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
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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…
Mind the Gap: Delaware Court of Chancery’s Clarification of the Implied Covenant’s Contractual Gap-Filling Role
Although the implied covenant of good faith and fair dealing applies to nearly every contract governed under Delaware law, many claims alleging its breach fail at the earliest stages of litigation. Even when an implied covenant claim survives such preliminary…
Second Circuit Clarifies Scope of “Property” that an FCA “Claim” May Seek
Earlier this month, the Second Circuit issued a notable decision on a rare FCA topic—whether a request to the government seeks “property,” such that the request falls within the FCA’s definition of a “claim.” The Second Circuit determined that a…
DOJ’s $5.15 Million FCA Settlement Reinforces Focus on Tariff and Customs Compliance
On August 5, 2026, DOJ announced a $5.15 million settlement with a Taiwanese light-emitting diode (“LED”) manufacturer and its Texas-based subsidiary to resolve allegations under the False Claims Act (“FCA”), the common law, and the Tariff Act of 1930, as…
Concessions and Particularity: How a Derivative Challenge to a Discounted Insider Financing Failed at the Pleading Stage
In the recent decision Marstrand Partners, L.P. v. Israel Biotech Fund I, L.P., C.A. No. 2024-0421-KSJM (Del. Ch. May 27, 2026), Chancellor McCormick dismissed a derivative challenge to a steeply discounted insider financing after holding that the plaintiff failed to plead demand…
$14.1 Million FCA Settlement Underscores Medicare Advantage Coding Scrutiny
On August 3, 2026, DOJ announced a $14.1 million settlement with a management services organization (“MSO”) for primary care groups to resolve allegations that the organization violated the False Claims Act by causing inaccurate diagnosis codes to be submitted to…
SB 253/SB 261 Update: What CARB’s 15-Day Modifications Mean for Business Compliance Plans
U.S.-based entities with at least $1 billion in global annual revenue that do business in California should revisit their 2026 SB 253 compliance plans following the release, by the California Air Resources Board (CARB), of 15-day modifications to its proposed…
NHTSA Announces a Host of Actions on Autonomous Vehicles
On July 30, on the last day of the SAE International Automated Transportation Symposium, the National Highway Traffic Safety Administration (NHTSA) released several rulemakings and announcements focused on automated driving systems (ADS). These announcements further NHTSA’s efforts to, in…