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Robinson+Cole Health Law Diagnosis

South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks

A clinical lab in Anderson, South Carolina, and its founder and CEO have agreed to pay a minimum of $6.8 million to settle a federal qui tam case based on allegations for paying illegal kickbacks to physicians in exchange for...more

Polsinelli

No Second-Guessing Required: First Circuit Limits FCA Liability for Clinical Labs

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Key Takeaways - Reliance on Physician Orders: Clinical laboratories may generally rely on physician orders to establish medical necessity and are not required to independently reassess clinical judgment....more

Polsinelli

2026 Employment Law Updates

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Effective January 1, 2026, numerous state and local government employment laws have taken effect. Below is a non-exhaustive summary of key employment law updates for January 2026....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | November 2025 Recap

This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2025. Regulators are signaling clear priorities: stronger enforcement, modernization of compliance standards,...more

Bass, Berry & Sims PLC

OIG Analyzes Market Share Rebates and Bundled Discounts Under the Discount Safe Harbor

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On December 18, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion 25-11, approving various discount structures, including bundled discounts and...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Regulatory and Business Factors Shaping the Dietary Supplement Industry in 2026

As we enter 2026, the dietary supplement industry faces a rapidly evolving landscape shaped by regulatory developments, shifting consumer expectations, and heightened scrutiny from both state and federal authorities....more

Cooley LLP

FDA Seeks Venture Capital Firm Input on New Contracting Approach

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On December 19, 2025, the Food and Drug Administration (FDA), part of the US Department of Health and Human Services, released a request for information (RFI) seeking input from venture capital firms on how the FDA can better...more

McDermott Will & Schulte

FDA loosens the reins: New AI and wearables guidance

On January 6, 2026, the US Food and Drug Administration (FDA) released updates to two guidance documents reflecting a move towards a more hands-off approach to digital health product regulation. Both updated guidance...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions: Year in Review

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At the end of 2024, we predicted that the healthcare mergers and acquisitions (M&A) market would pick up steam in 2025 given the combination of decreasing interest rates, a potential shift in the regulatory landscape with the...more

Holland & Knight LLP

The NIH-Proposed 15 Percent Indirect Cost Rate Cap Is Out – for Now

Holland & Knight LLP on

The U.S. Court of Appeals for the First Circuit on January 6, 2026, upheld a district court's decision to permanently enjoin and vacate guidance (Guidance) published by the National Institutes of Health (NIH) early last year....more

Akin Gump Strauss Hauer & Feld LLP

Digesting the New Dietary Guidelines with Key Takeaways for Regulated Entities

On January 7, 2026, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) released the highly anticipated 2025-2030 Dietary Guidelines for Americans (DGA). At roughly 10 pages,...more

Fox Rothschild LLP

Florida Severely Restricts Medical Marijuana Treatment Center Advertising and Marketing

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The rule adopts a restrictive framework under which anything not expressly permitted is prohibited. Its stated purpose is to ensure marijuana advertising remains medical in nature, factual, nonrecreational and not attractive...more

Stevens & Lee

Deadline Approaching: Part 2 Substance Use Disorder Treatment Records Privacy Regulations

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Following our Nov. 30, 2022 post regarding the proposed regulatory updates to the rules governing privacy of substance use disorder treatment records and our Mar. 12, 2024 post covering the Final Rule, we are posting again to...more

McGuireWoods LLP

Signaling More Flexibility, FDA Says More Wearable Devices Qualify for General Wellness Exception

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The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a more flexible regulatory...more

Ballard Spahr LLP

Mark Your Calendar: HIPAA Deadline on February 16

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The Health Insurance Portability and Accountability Act (HIPAA) regulations require updates to the Notice of Privacy Practices that health plan sponsors furnish to plan participants and health care providers furnish to...more

Bond Schoeneck & King PLLC

New York Amends and Strengthens Its Health Care “Shield” Law

During a flurry of end-of-year 2025 bill signings, Governor Kathy Hochul approved A5480C/S4914B, amending New York’s Shield Law (Shield Law) – a 2023 law intended to protect patients who receive and health care professionals...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Urgent! February Enforcement Date for Compliance with New 42 CFR Part 2 Rules Rapidly Approaching

With the February 16, 2026, compliance deadline rapidly approaching, health care providers that provide substance use disorder (SUD) treatment reimbursed by federal health care programs, including Medicaid, must ensure their...more

Latham & Watkins LLP

Private Capital’s Evolving Playbook for Healthcare and Life Sciences

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Private capital is poised to remain a driving force in healthcare and life sciences, even as the sector navigates a more complex and competitive environment. After a record-setting surge in 2024 — when global healthcare...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - January 2026

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Morgan Lewis

Counting the Days: Fifth Circuit Reverses Texas Hospitals’ DSH Rule Challenge

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The US Court of Appeals for the Fifth Circuit on December 9, 2025 reversed and remanded a decision from the US District Court for the Northern District of Texas that had vacated a 2023 federal regulation that threatened to...more

Womble Bond Dickinson

NIH Hits Pause: The SBIR/STTR Freeze Shaking America’s Innovation Pipeline

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The National Institutes of Health (NIH) ended all active Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding opportunities. (see NIH’s Notice NOT-OD-26-006)....more

Winthrop & Weinstine, P.A.

Federal Government Directs Minnesota to Freeze Provider Enrollment in Over a Dozen Health Care Programs

Yesterday afternoon (January 8, 2026), the Minnesota Department of Human Services (“DHS”) alerted providers that the Centers for Medicare & Medicaid Services (“CMS”) directed Minnesota to freeze new provider enrollments in...more

Orrick, Herrington & Sutcliffe LLP

New York State updates insurance law to include virtual credit cards

On December 19, the governor of New York enacted a law amending the insurance law and the public health law regarding the use of virtual credit cards by insurers and certain health care plans....more

Troutman Pepper Locke

Maine Court Enjoins HRSA’s 340B Rebate Pilot

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On December 29, 2025, Chief Judge Lance Walker of the U.S. District Court for the District of Maine granted the plaintiffs’ motion for a preliminary injunction in American Hospital Association v. Kennedy. The court enjoined...more

Orrick, Herrington & Sutcliffe LLP

FDA Eases Oversight for AI-Enabled Clinical Decision Support Software and Wearables

FDA Commissioner Marty Makary announced policy shifts that ease the path to market for certain digital health technologies, including AI- and generative AI-enabled clinical decision support software (CDS) and consumer...more

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