News & Analysis as of

Regulatory Requirements Healthcare

Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

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The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more

Jackson Lewis P.C.

Florida AHCA Proposed Rules Would Establish New Breach Reporting, Continuity Planning Requirements

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On September 17, 2025, the Florida Agency for Health Care Administration (AHCA) will hold its first public meeting to discuss proposed rules designed to enhance transparency and preparedness around health care information...more

Alston & Bird

New Maryland Law Regulates Use of AI in Health Care Utilization Management Reviews

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Our Health Care Group discusses what businesses need to know about a new law in Maryland that creates new requirements for health plans’ use of artificial intelligence in making coverage and treatment decisions....more

Baker Donelson

Powering Up Part 2: HHS Announced OCR Enforcement Authority for Part 2 Final Rule

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The Office for Civil Rights (OCR) will be ready to enforce the 2024 Part 2 Final Rule by the February 16, 2026, compliance deadline now that the U.S. Department of Health & Human Services (HHS) has delegated enforcement...more

Dickinson Wright

Friendly PC Model: 3 Key Ancillary Agreements for CPOM Compliance

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With the rebound of private equity (“PE”) activity in healthcare across the United States, the Corporate Practice of Medicine and Dentistry (“CPOM” or “CPOD”) has likewise experienced renewed focus by state legislatures and...more

Dentons

Ep. 77 – Keeping Up to Date on New Developments

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One of the biggest challenges for any busy compliance professional is staying abreast of all the changes in healthcare regulations, enforcement trends and risks. Yet doing so is critically important so that you have enough...more

Robinson+Cole Health Law Diagnosis

OIG Shines Spotlight on Billing for Remote Patient Monitoring

On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger...more

Troutman Pepper Locke

3 Takeaways From Recent Cyberattacks On Healthcare Cos.

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Significant data breaches have affected major players in the healthcare industry in the last year, with the methods of attack being as diverse as the affected entities themselves. Originally published in Law360 - June 4,...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Transportation/Hazardous Materials: Pipeline and Hazardous Materials Safety Administration Interpretive Letter Clarifying the...

The United States Pipeline and Hazardous Materials Safety Administration (“PHMSA”) addressed in an August 7th Interpretive Letter the application of the federal Hazardous Materials Regulations (“HMR”) to the transportation of...more

Sheppard Mullin Richter & Hampton LLP

State Antitrust Enforcement Roundup: Updates to Healthcare Merger Matrix; New Potential Legislation Targeting Private Equity and...

State oversight of healthcare transactions is continuing to undergo a significant transformation. As tracked in our updated Healthcare Merger Matrix, the number of states implementing or considering expanding antitrust laws...more

Quarles & Brady LLP

Alabama Board of Pharmacy Issues Non-Disciplinary Fine Schedule

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On August 20, 2025, the Alabama Board of Pharmacy (the “Board”) issued its long-awaited non-disciplinary penalty schedule via emergency rulemaking. The rule went into effect immediately and will expire on December 18, 2025....more

Roetzel & Andress

Protecting Your Business with Enforceable Non-Compete Provisions - Video Blog Post

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When creating or updating employment contracts, it’s important to carefully review any non-compete provisions as laws vary by state and many have recently changed. Roetzel shareholder Ericka Adler provides guidance to...more

Morgan Lewis - ML Benefits

Preparing for a Successful Annual Benefits Enrollment

Annual benefits enrollment, which for many companies will be in the coming months, typically lasts one to two weeks, but the preparation process begins several months in advance. For human resources (HR) and benefits teams,...more

Epstein Becker & Green

Hospital Associations Argue Premerger Notification Overhaul Was Unnecessary and Harmful to Industry

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During the Biden administration and under the leadership of then-Chair Lina Khan, the Federal Trade Commission (FTC) adopted sweeping changes to the Hart-Scott-Rodino (HSR) premerger notification requirements that went into...more

Gardner Law

Cybersecurity and the FCA: Illumina Signals "No Breach" Enforcement Risks

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A $9.8 million False Claims Act (FCA) settlement between Illumina Inc. and the U.S. Department of Justice (DOJ) is unique among cybersecurity enforcement actions because it didn’t result from a data breach, but, according to...more

Holland & Knight LLP

New Illinois Law Restricts Use of AI in Mental Health Therapy

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Illinois has become one of the first states to formally regulate the use of artificial intelligence (AI) in therapy and psychotherapy services. Enacted Aug. 1, 2025, the Wellness and Oversight for Psychological Resources Act...more

Stevens & Lee

New York Adopts Certificate of Need Amendments to Streamline Reviews of Health Facility Projects

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The New York State Department of Health (the Department) adopted amendments to its Certificate of Need (CON) regulations at Part 710 of Title 10 of the New York Codes, Rules and Regulations (NYCRR) to update, modernize and...more

Gardner Law

NTAP: How to Secure Supplemental Medicare Reimbursement in FY2027

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The New Technology Add-On Payment (NTAP) program remains one of the most powerful and underutilized tools for securing Medicare reimbursement for novel medical technologies. For eligible products, NTAP provides additional...more

Sheppard Mullin Richter & Hampton LLP

So You Want to Start a Concierge Medicine Practice? Here are Five Key Legal Considerations

With increased consolidation of traditional medical practices and declining reimbursement rates, many physicians are turning to alternative models like concierge medicine to preserve their independence. Concierge medicine...more

Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Alston & Bird

Health Care Week in Review | CMS Announces Oversight Initiative to Increase Medicaid and CHIP Citizenship Enforcement; HHS...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Foley & Lardner LLP

CY 2026 Medicare PFS Proposed Rule: Telehealth Takeaways

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In July 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule (the Proposed Rule), which included several proposed changes that aim to expand...more

Foley Hoag LLP

Can New State Licensing Pathways for Foreign Medical Graduates Reshape Physician Staffing and Recruitment Landscape?

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Key Takeaways: States are increasingly enacting and considering laws authorizing alternative licensing pathways for internationally-trained physicians to practice medicine in the United States....more

Holland & Knight LLP

New Florida Law Attempts to Provide Leeway for Certain Stem Cell Treatments

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A new law in Florida, CS/CS/SB 1768, allows physicians to market and administer stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain...more

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