On August 26, 2026, the Court of Chancery issued Dodiya v. Franklin, C.A. No. 2025-0932-LWW (Del. Ch. Aug. 26, 2026), concluding that the “striking breakdown in corporate governance” detailed in the complaint made the “predictable path to safe harbor”
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Eleventh Circuit Rejects Appointments Clause Challenge to Qui Tam Mechanism
In a landmark decision in Zafirov, the Eleventh Circuit yesterday rejected the argument that the FCA’s qui tam mechanism violates the Constitution’s Appointments Clause. Encouraged by concurring and dissenting opinions in which three Supreme Court Justices have recently questioned qui…
Federal Court Strikes Down New York’s Climate Change Superfund Act
On August 31, 2026, the U.S. District Court for the Northern District of New York struck down New York’s Climate Change Superfund Act (the Act). As we reported when the Act was signed into law in 2024, the Act established…
DOJ Continues Medicare Advantage Enforcement Focus with $541.5 Million Settlement
On August 26, 2026, the Department of Justice announced a $541.5 million settlement with a Florida-based provider group serving beneficiaries in the retirement community to resolve allegations that the group violated the False Claims Act by submitting invalid diagnosis codes…
Is my product a medical device? EU Court judgment clarifies that the test includes objective function and intended purpose, and provides guidance relevant to software and AI-enabled tools
The recent judgment of the Court of Justice of the European Union (CJEU or the Court) in Case C-427/24, Diagramm Halbach clarifies the key principles for determining whether a product falls within the definition of a medical device and will…
DOJ Announces Second Settlement Resolving FCA Allegations Based on Employment Discrimination
Earlier this week, the Department of Justice (“DOJ”) announced a $21.5 million settlement agreement with five Deloitte entities to resolve allegations that they violated the FCA by engaging in conduct DOJ alleges violated Title VII and Federal Acquisition Regulation (“FAR”)…
Heightened Means Heightened: Chancery’s First Read of SB 21’s New Presumption Shuts Down Demand Futility
In Ayers v. Foley (available here), the Delaware Court of Chancery recently became the first court to interpret Section 144(d)(2) of the Delaware General Corporation Law (DGCL), the provision added by Senate Bill 21 (SB 21) in 2025…
UK Looks To Modernize Medicines And Medical Device Regulation In The Era Of AI
A landmark program designed to deepen the regulatory partnership between the UK and the U.S., a regulatory ‘sandbox’ for AI as a medical device, evidence-gathering on AI regulation in healthcare, a consultation on a draft Rare Disease Therapies Regulatory Framework…
CMS’ CY 2027 OPPS and PFS Proposed Rules Include Major Changes to Reimbursement for 340B Hospitals, Data Reporting, and Digital Health
In July 2026, the Centers for Medicare & Medicaid Services (CMS or Agency) published two of their annual proposed rules: the CY 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Proposed Rule (OPPS-ASC Proposed Rule) and the CY…
Trending Issues in State AI Regulation as Seen Through Connecticut’s Omnibus AI Law (SB5)
Earlier this year, Connecticut enacted its Online Safety Act (“SB5”), now retitled the Connecticut Artificial Intelligence Responsibility and Transparency Act (the “CART Act”), which represents one of the most wide-ranging omnibus state artificial intelligence (“AI”) and online-safety laws enacted to…