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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

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

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

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

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

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

McDermott Will & Schulte

Massachusetts H.5159 Seeks to Reshape Private Equity in Healthcare

On December 30, 2024, both the Massachusetts House of Representatives and the Massachusetts Senate enacted House Bill 5159 (H.5159), and Governor Maura Healey signed it on January 8, 2025. The bill seeks to strengthen...more

IR Global

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

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In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

Ropes & Gray LLP

Massachusetts Passes Act Implementing Broad Oversight into For-Profit Investment in Health Care

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On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159, An Act Enhancing the Market Review Process (the “Act”) into law, effective April 8, 2025. The Act is a compromise redraft of the separate health...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

Foley & Lardner LLP

Massachusetts “Patients First Act” Implementation and Enforcement Re-Extended

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The Massachusetts Senate proposed an amendment on Monday December 2, 2024, that would delay implementation and enforcement of the 2021 Patients First Act addressing health care cost transparency. Section 31 of the amendment...more

Foley & Lardner LLP

Private Equity Investments in Oncology: Top Five Things to Know

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Although private equity (PE) sponsors have been active investors in the health care services industry for the last decade, PE-backed health care providers today constitute only 4% of the United States health market by...more

McNees Wallace & Nurick LLC

Pennsylvania Imposes New Limitations on Health Care Noncompetes

On July 17, 2024, Pennsylvania passed a new law concerning noncompete agreements within the healthcare industry, which is known as the Fair Contracting for Health Care Practitioners Act (the “Act”). The Act will take effect...more

King & Spalding

FTC Announces Final Rule Sweeping Consumer Digital Health Tech Under the Health Breach Notification Rule

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On April 26, the Federal Trade Commission (FTC) approved its Final Rule revising the Health Breach Notification Rule (HBNR) (“Final Rule”) by a 3-2 vote. The HBNR requires vendors of personal health records (PHR) and related...more

Sheppard Mullin Richter & Hampton LLP

Utah Providers – Are You Complying with the AI Policy Act?

If your organization has not updated its policies to comply with Utah’s Artificial Intelligence Policy Act (the “Act”), now is the time. As we noted in a prior blog post, this law took effect on May 1st. While it imposes...more

Cohen & Gresser LLP

DOJ’s Health Care Task Force Brings Holistic Approach to Policy and Enforcement

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The Antitrust Division of the U.S. Department of Justice (“DOJ”) last week announced the formation of a new task force to guide its enforcement strategy and policy approach to health care, with an apparent focus on industry...more

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

In Wake of Healthcare System Cyberattack, 22 State Attorneys General Call for Further Action of Data Privacy

On April 25, 2024, the attorneys general of 22 states issued a letter encouraging UnitedHealth Group and its subsidiary, Change Healthcare, to take additional steps to respond to a massively disruptive cyberattack. The broad,...more

Morrison & Foerster LLP

DOJ Releases 2024 COVID-19 Fraud Enforcement Task Force Report

On April 9, 2024, the United States Department of Justice (DOJ) released a report on the COVID-19 Fraud Enforcement Task Force (“Task Force”), by far DOJ’s most comprehensive review of the Task Force since its creation in...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | February 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting...more

Mintz

EnforceMintz — Artificial Intelligence and False Claims Act Enforcement

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Like most industries, the health care sector is grappling with the uses of artificial intelligence (AI) and what AI means for the future. At the same time, many health care companies already have integrated algorithms and AI...more

Davis Wright Tremaine LLP

HHS Reveals Strategy for Addressing Healthcare Sector Cybersecurity

The U.S. Department of Health and Human Services ("HHS") issued a concept paper describing its overarching strategy to address healthcare cybersecurity. The concept paper builds on the Biden-Harris Administration's National...more

Davis Wright Tremaine LLP

HHS Proposes Information Blocking Disincentives for Health Care Providers

While health care providers have been required to comply with the 21st Century Cures Act Information Blocking Rule (the Rule) since April 5, 2021, as of yet there is no enforcement mechanism in place with respect to the Rule...more

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