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Knobbe Martens

Federal Circuit Confirms Patent Eligibility of Gene Therapy Patent in Regenexbio Inc. v. Sarepta Therapeutics

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Genetically engineered cultured host cells containing recombinant nucleic acids useful for gene therapy are patent-eligible for being markedly different from anything occurring in nature....more

Ballard Spahr LLP

DOJ’s West Coast Health Care Fraud Strike Force: What LTC Facilities Need to Know

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What is the West Coast Health Care Fraud Strike Force? - DOJ’s Fraud Division announced the West Coast Health Care Fraud Strike Force on April 30, 2026, as a multidistrict enforcement initiative uniting the Division’s...more

Bass, Berry & Sims PLC

Federal Court Seizes $2 Million from Wound Care Clinic: What Providers, Distributors, and Manufacturers Need to Know

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Skin substitutes, bioengineered or natural materials designed to promote healing by replacing or supporting damaged skin, have become a key component of advanced wound care....more

McGuireWoods LLP

Mako Capital Launches, Invests in Mangrove Health

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Mako Capital Group has announced its launch. Mako, based in Miami, is a private equity firm specializing in acquiring lower-middle market U.S. companies in healthcare, financial and other services. Mako targets...more

Wiley Rein LLP

FDA Considers Modernizing Dietary Supplements’ Regulatory Pathway

Wiley Rein LLP on

The U.S. Food and Drug Administration’s (FDA) Office of Dietary Supplement Programs (ODSP) recently held a public meeting to solicit input from stakeholders on how the Agency should regulate modern dietary ingredient...more

Hogan Lovells

Navigating automation, robotics, AI, and data in a QMSR-driven manufacturing world

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We spend a lot of time with manufacturing leaders, quality teams, and in-house counsel who are all talking about the same basic issue, just from different angles: automation, AI, data, and how far to push “digital...more

McCarter & English, LLP

New Jersey 2025 Regulatory Updates: Part 1

This first installment of our overview of regulations finalized in 2025 summarizes recently adopted rules and amendments affecting healthcare providers, long-term care facilities, residential operators, and licensed...more

Morgan Lewis

AI for Healthcare Industry Leaders: Key Considerations for Artificial Intelligence in the Healthcare Industry in 2026

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As healthcare organizations increasingly embrace artificial intelligence (AI)—moving from common use cases in ambient dictation and revenue cycle management, to wide scale adoption across sectors—it brings increased legal,...more

Morgan Lewis

AI in Healthcare: Key Legal Questions to Address Before Deployment

Morgan Lewis on

This article outlines key questions and compliance concepts to consider based on common scenarios in which healthcare entities “feed the machine” with sensitive data. Explore all articles in our AI in Healthcare series. Key...more

Hogan Lovells

FDA AI tool Elsa 4.0 and HALO unveiled AI Summit to discuss FDA use of artificial intelligence

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FDA announced version 4.0 of Elsa, its internal AI chatbot for staff, and a new internal data platform called Harmonized AI & Lifecycle Operations for Data (“HALO”), which consolidates “more than 40 disparate application and...more

Morgan Lewis

AI in Healthcare: A Practical Checklist for Compliance and Risk Management

Morgan Lewis on

AI is rapidly being integrated into healthcare delivery, operations, and patient engagement, increasing legal and compliance complexity. This checklist highlights key risks and considerations across data use, contracting,...more

Thompson Coburn LLP

OIG’s FAQs Clarify Anti-Kickback Risk Despite Fair Market Value and Stark Compliance

Thompson Coburn LLP on

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently updated its General Questions Regarding Certain Fraud and Abuse Authorities FAQ page—a resource which offers the healthcare...more

Shumaker, Loop & Kendrick, LLP

Client Alert: The Government May Actually Be Here to Help – Health Insurance Portability and Accountability Act of 1996 (HIPAA)...

The United States Department of Health and Human Services (HHS) provides a helpful set of questions and answers on its website regarding the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Professionals...more

Morgan Lewis

Healthcare AI Deployment: Compliance Through Contracting, BAAs, and Data Governance As AI adoption accelerates, healthcare...

Morgan Lewis on

This article highlights key legal considerations for using AI systems with protected health information (PHI), with a focus on agreements, business associate obligations, and data governance. Explore all articles in our AI in...more

Pierce Atwood LLP

District of Massachusetts Issues Divergent Rulings in Website Tracking Privacy Class Actions

Pierce Atwood LLP on

In a trio of recent website tracking decisions, the District of Massachusetts resolved motions to dismiss privacy claims related to third-party tracking technologies on healthcare websites: Progin v. UMass Memorial Health...more

ArentFox Schiff

The Shot Heard ‘Round the Pharmacy’: FDA Takes Aim at GLP-1 Compounders

ArentFox Schiff on

On May 1, the US Food and Drug Administration (FDA) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. If finalized, this proposal would close the last remaining...more

Holland & Hart LLP

USCIS Creates New Path for Physician Cases Caught in Benefits Pause

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On April 30, 2026, USCIS updated its Screening and Vetting guidance page to add "applications associated with medical physicians" to the group of cases eligible for its internal hold-lift review process, a notable development...more

King & Spalding

FDA’s New Oversight Tool: One-Day Inspectional Assessments

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On May 6, 2026, the Food and Drug Administration (“FDA” or “the Agency”) issued a press release officially announcing a pilot program for one-day inspectional assessments. According to the press release, FDA quietly started...more

Morgan Lewis - As Prescribed

Adverse Events Centralized: What the Launch of FDA’s New Adverse Event Monitoring System Means for Companies

FDA announced on March 11, 2026 the launch of the Adverse Event Monitoring System (AEMS), a modernized database designed to centralize and streamline the analysis and publication of adverse event reports for all FDA-regulated...more

Adler Pollock & Sheehan P.C.

AI, Patent Strategy, and What Actually Drives Outcomes in 2026 – Part 2

Part 1 of this series focused on diligence and opinions. Patent prosecution is undergoing the same transition: AI has dramatically improved efficiency, but strategic value increasingly comes from understanding where...more

Polsinelli

New OIG FAQ Warns Fair Market Value Alone Does Not Shield AKS Liability

Polsinelli on

Key Takeaways - OIG’s new FAQ #17 reiterates that fair market value alone does not eliminate risk under the Federal Anti-Kickback Statute and emphasizes that AKS compliance depends on the full facts and circumstances,...more

Alston & Bird

Your AI Therapist May Need a Lawyer: Pennsylvania Brings Suit Against Chatbot Developer

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Our Health Care Group investigates a lawsuit against Character.AI that raises legal risks for AI platforms presenting themselves as licensed professionals and signals tightening regulatory scrutiny....more

Maynard Nexsen

Taking The Pulse, A Health Care and Life Sciences Video Podcast | Episode 276: Educating the Life Sciences Workforce with Wake...

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Hosts Heather and Lauren are joined by Leslie Isenhour, Dean of Biotechnologies and North Carolina BioNetwork Capstone Center at Wake Tech Community College. With the growing demand for life sciences talent in North Carolina,...more

Vorys, Sater, Seymour and Pease LLP

Vorys Benefits Brief: 2025 MHPAEA Report to Congress: Enforcement Activity Continues and the Need for Comparative Analyses Remains

The United States Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) recently issued the 2025 MHPAEA Report to Congress (the Report), summarizing enforcement activity related to...more

McDermott+

Reconciliation 2.0 and healthcare chances

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Congress returns from a one-week recess, with most focus on advancing reconciliation 2.0. Before leaving for recess, House Republicans passed the reconciliation 2.0 budget resolution, and the Senate this week will begin...more

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