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Maynard Nexsen

Oregon Passes Strictest Corporate Practice of Medicine Law in the Nation

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Concerned with business entities attempting to circumvent the ban on the corporate practice of medicine (CPOM) “through complex ownership structures,” and its impact on patient care and physician autonomy, Oregon Governor...more

Alston & Bird

Look Ahead to the Week of June 23, 2025: Reconciliation Crunch Time in the Senate as World on Edge Following U.S. Strikes on Iran

Alston & Bird on

Both the House and Senate are in session this week. Separately, President Trump is expected to travel to the Netherlands to participate in NATO’s annual summit – this following U.S. targeted strikes on three of Iran’s nuclear...more

Stevens & Lee

HIPAA Final Rule on Reproductive Health Care Privacy Struck Down

Stevens & Lee on

In June 2024, the U.S. Department of Health & Human Services’ Office for Civil Rights (HHS) issued a Final Rule modifying the HIPAA Privacy Rule to enhance reproductive health care privacy affecting all HIPAA covered entities...more

Jackson Lewis P.C.

Timing Is Everything: SCOTUS Shuts Down Retiree’s ADA Post-Employment Benefits Claim

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Do former employees have the right to sue their previous employer under Title I of the Americans with Disabilities Act (ADA) for discrimination in the administration of post-employment fringe benefits? Resolving a circuit...more

Ankura

Forensic Analytics in Pharmaceutical Fraud Investigations: Lessons from Recent Cases

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The pharmaceutical industry faces escalating risks from sophisticated fraud schemes, including counterfeit drug distribution, billing irregularities, and corporate malfeasance. Forensic analytics—powered by AI and advanced...more

King & Spalding

EUROPE - Navigating the Interplay Between EU AI Act and Medical Device Regulations: Strategic Update for the Healthcare Sectors

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Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more

Foley & Lardner LLP

Direct-to-Consumer Drug Ads Are Under Attack – Pharmaceutical Companies Beware

Foley & Lardner LLP on

On June 12, 2025, Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged in...more

Mitratech Holdings, Inc

Employee Support Through Disaster Response: 5 Routine-Building Strategies

Disasters disrupt more than just business operations. They interrupt lives, upend routines, and impact each employee in different ways. Whether facing a natural disaster, workplace violence, or other critical event, the...more

Epstein Becker & Green

Agencies’ Listening Sessions to Focus on Lowering Drug Prices Through Competition

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The Federal Trade Commission (FTC) and the Antitrust Division of the U.S. Department of Justice (DOJ), along with the U.S. Department of Commerce and the U.S. Department of Health and Human Services (collectively, “the...more

Polsinelli

Sixth Circuit Holds TPAs Do Not Get a Free Pass from ERISA’s Fiduciary Duties

Polsinelli on

In a decision about ERISA’s fiduciary duties and transparency, the Sixth Circuit in Tiara Yachts, Inc. v. Blue Cross Blue Shield of Michigan held that Blue Cross Blue Shield of Michigan (BCBSM), a third-party administrator...more

Stinson LLP

Minnesota Legislature 2025 Recap

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After decisive victories by Republicans at both the state and federal level in the 2024 general election, political prognosticators and pundits alike in Minnesota declared universally that the 2025 Minnesota legislature would...more

Nossaman LLP

Update: Colorado's Peer Review Privilege in Peril

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UPDATE: After two rounds of amendments in 2024 and legal challenges filed with the Colorado Supreme Court, proponents withdrew the ballot measure. For the moment, Colorado’s peer review protections remain in place....more

TNG Consulting

Should Clinicians on BITs Evaluate Risk?

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Clinicians play a crucial role in Behavioral Intervention Teams (BITs) and may be tasked with conducting certain types of risk assessments. However, this responsibility may not always align with their role. Their expertise is...more

Polsinelli

Texas Noncompete Shakeup: New Frontier for Health Care Practitioners

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Sweeping changes to noncompete covenants are set to take effect on September 1, 2025, for health care employers in Texas. These changes stem from recent amendments to Texas’ noncompete statute....more

Hall Benefits Law

How Plan Sponsors Can Mitigate Risk in PBM Contracts

Hall Benefits Law on

For employers offering benefit plans, fiduciary responsibility is not just a legal designation. Under the Employee Retirement Income Security Act of 1974, as amended, the fiduciary duty is the highest standard of care...more

Holland & Knight LLP

FDA Announces "National Priority Voucher" Program to Accelerate Reviews of New Drugs

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The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced on June 17, 2025, the creation of a new initiative called the "Commissioner's National Priority Voucher" (CNPV)...more

Foley Hoag LLP

CMS Rescinds Post-Dobbs EMTALA Guidance, Raising New Questions for Emergency Departments

Foley Hoag LLP on

I. Key Takeaways - Federal enforcement under the Emergency Medical Treatment and Labor Act (EMTALA) may be changing after the Centers for Medicare & Medicaid Services (CMS) rescinded guidance issued under the Biden...more

Sheppard Mullin Richter & Hampton LLP

What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”) for allegedly promoting its diagnostic product...more

Jenner & Block

Inclusion of Microplastics in the Sixth Unregulated Contaminant Monitoring Rule?

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According to a Law360 article, U.S. EPA said in a statement to Law360 that it’s reviewing a November 2024 petition from 175 environmental groups to include microplastics in the Sixth Unregulated Contaminant Monitoring Rule...more

Bass, Berry & Sims PLC

Court Vacates HIPAA 2024 Final Rule Related to Reproductive Health Care Privacy

Bass, Berry & Sims PLC on

On June 18, 2025, the U.S. District Court for the Northern District of Texas issued an opinion that vacates the 2024 final rule that enhanced privacy protections for protected health information (PHI) related to reproductive...more

Sheppard Mullin Richter & Hampton LLP

FDA Ratchets Enforcement on Social Media Promotion in New Warning Letter

The U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently posted a warning letter (the “Letter”, issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO,...more

Wiley Rein LLP

Federal Judge Blocks NIH Grant Cuts, Rejecting DOJ’s Claims of Unlawful Discrimination

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WHAT: A Massachusetts federal judge blocked the National Institutes of Health (NIH) from cutting hundreds of programs that provide grants to universities, hospitals, and other organizations. The judge found that NIH offered...more

Smart & Biggar

Health Canada consultation on revised biosimilar guidance: no requirement for comparative clinical efficacy and safety trials

Smart & Biggar on

On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which includes numerous proposed revisions to the current guidance...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Commissioner’s National Priority Voucher Program to Accelerate Drug Application Review Process and Support National...

On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a new program that aims to speed up drug application review for companies aligned with U.S....more

Bergeson & Campbell, P.C.

USDA TO THE RESCUE! First, Immigration Policies — Will MAHA be Next?

The U.S. Department of Agriculture (USDA) has been around for more than 150 years, stressing the importance of American agriculture to a bountiful food production system since Abraham Lincoln first signed it into being in...more

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