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Regulatory Authority Department of Health and Human Services (HHS)

Akerman LLP - Health Law Rx

Federal Court Vacates 2024 HIPAA Privacy Rule Modifications That Supported Reproductive Healthcare Privacy: What Regulated...

On June 18, 2025, the U.S. District Court for the Northern District of Texas issued an order in Purl v. United States Department of Health and Human Services, No. 2:24-CV-228-Z (N.D. Tex. 2025) (the June 18 Order) that...more

Sheppard Mullin Richter & Hampton LLP

Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance

A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more

Goodwin

Federal Court Affirms HRSA Authority to Preapprove 340B Rebate Models but Urges HRSA to Reconsider Rejection of Rebate Model

Goodwin on

In a May 15, 2025, opinion, Judge Dabney Friedrich of the US District Court for the District of Columbia denied drugmakers’ motions for summary judgment against the US Department of Health and Human Services and the Health...more

Stevens & Lee

U.S. Supreme Court Readies to Decide an Important Separation of Powers Issue

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With May having begun, we have entered the zone in which the Supreme Court will be announcing decisions in the most important cases of this term. Among them is Federal Communications Commission v. Consumers’ Research, a...more

Arnall Golden Gregory LLP

Court Strikes Down Nursing Home Minimum Staffing Rule

On April 7, 2025, the United States District Court for the Northern District of Texas ruled in favor of the American Health Care Association (“AHCA”) in its lawsuit against Health and Human Services (“HHS”) Secretary Robert...more

Marshall Dennehey

Legal Update for Special Education Law – Updates from the U.S. Department of Education

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The Uncertain Future of Special Education: Presidential Authority and the Proposed Shift to HHS - With the United States Department of Education in a state of flux at the national level, one question that looms large is the...more

Ropes & Gray LLP

District Court Embraces Loper Bright and Overturns FDA Laboratory Developed Test Rule – What Lies Ahead?

Ropes & Gray LLP on

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case...more

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

Farrell Fritz, P.C.

New York Court of Appeals Upholds Adult Home Admission Regulations

Farrell Fritz, P.C. on

New York Department of Health (DOH) regulations provide that an adult home may not admit additional residents with serious mental illness if it has a capacity of 80 or more beds and its resident population is over 25% persons...more

Baker Donelson

Texas Court Issues Injunction on 2024 HIPAA Reproductive Privacy Rule

Baker Donelson on

The HIPAA Privacy Rule to Support Reproductive Health Care Privacy went into effect on June 24, 2024. The 2024 Final Rule strengthens privacy protections for medical records and other health information related to...more

Holland & Knight LLP

OCR Shores Up Access to Healthcare with Nondiscrimination Protections

Holland & Knight LLP on

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

Burr & Forman

Federal Agency Deference Eliminated, Now What?

Burr & Forman on

On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Hall Benefits Law

Courts Issue Injunctions Blocking Expansion of ACA Section 1557 to Prohibit Discrimination Based on Gender Identity

Hall Benefits Law on

A Mississippi federal district court has issued a nationwide injunction and stay on some of the new federal regulations concerning Affordable Care Act (ACA) Section 1557, which prohibits discrimination in specified health...more

Baker Donelson

60 Days After Loper: Health Care Impact of Chevron Deference's End

Baker Donelson on

The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more

Bass, Berry & Sims PLC

Chevron No More: The Impact on Benefit Plans

Bass, Berry & Sims PLC on

On June 28, 2024, the Supreme Court issued its opinion in Loper Bright Enterprises v. Raimondo, Secretary of Commerce and Relentless, Inc. v. Department of Commerce (Loper Bright), overturning Chevron U.S.A. Inc v. Natural...more

Bass, Berry & Sims PLC

Healthcare Private Equity: What to Expect for the Rest of 2024

Bass, Berry & Sims PLC on

Although the U.S. healthcare industry has weathered the storm over the past couple of years, we may be reaching calmer waters in the coming months. Dry powder held by U.S. private equity investors has reached an all-time...more

Parker Poe Adams & Bernstein LLP

Two Recent Supreme Court Decisions Could Dramatically Impact Health Care Regulatory Challenges at the Federal and State Levels

For nearly 40 years, federal courts have been required to defer to an agency’s interpretation of an ambiguous statute, even if the court did not agree with that interpretation. This deference, commonly referred to as Chevron...more

BakerHostetler

The Future for Healthcare Is So Loper Bright, I Gotta Wear Shades

BakerHostetler on

On June 28, in Loper Bright Enterprises v. Raimondo (Loper Bright), the U.S. Supreme Court overturned the doctrine of Chevron deference, upending 40 years of precedent and significantly shifting power to the courts to...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Troutman Pepper Locke

2024 Mid-Year Review: State AGs Shaping Regulatory Landscapes

Troutman Pepper Locke on

In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

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In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

Bradley Arant Boult Cummings LLP

The Overturn of Chevron: A New Design for Healthcare Law

On June 28, 2024, SCOTUS overturned the long-standing Chevron doctrine in its decision Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce. The Court’s ruling will have a significant impact on...more

Stevens & Lee

A New Arena for Future Challenges to CMS Regulations – the Overturn of Chevron

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On June 28, 2024, the Supreme Court overruled Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., and consequently invalidated the “Chevron Deference” — a cornerstone of administrative law since 1984. In the 6-3 decision...more

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