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McDermott+

Site neutrality is on the menu in the CY 2026 Medicare Outpatient Prospective Payment System proposed rule

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Last week, the Centers for Medicare & Medicaid Services (CMS) issued two major regs: the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed rule and the CY 2026 Outpatient Prospective Payment System (OPPS)...more

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

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Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

McDermott Will & Emery

GLP-1 Update: Court Backs FDA in Tirzepatide Compounding Case

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On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more

Pullman & Comley - Connecticut Health Law

Three Bills Affecting Health Care Transactions That Will Not Be Signed into Law This Year

Members of the health care community may recall that the 2025 legislative session of the Connecticut General Assembly started out with Governor Lamont signing into law an emergency certificate of need (CON) process for...more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

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Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

McDermott Will & Emery

Colorado Fails to Amend Groundbreaking AI Law: What Happened and What’s Next

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On May 5, 2025, the Colorado Senate rejected an attempt by state lawmakers to amend Colorado’s landmark artificial intelligence (AI) law, known as Senate Bill (SB) 205. Colorado State Senator Robert Rodriguez and State...more

Clark Hill PLC

Right To Know - May 2025, Vol. 29

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Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Virginia Governor Signs Bill Restricting Minor’s Use of Social Media:...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Bass, Berry & Sims PLC

Washington Enacts “Mini-HSR” Law, Expanding State-Level Premerger Filing Requirements

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On April 4, Washington became the first state to adopt the Uniform Premerger Notification Act (Act) when Washington Governor Jay Inslee signed the bill into law. The new statute imposes state-level premerger filing...more

Health Care Compliance Association (HCCA)

Advancing shared accountability to reduce regulatory burden, promote well-being

Introduction: A different perspective - Within the compliance profession, Cecilia Fellouse has noted, “Under the weight of incessant regulatory demands, individuals and teams often fall prey to compliance fatigue. This...more

Bradley Arant Boult Cummings LLP

Alabama CON Report - April 2025

I. II. Certificate of Need Program - A. AL2024-025, 211-213 Ana Drive Operations, LLC d/b/a Hilltop at Glenwood II, Lauderdale County, AL: Proposes to convert sixteen (16) existing assisted living facility (ALF) beds into...more

King & Spalding

CMS Issues IPPS and LTCH Proposed Rule for FY 2026

King & Spalding on

On Friday, April 11, 2025, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule for Fiscal Year (FY) 2026 (the Proposed...more

Quarles & Brady LLP

Alabama Bill Rewriting Pharmacy Practice Act Clears Senate Hurdle

Quarles & Brady LLP on

As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more

A&O Shearman

European Health Data Space Regulation sets requirements for electronic health record systems

A&O Shearman on

On March 5, 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (the Regulation)...more

McDermott+

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off

McDermott+ on

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off - It’s March, which means one thing for sports fans: the madness of the NCAA men’s and women’s basketball tournaments. However, to folks in the...more

Holland & Knight LLP

Holland & Knight Health Dose: March 25, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McGuireWoods LLP

Texas House Bill 3749 Proposes Stricter Regulations for Medical Spas

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As the medical spa industry rapidly expands, states are increasing regulatory oversight to ensure patient safety and compliance with medical standards. Texas is the latest state to propose legislation targeting med spas,...more

Holland & Knight LLP

Holland & Knight Health Dose: March 19, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott Will & Emery

Trending in Telehealth: February 2025

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Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

McDermott+

Coding Update - CPT Editorial Panel Meeting: What’s on the Agenda and Why It Matters

McDermott+ on

The American Medical Association (AMA) CPT®1 Editorial Panel will meet in Brooklyn, New York, from May 1 to 3, 2025. The meeting agenda includes proposals to create new current procedural terminology (CPT) codes and to revise...more

McDermott+

Trump Administration Executive Order Tracker

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 25 - February 2025

Amidst the usual suits and blazers, white dresses and tuxedos have been appearing with increasing frequency around the Georgia State Capitol this spring. Apparently word is out amongst the city’s photographers that the...more

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