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Polsinelli

A Settlement, Not a Sigh of Relief: What the FTC’s Express Scripts Deal Signals for Enforcement Risk

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The FTC’s newly announced settlement with Express Scripts marks a pivotal moment in the government’s campaign against pharmacy benefit manager pricing practices—and it should be read as more than a single-company resolution....more

Foley Hoag LLP - Security, Privacy and the...

42 C.F.R. Part 2 Civil Enforcement is Here: What Substance Use Disorder Providers Need to Know

February 16, 2026 marks a significant milestone for substance use disorder (SUD) treatment providers across the country. The HHS Office for Civil Rights (OCR) has announced that, effective on February 16, 2026, it will begin...more

Goodwin

Antitrust & Competition Healthcare Year in Review 2025

Goodwin on

Federal and state antitrust regulators continued their ongoing focus on healthcare issues in 2025. ...more

Cozen O'Connor

FDA Outlines Flexible Requirements to Support Cell and Gene Therapy Innovation

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The FDA recently shared information regarding its flexible approach to overseeing chemistry, manufacturing, and control (CMC) requirements for cell and gene therapies (CGT). Due to the unique nature of the characteristics of...more

Wiley Rein LLP

Time Flies! Cosmetic Manufacturing Facilities are Due for FDA Registration Renewal

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Manufacturers and processors of U.S.-distributed cosmetic products must renew their facility registration for the first time by July 1, 2026. To assist with the biennial registration requirement, the Food and Drug...more

Husch Blackwell LLP

Enforcement Ramps Up on Patient Right of Access: What Providers Need to Know 

Husch Blackwell LLP on

The Health Insurance Portability and Accountability Act (HIPAA) has long been the cornerstone of patient privacy and data protection. Among its most patient-centric provisions is the Right of Access rule, which guarantees...more

Hogan Lovells

Pharma and biotech innovation and competition in 2026: Five areas to watch

Hogan Lovells on

FDA has undergone fundamental changes under the Trump administration. The agency is smaller, but is it smarter? Commissioner Makary has embraced AI and appears to be looking for new ways to abbreviate clinical development for...more

Rivkin Radler LLP

Expect Increase in FTC Noncompete Enforcement Despite Withdrawal of Nationwide Ban

Rivkin Radler LLP on

Noncompete agreements remain in the Federal Trade Commission’s crosshairs. Although the FTC abandoned its pursuit of a nationwide ban, targeted enforcement is here, and the healthcare industry specifically has been placed on...more

Rivkin Radler LLP

Medical Aid in Dying Is Now Legal in NY

Rivkin Radler LLP on

On February 6, 2026, New York Governor Kathy Hochul signed the Medical Aid in Dying Act (MAID), making New York the 13th state to adopt similar legislation along with the District of Columbia. MAID has created a new Article...more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: Arsenal Sells MaxHealth to CenterWell

McGuireWoods LLP on

Arsenal Capital has sold MaxHealth to CenterWell, according to a news release. MaxHealth, founded in 2015 and based in Tampa, Florida, is a network of primary care facilities for adults and seniors with over 50 locations...more

McGuireWoods LLP

New CMS Rules Are Reshaping DMEPOS Deals

McGuireWoods LLP on

On Jan. 1, 2026, several significant changes from the Centers for Medicare & Medicaid Services (CMS) took effect for suppliers of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). A key change is the...more

Ropes & Gray LLP

A QMSR State of Mind: FDA Adopts New Inspection Approach for Medical Devices as Quality Management System Regulation Takes Effect

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On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR....more

Offit Kurman

Telehealth Access for Medicare Patients: Consolidated Appropriations Act Extends Key Policies

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Healthcare providers that rely on telehealth to serve Medicare patients can continue to do so as a result of an extension of the Medicare telehealth rules that were originally implemented during the COVID-19 Public Health...more

McDermott+

Healthcare Preview for the Week of: February 17, 2026

McDermott+ on

Both the House and Senate are in recess this week, for the first time this year. Despite that, negotiations continue on fiscal year (FY) 2026 funding for the US Department of Homeland Security (DHS), which is the only federal...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Change of Ownership in Health Care

For health care leaders and compliance officers, understanding the regulatory and contractual implications of a “Change of Ownership” (CHOW) is critical to maintaining operational continuity and regulatory compliance. The...more

Quarles & Brady LLP

Go for Gold: 42 CFR Part 2 Compliance Deadline and HHS Enforcement is Here

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This winter, health care providers have been training for an important event. The compliance deadline for significant amendments to 42 CFR Part 2 (Part 2), the federal regulation governing the confidentiality of substance use...more

Benesch

The Long Tail of the Opioid Crisis: How AGs Continue to Pursue Manufacturers, Distributors, Pharmacies

Benesch on

The Opioid crisis has been a perennial priority for state attorneys general, and was the marquis priority for the National Association of Attorneys General (NAAG) in both 2023 (under OH AG Dave Yost) and 2025 (under NH AG...more

Spilman Thomas & Battle, PLLC

Florida’s Healthcare System and the Impacts from the One Big Beautiful Bill and Legislation

Businesses, especially those in healthcare like providers, payors, managed care organizations, pharmacies, long-term care operators, and supply chain vendors, are increasingly affected by federal and state efforts to reduce...more

Hinshaw & Culbertson - Employment Law...

Expanded Sick and Safe Time Benefits on the Horizon for NYC Employees

Employees who work in New York City enjoy some of the most expansive sick and safe leave benefits in the nation. On February 22, 2026, those benefits will become even better for workers....more

Quarles & Brady LLP

340B Program Alert: Despite Recent Setbacks, HRSA Continues to Advance Potential 340B Rebate Model Pilot

Quarles & Brady LLP on

A little over a month after a federal circuit court blocked the Health Resources and Services Administration’s (HRSA) scheduled implementation of its 340B Rebate Model Pilot Program largely due to procedural deficiencies,...more

Ballard Spahr LLP

Government Issues New Model HIPAA Notice

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With the deadline for revising the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Notice of Privacy Practices set for yesterday, February 16, 2026—which was extended to today because of the federal...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - February 2026 #2

News Briefs - Trump Signs Funding Package Including Key Healthcare Provisions - President Trump signed into law a funding bill that ended a short-term partial government shutdown, funds the Department of Health and Human...more

Alston & Bird

New Jersey Expands HIPAA-Based Exemptions Under Its Comprehensive Privacy Law

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On January 20, 2026, the New Jersey Governor signed Assembly Bill A5017 (“Amendment”), amending the New Jersey Data Protection Act (“NJDPA”). The Amendment exempts data that is not protected health information (“non-PHI”)...more

Holland & Knight LLP

A New Era of Antitrust Risk: DOJ Issues First $1 Million Whistleblower Payout

Holland & Knight LLP on

The Antitrust Division of the U.S. Department of Justice's (DOJ) issued its first-ever antitrust whistleblower award on January 29, 2026 – a $1 million payment to an individual whose report exposed a bid rigging and fraud...more

Mogin Law LLP

Hyperscalers in Healthcare & Life Sciences

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Hyperscalers increasingly sit behind core healthcare delivery and life‑sciences innovation. Cloud storage and compute now support electronic health records (EHRs), telehealth platforms, imaging archives, clinical trial...more

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