News & Analysis as of

Final Rules Department of Health and Human Services (HHS) Executive Orders

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

Lathrop GPM

Flying Through the Whirlwind: Health Care Industry Continues To Be Buffeted as Administration Rolls Out New Initiatives

Lathrop GPM on

Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

Hogan Lovells on

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

DLA Piper

Food and Beverage News and Trends - March 2025 #2

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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

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...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The Department of Health and Human Services (HHS) recently rescinded its policy dating back to 1971 to now allow its agencies and offices to quickly alter certain rules and regulations without public notice and comment.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

Saul Ewing LLP

Trump on Transparency: Making America Healthy Again Through Executive Order 14221; How Plan Sponsors Can Respond

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One mandate under the PPACA required health care providers, non-grandfathered health insurance issuers and self-insured group health plans to provide consumers with access to information about the cost of services before they...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

McDermott+

Regs and De-Regs: What to Watch Out for Next

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It is relatively quiet on the healthcare regulatory front. The Trump administration is currently filling out its leadership team within the US Department of Health and Human Services (HHS), with the confirmation process of...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

Holland & Knight LLP

OCR Shores Up Access to Healthcare with Nondiscrimination Protections

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Access to quality healthcare services has long been a priority of the U.S. Department of Health and Human Services (HHS), and through its Office for Civil Rights (OCR) this agency has, since at least 2001, sought to provide...more

King & Spalding

End of Year Compliance Updates

King & Spalding on

On June 25, 2024, the Office for Civil Rights and the U.S. Department of Health and Human Services issued the HIPAA Privacy Rule To Support Reproductive Health Care (the “HIPAA Final Rule”) aimed at strengthening privacy...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 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....more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

Fenwick & West LLP on

On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

Mintz - Health Care Viewpoints

HHS, ONC HTI-1 Final Rule Introduces New Transparency Requirements for Artificial Intelligence in Certified Health IT

The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy...more

BakerHostetler

Federal Government Addresses AI Transparency and Safety in Healthcare

BakerHostetler on

On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more

McDermott+

McDermottPlus Check-Up: November 3, 2023

McDermott+ on

CONGRESS - House Ways & Means Chair Smith, House Energy & Commerce Chair Rodgers and Senate Finance Ranking Member Crapo Call for Withdrawal of Nurse Staffing Mandate. Rep. Smith (R-MO), Rep. Rodgers (R-WA) and Sen. Crapo...more

King & Spalding

HHS Withdraws Two Trump Administration Rules Limiting the Agency’s Use of Guidance Documents in Civil Enforcement Actions

King & Spalding on

On Friday, July 22, 2022, HHS issued a final rule (Final Rule), rescinding two regulations issued at the end of the Trump Administration on December 7, 2020, and January 14, 2021, that would have significantly altered the...more

Sheppard Mullin Richter & Hampton LLP

2023 Payment Rule’s Nondiscrimination Provisions and Anticipation of New Section 1557 Rules

On January 5, 2022, we discussed the Notice of Benefit and Payment Parameters for 2023 proposed rule released by the Centers for Medicare & Medicaid Services (CMS). On April 28, 2022, CMS issued the NBPP 2023 Final Rule. CMS...more

King & Spalding

HHS Proposes Repeal of Two Trump Administration Rules on Guidance, Enforcement, and Adjudication Procedures

King & Spalding on

On October 20, 2021, HHS published in the Federal Register a proposal to repeal two final rules issued during the Trump administration. The final rules up for repeal are the “Department of Health and Human Services Good...more

ArentFox Schiff

Investigations Newsletter: Individual Prosecutions Down But Corporate Resolutions Steady for DOJ’s Fraud Section in 2020, with...

ArentFox Schiff on

Individual Prosecutions Down But Corporate Resolutions Steady for DOJ’s Fraud Section in 2020, with More in the Pipeline - The Department of Justice’s (“DOJ”) Fraud Section recently released a year-in-review report that...more

Sheppard Mullin Richter & Hampton LLP

Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of...

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially...more

ArentFox Schiff

What Should Pharma Companies Expect From the Biden Administration?

ArentFox Schiff on

With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more

Foley Hoag LLP - Medicaid and the Law

President Biden Takes First Step Towards Reversing Trump Era Medicaid Policies

On January 28th, President Biden issued an “Executive Order on Strengthening Medicaid and the Affordable Care Act.” The E.O. states that the Biden Administration will promote policies that “protect and strengthen Medicaid and...more

Sheppard Mullin Richter & Hampton LLP

Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more

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