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Disclosure Requirements Health Care Providers Enforcement Actions

Ropes & Gray LLP

Navigating TRAIGA: Texas’s New AI Compliance Framework

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On June 22, 2025, Texas enacted the Texas Responsible Artificial Intelligence Governance Act (“TRAIGA”), putting it at the forefront of state-level AI regulation in the United States. TRAIGA becomes effective January 1, 2026....more

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

McGuireWoods LLP

CMS Nearly Doubles Prior Stark Self-Disclosure Dollar Record in 2024

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The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2024 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark...more

Wiley Rein LLP

Trump Prioritizes Health Care Pricing Transparency in New Executive Order

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On Tuesday, February 25, 2025, President Trump issued an Executive Order (EO), “Making America Healthy Again By Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information.” The EO aims to improve...more

Kerr Russell

The Corporate Transparency’s Act’s Impact on Medical Practices: Understanding Physicians’ Obligations Amid Recent Judicial and...

Kerr Russell on

Medical practices across the United States are grappling with new compliance obligations under the Corporate Transparency Act (CTA). This article addresses the CTA’s applicability to medical practices, its current legal...more

Robinson+Cole Health Law Diagnosis

Massachusetts Expands FCA Liability to Owners and Private Equity Investors

Under a new 2025 law, Massachusetts is one of the first in the nation to broaden its state False Claims Act (FCA) to require disclosures by investors and owners of health care entities. On January 8, 2025, Governor Maura...more

McDermott Will & Emery

New Requirements for Illinois Dental Practices Using Third-Party Financing

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Third-party financing services are frequently used by patients to finance out-of-pocket dental expenses. Effective January 1, 2025, dental practices in Illinois are prohibited from facilitating or assisting with patient...more

King & Spalding

FTC Proposes Enforcement Action Prohibiting GoodRx from Disclosing Users’ Health Information for Advertising

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On February 1, 2023, the Federal Trade Commission (FTC) announced that it has taken enforcement action for the first time under its Health Breach Notification Rule (HBNR) against GoodRx Holdings Inc. (GoodRx), for allegedly...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

McDermott Will & Emery

2018 Digital Health Data Developments – Navigating Change in 2019

Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more

Mintz - Health Care Viewpoints

Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers...more

Cooley LLP

Blog: On a Roll . . . Vermont Attorney General Posts Two More Enforcement Actions for Gift Ban & Disclosure Law

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The Vermont Attorney General (VT AG) posted its third round of enforcement actions of 2015 against a manufacturer of surgical microscopes and a dental products company....more

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