this week’s installment of our blog series on the U.S. Department of Health and Human Services’ (HHS) HIPAA Security Rule updates in its January 6 Notice of Proposed Rulemaking (NPRM), we are exploring the proposed updates...more

Bass, Berry & Sims PLC

Can the NIH Cap Indirect Cost Rates at 15%?

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Note: This post was updated with new information on February 13, 2025. On February 7, the National Institutes of Health (NIH) issued Supplemental Guidance to its 2024 NIH Grants Policy Statement, Indirect Cost Rates,...more

Holland & Knight LLP

Holland & Knight Health Dose: January 29, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

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