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Polsinelli

FDA Tightens the Belt on GLP-1 Compounding, Escalating Threat of Enforcement

Polsinelli on

Key Takeaways : On Feb. 6, 2026, FDA announced that it would take action to restrict access to GLP-1 ingredients for non-FDA approved compounded drugs....more

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

HIPAA Enforcement: A Look Ahead at 2026 Informed by 2025's Inflection Points

The healthcare ecosystem has closed the book on a volatile 2025, and HIPAA enforcement has moved into 2026 with sharper edges, wider apertures, and higher stakes. Regulators spent 2025 refining the tools they use, broadening...more

Morgan Lewis

Navigating China’s New 2026 Implementing Regulations of the Drug Administration Law

Morgan Lewis on

The State Council of the PRC promulgated the Implementing Regulations of the Drug Administration Law (2026 Revisions) on January 27, 2026, set to take effect on May 15, 2026. This LawFlash provides a summary of the law and...more

Morgan Lewis

CMS Launches $50B Rural Health Transformation Program

Morgan Lewis on

The Centers for Medicare and Medicaid Services recently announced its award decisions for the Rural Health Transformation Program, established as part of the One Big Beautiful Bill Act, and provided a summary of each state...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2026

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2025 was an incredibly busy year for digital health, and 2026 is likely to be no different. This edition of Vital Signs covers numerous developments, along with a look to 2026 in Industry Insights. Thank you to our Jones Day...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s New Enforcement Discretion on ‘No Artificial Colors’ Claims: Implications and Risks for Food Manufacturers

On February 5, 2026, the Food and Drug Administration (FDA) announced a significant shift in its enforcement approach to voluntary labeling claims regarding artificial colors in foods....more

McDermott Will & Schulte

Illinois lawmakers seek to expand scope of AG healthcare transaction review

On February 4 and 5, 2026, Illinois lawmakers introduced parallel bills (House Bill (HB) 5000 and Senate Bill (SB) 3463) that would amend Illinois’ healthcare transaction reporting framework to broaden the types of...more

McDermott+

Healthcare Preview for the Week of: February 9, 2026

McDermott+ on

This week, congressional attention will be mainly on funding for the US Department of Homeland Security (DHS) for fiscal year (FY) 2026, which is set to expire this Friday....more

Bradley Arant Boult Cummings LLP

Don’t Stop Me Now: Alabama Court Tells Unhappy Applicants for Medical Cannabis Licenses to Chill for Now

Last Friday, we saw an important development in the tortuous quest to issue integrated medical cannabis licenses in Alabama. Bottom line: The show will go on....more

Hogan Lovells

Latest congressional spending package includes important updates for orphan disease and pediatric drug development

Hogan Lovells on

On February 3, 2026, President Trump signed into law the Mikaela Naylon Give Kids A Chance Act as part of the Consolidated Appropriations Act (CAA) of 2026. The CAA codifies FDA's interpretation of the scope of orphan drug...more

Jones Day

HHS Signals Policy Direction to Accelerate Adoption of AI in Clinical Care

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On December 23, 2025, the U.S. Department of Health and Human Services ("HHS") issued a request for information ("RFI") seeking input on ways it could accelerate the adoption and use of AI as a part of clinical care,...more

Knobbe Martens

Practical Application and Particular Treatment: What the USPTO’s December 4 Memorandum Means for Life Sciences §101 Eligibility

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The USPTO’s December 4, 2025 memorandum on Subject Matter Eligibility Declarations (SMEDs) seeks to raise awareness of the “underutilized path” of submitting Rule 132 declarations, referred to as “SMEDs”, for supporting §101...more

Genova Burns LLC

Second Court Issues 10(j) Injunction Applying the Stricter Starbucks Standard

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SCOTUS’s recent adoption of a stricter standard for issuing unfair labor practice injunctions did not prevent Region Four of the NLRB from securing an injunction against a residential treatment facility’s subcontracting the...more

Morgan Lewis

Does GLP-1 Compounding Foretell Patent Enforcement Outside the Hatch-Waxman Framework?

Morgan Lewis on

Recent developments involving compounded GLP-1 products have renewed questions about compounded drugs as a potential quasi-generic competitor. This LawFlash examines the regulatory limits on drug compounding and highlights...more

Sheppard Mullin Richter & Hampton LLP

The Fix Is In: New Jersey Tweaks Its Privacy Law

New Jersey’s existing, comprehensive privacy law was amended at the end of last month, with some tweaks that mirror changes seen in other privacy laws. (For example, changes that went into place for the Connecticut law last...more

Sheppard Mullin Richter & Hampton LLP

Governor Hochul’s 2026 State of the State: What the Executive Budget Really Tells Us About Healthcare and Medicaid

Governor Hochul’s 2026 State of the State Agenda, released in January, and the FY 2027 Executive Budget are best understood as two parts of a single healthcare strategy. The Agenda sets the direction; the Budget supplies the...more

Mintz - Health Care Viewpoints

What PBMs and Group Health Plans Need to Know About the Department of Labor’s Proposed PBM Fee Disclosure Rule

On January 30, 2026, the Department of Labor released a proposed rule (Proposed Rule) that would end long‑running confusion about how ERISA disclosure obligations apply to PBMs under the Consolidated Appropriations Act, 2021,...more

Holland & Hart - Health Law Blog

Do the New Substance Use Disorder Record Rules Apply to You?

The revised federal rules for substance use disorder (“SUD”) records will be enforced effective February 16, 2026. (42 CFR part 2, hereafter “Part 2”). Failure to comply with the new Part 2 rules may subject healthcare...more

Foley & Lardner LLP

Single‑Reference Disclosures and the Motivation‑to‑Combine Requirement

Foley & Lardner LLP on

In January 2026, the Federal Circuit issued a nonprecedential opinion in Guardant Health, Inc. v. University of Washington (Slip Op. 2024-1129, Jan. 23, 2026) that, while not binding precedent, is nevertheless highly relevant...more

King & Spalding

CMS Announces Changes to CY 2027 Medicare Advantage Capitation Rates and Part D Payment Policies

King & Spalding on

On January 26, 2026, CMS released its Advance Notice of Methodological Changes for Calendar Year (CY) 2027 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (Advance Notice). The Advance...more

King & Spalding

FTC’s “Landmark” Settlement with Pharmacy Benefit Manager Express Scripts: Impact on Pharma

King & Spalding on

On February 4, 2026, the Federal Trade Commission (FTC) announced what it called a “landmark” settlement with Express Scripts, Inc. (ESI) in its enforcement action alleging anticompetitive practices under Section 5 of the FTC...more

Brownstein Hyatt Farber Schreck

A Closer Look at FDA Policies Included in the Consolidated Appropriations Act

The recently enacted Consolidated Appropriations Act (H.R. 7148) includes several Food and Drug Administration (FDA) policies that were repeatedly considered in the House and Senate but were stalled for years before finally...more

Polsinelli

OIG’s New Medicare Advantage Program Compliance Guidance: What Providers Need to Know

Polsinelli on

Key Takeaways - OIG’s new Medicare Advantage Industry Segment-Specific Compliance Program Guidance (MA ICPG) highlights major compliance risk areas and provides practical guidance for MA plans and other parties....more

Baker Donelson

Department of Justice Reports Record-Breaking $6.8 Billion Year in False Claims Act Recoveries

Baker Donelson on

When the second Trump administration took office, many legal commentators anticipated major changes to the Department of Justice's (DOJ) enforcement efforts. Some declared federal white-collar enforcement dead as the...more

Haynes Boone

FDA Takes Steps to Ease Path for Non-Petroleum Food Colors

Haynes Boone on

After years of maintaining a policy that any added color in food is “artificial color,” the U.S. Food and Drug Administration (FDA) issued a letter to industry announcing that it will exercise enforcement discretion as to the...more

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