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Regulatory Agenda Compliance Healthcare

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

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...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 & Schulte

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

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

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

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

Baker Botts L.L.P.

Virginia Legislature Passes First AI Bill of 2025--Now Awaits Governor's Approval

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Virginia has become the first state in 2025 to pass comprehensive artificial intelligence regulation, with lawmakers approving the "High-Risk Artificial Intelligence Developer and Deployer Act" (HB 2094). The legislation,...more

McDermott Will & Schulte

SB 5387 Aims to Codify Restrictive CPOM Doctrine in Washington

On January 21, 2025, the Washington state legislature introduced Senate Bill (SB) 5387, aiming to codify a restrictive state prohibition on the corporate practice of healthcare, commonly referred to as a corporate practice of...more

Health Care Compliance Association (HCCA)

‘Waking Up With Panic Attacks’: NIH 15% Plan Caps Tumultuous Weeks Under New Administration

If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more

Lowenstein Sandler LLP

Trump Administration Plans Aggressive FCA Enforcement

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At the Federal Bar Association’s annual qui tam conference in Washington, D.C. on Feb. 20, 2025, the Deputy Assistant Attorney General for the Department of Justice’s (DOJ) Commercial Litigation Branch, Michael Granston, said...more

Husch Blackwell LLP

California Legislature Takes Another Swing at Private Equity Participation in Healthcare

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Last fall, private equity and hedge fund investors were given a reprieve from the prospect of increased oversight of healthcare transactions when California Governor Gavin Newsom unexpectedly vetoed Assembly Bill 3129 (AB...more

Rivkin Radler LLP

NYS OMIG Publishes 2025 Work Plan

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On January 29, the New York State Office of the Medicaid Inspector General (OMIG) published its 2025 Work Plan, which provides a preview of the OMIG’s program integrity initiatives for the upcoming year. While this post...more

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

Mintz - Health Care Viewpoints

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team...more

Foley Hoag LLP - White Collar Law &...

New Massachusetts Healthcare Law Targets Private Equity, REITs, and MSOs; Expands State False Claims Act

On January 8, 2025, Governor Maura Healey signed House Bill 5159 into law, toughening the rules and increasing the risks for private equity (PE) companies, real estate investment trusts (REITs), and management services...more

NAVEX

Exploring California’s AI Laws

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California sets the pace for all sorts of trends in the world – so perhaps compliance officers should take note of two recent advisories the state’s attorney general published on artificial intelligence. They capture a lot...more

Akin Gump Strauss Hauer & Feld LLP

Geneva Insights - February 2025

International Geneva – A global governance ecosystem of over 40 international organizations, 178 country representations and 700+ non-governmental organizations....more

Proskauer - Health Care Law Brief

Spurred on by the Steward Health Care Bankruptcy, Massachusetts Adopts Bill Regulating Private Equity and REITs in Health Care,...

On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill 5159 (the “Bill”). The Bill grants the state new regulatory powers to oversee and review health care transactions involving private equity...more

ArentFox Schiff

California Claps Back on Insurer Use of AI to Deny Needed Medical Care Decisions

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California is leading the way in ensuring that determinations of medically necessary health care services are made by licensed physicians and not artificial intelligence (AI) algorithms....more

Cozen O'Connor

California Passes Flurry of Year-End AI Legislation

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In 2024, the California legislature passed 17 laws related to artificial intelligence (AI). These new laws cover various themes and industries, including but not limited to deepfakes, training data disclosures, health care,...more

Foley & Lardner LLP

DEA Unveils Long-Overdue Special Registration for Telemedicine in Proposed Rule

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In the final days of the Biden administration, the Drug Enforcement Administration (DEA) released a proposed rule that would allow practitioners with a Special Registration to prescribe Schedule III-V, and in limited...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Husch Blackwell LLP

New Legislation Revises Massachusetts' Determination of Need Statute

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On January 8, 2025, Massachusetts Governor Maura Healey signed into law “An Act Enhancing the Health Care Market Review Process.” Part of this sweeping healthcare oversight law includes changes to the Determination of Need...more

Health Care Compliance Association (HCCA)

Recognized Security Practices ‘Saved’ Covered Entity $60K of $300K Fine, But Which Ones Remain a Mystery

Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2024

Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more

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