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Stotler Hayes Group, LLC

Guardians, Fiduciary Duties

So, you need to file a Medicaid application to secure Medicaid benefits for someone who is incapacitated or incompetent – someone who, due to mental and/or physical impairments, lacks sufficient understanding or capacity to...more

Sheppard

Our Takeaways from the 2026 FDLI Annual Conference

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Another Food and Drug Law Institute (FDLI) Annual Conference is in the books, and the Food and Drug Administration’s (FDA) messaging at the 2026 edition blended big-picture aspirations with clear near-term change. Right from...more

Downs Rachlin Martin PLLC

Prior Concussions Significantly Increase the Risk of Long-Term Disability after a Motor Vehicle Crash

A Canadian Study published on-line in January 2026 by the Journal of the American Medical Association, JAMA Network Open, finds that a history of prior concussion is associated with a 15% increase in the risk of long-term...more

Goodwin

FDA Issues Draft Guidance on Safety Testing for Gene Editing Therapies

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On April 14, 2026, the United States Food and Drug Administration (“FDA”) issued a draft guidance for sponsors seeking approval of human gene-editing therapy products involving gene-editing technologies. ...more

Troutman Pepper Locke

Partial Marijuana Rescheduling: Where Things Stand

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In April 2026, the U.S. Department of Justice (DOJ) and Drug Enforcement Administration (DEA) announced a significant shift in federal cannabis policy. Effective immediately, the following categories of marijuana have been...more

Offit Kurman

Cannabis Tax Relief Is Here — But IRS Risk Is Just Beginning

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For years, cannabis operators have functioned under a fundamentally distorted tax regime. Section 280E denied deductions that every other business takes for granted, forcing companies to pay tax on something closer to gross...more

McDermott+

McDermott+ Check-Up: May 8, 2026

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Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Cassidy convened two healthcare hearings in Louisiana in advance of his Senate primary on May 16, 2026. He was the only committee member in attendance....more

Butler Snow LLP

AI in Health Care Is Scaling Quickly—As Regulation Lags, Internal Controls Need to Keep Pace

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Recent developments suggest that major health care and life sciences organizations are expanding their use of AI beyond trial initiatives and targeted applications, while federal and state policymakers struggle to develop...more

Bradley Arant Boult Cummings LLP

Schedule III and the Workplace: How Marijuana Rescheduling Could Reshape Employment Law

On April 22, 2026, Acting Attorney General Todd Blanche issued a final order immediately placing both FDA-approved marijuana products and state-regulated medical marijuana products in Schedule III of the Controlled Substances...more

McGuireWoods LLP

Medicare Billers Face First New Pricing in Years and Compressed CLFS Timelines

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On May 1, 2026, CMS published three interconnected Federal Register notices that set the stage for how Medicare will price clinical laboratory tests in calendar year 2027. They announce the rechartering and new membership of...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2026 #1

News Briefs - Administration Exempts Foreign Doctors From Travel Ban - Foreign doctors will be able to receive visas allowing them to practice in the United States, after the Trump administration quietly changed a policy to...more

Hogan Lovells

FDA seeks input on real-time clinical trials pilot, AI use in studies

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The U.S. Food and Drug Administration (FDA) announced a “real-time clinical trials” (RTCT) pilot program to permit agency reviewers to review study data simultaneously with its collection by investigators. FDA also issued an...more

MG+M The Law Firm

New Contaminants Identified in EPA's CCL 6 Signify a Shift in Drinking Water Regulations

MG+M The Law Firm on

Overview of Additions to CCL 6 - On April 2, 2026, the United States Environmental Protection Agency (EPA) announced that per- and polyfluoroalkyl substances (PFAS), microplastics, pharmaceuticals, and disinfection...more

Hogan Lovells

The concept of human oversight over AI in medical devices AI summit to discuss evolving global regulatory frameworks

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For AI-based medical devices (AIMDs), one of the crucial questions arising is how to ensure that users of the AIMD (e.g., physicians) can still ultimately oversee and steer diagnostic and treatment decisions. In response to...more

Troutman Pepper Locke

Proposed State Privacy and AI Law Update: May 11, 2026

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Last week, Connecticut’s legislature passed a bill to amend the state’s consumer data privacy law and establish a data broker registration law, Iowa’s governor signed a chatbot bill into law, Colorado’s legislature passed a...more

Troutman Pepper Locke

Ohio Attorney General Dave Yost Announces Resignation

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On May 7, 2026, Ohio Attorney General (AG) Dave Yost announced his resignation after having served in the role since 2019. Yost’s resignation is effective at midnight on June 7, 2026. Yost is vacating his position to join...more

Hogan Lovells

CMS Health Tech Ecosystem moves from vision to deployment - AI Summit to focus on evolving health data access

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The U.S. Centers for Medicare and Medicaid Services (CMS) recently hosted its “HealthTech Ecosystem Live! First Wave” Launch, during which the agency announced the first apps that it is recommending to Medicare through the...more

Winthrop & Weinstine, P.A.

Legislative Top 5 - May 2026 #2

228 Hours and Counting… As of noon on Friday, May 8, there will be exactly 228 hours left in the 2026 Legislative Session before the required Constitutional adjournment deadline of midnight on Monday, May 18. With this...more

Polsinelli

Beyond the Pump: The Iran War’s Adverse Impact on U.S. Health Care

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Key Takeaways - The closure of the Strait of Hormuz following the U.S.-Iran conflict is disrupting global health care supply chains and increasing costs for critical medical products....more

Arnall Golden Gregory LLP

CMS Calls on States to Submit Medicaid Provider Revalidation Strategies: What Providers Need to Know

Key Takeaways - The Centers for Medicare and Medicaid Services has directed states to expedite Medicaid provider revalidation, requiring two-year revalidation strategies within 30 days and focusing on high-risk providers not...more

Baker Donelson

DOJ Fraud Qui Tam Enforcement is Coming into FOCUS

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Department of Justice (DOJ) announced the Fraud Oversight through Careful Use of Statistics (FOCUS) Initiative on April 30, 2026, a new effort designed to increase False Claims Act (FCA) enforcement through partnerships with...more

Arnall Golden Gregory LLP

Won’t Get Fooled Again: FDA Tells a Drug Company Don't Rely on AI

Key Takeaways - The Food & Drug Administration issued a Warning Letter citing a drug company for inappropriate use of AI in pharmaceutical manufacturing, marking what appears to be the first time the agency has specifically...more

Robinson+Cole Data Privacy + Security Insider

Privacy Trends Fashion, Beauty, and Wearable Tech Brands Need to Watch

Fashion, beauty, and wearable technology brands are heading into 2026 with a lot more to think about concerning data privacy. What used to feel like a back-end legal issue is now shaping how companies design products,...more

Latham & Watkins LLP

CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices

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On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway....more

Verrill

Navigating PBM Reform: Regulatory Changes, Market Shifts, and Practical Guidance for ERISA Fiduciaries

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Pharmacy Benefit Manager (“PBM”) arrangements have long relied on rebates with limited transparency into true drug costs. Recent regulatory and market developments represent a shift toward greater transparency and better net...more

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