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Regulatory Requirements Enforcement Actions Healthcare

Cozen O'Connor

Washington Becomes First State to Require Premerger Notification Filing

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Washington AG Nick Brown announced that Washington is the first state to require companies to file a premerger notification with the state AG’s office concurrently with the federal filing required under the Hart-Scott-Rodino...more

Fennemore

Federal and California’s Shared Interest in Promoting Open Competition: Isn’t it Ironic?

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This article provides a brief history of California’s pro-competition law and describes the stalled federal initiative to extend a similar noncompete ban nationally, notwithstanding the overlapping policy interests expressed...more

Cozen O'Connor

Washington and Colorado Enact Uniform Premerger Notification Laws: What Businesses Need to Know About The New Era in State AG...

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As of July 27, Washington State is now the first state to enact a uniform antitrust premerger notification law, and as of August 6, 2025, Colorado will be the second. Both new notification laws are similar, as they are...more

Hinshaw & Culbertson - Health Care

Emergency Alert! HHS Restricts Care for Immigrants—Health Centers Must Act Now

Overview of Key Changes and Immediate Impacts - Key Policy Shift: Section 330 Grants now treated as a “Federal Public Benefit” - The U.S. Department of Health and Human Services (HHS) now classifies the Health Center Program...more

Arnall Golden Gregory LLP

OIG Audit Finds Cybersecurity Gaps at Large Northeastern Hospital

On July 11, 2025, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) posted a report that announced the findings of a cybersecurity audit it conducted of a large Northeastern...more

Greenbaum, Rowe, Smith & Davis LLP

Navigating New Jersey’s Medical Spa Regulatory Landscape: Key Compliance and Risk Management Considerations

The medical spa industry is thriving, but with growth comes complexity, particularly in New Jersey where healthcare and professional licensing rules intersect with business and real-estate regulations. For physicians, nurses,...more

Buchalter

9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

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The Eliminating Kickbacks in Recovery Act, enacted in 2018, was a bombshell for the addiction treatment and diagnostic laboratory industries. For the first time, paying commissions for sales and marketing services was...more

BakerHostetler

In Case of First Impression, Looking to AKS Precedent, Ninth Circuit Affirms EKRA Conviction for Improper Payments to Marketers

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In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Ropes & Gray LLP

U.S. District Court Ruling Vacates HIPAA Final Rule that Strengthened Privacy Protections for Reproductive Health Information

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On June 18, 2025, the United States District Court for the Northern District of Texas Amarillo Division issued an opinion, Purl v. Department of Health and Human Services, declaring the U.S. Department of Health and Human...more

Mintz - Health Care Viewpoints

FDA in Flux — July 2025 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Bodman

DOJ Data Security Program – Another Privacy and Security Law that Impacts the Health Care Industry

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The Department of Justice (“DOJ”) implemented the Data Security Program (“DSP”) intending to prevent access to Americans’ bulk sensitive personal data and government-related data by Countries of Concern. The DSP is aimed at...more

Clark Hill PLC

Beyond HIPAA: How state laws are reshaping health data compliance

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We are in an era where smartphones track sleep patterns, fitness apps monitor heart rates, and online searches reveal sensitive medical inquiries. As a result, the notion of “health data” has expanded dramatically. This...more

Quarles & Brady LLP

HIPAA Reproductive Health Rule Vacated Nationally

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A federal judge in Texas has vacated almost all of the 2024 HIPAA Rule to Support Reproductive Health Care Privacy that created special protections for reproductive health care information, finding that the U.S. Department of...more

Jackson Lewis P.C.

OFCCP Extends Enforcement Moratorium for VAHBP Providers Until 2027

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In a move the Agency reported is designed to maintain healthcare access for active and retired service members and their families, the Office of Federal Contract Compliance Programs (OFCCP) has announced a two-year extension...more

Keating Muething & Klekamp PLL

OSHA’s Updated Inspection Program: What Employers Should Know and Expect

On May 20, 2025, the Occupational Safety and Health Administration (OSHA) updated its Site-Specific Targeting (SST) inspection program. The SST inspection program is OSHA’s primary planned inspection initiative for...more

DLA Piper

Food and Beverage News and Trends - June 2025 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. On June 9, HHS Secretary Robert F. Kennedy, Jr., announced that he is “retiring”...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

McDermott Will & Emery

CMS Requires Hospitals to Publish More Pricing Information, Signals Focus on Enforcement

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On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) released new guidance for compliance with the hospital price transparency rule and published a request for information (RFI) seeking ways to bolster hospital...more

Wiley Rein LLP

FTC Sends Warning Letters to 37 Eyeglass and Contact Lens Prescribers Over Possible Rule Violations

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On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...more

Greenbaum, Rowe, Smith & Davis LLP

Legal Risks and Challenges for Private Equity in Healthcare Acquisitions

Private Equity (PE) firms continue to be significant players in U.S. healthcare, acquiring assets across various sectors such as physician practices, home health, behavioral health, and urgent care. However, recent legal...more

Proskauer - Health Care Law Brief

CMS to Immediately Begin Auditing Medicare Advantage Plans in Significant Expansion of Enforcement Efforts

On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more

Quarles & Brady LLP

Departments Will Not Enforce 2024 Final Rule under MHPAEA

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The Trump Administration has just announced that it will pause enforcement of the September 2024 final rule (“Final Rule”) under the Mental Health Parity and Addiction Equity Act (“MHPAEA”)....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

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