News & Analysis as of

Healthcare Enforcement

ArentFox Schiff

Navigating OIG’s Advisory Opinion on Medical Device Billing Arrangements and Anti-Kickback Statute Risks

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On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device...more

Robinson+Cole Data Privacy + Security Insider

Purl v HHS: Resetting the Reproductive Health Privacy Landscape

Reproductive health privacy is once again in the legal spotlight with a recent federal district court decision that struck down nearly all of a recent rule under the Health Insurance Portability and Accountability Act (HIPAA)...more

Troutman Pepper Locke

CFPB Will Not Reissue Medical Debt Advisory Opinion

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On July 14, the Consumer Financial Protection Bureau (CFPB or Bureau) filed a status report announcing its decision not to reissue its Medical Debt Collection Advisory Opinion, which had been issued in 2024 to “remind debt...more

DLA Piper

China Releases First-of-its-kind Compliance Case Handbook for Life Sciences Companies

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The Shanghai Administration for Market Regulation (AMR) has released a set of illustrative sample cases under the Compliance Guidelines for Pharmaceutical Companies to Prevent Commercial Bribery Risks (《医药企业防范商业贿赂风险合规指引》)...more

Fenwick & West LLP

Supreme Court's McLaughlin Decision Creates New Uncertainty for Healthcare Text Message Compliance

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The Supreme Court's decision in McLaughlin Chiropractic Associates v. McKesson Corporation seismically shifts how courts will evaluate FCC interpretations of the TCPA, creating new compliance challenges for healthcare...more

King & Spalding

CMS Escalates Aggressive Rates Cut in Home Health Prospective Payment System Proposed Rule for CY 2026

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On June 30, 2025, CMS issued its annual Home Health Prospective Payment System Proposed Rule for Calendar Year (CY) 2026 (the Proposed Rule). The Proposed Rule continues the agency’s policy of using provisions of the...more

Cranfill Sumner LLP

Navigating Stark Law and the Anti-Kickback Statute (AKS) in 2025: A Snapshot Guide for Medical Practices

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In today’s healthcare environment, compliance with federal regulations is more than a legal necessity—it’s a cornerstone of ethical and sustainable practice management. Two of the most critical laws that medical practices...more

Morrison & Foerster LLP

NIS 2: Strengthening Europe’s Cyber Defenses

European cybersecurity risk management and reporting obligations have received a substantial facelift. The Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (“NIS 2”) became effective...more

Husch Blackwell LLP

DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know

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On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more

Sheppard Mullin Richter & Hampton LLP

The One Big Beautiful Bill Act’s Proposed Moratorium on State AI Legislation: What Healthcare Organizations Should Know

Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...more

Perkins Coie

New Utah AI Laws Change Disclosure Requirements and Identity Protections, Target Mental Health Chatbots

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Key Takeaways - - Utah has introduced five new bills that further shape its existing Artificial Intelligence Policy Act and add new requirements. - Both the scope of disclosure requirements surrounding the use of AI...more

McCarter & English, LLP

Recent Trends in State Antitrust Enforcement

State attorneys general (state AGs) are expected to ramp up antitrust enforcement. Some would argue that enforcement is an effort to fill a perceived gap left by the Trump administration, but state AGs have been signaling...more

Katten Muchin Rosenman LLP

Have You Done Your Part to Comply with Part 2 Changes?

Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...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

Goodwin

The Impact of Trump’s Executive Order on Eliminating Information Silos

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Hello, everyone. My name is Allan Medina. I am a partner in Goodwin’s Washington, DC, office, with a practice focus on government investigations. I’m here with Liza Craig, who is also a partner in the DC office. We are...more

Dentons

Ep. 52 – Prioritize Hospital Price Transparency Compliance

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On February 25, 2025, President Trump signed an Executive Order directing federal agencies to “rapidly implement and enforce” federal healthcare price transparency regulations....more

Verrill

Healthcare Costs Demystified: Trump's New Executive Order on Healthcare Price Transparency Explained

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President Trump’s Executive Order 14224 reinforces and expands a 2019 Executive Order which aimed to improve healthcare price transparency. On February 25, 2025, President Trump signed a new 2025 Executive Order entitled...more

Bradley Arant Boult Cummings LLP

Backwards Down the Number Line: Assessing the State of Alabama’s Medical Cannabis Program Four Years After Its Enactment

Ronald Reagan famously asked voters, on the eve of the 1980 presidential election, to ask themselves whether they were better off than they were four years ago. It was a powerful question that asked Americans to take stock of...more

Mintz - Health Care Viewpoints

Will New York Be Next to Regulate Specifically Personal Health Information to Further, and Possibly Re-Write, a New Paradigm of...

The New York legislature passed its version of Washington’s My Health My Data Act (“WA MHMDA”) on January 22, 2025. Currently awaiting action by Governor Kathy Hochul, the New York Health Information Privacy Act (“NY HIPA”)...more

Akin Gump Strauss Hauer & Feld LLP

Making America Healthy Again By Empowering Patients With Clear, Accurate, and Actionable Healthcare Pricing Information (Trump EO...

The EO announces a policy of the United States to put patients first and ensure they have the necessary information to make well-informed healthcare decisions. The order builds upon Executive Order 13877 (Improving Price and...more

MoFo Life Sciences

Patents and Trade Secrets in AI and Life Sciences

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Holland & Knight LLP

Massachusetts to Require License for Office-Based Surgical Centers

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Many existing office-based surgical centers in Massachusetts will soon be required to obtain a new type of healthcare facility license. Massachusetts Gov. Maura Healey signed House Bill No. 5159 into law on Jan. 8, 2025,...more

McDermott Will & Emery

This Week in 340B: January 14 – 20, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

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The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

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