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Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Epstein Becker & Green

DOJ Launches Cross-Agency Trade Fraud Task Force: What Importers and Businesses Need to Know

On August 29, 2025, the U.S. Department of Justice (DOJ) announced the creation of a new Trade Fraud Task Force (“Task Force”)....more

DLA Piper

Food and Beverage News and Trends - September 2025

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....more

Alston & Bird

New Maryland Law Regulates Use of AI in Health Care Utilization Management Reviews

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Our Health Care Group discusses what businesses need to know about a new law in Maryland that creates new requirements for health plans’ use of artificial intelligence in making coverage and treatment decisions....more

Baker Donelson

Powering Up Part 2: HHS Announced OCR Enforcement Authority for Part 2 Final Rule

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The Office for Civil Rights (OCR) will be ready to enforce the 2024 Part 2 Final Rule by the February 16, 2026, compliance deadline now that the U.S. Department of Health & Human Services (HHS) has delegated enforcement...more

Hogan Lovells

FDA releasing Complete Response Letters for drugs and biologics that have not yet been approved

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The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more

Quinn Emanuel

The White Collar Appeal: Second Circuit Holds That Judges Can’t Increase Sentences to Offset Reductions from the First Step Act or...

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In a case of first impression in the federal Courts of Appeals, the Second Circuit held that district courts may not consider a defendant’s potential eligibility for a sentence reduction under the First Step Act or programs...more

Cozen O'Connor

Pennsylvania Perspective for Thursday, September 4, 2025

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Gov. Shapiro Navigates SEPTA Crisis Amid Budget Stalemate - Governor Josh Shapiro (D) is caught between House Democrats and Senate Republicans as he tries to secure long-term funding for SEPTA, which has already cut service...more

Morgan Lewis - As Prescribed

Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?

On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more

Woodruff Sawyer

When Doctors Disappear: Addressing the Human Cost of a Strained Workers’ Comp System

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In the last few years, there has been a growing shortage of physicians to treat workers’ compensation cases across the country. Employees who are injured on the job are finding it increasingly difficult to access timely and...more

Proskauer - Proskauer For Good

Proskauer Secures Landmark Settlement with New York State to Expand Access to Children’s Mental Health Services

A Proskauer team, along with Disability Rights New York (DRNY), Children’s Rights New York (CRNY) and the National Health Law Program (NHeLP), reached a preliminary settlement agreement with the State of New York in C.K. v....more

Katten Muchin Rosenman LLP

CMS Releases FAQ Discussing New WISeR Model

As a follow-up to its recent announcement of the new Wasteful and Inappropriate Service Reduction (WISeR) Model (which we have previously covered here: CMS Unveils New Prior Authorization “WISeR Model” for Electrical Nerve...more

Bergeson & Campbell, P.C.

Microplastics in 2025: Regulatory Trends and Updates

Microplastics are, in recent years, at the forefront of regulatory and policy driven conversations across the United States. Regulatory measures to address microplastics at both state and federal levels have been introduced...more

McGuireWoods LLP

The Fertility Economy: Where Science Meets Market Demand

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The fertility and reproductive health sectors are experiencing dynamic growth, driven by shifting demographics, evolving societal attitudes and rapid technological advancement. The global fertility market size is expected to...more

Quinn Emanuel

Federal Judge Rules on Patent Damages Issue in Mallinckrodt v. Airgas Case

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A Delaware federal judge has issued a decision regarding the date that a hypothetical negotiation would have taken place, a decision that impacts the amount of damages that could be recovered in the patent dispute between...more

McDermott Will & Schulte

MHRA announces changes to international reliance and in vitro diagnostic devices rules

In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in vitro diagnostic devices. In...more

Hanzo

Compliance Under Pressure: Audit Readiness for Healthcare Providers

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In today’s healthcare environment, compliance is a defining element of patient care quality, operational integrity, and public trust. Oversight from agencies such as the Office for Civil Rights (OCR), the Centers for Medicare...more

Womble Bond Dickinson

The MAHA Report and the Definition of Ultra-Processed Foods

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Earlier this year, President Trump formed the Make America Healthy Again Commission. The Commission included representatives from more than a dozen government agencies.  ...more

Beveridge & Diamond PC

States Join FDA in the MAHA War on Food Ingredients

Food and food ingredient manufacturers take note: it’s not just the U.S. Food and Drug Administration (FDA) advancing “Make America Healthy Again” (MAHA) priorities. States are increasingly involved, as well. Several have...more

Bradley Arant Boult Cummings LLP

The ABCs of CBD? Kind of… 8th Circuit Affirms Termination of Employee Failing Drug Test for Hemp Pain Oil

You want a safe workplace and have adopted a Drug Free Workplace policy. You may even have government contracts that require you to drug test your employees. How does the brave new world of legalized marijuana, medical...more

Health Care Compliance Association (HCCA)

UPICs May Audit Skin Substitutes Twice; Are Lawsuits Against Manufacturers Coming?

As the audits and investigations of wound care procedures with skin substitutes march on, providers who were audited once by a CMS unified program integrity contractor (UPIC) should prepare for a second round. And if the UPIC...more

Dickinson Wright

Friendly PC Model: 3 Key Ancillary Agreements for CPOM Compliance

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With the rebound of private equity (“PE”) activity in healthcare across the United States, the Corporate Practice of Medicine and Dentistry (“CPOM” or “CPOD”) has likewise experienced renewed focus by state legislatures and...more

Akerman LLP - Health Law Rx

AHCA Proposes New Rule Requiring Providers to Implement Data Breach Continuity Plans

The Florida Agency for Health Care Administration (AHCA or the Agency) recently issued a new proposed rule that would require all “providers” licensed by AHCA to have a “continuity plan” for data and information technology...more

Dentons

Ep. 77 – Keeping Up to Date on New Developments

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One of the biggest challenges for any busy compliance professional is staying abreast of all the changes in healthcare regulations, enforcement trends and risks. Yet doing so is critically important so that you have enough...more

FordHarrison

Several Changes to Illinois Employee Blood and Organ Donation Leave Act: Employers Still Left Wondering Whether They Must Pay for...

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Illinois HB 1616, signed into law on August 15, 2025, has made several important changes to the Employee Blood and Organ Donation Leave Act, but has also left a trail of confusion relating to whether the leave must be paid....more

TNG Consulting

The Importance of Documentation in BIT/CARE Team Work (Part 2)

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This week, we are building on our previous discussion of why documentation is essential for BIT/CARE Teams. In this installment, we introduce practical strategies, drawing from industry guidance and additional best practices...more

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