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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Akerman LLP - Health Law Rx

The Zafirov Appellate Argument — Panel Steers Parties to Address Whistleblower Control

The much-anticipated appellate showdown regarding the constitutionality of the whistleblower (or qui tam) provision of the federal False Claims Act (FCA) took place before a three-judge panel of the Eleventh Circuit Court of...more

Oberheiden P.C.

Healthcare & the Whistleblower Protection Act: Answers to FAQs

Oberheiden P.C. on

Healthcare fraud is a major issue. According to federal government estimates, it costs taxpayers in the realm of $100 billion every year. While the U.S. Department of Justice (DOJ) and U.S. Department of Health and Human...more

Maynard Nexsen

Episode 265: Redesigning Clinical Trials Through Technology with Patrick McCarthy of Validcare

Maynard Nexsen on

Hosts Heather and Lauren sit down with Patrick McCarthy, CEO of Validcare, to discuss how technology is reshaping the future of clinical research. Patrick shares how Validcare is re-engineering the traditional CRO model,...more

Thompson Coburn LLP

The Importance of Coordinated Oversight in Internal Health Care Investigations

Thompson Coburn LLP on

Internal investigations are an important component of an effective legal and compliance program within health care organizations. These investigations may arise from many varied situations ranging from patient complaints,...more

Krieg DeVault

DEA Extends COVID-Era Telemedicine Flexibilities to December 31, 2026

Krieg DeVault on

On December 31, 2025, the Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) announced that that they were issuing a Fourth Temporary Extension of the COVID-19 Telemedicine...more

Troutman Pepper Locke

2025 State AG Year in Review

Troutman Pepper Locke on

State attorneys general (AGs) are among the most active and influential regulators in the U.S., using broad statutory authority, political visibility, and growing technical knowledge to shape policy and enforcement across...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Apple chooses Google Gemini AI to power updated Siri, AI tool discovers treatment for rare disease, US imposes...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court to Resolve Dispute Over Marketing of “Skinny Labeled” Generics

The Hatch-Waxman Act has always represented a delicate balance between the interests of innovator and generic drugmakers: innovators seek to maintain exclusivity as broadly and long as possible, generics seek to come to...more

Morrison & Foerster LLP

Supreme Court Takes Up Hikma v. Amarin

On Friday, the Supreme Court granted certiorari in Hikma Pharmaceuticals v. Amarin Pharma, ending an almost three-year lull in patent cases at the Court. The case presents two related questions, one framed specifically in the...more

Hissey, Mulderig & Friend, PLLC

Ozempic Blindness Lawsuits: Legal Claims Allege GLP-1 Drugs Linked to NAION Vision Loss

Glucagon-like peptide-1 receptor agonist drugs (commonly referred to as GLP-1 agonists) have become widely prescribed for type 2 diabetes and weight loss. Medications such as Ozempic, Wegovy, Mounjaro, and other GLP-1 drugs...more

Morgan Lewis - As Prescribed

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device regulatory submissions. ...more

Groom Law Group, Chartered

This Week From the Hill (January 11 – 17, 2026)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

Ice Miller

The Trump Administration Releases the “New Pyramid”

Ice Miller on

Earlier this week, the Departments of Health and Human Services (HHS) and Agriculture (USDA) published the 2025–2030 Dietary Guidelines, with HHS as the primary author....more

Hogan Lovells

The Decree amending, adding, and repealing various provisions of the General Health Law was published in the federal official...

Hogan Lovells on

On January 15th, 2026, the Decree amending, adding, and repealing various provisions of the General Health Law (“Amendment”) was published in the Federal Official Gazette. While the prohibition of vaping devices has drawn...more

Epstein Becker & Green

False Claims Act Recoveries Reach Historic Highs in FY 2025: What It Signals for Health Care and Life Sciences Companies in 2026...

Epstein Becker & Green on

On January 16, 2026, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics, announcing that FCA settlements and judgments exceeded $6.8 billion in the fiscal year (FY) ending...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Supreme Court to Address ‘Skinny Label’ Patent Disputes

On January 16, 2026, the U.S. Supreme Court agreed to hear Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., a patent dispute that could reshape the landscape of generic drug competition and patent enforcement....more

DLA Piper

FDA Updates Its Clinical Decision Support And General Wellness Guidances: Key points

DLA Piper on

The United States Food and Drug Administration (FDA) issued revisions this month to its guidance documents "Clinical Decision Support Software" (CDS Guidance) and "General Wellness: Policy for Low Risk Devices" (General...more

DLA Piper

Three New Drug Pricing Models For Manufacturer Rebates: Key Implications

DLA Piper on

The Center for Medicare and Medicaid Innovation (CMMI) recently released information about three new models aimed at testing alternative calculations for manufacturer rebates, to ensure net drug prices are closer to those in...more

DLA Piper

Updated 2025–2030 Dietary Guidelines for Americans Emphasize Consumption Of “Real Foods”

DLA Piper on

On January 7, 2025, the US Departments of Health and Human Services and Agriculture released the long-awaited 2025–2030 Dietary Guidelines for Americans (DGAs or Guidelines), marking “the most significant reset of federal...more

Hendershot Cowart P.C.

Clinical Labs, You're Not the Medical Necessity Police: First Circuit Clarifies Lab Liability Under the FCA

Hendershot Cowart P.C. on

On December 1, 2025, the First Circuit Court of Appeals delivered a decision that should bring welcome relief to clinical laboratories facing False Claims Act (FCA) allegations. In United States ex rel. OMNI Healthcare,...more

Troutman Pepper Locke

From Diligence to Post-Closing: What’s Shifting in 2026 Health Care Transactions

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On the heels of the 44th Annual J.P. Morgan Health Care Conference, Troutman Pepper Locke attorneys Joe Kadlec and Emma Trivax discuss how AI, shifting regulatory scrutiny, and evolving investor oversight are reshaping health...more

Ankura

2025 – Pharmacy Benefit Management Regulatory Snapshot – Federal, State, and the Initiation of New Drug Pricing Concepts

Ankura on

Throughout 2025, Congress introduced several bills related to the pharmacy benefit management (PBM) industry. As with the 118th Congress in 2024 (see The Focus of Federal Proposals on Pharmacy Benefit Management – 118th...more

Haynes Boone

The Push Toward Real Food: State Law Changes in 2025

Haynes Boone on

Americans are beginning the new year with a new food pyramid. Whole proteins, fruits, and vegetables are at the top, while processed foods—especially ultraprocessed foods—are out of favor. But this movement began long before...more

Burr & Forman

CMS Makes Permanent Significant Changes to Medicare Physician Supervision Rules

Burr & Forman on

As part of its calendar year 2026 Medicare Physician Fee Schedule, the Centers for Medicare and Medicaid Services (“CMS”) made permanent a major change to its physician direct supervision rules. Effective January 1, 2026, for...more

Hogan Lovells

Se publica en el Diario Oficial de la Federación el Decreto por el que se reforman, adicionan y derogan diversas disposiciones de...

Hogan Lovells on

El 15 de enero de 2026 se publicó en el Diario Oficial de la Federación el Decreto por el que se reforman, adicionan y derogan diversas disposiciones de la Ley General de SaludAunque se ha destacado la prohibición de los...more

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