DROPLETS
Manufacturers of hardware and software sold in the EU face a 24-hour deadline to report actively exploited vulnerabilities and severe incidents under the Cyber Resilience Act, with key obligations taking effect on September 11, 2026.
The EU's Cyber Resilience Act (CRA) will impose significant new cybersecurity obligations, with reporting duties for manufacturers taking effect September 11, 2026. The rules apply to nearly all hardware and software with a data connection ("products with digital elements") made available on the EU market. This creates a harmonized, stringent framework across the EU, requiring manufacturers to report actively exploited vulnerabilities and severe security incidents to national authorities via a central EU platform. An initial notification is required within 24 hours of awareness, followed by a more detailed report within 72 hours. Penalties for non-compliance are severe, reaching up to €15 million or 2.5% of global annual turnover. The obligations also extend to vulnerabilities in third-party components. Counsel should advise clients to immediately identify covered products and establish internal procedures for rapid incident detection and reporting to meet the tight timelines. The CRA's broader product security and conformity requirements will apply from December 11, 2027.
In a global first, a UK disciplinary tribunal has removed a lawyer from a professional register for repeatedly relying on AI-hallucinated authorities, signaling a new era of accountability for technology use.
In what appears to be a global first, the UK’s Solicitors Disciplinary Tribunal has removed a lawyer from the Register of Foreign Lawyers for using AI-generated fake legal authorities. The case, SRA v Abhishek Kumar, is a landmark for professional ethics in the AI era. Kumar relied on hallucinated citations while defending himself in a disciplinary hearing, and then, after being warned, submitted a further response containing more false material generated by AI. The tribunal deemed the misconduct so severe that it would have warranted removal from the register on its own, apart from other serious allegations against him. This decision establishes a high-stakes precedent, signaling that lawyers are fully accountable for the work product of generative AI. While U.S. courts have sometimes treated similar errors with financial penalties, especially when counsel is candid and quick to correct, the Kumar case demonstrates that repeating the offense or failing to exercise candor with the court can lead to career-ending sanctions. Firms should urgently review their AI use policies and verifi
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Private educational institutions face the loss of their 501(c)(3) status under proposed Treasury rules that prohibit using race as a factor in any school program, reversing longstanding IRS guidance.
The U.S. Treasury and IRS have issued proposed regulations that would strip 501(c)(3) tax-exempt status from any private educational institution—from K-12 to universities—that uses race, color, or national or ethnic origin in its programs. This proposal marks a major policy shift by explicitly prohibiting discrimination "for any purpose," thereby eliminating longstanding exceptions under IRS Revenue Procedure 75-50 that permitted race-based scholarships and other programs designed to promote diversity. The move is intended to align tax policy with recent Supreme Court decisions limiting affirmative action. For private schools and universities, the financial and operational stakes are high, as the loss of tax-exempt status would be catastrophic. The rules also impact donor relations, as institutions may need to modify existing race-restricted charitable gifts. Counsel should advise affected clients to immediately audit all admissions, scholarship, and other programs for race-based criteria. Comments on the proposed regulations are due by Nov. 3, 2026. The rules, if finalized, would ap
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A bill passed by the California Legislature would for the first time extend the state's main antitrust law to cover monopolizing conduct by a single firm, awaiting the governor's signature.
The California Legislature has passed a bill that would significantly expand the state's primary antitrust law, the Cartwright Act, to cover single-firm monopolizing and monopsonizing conduct. The bill, AB 1776, passed both chambers with veto-proof majorities and now awaits Governor Gavin Newsom's signature. If signed by September 30, 2026, it will become effective on January 1, 2027.
This marks a major shift in California's antitrust enforcement landscape, which has historically focused on concerted action between multiple firms. The new provision would empower the state attorney general and district attorneys to bring enforcement actions against dominant companies for their unilateral business practices. To secure passage, the bill was narrowed from its original form, most notably by removing a private right of action and limiting its use in unfair-competition lawsuits.
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Citing compliance burdens and unintended consequences, the SEC has proposed eliminating the two-year ban on advisory fees from government entities after political contributions.
On September 3, 2026, the U.S. Securities and Exchange Commission proposed rescinding Rule 206(4)-5 of the Investment Advisers Act, commonly known as the "pay-to-play" rule. The 2010 rule prohibits an investment adviser from being compensated for advisory services to a state or local government entity for two years after the adviser or certain employees make a political contribution to an official of that entity.
In its proposal, the SEC cited the rule's complexity, significant compliance burdens, and unintended consequences, such as some advisers instituting blanket bans on political speech. The agency suggested that other safeguards—including advisers' fiduciary duties, antifraud provisions, and existing election laws—may be sufficient to prevent quid pro quo corruption.
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Australian energy regulators and governments have proposed a raft of significant changes affecting data centres, automated bidding, market contracts, and gas network transitions.
A flurry of regulatory activity in Australia's energy markets signals significant changes for market participants. The Australian Energy Market Commission (AEMC) has advised that data centres should be required to offset their consumption with new renewable generation and firming capacity. In parallel, the New South Wales government has introduced a framework requiring data centres to contribute to network upgrade costs. Separately, the Australian Energy Regulator (AER) issued a compliance bulletin clarifying expectations for participants using automated bidding services. Regulators are also advancing the design of new financial instruments, including swaps and cap contracts under an ISDA framework, to help manage price volatility. For sophisticated clients and their counsel, these parallel developments create new costs, compliance obligations, and commercial opportunities. The proposed data centre rules will materially affect project economics, while new market contracts will alter hedging strategies. Stakeholders should monitor the various consultation periods for draft rules, with
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The Consumer Financial Protection Bureau's Office of Inspector General finds that recent agency cutbacks paused 463 supervisory events and created a backlog of more than 17,000 consumer complaints.
A report from the Consumer Financial Protection Bureau's (CFPB) Office of Inspector General (OIG), prompted by congressional request, details the operational impact of stop-work orders, contract cancellations, and workforce changes at the agency in early 2025. The OIG found the actions led to a temporary halt of all supervision and examination activities, pausing 463 supervisory events. They also created a backlog of approximately 17,100 consumer complaints requiring manual routing as of June 2026.
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The UK government has rejected calls for a special administration regime for financially distressed universities, leaving a fragmented and inadequate legal framework to handle a potential institutional failure.
The UK government has declined to create a special administration regime (SAR) for the higher education sector, despite a House of Commons Education Committee report warning that the government is unprepared for a university failure. The Office for Students, the sector's regulator, has reportedly identified dozens of institutions at risk of market exit.
Sophisticated counsel and clients should care because the failure of a university would have severe consequences for students, creditors, research grants, and local economies. The existing insolvency framework is ill-equipped for the unique legal structures of many universities, which are often statutory corporations or established by Royal Charter rather than standard companies. This creates uncertainty around the availability of administration and the suitability of other processes like compulsory liquidation. Without a bespoke SAR, a university failure risks a disorderly outcome, with significant legal challenges concerning student loan funding, degree-awarding powers, and the treatment of charitable assets. Stakeholders should mo
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The SEC has proposed the first major modernization of the regulatory framework for transfer agents since the 1980s, introducing new compliance, cybersecurity, and operational requirements.
The SEC has proposed the first comprehensive update to the rules governing registered transfer agents in four decades, citing the need to address risks from technology and the expanded role of these market intermediaries. The proposed rules would introduce significant new compliance burdens, including a first-ever requirement for all transfer agents to establish, maintain, and enforce a board-approved written compliance program. A new rule would also directly regulate the process for placing and removing restrictive stock legends—a frequent subject of SEC enforcement actions—and would create a safe harbor for agents who obtain an appropriate legal opinion or conduct their own documented analysis. Further amendments aim to modernize requirements for cybersecurity, business continuity planning, and electronic recordkeeping. Transfer agents and the issuers who rely on them should evaluate their current procedures against the proposal and consider submitting comments by the November 3, 2026, deadline.
A new memorandum of understanding facilitates SEC access to FDA records, signaling heightened scrutiny of issuer disclosures and insider trading in the pharma and biotech sectors.
The US Securities and Exchange Commission (SEC) and Food and Drug Administration (FDA) signed a Memorandum of Understanding on August 31, 2026, creating a formal framework for sharing information to support each agency's regulatory and enforcement responsibilities. While not creating new substantive law, the pact gives the SEC a more direct and standardized process for obtaining non-public information from the FDA, making it easier to investigate whether a company's public statements about clinical trial results, product approvals, or other FDA interactions are false or misleading.
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In a case of first impression, the Court of Chancery found gross negligence and a misleading proxy defeated DGCL § 144 protections, but common law exculpation still shielded most directors from liability.
In its first opinion analyzing DGCL Section 144 safe harbors in a merger challenge, 'Dodiya v. Franklin', the Delaware Court of Chancery denied a motion to dismiss claims that the provisions protected a conflicted buyout of Whole Earth Brands. The acquirer was a major stockholder whose son was the company's interim CEO and allegedly leaked confidential valuation data to his father's entity.
The decision clarifies that the safe harbor for disinterested director approval can be lost if a board acts with gross negligence, which the court found conceivable where directors restored the son's access to sensitive data despite his previous leak and refusal to sign an NDA. It also confirms the stockholder-vote safe harbor is unavailable if the proxy contains material misstatements. Critically, however, the court reinforced the power of charter exculpation clauses, dismissing claims against most directors by finding their flawed conduct constituted an exculpated breach of care, not bad faith. Claims survived only against the two fiduciaries with direct financial conflicts. Counsel advising on
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A new report outlines how litigation funding, cross-border plaintiff coordination, and AI-driven claim identification are transforming collective litigation from a local legal problem into a global business risk.
A report summarizing a global class action summit warns that collective litigation has become a coordinated, global business risk for multinational companies. Sophisticated counsel should be aware that the traditional, jurisdiction-by-jurisdiction defense model is no longer sufficient. The report highlights several interlocking trends: third-party litigation funding is industrializing claim portfolios, claimant law firms are coordinating strategies across borders, and plaintiffs are leveraging AI to identify opportunities and file claims at scale and low cost. These dynamics create new categories of exposure, particularly for companies making public sustainability commitments or selling products in multiple markets. In-house counsel are advised to adopt a proactive, cross-border defense strategy that involves mapping funder relationships, tracking the development of legal theories across jurisdictions, and anticipating how regulatory action in one country might trigger private litigation in another.
In a direct split with the Ninth Circuit, the Fifth Circuit has rejected the long-standing 'server test' for online copyright infringement, creating new uncertainty for platforms that embed or frame third-party content.
The U.S. Court of Appeals for the Fifth Circuit, in Emmerich Newspapers v. Particle Media, has rejected the Ninth Circuit’s influential 'server test' for determining copyright infringement by online platforms that embed or frame third-party content. The court disagreed with the test's premise that an infringer must store a copy of the work on its own server, focusing instead on who 'transmits' the content. While the court still found the defendant news aggregator did not infringe on these facts, its rejection of the underlying doctrine creates a significant circuit split. The court also revived a Digital Millennium Copyright Act (DMCA) claim by holding that URLs can, in certain circumstances, qualify as protected copyright management information (CMI).
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The national group representing state banking regulators has endorsed federal legislation that would prevent states from using a DIDMCA opt-out to apply their interest-rate caps to loans made by out-of-state, state-chartered banks.
The Conference of State Bank Supervisors (CSBS) has endorsed federal legislation that would significantly clarify the rules for interstate lending by state-chartered banks. The bill, H.R. 7866, addresses a key dispute under the Depository Institutions Deregulation and Monetary Control Act (DIDMCA), specifying that a state's decision to 'opt out' of federal interest-rate preemption applies only to banks chartered within its own borders. This interpretation directly counters efforts by Colorado and Oregon to impose their local interest-rate caps on loans made by out-of-state banks to their residents. The CSBS endorsement is significant because it aligns the nation's state regulators with the FDIC, the OCC, and financial industry plaintiffs who are challenging the states' position in federal court. This broad consensus strengthens the argument against state overreach and provides momentum for a legislative solution. Counsel for financial institutions should monitor the House Financial Services Committee's planned markup of the bill, as well as the parallel litigation pending before the
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Two former senior CFPB officials have proposed five structural reforms to increase the agency's stability and effectiveness amid leadership changes, arguing against "regulatory whiplash" that creates industry uncertainty.
Two former senior officials of the Consumer Financial Protection Bureau (CFPB) are proposing structural reforms to insulate the agency from the "regulatory whiplash" that occurs with changing presidential administrations. In a recent commentary, the former officials argue that constant shifts in enforcement priorities and the withdrawal of prior guidance create substantial uncertainty for financial institutions, potentially increasing costs for consumers and chilling innovation.
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The White House has imposed import bans on certain Canadian products, including alcohol and dairy, under Section 338 of the Tariff Act of 1930 in a significant escalation of the ongoing trade dispute.
In a significant escalation of a bilateral trade dispute, the White House has invoked Section 338 of the Tariff Act of 1930 to impose import bans on a range of Canadian goods. The presidential proclamations, issued September 8, 2026, were a direct response to Canadian retaliatory tariffs and are set to take effect on September 29. The banned products include certain alcoholic beverages, dairy products, molasses, and motorcycle products. These measures compound existing 50% tariffs on other Canadian goods that took effect in August.
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A publicly traded fintech will acquire its national bank partner for $590 million in cash, signaling a strategic shift from the partnership model to direct bank ownership and supervision.
A publicly traded fintech announced a definitive agreement to acquire the parent company of its longtime national bank partner for $590 million in cash. This transaction marks a significant strategic shift away from the common bank-partnership model toward direct ownership. For sophisticated counsel and their clients, this deal highlights an emerging trend where mature fintechs pursue acquisitions as a potentially faster alternative to a de novo charter for securing banking capabilities. The benefits include potentially lower funding costs, eliminating sponsor-bank fees, and greater control over product expansion. However, the move also invites direct prudential supervision by the Office of the Comptroller of the Currency and the Federal Reserve, and the acquirer will become a bank holding company subject to the Bank Holding Company Act. The key development to watch is the regulatory approval process for this deal, which, if successful, may spur other large fintechs to follow a similar acquisition path.
The agency plans more foreign inspections and greater transparency on data-access issues, urging sponsors to bake inspectability into their regulatory strategy from the start.
The US Food and Drug Administration has signaled it will intensify its scrutiny of clinical trial data from outside the United States. In a recent policy statement, agency leaders from the drug, biologics, and device centers committed to increasing foreign bioresearch monitoring (BIMO) inspections, including for early-stage Phase 1 trials, and refining risk-based criteria for site selection. The FDA also plans to increase transparency by publishing more information about inspection findings and any barriers encountered, such as sites denying or conditioning access.
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The White House domestic policy advisor's nomination signals potential policy shifts on cannabis, mifepristone, vaccines, and drug pricing, setting up a likely contentious Senate confirmation process.
President Trump has nominated Dr. Heidi Overton, currently a White House domestic policy advisor, to serve as the next Commissioner of the Food and Drug Administration (FDA). The announcement sets the stage for a confirmation process that will be closely watched by the life sciences, pharmaceutical, and other FDA-regulated industries.
Sophisticated counsel and clients care because Dr. Overton’s past policy writings and work suggest potential for significant regulatory shifts. Priorities mentioned by the administration include faster drug approvals, clinical trial reforms, and lower drug prices. Her previous work indicates specific positions on key issues, including expanding medical marijuana research, revising childhood vaccine recommendations, and restoring stricter Risk Evaluation and Mitigation Strategy (REMS) safeguards for mifepristone. These positions could lead to material changes in FDA policy and enforcement affecting product development, approval pathways, and market access.
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The SEC has sent four significant rulemaking proposals to OIRA for review, signaling potential changes to shareholder proposals, proxy solicitations, executive pay disclosure, and retail investor access to private markets.
The SEC has signaled a significant regulatory shift by submitting four major rulemaking packages to the Office of Information and Regulatory Affairs (OIRA) for pre-publication review. The proposals, advanced in late August 2026, target fundamental aspects of securities law and corporate governance. Key among them is a proposal to rescind Rule 14a-8's federal framework for shareholder proposals, a move that would dramatically alter the dynamics of shareholder activism. Other proposals aim to modernize proxy solicitation, reform executive compensation disclosure, and enhance retail investor access to private markets. These potential changes represent a major development for all public companies, as they could reshape shareholder relations, capital-raising strategies, and disclosure obligations. While these are still preliminary steps, the breadth of the proposals indicates a significant policy agenda. Corporate counsel should closely monitor the progress of OIRA's review, which can take up to 90 days, and prepare to analyze the formal proposing releases as soon as they are published by
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A US Department of Homeland Security proposal would eliminate the 60-day post-employment grace period for many nonimmigrant visa holders, requiring them to depart the US immediately after a job loss.
The US Department of Homeland Security (DHS) has proposed a rule to eliminate the 60-day grace period for terminated nonimmigrant workers in key employment-based visa categories, including H-1B, L-1, O-1, and TN. This flexibility, established in 2017, currently allows these workers to seek new employment, change their immigration status, or arrange for departure without being considered out of status.
If the rule is finalized, affected workers could be required to leave the US immediately upon job loss unless they secure another lawful basis to remain. The change presents significant challenges for both employees and their employers. For workers, it drastically shortens the window to find a new sponsor. For companies, it complicates terminations and recruiting, as foreign-national candidates might have to leave the country before a new sponsorship petition can be completed, disrupting hiring timelines.
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A supplemental proposed rule seeks to narrow federal Clean Water Act jurisdiction by providing bright-line definitions for key terms left ambiguous after the Supreme Court’s Sackett decision.
The EPA and the Army Corps of Engineers have issued a supplemental notice of proposed rulemaking to further clarify the definition of “waters of the United States” (WOTUS) under the Clean Water Act. The proposal, which follows an initial rule proposed in 2025, aims to align federal regulations with the Supreme Court's 2023 decision in 'Sackett v. EPA'. The new alternatives provide more concrete, bright-line definitions for key jurisdictional terms such as “relatively permanent” and “continuous surface connection,” notably removing a controversial “wet season” concept from the earlier draft.
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The UK's Employment Appeal Tribunal has overturned a ruling against a major retailer, finding that recruitment and retention pressures can be a legitimate reason for paying warehouse staff more than retail staff for work of equal value.
The UK's Employment Appeal Tribunal (EAT) reversed a lower tribunal decision, ruling in favor of retailer Next in an equal pay case brought by thousands of its female store employees. The claimants successfully argued at the first stage that their work was of equal value to that of higher-paid, predominantly male warehouse workers. However, the EAT found the lower tribunal erred in rejecting the company’s justification for the pay gap. It held that the need to recruit and retain warehouse workers in a distinct and more competitive labor market constituted a legitimate business aim. The resulting pay differential was deemed a proportionate measure to address these market pressures, rather than an act of sex discrimination. This decision provides significant authority for UK employers seeking to justify pay differences between roles of equal value by using a 'material factor' defense based on genuine market conditions. It underscores the importance for businesses to meticulously document the commercial reasons for their pay structures, as this evidence is critical in defending against
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In a first-of-its-kind decision, the French Anti-Corruption Agency's Sanctions Commission imposed direct financial penalties on a company and its chairman for failing to implement an adequate anti-corruption compliance program.
The French Anti-Corruption Agency's (AFA) Sanctions Commission has imposed its first-ever direct financial penalties for non-compliance with the Sapin II Act's anti-corruption requirements. The commission fined a company €350,000 and its chairman €60,000 after an audit revealed it had implemented only one of eight mandatory compliance measures. This decision establishes a significant new precedent in French enforcement, as the AFA moved directly to sanctions without issuing a prior formal notice, a departure from past practice.
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The U.S. national-security investment review body saw a 7% increase in total filings in 2025, but its lower clearance rate for declarations and steady enforcement activity signal a more challenging environment for foreign investors.
The Committee on Foreign Investment in the United States (CFIUS) has released its annual report for calendar year 2025, revealing a 7% increase in total filings to 347. Despite the rise, the number of unique transactions reviewed held steady, indicating more withdrawals and refilings. The report shows a notable shift in the handling of short-form declarations; while their use rose 21%, the clearance rate fell from 78% in 2024 to 66% in 2025. Consequently, the rate at which CFIUS requested a full notice following a declaration review reached a three-year high of 26%.
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The court reversed a district court's finding that the whistleblower provision violates the Appointments Clause, but the ruling deepens a debate that may soon reach the Supreme Court.
The U.S. Court of Appeals for the Eleventh Circuit has reversed a district court's decision that the False Claims Act's (FCA) qui tam provision was unconstitutional. In United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, the appellate court held that private whistleblowers, or relators, who pursue declined cases on behalf of the government are not "officers" of the United States and therefore do not violate the Constitution's Appointments Clause.
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Self-represented litigants in Australia are using generative AI to file apparently sophisticated employment claims at no cost, creating a new cost asymmetry for employers who must pay to defend them.
Generative AI is creating a significant cost imbalance in Australian employment litigation. Self-represented litigants are leveraging the technology to draft apparently sophisticated pleadings and submissions at little to no personal expense. While these documents may appear well-structured, they often lack sound legal judgment, leading to over-pleading and the pursuit of marginal arguments. For employers, this trend significantly increases the cost of defending claims in the Fair Work Act’s “no-costs” jurisdiction, as each AI-generated point must be assessed and addressed. This asymmetry can pressure companies into settling weak claims simply to avoid high legal fees.
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Generative AI license agreements increasingly restrict using the platform or its output to train or develop competing products, but market terms vary widely on the scope of these key limitations.
As organizations adopt generative AI, providers are embedding non-competition clauses in license agreements to protect their proprietary models. This guide highlights a critical and evolving point of negotiation: restrictions on using the AI to train, improve, or develop competing offerings. A central ambiguity exists between use of the AI "platform" versus use of the AI-generated "output," with significant uncertainty over whether a contractual restriction on the former implicitly covers the latter. For corporate counsel, this distinction is crucial, as overly broad terms can severely limit a company's ability to innovate or use AI-generated content for core business purposes. Conversely, AI providers risk devaluing their intellectual property without carefully drafted protections. With no clear market consensus or judicial precedent, counsel for both licensors and licensees must proactively and explicitly define the scope of these restrictions, clarifying their application to both the platform and its output to align with commercial objectives and mitigate future disputes.
Parliament has changed Australia's merger laws, replacing the automatic voiding of non-notified deals with a court-supervised process and clarifying rules on joint control.
Australia's Parliament has passed targeted but significant amendments to its mandatory merger control regime under the Competition and Consumer Act. The most notable change removes the rule that automatically voided a notifiable transaction that was completed without ACCC approval. Now, the ACCC must apply to the Federal Court for a declaration to void such a transaction, which the court can deny if it deems the outcome "undesirable," for instance due to harm to innocent third parties. This provides a crucial safety net against inadvertent non-compliance.
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The guidance details regulatory expectations for the required periodic risk assessments under New York's pioneering cybersecurity regulation for financial institutions.
The New York State Department of Financial Services (NYDFS) has issued new guidance on the risk assessments required under its landmark Cybersecurity Regulation (23 NYCRR 500). The guidance, released September 10, 2026, clarifies regulatory expectations for how financial institutions should conduct these foundational assessments, which must be performed periodically to inform their entire cybersecurity program.
Sophisticated counsel and their clients care because the NYDFS regulation is a critical compliance framework for thousands of banks, insurers, and other financial services companies operating in New York. The risk assessment is not a check-the-box exercise; it is the basis for the entity’s security controls, policies, and procedures. Failure to conduct an adequate assessment is a primary target in regulatory examinations and enforcement actions. This guidance provides a clearer roadmap for meeting DFS expectations and defending the methodology. Covered entities should immediately review the guidance with their legal and technology teams to identify any gaps in their current r
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The Internal Revenue Service has issued proposed regulations that would deny 501(c)(3) status to private schools with policies that discriminate based on race, color, or national origin, regardless of intent.
The IRS on September 4, 2026, proposed new regulations that would render any private school with a racially discriminatory policy ineligible for tax-exempt status under Section 501(c)(3). Critically, the proposed rules would apply to any policy that discriminates on the basis of race, color, or national or ethnic origin in effect, regardless of the school's intent. This represents a significant potential shift in IRS enforcement, moving from an intent-based standard to an effects-based one.
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The Common Cents Act aims to standardize rounding for cash purchases amid a national penny shortage, creating potential conflicts with state laws and raising tax and consumer protection issues.
The U.S. Senate is poised to pass the Common Cents Act, which would establish uniform federal rules for rounding cash retail transactions to the nearest five cents. The move, reportedly prompted by a national penny shortage after production ceased in 2025, is expected to be approved by the House of Representatives. While intended to create consistency, the proposed legislation presents significant challenges for retailers. The act raises consumer protection questions over potential discrepancies in sales tax collection between cash purchases, which would be rounded, and electronic ones, which would not. Critically, the bill's reliance on the Commerce Clause for authority is questionable, as cash transactions are arguably intrastate. This creates a complex compliance environment for national retailers, who must navigate the new federal mandate alongside numerous, and potentially conflicting, state laws that already address the issue. Counsel should monitor the bill's final text and prepare to advise on preemption issues and potential constitutional challenges.
The Eastern District of Texas held that the customer-suit exception does not shield technology users from patent litigation when infringement claims are based on how the technology is used, not just its design.
A federal court in the Eastern District of Texas ruled that the customer-suit exception does not apply to patent claims covering a method of use. In Near Field Electronics v. Enterprise Holdings, defendants sought to stay infringement suits, arguing the core dispute was already being litigated by product manufacturers in separate declaratory judgment actions. The court denied the stay, reasoning that a ruling concerning the manufacturers would not resolve whether customer-defendants independently infringed through their specific use of the technology.
This decision limits a key defense strategy for end-users sued for patent infringement. Companies can no longer assume that a supplier's litigation will automatically pause proceedings against them, especially in cases involving method claims. This forces downstream users to mount an earlier and more independent defense, potentially increasing litigation costs and complexity.
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A confluence of new statutes and plaintiff-friendly judicial interpretations, all backed by potent statutory damages, has made the state a leading jurisdiction for high-stakes consumer litigation.
Oregon has rapidly become one of the nation’s most hazardous jurisdictions for consumer class actions, with federal filings more than doubling since 2022. A convergence of legislative and judicial developments has created a uniquely plaintiff-friendly environment, attracting specialist firms from out of state. At the core is Oregon’s Unlawful Trade Practices Act (UTPA), which provides for statutory damages of $200 per violation, allowing for massive aggregate damage claims without proof of individualized harm. This potent enforcement mechanism is now being fueled by a host of new laws creating predicate violations, including strict new rules on drip pricing, the collection of geolocation data, and the reporting of medical debt. A 2024 Oregon Supreme Court decision has also broadened the scope for "greenwashing" claims. The compounding risk means that even technical compliance gaps can lead to nine-figure exposure. Companies selling to Oregon consumers must proactively audit their pricing displays, privacy policies, advertising claims, and TCPA consent procedures to navigate this high
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New European Commission guidelines on exclusionary abuse of dominance signal a more aggressive enforcement posture against market-leading firms.
The European Commission has published new guidelines detailing its enforcement priorities for exclusionary abuses of dominance under Article 102 of the Treaty on the Functioning of the European Union. This recalibrated framework reportedly signals a shift toward a more aggressive enforcement posture, potentially moving away from a strictly economics-based analysis to a more effects-based approach for certain types of conduct.
For corporate counsel, this development is critical. It heightens compliance risk for companies with substantial market shares in the EU, as commercial strategies involving rebates, tying, or pricing may face increased scrutiny. The guidelines could make it easier for the Commission to bring cases against allegedly dominant firms. Businesses with significant European operations should review the new guidance to assess its impact on their commercial practices and ensure their compliance programs are sufficiently robust. The key development to watch will be the first enforcement actions and court challenges brought under this new framework.
President Sheinbaum has submitted a legislative proposal to create a formal screening process for foreign investments in sensitive sectors, similar to the CFIUS regime in the United States.
On August 30, 2026, the administration of Mexican President Claudia Sheinbaum submitted a bill to the Senate to amend the country's Foreign Investment Law. The proposal aims to establish a formal national security screening mechanism for foreign direct investment in sensitive industries.
Sophisticated counsel and clients with interests in Mexico should take note. While the National Commission of Foreign Investment (CNIE) technically has the authority to block acquisitions on national security grounds, this power has been rarely used due to a lack of specific guidelines. The reform signals a significant shift toward a more structured and potentially stringent review process, mirroring regimes like the Committee on Foreign Investment in the United States (CFIUS). This could create new regulatory hurdles, extend transaction timelines, and increase deal uncertainty for foreign investors, particularly in sectors like technology, energy, and infrastructure.
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Recent SEC actions, including a new accounting fraud unit and an information-sharing deal with the FDA, signal heightened scrutiny for public companies, life sciences firms, private funds, and their executives.
The SEC has signaled a broad enforcement push through several recent actions. The agency established a new Financial Reporting and Accounting Unit within its Enforcement Division, designed to focus resources on complex accounting fraud and auditor misconduct. It also entered into a three-year memorandum of understanding with the FDA to streamline access to nonpublic information, enhancing its oversight of public life sciences companies' disclosures regarding clinical trials and product approvals.
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New legislation proposed in Florida would hold companies that own, control, or distribute an AI chatbot strictly liable if the system is involved in a crime.
Florida Attorney General James Uthmeier has proposed legislation that would establish corporate liability when an AI chatbot is involved in criminal activity. The bill would apply to any business that owns, controls, distributes, or profits from an AI system, including any entity with practical control over its design, training, development, or safety settings, if the system is available to users in Florida. Potential penalties include fines, restitution to victims, and a court-appointed monitor.
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A new voluntary Code of Practice offers a clear path for providers and deployers to comply with the EU AI Act's Article 50 transparency obligations, and non-signatories may face greater regulatory scrutiny.
In the first month since its publication, approximately 190 organizations have signed the EU's new voluntary Code of Practice on Transparency of AI-generated Content. The Code provides a framework for companies to meet their transparency obligations under Article 50 of the EU AI Act, which largely took effect in August 2026. Early signatories include major technology providers like Google, OpenAI, and Anthropic, who have publicly detailed their implementation of technical measures like digital watermarking to align with the Code.
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A new proposed rule would end the 60-day discretionary grace period for certain nonimmigrant visa holders after their employment ends, requiring immediate departure or a change of status.
U.S. Citizenship and Immigration Services (USCIS) has published a proposed rule to eliminate the 60-day discretionary grace period that certain nonimmigrant workers may receive after their employment is terminated. This long-standing policy allows individuals in classifications such as H-1B, L-1, and O-1 a window to find a new sponsoring employer, change to a different visa status, or prepare to depart the country without being considered unlawfully present. The removal of this buffer would create significant challenges for both employers and their foreign-national employees, introducing immediate immigration consequences upon job separation.
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Responding to regulatory pressure, Australia's Financial Services Council has released a new mandatory standard for private credit managers, effective July 2027.
Australia's Financial Services Council (FSC) has issued a mandatory new standard for the private credit sector, responding to regulatory pressure and recent high-profile collapses. Standard 30, which takes effect on July 1, 2027, is compulsory for all FSC full members managing private market funds and establishes a formal definition of "private credit" for the first time. The new framework sets obligations across seven pillars: governance, credit risk management, fees and transparency, valuation governance, liquidity risk, fund leverage, and conflicts of interest.
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A Federal Circuit panel invalidated a Covid-19 treatment patent, finding a one-character difference between a provisional application and the issued patent fatal to its priority claim against Pfizer's intervening prior art.
The U.S. Court of Appeals for the Federal Circuit affirmed the invalidation of an Enanta Pharmaceuticals patent for a coronavirus treatment, holding it could not claim priority to its 2020 provisional application because of a critical one-character discrepancy. The provisional disclosed a chemical group starting with two carbon atoms ("C2-C12"), while the later patent claimed a group that also included the one-carbon option ("C1-C12"). The court rejected arguments that this was a correctable typo, stating "C2 is simply different from C1."
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Two major US bank regulators will now require a link to material financial harm before citing an 'unsafe or unsound practice' or issuing a formal matter requiring attention.
The Office of the Comptroller of the Currency (OCC) and the Federal Deposit Insurance Corporation (FDIC) have issued a joint final rule changing how they supervise and discipline regulated banks. Effective November 2, 2026, the rule formally defines an 'unsafe or unsound practice' for the first time, requiring a link to likely or actual material financial harm. It also raises the standard for issuing formal 'matters requiring attention' (MRAs), which must now be tied to conduct that could reasonably be expected to cause such harm.
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The European Data Protection Board has released awaited draft guidelines on data anonymisation, introducing a new perspective-based test that could reshape how organizations share and use data under the GDPR.
The European Data Protection Board (EDPB) has published long-awaited draft guidelines on data anonymisation under the GDPR, aiming to create a clearer standard following a key 2025 Court of Justice of the EU ruling. The guidance establishes a new framework centered on whether an individual is identifiable by any "means reasonably likely to be used" from the perspective of each "relevant entity." This approach allows for a dataset to be considered anonymous for a recipient even if the disclosing controller retains the ability to re-identify individuals, potentially easing data sharing for analytics and research. However, the guidelines broaden the risk assessment to include adversarial actors like cybercriminals and clarify that contractual "no re-identification" clauses are not a substitute for robust technical measures. The EDPB also confirms that anonymisation itself is a form of data processing that requires a lawful basis. The consultation on these significant draft rules is open until October 2026, and firms should begin evaluating their existing data strategies against this new
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In a case with broad implications for online publishers, the Fifth Circuit adopted a new test for infringement claims based on embedded content and held that URLs can sometimes qualify as protected copyright management information.
The U.S. Court of Appeals for the Fifth Circuit, in 'Emmerich v. Particle Media,' declined to follow the Ninth Circuit's influential 'server test' for copyright infringement. That test generally shields websites from liability for embedding content hosted on other servers. The court introduced a new 'Transmit Requirement,' which focuses on whether the embedded content originates from an authorized source and whether the transmission itself was authorized.
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Recent US bankruptcy court decisions offer key guidance on recognizing foreign insolvencies, including a path for cannabis companies via Canadian proceedings.
Three recent US bankruptcy court decisions have clarified the requirements for recognizing foreign insolvency proceedings under Chapter 15. Most notably, a Delaware court recognized the Canadian restructuring of a cannabis holding company. This decision is significant because US courts typically deny bankruptcy protection to cannabis-related businesses due to federal illegality. The apparent workaround—using a foreign proceeding for a holding company that does not directly handle cannabis operations, combined with a lack of objection from the US Trustee—may signal a new path for the industry to access US courts.
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A new HHS OIG advisory opinion warns that royalties tied to broad product-line sales, rather than specific physician innovations, pose a high Anti-Kickback Statute risk even when structured with common compliance safeguards.
The US Department of Health and Human Services' Office of Inspector General (OIG) issued an unfavorable advisory opinion (AO 26-10) on a proposed physician consulting arrangement from an orthopedic device manufacturer. The proposal involved paying physicians a "Product Line Royalty" calculated as a percentage of net sales across an entire product line, not just for specific products the consultant helped develop.
The OIG concluded the arrangement posed a high risk of fraud and abuse under the federal Anti-Kickback Statute (AKS). The agency's primary concern was that the compensation structure could incentivize physicians to leverage their influence—through teaching, training, and proctoring other providers—to drive downstream sales across the product portfolio. This blurs the line between legitimate payment for innovation and a reward for generating business.
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A proposed federal law would require free, prior, and informed consent from Indigenous and Afro-Mexican communities for a wide range of development projects, imposing significant new costs and obligations on companies.
Mexico’s executive branch has published a draft General Law on the Rights of Indigenous and Afro-Mexican Peoples, initiating a formal consultation process. The proposed law would establish a nationwide procedure for obtaining the free, prior, and informed consent of these communities for any legislative or administrative measure that may affect them, including the authorization of mining, energy, infrastructure, and natural-resource projects.
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A new decision deepens a circuit split on whether the Fair Labor Standards Act provides a remedy for unpaid non-overtime hours in a week when an employee also works overtime.
The U.S. Court of Appeals for the Third Circuit held that the Fair Labor Standards Act (FLSA) does not create a cause of action for "overtime gap time" claims, which seek compensation for unpaid non-overtime hours in a workweek where an employee has also worked overtime. The case, Secretary of Labor v. Comprehensive Healthcare Management Services, reversed a district court decision and rejected the Department of Labor's (DOL) long-standing interpretation that proper overtime calculation requires prior payment of all straight-time wages.
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The UK's Financial Conduct Authority has proposed a comprehensive overhaul of its reporting rules for asset managers, introducing a new regime called "FRAME" that will create divergence from EU requirements.
The UK's Financial Conduct Authority (FCA) has issued a consultation paper proposing a sweeping reform of reporting obligations for asset managers. The new regime, called Fund Reporting for Asset Management Entities (FRAME), would replace several existing returns, including those under the current AIFMD framework, with a new, UK-specific system.
Sophisticated counsel and clients care because the proposal introduces a "proportionate," tiered approach, with "essential," "enhanced," and "event-based" reporting obligations determined by a fund's net asset value (NAV)—a shift from the EU's gross-asset calculation. A key threshold is set at £500 million NAV. This new framework will apply to both UK and third-country alternative investment fund managers (AIFMs) marketing in the UK, creating a significant divergence from EU reporting standards. Managers who previously repurposed AIFMD reports for UK compliance will need to adapt to entirely new requirements.
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Manufacturers of hardware and software sold in the EU face a 24-hour deadline to report actively exploited vulnerabilities and severe incidents under the Cyber Resilience Act, with key obligations taking effect on September 11, 2026.
The EU's Cyber Resilience Act (CRA) will impose significant new cybersecurity obligations, with reporting duties for manufacturers taking effect September 11, 2026. The rules apply to nearly all hardware and software with a data connection ("products with digital elements") made available on the EU market. This creates a harmonized, stringent framework across the EU, requiring manufacturers to report actively exploited vulnerabilities and severe security incidents to national authorities via a central EU platform. An initial notification is required within 24 hours of awareness, followed by a more detailed report within 72 hours. Penalties for non-compliance are severe, reaching up to €15 million or 2.5% of global annual turnover. The obligations also extend to vulnerabilities in third-party components. Counsel should advise clients to immediately identify covered products and establish internal procedures for rapid incident detection and reporting to meet the tight timelines. The CRA's broader product security and conformity requirements will apply from December 11, 2027.
A bill passed by the California Legislature would for the first time extend the state's main antitrust law to cover monopolizing conduct by a single firm, awaiting the governor's signature.
The California Legislature has passed a bill that would significantly expand the state's primary antitrust law, the Cartwright Act, to cover single-firm monopolizing and monopsonizing conduct. The bill, AB 1776, passed both chambers with veto-proof majorities and now awaits Governor Gavin Newsom's signature. If signed by September 30, 2026, it will become effective on January 1, 2027.
This marks a major shift in California's antitrust enforcement landscape, which has historically focused on concerted action between multiple firms. The new provision would empower the state attorney general and district attorneys to bring enforcement actions against dominant companies for their unilateral business practices. To secure passage, the bill was narrowed from its original form, most notably by removing a private right of action and limiting its use in unfair-competition lawsuits.
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Parliament has changed Australia's merger laws, replacing the automatic voiding of non-notified deals with a court-supervised process and clarifying rules on joint control.
Australia's Parliament has passed targeted but significant amendments to its mandatory merger control regime under the Competition and Consumer Act. The most notable change removes the rule that automatically voided a notifiable transaction that was completed without ACCC approval. Now, the ACCC must apply to the Federal Court for a declaration to void such a transaction, which the court can deny if it deems the outcome "undesirable," for instance due to harm to innocent third parties. This provides a crucial safety net against inadvertent non-compliance.
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New European Commission guidelines on exclusionary abuse of dominance signal a more aggressive enforcement posture against market-leading firms.
The European Commission has published new guidelines detailing its enforcement priorities for exclusionary abuses of dominance under Article 102 of the Treaty on the Functioning of the European Union. This recalibrated framework reportedly signals a shift toward a more aggressive enforcement posture, potentially moving away from a strictly economics-based analysis to a more effects-based approach for certain types of conduct.
For corporate counsel, this development is critical. It heightens compliance risk for companies with substantial market shares in the EU, as commercial strategies involving rebates, tying, or pricing may face increased scrutiny. The guidelines could make it easier for the Commission to bring cases against allegedly dominant firms. Businesses with significant European operations should review the new guidance to assess its impact on their commercial practices and ensure their compliance programs are sufficiently robust. The key development to watch will be the first enforcement actions and court challenges brought under this new framework.
The UK government has rejected calls for a special administration regime for financially distressed universities, leaving a fragmented and inadequate legal framework to handle a potential institutional failure.
The UK government has declined to create a special administration regime (SAR) for the higher education sector, despite a House of Commons Education Committee report warning that the government is unprepared for a university failure. The Office for Students, the sector's regulator, has reportedly identified dozens of institutions at risk of market exit.
Sophisticated counsel and clients should care because the failure of a university would have severe consequences for students, creditors, research grants, and local economies. The existing insolvency framework is ill-equipped for the unique legal structures of many universities, which are often statutory corporations or established by Royal Charter rather than standard companies. This creates uncertainty around the availability of administration and the suitability of other processes like compulsory liquidation. Without a bespoke SAR, a university failure risks a disorderly outcome, with significant legal challenges concerning student loan funding, degree-awarding powers, and the treatment of charitable assets. Stakeholders should mo
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Recent US bankruptcy court decisions offer key guidance on recognizing foreign insolvencies, including a path for cannabis companies via Canadian proceedings.
Three recent US bankruptcy court decisions have clarified the requirements for recognizing foreign insolvency proceedings under Chapter 15. Most notably, a Delaware court recognized the Canadian restructuring of a cannabis holding company. This decision is significant because US courts typically deny bankruptcy protection to cannabis-related businesses due to federal illegality. The apparent workaround—using a foreign proceeding for a holding company that does not directly handle cannabis operations, combined with a lack of objection from the US Trustee—may signal a new path for the industry to access US courts.
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In a case of first impression, the Court of Chancery found gross negligence and a misleading proxy defeated DGCL § 144 protections, but common law exculpation still shielded most directors from liability.
In its first opinion analyzing DGCL Section 144 safe harbors in a merger challenge, 'Dodiya v. Franklin', the Delaware Court of Chancery denied a motion to dismiss claims that the provisions protected a conflicted buyout of Whole Earth Brands. The acquirer was a major stockholder whose son was the company's interim CEO and allegedly leaked confidential valuation data to his father's entity.
The decision clarifies that the safe harbor for disinterested director approval can be lost if a board acts with gross negligence, which the court found conceivable where directors restored the son's access to sensitive data despite his previous leak and refusal to sign an NDA. It also confirms the stockholder-vote safe harbor is unavailable if the proxy contains material misstatements. Critically, however, the court reinforced the power of charter exculpation clauses, dismissing claims against most directors by finding their flawed conduct constituted an exculpated breach of care, not bad faith. Claims survived only against the two fiduciaries with direct financial conflicts. Counsel advising on
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Manufacturers of hardware and software sold in the EU face a 24-hour deadline to report actively exploited vulnerabilities and severe incidents under the Cyber Resilience Act, with key obligations taking effect on September 11, 2026.
The EU's Cyber Resilience Act (CRA) will impose significant new cybersecurity obligations, with reporting duties for manufacturers taking effect September 11, 2026. The rules apply to nearly all hardware and software with a data connection ("products with digital elements") made available on the EU market. This creates a harmonized, stringent framework across the EU, requiring manufacturers to report actively exploited vulnerabilities and severe security incidents to national authorities via a central EU platform. An initial notification is required within 24 hours of awareness, followed by a more detailed report within 72 hours. Penalties for non-compliance are severe, reaching up to €15 million or 2.5% of global annual turnover. The obligations also extend to vulnerabilities in third-party components. Counsel should advise clients to immediately identify covered products and establish internal procedures for rapid incident detection and reporting to meet the tight timelines. The CRA's broader product security and conformity requirements will apply from December 11, 2027.
The guidance details regulatory expectations for the required periodic risk assessments under New York's pioneering cybersecurity regulation for financial institutions.
The New York State Department of Financial Services (NYDFS) has issued new guidance on the risk assessments required under its landmark Cybersecurity Regulation (23 NYCRR 500). The guidance, released September 10, 2026, clarifies regulatory expectations for how financial institutions should conduct these foundational assessments, which must be performed periodically to inform their entire cybersecurity program.
Sophisticated counsel and their clients care because the NYDFS regulation is a critical compliance framework for thousands of banks, insurers, and other financial services companies operating in New York. The risk assessment is not a check-the-box exercise; it is the basis for the entity’s security controls, policies, and procedures. Failure to conduct an adequate assessment is a primary target in regulatory examinations and enforcement actions. This guidance provides a clearer roadmap for meeting DFS expectations and defending the methodology. Covered entities should immediately review the guidance with their legal and technology teams to identify any gaps in their current r
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The UK's Employment Appeal Tribunal has overturned a ruling against a major retailer, finding that recruitment and retention pressures can be a legitimate reason for paying warehouse staff more than retail staff for work of equal value.
The UK's Employment Appeal Tribunal (EAT) reversed a lower tribunal decision, ruling in favor of retailer Next in an equal pay case brought by thousands of its female store employees. The claimants successfully argued at the first stage that their work was of equal value to that of higher-paid, predominantly male warehouse workers. However, the EAT found the lower tribunal erred in rejecting the company’s justification for the pay gap. It held that the need to recruit and retain warehouse workers in a distinct and more competitive labor market constituted a legitimate business aim. The resulting pay differential was deemed a proportionate measure to address these market pressures, rather than an act of sex discrimination. This decision provides significant authority for UK employers seeking to justify pay differences between roles of equal value by using a 'material factor' defense based on genuine market conditions. It underscores the importance for businesses to meticulously document the commercial reasons for their pay structures, as this evidence is critical in defending against
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Self-represented litigants in Australia are using generative AI to file apparently sophisticated employment claims at no cost, creating a new cost asymmetry for employers who must pay to defend them.
Generative AI is creating a significant cost imbalance in Australian employment litigation. Self-represented litigants are leveraging the technology to draft apparently sophisticated pleadings and submissions at little to no personal expense. While these documents may appear well-structured, they often lack sound legal judgment, leading to over-pleading and the pursuit of marginal arguments. For employers, this trend significantly increases the cost of defending claims in the Fair Work Act’s “no-costs” jurisdiction, as each AI-generated point must be assessed and addressed. This asymmetry can pressure companies into settling weak claims simply to avoid high legal fees.
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A new decision deepens a circuit split on whether the Fair Labor Standards Act provides a remedy for unpaid non-overtime hours in a week when an employee also works overtime.
The U.S. Court of Appeals for the Third Circuit held that the Fair Labor Standards Act (FLSA) does not create a cause of action for "overtime gap time" claims, which seek compensation for unpaid non-overtime hours in a workweek where an employee has also worked overtime. The case, Secretary of Labor v. Comprehensive Healthcare Management Services, reversed a district court decision and rejected the Department of Labor's (DOL) long-standing interpretation that proper overtime calculation requires prior payment of all straight-time wages.
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Australian energy regulators and governments have proposed a raft of significant changes affecting data centres, automated bidding, market contracts, and gas network transitions.
A flurry of regulatory activity in Australia's energy markets signals significant changes for market participants. The Australian Energy Market Commission (AEMC) has advised that data centres should be required to offset their consumption with new renewable generation and firming capacity. In parallel, the New South Wales government has introduced a framework requiring data centres to contribute to network upgrade costs. Separately, the Australian Energy Regulator (AER) issued a compliance bulletin clarifying expectations for participants using automated bidding services. Regulators are also advancing the design of new financial instruments, including swaps and cap contracts under an ISDA framework, to help manage price volatility. For sophisticated clients and their counsel, these parallel developments create new costs, compliance obligations, and commercial opportunities. The proposed data centre rules will materially affect project economics, while new market contracts will alter hedging strategies. Stakeholders should monitor the various consultation periods for draft rules, with
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A supplemental proposed rule seeks to narrow federal Clean Water Act jurisdiction by providing bright-line definitions for key terms left ambiguous after the Supreme Court’s Sackett decision.
The EPA and the Army Corps of Engineers have issued a supplemental notice of proposed rulemaking to further clarify the definition of “waters of the United States” (WOTUS) under the Clean Water Act. The proposal, which follows an initial rule proposed in 2025, aims to align federal regulations with the Supreme Court's 2023 decision in 'Sackett v. EPA'. The new alternatives provide more concrete, bright-line definitions for key jurisdictional terms such as “relatively permanent” and “continuous surface connection,” notably removing a controversial “wet season” concept from the earlier draft.
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The agency plans more foreign inspections and greater transparency on data-access issues, urging sponsors to bake inspectability into their regulatory strategy from the start.
The US Food and Drug Administration has signaled it will intensify its scrutiny of clinical trial data from outside the United States. In a recent policy statement, agency leaders from the drug, biologics, and device centers committed to increasing foreign bioresearch monitoring (BIMO) inspections, including for early-stage Phase 1 trials, and refining risk-based criteria for site selection. The FDA also plans to increase transparency by publishing more information about inspection findings and any barriers encountered, such as sites denying or conditioning access.
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The White House domestic policy advisor's nomination signals potential policy shifts on cannabis, mifepristone, vaccines, and drug pricing, setting up a likely contentious Senate confirmation process.
President Trump has nominated Dr. Heidi Overton, currently a White House domestic policy advisor, to serve as the next Commissioner of the Food and Drug Administration (FDA). The announcement sets the stage for a confirmation process that will be closely watched by the life sciences, pharmaceutical, and other FDA-regulated industries.
Sophisticated counsel and clients care because Dr. Overton’s past policy writings and work suggest potential for significant regulatory shifts. Priorities mentioned by the administration include faster drug approvals, clinical trial reforms, and lower drug prices. Her previous work indicates specific positions on key issues, including expanding medical marijuana research, revising childhood vaccine recommendations, and restoring stricter Risk Evaluation and Mitigation Strategy (REMS) safeguards for mifepristone. These positions could lead to material changes in FDA policy and enforcement affecting product development, approval pathways, and market access.
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Citing compliance burdens and unintended consequences, the SEC has proposed eliminating the two-year ban on advisory fees from government entities after political contributions.
On September 3, 2026, the U.S. Securities and Exchange Commission proposed rescinding Rule 206(4)-5 of the Investment Advisers Act, commonly known as the "pay-to-play" rule. The 2010 rule prohibits an investment adviser from being compensated for advisory services to a state or local government entity for two years after the adviser or certain employees make a political contribution to an official of that entity.
In its proposal, the SEC cited the rule's complexity, significant compliance burdens, and unintended consequences, such as some advisers instituting blanket bans on political speech. The agency suggested that other safeguards—including advisers' fiduciary duties, antifraud provisions, and existing election laws—may be sufficient to prevent quid pro quo corruption.
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The Consumer Financial Protection Bureau's Office of Inspector General finds that recent agency cutbacks paused 463 supervisory events and created a backlog of more than 17,000 consumer complaints.
A report from the Consumer Financial Protection Bureau's (CFPB) Office of Inspector General (OIG), prompted by congressional request, details the operational impact of stop-work orders, contract cancellations, and workforce changes at the agency in early 2025. The OIG found the actions led to a temporary halt of all supervision and examination activities, pausing 463 supervisory events. They also created a backlog of approximately 17,100 consumer complaints requiring manual routing as of June 2026.
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The national group representing state banking regulators has endorsed federal legislation that would prevent states from using a DIDMCA opt-out to apply their interest-rate caps to loans made by out-of-state, state-chartered banks.
The Conference of State Bank Supervisors (CSBS) has endorsed federal legislation that would significantly clarify the rules for interstate lending by state-chartered banks. The bill, H.R. 7866, addresses a key dispute under the Depository Institutions Deregulation and Monetary Control Act (DIDMCA), specifying that a state's decision to 'opt out' of federal interest-rate preemption applies only to banks chartered within its own borders. This interpretation directly counters efforts by Colorado and Oregon to impose their local interest-rate caps on loans made by out-of-state banks to their residents. The CSBS endorsement is significant because it aligns the nation's state regulators with the FDIC, the OCC, and financial industry plaintiffs who are challenging the states' position in federal court. This broad consensus strengthens the argument against state overreach and provides momentum for a legislative solution. Counsel for financial institutions should monitor the House Financial Services Committee's planned markup of the bill, as well as the parallel litigation pending before the
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Two former senior CFPB officials have proposed five structural reforms to increase the agency's stability and effectiveness amid leadership changes, arguing against "regulatory whiplash" that creates industry uncertainty.
Two former senior officials of the Consumer Financial Protection Bureau (CFPB) are proposing structural reforms to insulate the agency from the "regulatory whiplash" that occurs with changing presidential administrations. In a recent commentary, the former officials argue that constant shifts in enforcement priorities and the withdrawal of prior guidance create substantial uncertainty for financial institutions, potentially increasing costs for consumers and chilling innovation.
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Responding to regulatory pressure, Australia's Financial Services Council has released a new mandatory standard for private credit managers, effective July 2027.
Australia's Financial Services Council (FSC) has issued a mandatory new standard for the private credit sector, responding to regulatory pressure and recent high-profile collapses. Standard 30, which takes effect on July 1, 2027, is compulsory for all FSC full members managing private market funds and establishes a formal definition of "private credit" for the first time. The new framework sets obligations across seven pillars: governance, credit risk management, fees and transparency, valuation governance, liquidity risk, fund leverage, and conflicts of interest.
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Two major US bank regulators will now require a link to material financial harm before citing an 'unsafe or unsound practice' or issuing a formal matter requiring attention.
The Office of the Comptroller of the Currency (OCC) and the Federal Deposit Insurance Corporation (FDIC) have issued a joint final rule changing how they supervise and discipline regulated banks. Effective November 2, 2026, the rule formally defines an 'unsafe or unsound practice' for the first time, requiring a link to likely or actual material financial harm. It also raises the standard for issuing formal 'matters requiring attention' (MRAs), which must now be tied to conduct that could reasonably be expected to cause such harm.
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The UK's Financial Conduct Authority has proposed a comprehensive overhaul of its reporting rules for asset managers, introducing a new regime called "FRAME" that will create divergence from EU requirements.
The UK's Financial Conduct Authority (FCA) has issued a consultation paper proposing a sweeping reform of reporting obligations for asset managers. The new regime, called Fund Reporting for Asset Management Entities (FRAME), would replace several existing returns, including those under the current AIFMD framework, with a new, UK-specific system.
Sophisticated counsel and clients care because the proposal introduces a "proportionate," tiered approach, with "essential," "enhanced," and "event-based" reporting obligations determined by a fund's net asset value (NAV)—a shift from the EU's gross-asset calculation. A key threshold is set at £500 million NAV. This new framework will apply to both UK and third-country alternative investment fund managers (AIFMs) marketing in the UK, creating a significant divergence from EU reporting standards. Managers who previously repurposed AIFMD reports for UK compliance will need to adapt to entirely new requirements.
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A publicly traded fintech will acquire its national bank partner for $590 million in cash, signaling a strategic shift from the partnership model to direct bank ownership and supervision.
A publicly traded fintech announced a definitive agreement to acquire the parent company of its longtime national bank partner for $590 million in cash. This transaction marks a significant strategic shift away from the common bank-partnership model toward direct ownership. For sophisticated counsel and their clients, this deal highlights an emerging trend where mature fintechs pursue acquisitions as a potentially faster alternative to a de novo charter for securing banking capabilities. The benefits include potentially lower funding costs, eliminating sponsor-bank fees, and greater control over product expansion. However, the move also invites direct prudential supervision by the Office of the Comptroller of the Currency and the Federal Reserve, and the acquirer will become a bank holding company subject to the Bank Holding Company Act. The key development to watch is the regulatory approval process for this deal, which, if successful, may spur other large fintechs to follow a similar acquisition path.
A new HHS OIG advisory opinion warns that royalties tied to broad product-line sales, rather than specific physician innovations, pose a high Anti-Kickback Statute risk even when structured with common compliance safeguards.
The US Department of Health and Human Services' Office of Inspector General (OIG) issued an unfavorable advisory opinion (AO 26-10) on a proposed physician consulting arrangement from an orthopedic device manufacturer. The proposal involved paying physicians a "Product Line Royalty" calculated as a percentage of net sales across an entire product line, not just for specific products the consultant helped develop.
The OIG concluded the arrangement posed a high risk of fraud and abuse under the federal Anti-Kickback Statute (AKS). The agency's primary concern was that the compensation structure could incentivize physicians to leverage their influence—through teaching, training, and proctoring other providers—to drive downstream sales across the product portfolio. This blurs the line between legitimate payment for innovation and a reward for generating business.
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A US Department of Homeland Security proposal would eliminate the 60-day post-employment grace period for many nonimmigrant visa holders, requiring them to depart the US immediately after a job loss.
The US Department of Homeland Security (DHS) has proposed a rule to eliminate the 60-day grace period for terminated nonimmigrant workers in key employment-based visa categories, including H-1B, L-1, O-1, and TN. This flexibility, established in 2017, currently allows these workers to seek new employment, change their immigration status, or arrange for departure without being considered out of status.
If the rule is finalized, affected workers could be required to leave the US immediately upon job loss unless they secure another lawful basis to remain. The change presents significant challenges for both employees and their employers. For workers, it drastically shortens the window to find a new sponsor. For companies, it complicates terminations and recruiting, as foreign-national candidates might have to leave the country before a new sponsorship petition can be completed, disrupting hiring timelines.
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A new proposed rule would end the 60-day discretionary grace period for certain nonimmigrant visa holders after their employment ends, requiring immediate departure or a change of status.
U.S. Citizenship and Immigration Services (USCIS) has published a proposed rule to eliminate the 60-day discretionary grace period that certain nonimmigrant workers may receive after their employment is terminated. This long-standing policy allows individuals in classifications such as H-1B, L-1, and O-1 a window to find a new sponsoring employer, change to a different visa status, or prepare to depart the country without being considered unlawfully present. The removal of this buffer would create significant challenges for both employers and their foreign-national employees, introducing immediate immigration consequences upon job separation.
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The White House has imposed import bans on certain Canadian products, including alcohol and dairy, under Section 338 of the Tariff Act of 1930 in a significant escalation of the ongoing trade dispute.
In a significant escalation of a bilateral trade dispute, the White House has invoked Section 338 of the Tariff Act of 1930 to impose import bans on a range of Canadian goods. The presidential proclamations, issued September 8, 2026, were a direct response to Canadian retaliatory tariffs and are set to take effect on September 29. The banned products include certain alcoholic beverages, dairy products, molasses, and motorcycle products. These measures compound existing 50% tariffs on other Canadian goods that took effect in August.
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The U.S. national-security investment review body saw a 7% increase in total filings in 2025, but its lower clearance rate for declarations and steady enforcement activity signal a more challenging environment for foreign investors.
The Committee on Foreign Investment in the United States (CFIUS) has released its annual report for calendar year 2025, revealing a 7% increase in total filings to 347. Despite the rise, the number of unique transactions reviewed held steady, indicating more withdrawals and refilings. The report shows a notable shift in the handling of short-form declarations; while their use rose 21%, the clearance rate fell from 78% in 2024 to 66% in 2025. Consequently, the rate at which CFIUS requested a full notice following a declaration review reached a three-year high of 26%.
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President Sheinbaum has submitted a legislative proposal to create a formal screening process for foreign investments in sensitive sectors, similar to the CFIUS regime in the United States.
On August 30, 2026, the administration of Mexican President Claudia Sheinbaum submitted a bill to the Senate to amend the country's Foreign Investment Law. The proposal aims to establish a formal national security screening mechanism for foreign direct investment in sensitive industries.
Sophisticated counsel and clients with interests in Mexico should take note. While the National Commission of Foreign Investment (CNIE) technically has the authority to block acquisitions on national security grounds, this power has been rarely used due to a lack of specific guidelines. The reform signals a significant shift toward a more structured and potentially stringent review process, mirroring regimes like the Committee on Foreign Investment in the United States (CFIUS). This could create new regulatory hurdles, extend transaction timelines, and increase deal uncertainty for foreign investors, particularly in sectors like technology, energy, and infrastructure.
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The Eastern District of Texas held that the customer-suit exception does not shield technology users from patent litigation when infringement claims are based on how the technology is used, not just its design.
A federal court in the Eastern District of Texas ruled that the customer-suit exception does not apply to patent claims covering a method of use. In Near Field Electronics v. Enterprise Holdings, defendants sought to stay infringement suits, arguing the core dispute was already being litigated by product manufacturers in separate declaratory judgment actions. The court denied the stay, reasoning that a ruling concerning the manufacturers would not resolve whether customer-defendants independently infringed through their specific use of the technology.
This decision limits a key defense strategy for end-users sued for patent infringement. Companies can no longer assume that a supplier's litigation will automatically pause proceedings against them, especially in cases involving method claims. This forces downstream users to mount an earlier and more independent defense, potentially increasing litigation costs and complexity.
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A Federal Circuit panel invalidated a Covid-19 treatment patent, finding a one-character difference between a provisional application and the issued patent fatal to its priority claim against Pfizer's intervening prior art.
The U.S. Court of Appeals for the Federal Circuit affirmed the invalidation of an Enanta Pharmaceuticals patent for a coronavirus treatment, holding it could not claim priority to its 2020 provisional application because of a critical one-character discrepancy. The provisional disclosed a chemical group starting with two carbon atoms ("C2-C12"), while the later patent claimed a group that also included the one-carbon option ("C1-C12"). The court rejected arguments that this was a correctable typo, stating "C2 is simply different from C1."
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A new report outlines how litigation funding, cross-border plaintiff coordination, and AI-driven claim identification are transforming collective litigation from a local legal problem into a global business risk.
A report summarizing a global class action summit warns that collective litigation has become a coordinated, global business risk for multinational companies. Sophisticated counsel should be aware that the traditional, jurisdiction-by-jurisdiction defense model is no longer sufficient. The report highlights several interlocking trends: third-party litigation funding is industrializing claim portfolios, claimant law firms are coordinating strategies across borders, and plaintiffs are leveraging AI to identify opportunities and file claims at scale and low cost. These dynamics create new categories of exposure, particularly for companies making public sustainability commitments or selling products in multiple markets. In-house counsel are advised to adopt a proactive, cross-border defense strategy that involves mapping funder relationships, tracking the development of legal theories across jurisdictions, and anticipating how regulatory action in one country might trigger private litigation in another.
A confluence of new statutes and plaintiff-friendly judicial interpretations, all backed by potent statutory damages, has made the state a leading jurisdiction for high-stakes consumer litigation.
Oregon has rapidly become one of the nation’s most hazardous jurisdictions for consumer class actions, with federal filings more than doubling since 2022. A convergence of legislative and judicial developments has created a uniquely plaintiff-friendly environment, attracting specialist firms from out of state. At the core is Oregon’s Unlawful Trade Practices Act (UTPA), which provides for statutory damages of $200 per violation, allowing for massive aggregate damage claims without proof of individualized harm. This potent enforcement mechanism is now being fueled by a host of new laws creating predicate violations, including strict new rules on drip pricing, the collection of geolocation data, and the reporting of medical debt. A 2024 Oregon Supreme Court decision has also broadened the scope for "greenwashing" claims. The compounding risk means that even technical compliance gaps can lead to nine-figure exposure. Companies selling to Oregon consumers must proactively audit their pricing displays, privacy policies, advertising claims, and TCPA consent procedures to navigate this high
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The European Data Protection Board has released awaited draft guidelines on data anonymisation, introducing a new perspective-based test that could reshape how organizations share and use data under the GDPR.
The European Data Protection Board (EDPB) has published long-awaited draft guidelines on data anonymisation under the GDPR, aiming to create a clearer standard following a key 2025 Court of Justice of the EU ruling. The guidance establishes a new framework centered on whether an individual is identifiable by any "means reasonably likely to be used" from the perspective of each "relevant entity." This approach allows for a dataset to be considered anonymous for a recipient even if the disclosing controller retains the ability to re-identify individuals, potentially easing data sharing for analytics and research. However, the guidelines broaden the risk assessment to include adversarial actors like cybercriminals and clarify that contractual "no re-identification" clauses are not a substitute for robust technical measures. The EDPB also confirms that anonymisation itself is a form of data processing that requires a lawful basis. The consultation on these significant draft rules is open until October 2026, and firms should begin evaluating their existing data strategies against this new
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The Common Cents Act aims to standardize rounding for cash purchases amid a national penny shortage, creating potential conflicts with state laws and raising tax and consumer protection issues.
The U.S. Senate is poised to pass the Common Cents Act, which would establish uniform federal rules for rounding cash retail transactions to the nearest five cents. The move, reportedly prompted by a national penny shortage after production ceased in 2025, is expected to be approved by the House of Representatives. While intended to create consistency, the proposed legislation presents significant challenges for retailers. The act raises consumer protection questions over potential discrepancies in sales tax collection between cash purchases, which would be rounded, and electronic ones, which would not. Critically, the bill's reliance on the Commerce Clause for authority is questionable, as cash transactions are arguably intrastate. This creates a complex compliance environment for national retailers, who must navigate the new federal mandate alongside numerous, and potentially conflicting, state laws that already address the issue. Counsel should monitor the bill's final text and prepare to advise on preemption issues and potential constitutional challenges.
A proposed federal law would require free, prior, and informed consent from Indigenous and Afro-Mexican communities for a wide range of development projects, imposing significant new costs and obligations on companies.
Mexico’s executive branch has published a draft General Law on the Rights of Indigenous and Afro-Mexican Peoples, initiating a formal consultation process. The proposed law would establish a nationwide procedure for obtaining the free, prior, and informed consent of these communities for any legislative or administrative measure that may affect them, including the authorization of mining, energy, infrastructure, and natural-resource projects.
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The SEC has proposed the first major modernization of the regulatory framework for transfer agents since the 1980s, introducing new compliance, cybersecurity, and operational requirements.
The SEC has proposed the first comprehensive update to the rules governing registered transfer agents in four decades, citing the need to address risks from technology and the expanded role of these market intermediaries. The proposed rules would introduce significant new compliance burdens, including a first-ever requirement for all transfer agents to establish, maintain, and enforce a board-approved written compliance program. A new rule would also directly regulate the process for placing and removing restrictive stock legends—a frequent subject of SEC enforcement actions—and would create a safe harbor for agents who obtain an appropriate legal opinion or conduct their own documented analysis. Further amendments aim to modernize requirements for cybersecurity, business continuity planning, and electronic recordkeeping. Transfer agents and the issuers who rely on them should evaluate their current procedures against the proposal and consider submitting comments by the November 3, 2026, deadline.
A new memorandum of understanding facilitates SEC access to FDA records, signaling heightened scrutiny of issuer disclosures and insider trading in the pharma and biotech sectors.
The US Securities and Exchange Commission (SEC) and Food and Drug Administration (FDA) signed a Memorandum of Understanding on August 31, 2026, creating a formal framework for sharing information to support each agency's regulatory and enforcement responsibilities. While not creating new substantive law, the pact gives the SEC a more direct and standardized process for obtaining non-public information from the FDA, making it easier to investigate whether a company's public statements about clinical trial results, product approvals, or other FDA interactions are false or misleading.
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The SEC has sent four significant rulemaking proposals to OIRA for review, signaling potential changes to shareholder proposals, proxy solicitations, executive pay disclosure, and retail investor access to private markets.
The SEC has signaled a significant regulatory shift by submitting four major rulemaking packages to the Office of Information and Regulatory Affairs (OIRA) for pre-publication review. The proposals, advanced in late August 2026, target fundamental aspects of securities law and corporate governance. Key among them is a proposal to rescind Rule 14a-8's federal framework for shareholder proposals, a move that would dramatically alter the dynamics of shareholder activism. Other proposals aim to modernize proxy solicitation, reform executive compensation disclosure, and enhance retail investor access to private markets. These potential changes represent a major development for all public companies, as they could reshape shareholder relations, capital-raising strategies, and disclosure obligations. While these are still preliminary steps, the breadth of the proposals indicates a significant policy agenda. Corporate counsel should closely monitor the progress of OIRA's review, which can take up to 90 days, and prepare to analyze the formal proposing releases as soon as they are published by
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Private educational institutions face the loss of their 501(c)(3) status under proposed Treasury rules that prohibit using race as a factor in any school program, reversing longstanding IRS guidance.
The U.S. Treasury and IRS have issued proposed regulations that would strip 501(c)(3) tax-exempt status from any private educational institution—from K-12 to universities—that uses race, color, or national or ethnic origin in its programs. This proposal marks a major policy shift by explicitly prohibiting discrimination "for any purpose," thereby eliminating longstanding exceptions under IRS Revenue Procedure 75-50 that permitted race-based scholarships and other programs designed to promote diversity. The move is intended to align tax policy with recent Supreme Court decisions limiting affirmative action. For private schools and universities, the financial and operational stakes are high, as the loss of tax-exempt status would be catastrophic. The rules also impact donor relations, as institutions may need to modify existing race-restricted charitable gifts. Counsel should advise affected clients to immediately audit all admissions, scholarship, and other programs for race-based criteria. Comments on the proposed regulations are due by Nov. 3, 2026. The rules, if finalized, would ap
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The Internal Revenue Service has issued proposed regulations that would deny 501(c)(3) status to private schools with policies that discriminate based on race, color, or national origin, regardless of intent.
The IRS on September 4, 2026, proposed new regulations that would render any private school with a racially discriminatory policy ineligible for tax-exempt status under Section 501(c)(3). Critically, the proposed rules would apply to any policy that discriminates on the basis of race, color, or national or ethnic origin in effect, regardless of the school's intent. This represents a significant potential shift in IRS enforcement, moving from an intent-based standard to an effects-based one.
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In a global first, a UK disciplinary tribunal has removed a lawyer from a professional register for repeatedly relying on AI-hallucinated authorities, signaling a new era of accountability for technology use.
In what appears to be a global first, the UK’s Solicitors Disciplinary Tribunal has removed a lawyer from the Register of Foreign Lawyers for using AI-generated fake legal authorities. The case, SRA v Abhishek Kumar, is a landmark for professional ethics in the AI era. Kumar relied on hallucinated citations while defending himself in a disciplinary hearing, and then, after being warned, submitted a further response containing more false material generated by AI. The tribunal deemed the misconduct so severe that it would have warranted removal from the register on its own, apart from other serious allegations against him. This decision establishes a high-stakes precedent, signaling that lawyers are fully accountable for the work product of generative AI. While U.S. courts have sometimes treated similar errors with financial penalties, especially when counsel is candid and quick to correct, the Kumar case demonstrates that repeating the offense or failing to exercise candor with the court can lead to career-ending sanctions. Firms should urgently review their AI use policies and verifi
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In a direct split with the Ninth Circuit, the Fifth Circuit has rejected the long-standing 'server test' for online copyright infringement, creating new uncertainty for platforms that embed or frame third-party content.
The U.S. Court of Appeals for the Fifth Circuit, in Emmerich Newspapers v. Particle Media, has rejected the Ninth Circuit’s influential 'server test' for determining copyright infringement by online platforms that embed or frame third-party content. The court disagreed with the test's premise that an infringer must store a copy of the work on its own server, focusing instead on who 'transmits' the content. While the court still found the defendant news aggregator did not infringe on these facts, its rejection of the underlying doctrine creates a significant circuit split. The court also revived a Digital Millennium Copyright Act (DMCA) claim by holding that URLs can, in certain circumstances, qualify as protected copyright management information (CMI).
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Generative AI license agreements increasingly restrict using the platform or its output to train or develop competing products, but market terms vary widely on the scope of these key limitations.
As organizations adopt generative AI, providers are embedding non-competition clauses in license agreements to protect their proprietary models. This guide highlights a critical and evolving point of negotiation: restrictions on using the AI to train, improve, or develop competing offerings. A central ambiguity exists between use of the AI "platform" versus use of the AI-generated "output," with significant uncertainty over whether a contractual restriction on the former implicitly covers the latter. For corporate counsel, this distinction is crucial, as overly broad terms can severely limit a company's ability to innovate or use AI-generated content for core business purposes. Conversely, AI providers risk devaluing their intellectual property without carefully drafted protections. With no clear market consensus or judicial precedent, counsel for both licensors and licensees must proactively and explicitly define the scope of these restrictions, clarifying their application to both the platform and its output to align with commercial objectives and mitigate future disputes.
New legislation proposed in Florida would hold companies that own, control, or distribute an AI chatbot strictly liable if the system is involved in a crime.
Florida Attorney General James Uthmeier has proposed legislation that would establish corporate liability when an AI chatbot is involved in criminal activity. The bill would apply to any business that owns, controls, distributes, or profits from an AI system, including any entity with practical control over its design, training, development, or safety settings, if the system is available to users in Florida. Potential penalties include fines, restitution to victims, and a court-appointed monitor.
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A new voluntary Code of Practice offers a clear path for providers and deployers to comply with the EU AI Act's Article 50 transparency obligations, and non-signatories may face greater regulatory scrutiny.
In the first month since its publication, approximately 190 organizations have signed the EU's new voluntary Code of Practice on Transparency of AI-generated Content. The Code provides a framework for companies to meet their transparency obligations under Article 50 of the EU AI Act, which largely took effect in August 2026. Early signatories include major technology providers like Google, OpenAI, and Anthropic, who have publicly detailed their implementation of technical measures like digital watermarking to align with the Code.
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In a first-of-its-kind decision, the French Anti-Corruption Agency's Sanctions Commission imposed direct financial penalties on a company and its chairman for failing to implement an adequate anti-corruption compliance program.
The French Anti-Corruption Agency's (AFA) Sanctions Commission has imposed its first-ever direct financial penalties for non-compliance with the Sapin II Act's anti-corruption requirements. The commission fined a company €350,000 and its chairman €60,000 after an audit revealed it had implemented only one of eight mandatory compliance measures. This decision establishes a significant new precedent in French enforcement, as the AFA moved directly to sanctions without issuing a prior formal notice, a departure from past practice.
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The court reversed a district court's finding that the whistleblower provision violates the Appointments Clause, but the ruling deepens a debate that may soon reach the Supreme Court.
The U.S. Court of Appeals for the Eleventh Circuit has reversed a district court's decision that the False Claims Act's (FCA) qui tam provision was unconstitutional. In United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, the appellate court held that private whistleblowers, or relators, who pursue declined cases on behalf of the government are not "officers" of the United States and therefore do not violate the Constitution's Appointments Clause.
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Recent SEC actions, including a new accounting fraud unit and an information-sharing deal with the FDA, signal heightened scrutiny for public companies, life sciences firms, private funds, and their executives.
The SEC has signaled a broad enforcement push through several recent actions. The agency established a new Financial Reporting and Accounting Unit within its Enforcement Division, designed to focus resources on complex accounting fraud and auditor misconduct. It also entered into a three-year memorandum of understanding with the FDA to streamline access to nonpublic information, enhancing its oversight of public life sciences companies' disclosures regarding clinical trials and product approvals.
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In a case with broad implications for online publishers, the Fifth Circuit adopted a new test for infringement claims based on embedded content and held that URLs can sometimes qualify as protected copyright management information.
The U.S. Court of Appeals for the Fifth Circuit, in 'Emmerich v. Particle Media,' declined to follow the Ninth Circuit's influential 'server test' for copyright infringement. That test generally shields websites from liability for embedding content hosted on other servers. The court introduced a new 'Transmit Requirement,' which focuses on whether the embedded content originates from an authorized source and whether the transmission itself was authorized.
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Grade 3 — worth a glance, not the full analysis.
- State AGs Oppose FAA Rule Preempting Airline Labor Law
A coalition of 18 state attorneys general argues the FAA's proposal to preempt state meal and rest break laws for flight crews exceeds federal authority and undermines worker welfare.
- DOE Weighs Bulk-Power System Foreign Equipment Ban
The US Department of Energy is soliciting public comment on a Trump-era executive order that could prohibit transactions involving bulk-power system electric equipment from foreign adversaries.
- PTAB eases Markush group requirements for biomarker patents
PTAB reverses examiner rejection, finding structurally distinct microRNAs form proper Markush group when functionally interchangeable for claimed invention.
- Delaware Expands Privacy Law with AI Employment Data Protections
Delaware's new data privacy bills, effective January 1, 2027, expand sensitive data categories and restrict AI tools used in hiring and employment decisions.
- Ardmore BLO appeal in doubt after group companies enter CVAs
The Court of Appeal was set to hear Ardmore's challenge to Building Liability Orders under the Building Safety Act, but recent CVA filings may derail the December 2026 hearing.
- New Jersey Seeks Supreme Court Review of Prediction Market Jurisdiction Split
After Third and Ninth Circuits diverged on prediction market regulation, New Jersey's petition asks SCOTUS to resolve state-federal authority over these platforms.
- German Court Rules on Equal Pay Presumption Rebuttal
A German labor court found that while a pay gap with even one male colleague creates a presumption of discrimination, employers can rebut it with objective, gender-neutral factors such as longer tenure.
- US-Venezuela Energy Agreements Signal Major Policy Shift
Recent announcements by the U.S. and Venezuelan governments may signal one of the most significant shifts in Western Hemisphere energy policy in decades, with potential consequences for the oil and gas industry.
- NJ Court Upholds § 363 Protections for Asset Buyer from Successor Liability
A New Jersey district court affirmed that a well-drafted § 363 sale order and proper notice can protect an asset purchaser from the debtor's legacy product liability claims.
- New York Employers Must Allow Employee Access to Personnel Files
Governor Hochul signed S3460 into law, requiring NY employers to let employees inspect personnel records twice yearly and notify them within 10 days when negative information is added to their files.
- Guide to Taking Direct, Asset-Level Security in NAV Loans
A guide explains key considerations for lenders when taking direct, asset-level security in NAV facilities, addressing transfer restrictions, jurisdictional issues, and perfection mechanics.
- CARB releases intake platform, guidance for California climate reporting
California Air Resources Board issues optional online portal and procedural guidance for companies to submit Scope 1 and Scope 2 GHG emissions data by November 10, 2026 deadline under SB 253.
- SBA Proposes Major Expansion of Small Business Size Standards
The SBA's August 2026 proposed rule would reconfigure size standards for government contractors, potentially adding 114,541 businesses to the small business pool.
- Ninth Circuit Vacates CFAA Injunction Against Perplexity's Comet
The Ninth Circuit has vacated a lower court injunction that had barred Perplexity's AI agent from accessing websites, marking a significant development in CFAA jurisprudence affecting AI data collection practices.
- UK, EU M&A Summer 2026 Developments Analyzed
A new law firm guide summarizes key English and European court decisions and market trends impacting M&A transactions over the summer of 2026.
- California BCSA Prioritizes AI and Emerging Tech Scrutiny
California's new Business and Consumer Services Agency will examine whether businesses' use of AI, chatbots, and automated tools harm consumers or violate licensing requirements.
- Delaware Expands Consumer Privacy and Data-Breach Laws
Recent amendments lower applicability thresholds and add new requirements for handling sensitive data, managing vendors, and using automated decision-making tools.
- Guide to Irish Alternative Investment Funds
A new country-comparative guide from K&L Gates outlines the legal and regulatory framework for alternative investment funds domiciled in Ireland.
- NYC Opens First Office of Worker Power to Support Labor Organizing
New York City has established the nation's first municipal office dedicated to helping workers organize, connecting them with unions and informing them of their workplace rights.
- Alcohol Regulation Update: FDA Proposes GRAS Rule, States Tweak Laws
The US Food and Drug Administration has proposed a rule to mandate "generally recognized as safe" (GRAS) notifications, while states including Michigan and Colorado enacted new local laws.
- EU ETIAS Travel Authorization System Now Expected in Late 2026
Employers with personnel who travel to Europe for business should prepare for the new ETIAS pre-authorization requirement, now projected to launch in Q4 2026.
- Australian Federal Court affirms true employer test in group insolvency
In Brauer v Coburn Resources, the Court held formal employment contracts naming the holding company as employer will ordinarily prevail, protecting secured creditor distributions in corporate group insolvencies.
- SEC Proposes Rescinding Investment Adviser Pay-to-Play Rule
The SEC voted September 3, 2026 to propose eliminating Rule 206(4)-5, citing unintended consequences including blanket political contribution bans and hiring obstacles, shifting to a principles-based antifraud approach.
- NYC Agencies Partner on White-Collar and Consumer Enforcement
The Manhattan District Attorney’s Office and the NYC Department of Consumer and Worker Protection have formed a partnership to jointly investigate and prosecute white-collar and consumer-protection cases.
- Federal Circuit affirms district courts can decide patent eligibility after improper venue
The Federal Circuit ruled that a district court does not abuse its discretion by addressing patent eligibility under 35 USC § 101 even after finding venue improper under 28 USC § 1400(b).
- CD Cal Awards $1M+ Against Repeat Trademark Infringer
A California federal court awarded $1 million in statutory damages and declared the matter an "exceptional case" against a repeat trademark infringer that violated a consent judgment.
- Latham Publishes 2026 FPI Guide for US Capital Market Access
Latham & Watkins releases updated guide helping foreign private issuers navigate US securities regulations for debt and equity offerings.
- Federal Circuit clarifies Alice eligibility and Fujitsu infringement standards
Result-oriented optimization claims are patent-ineligible abstract ideas, while specific constellation claims reciting concrete implementations survive; industry standards may prove infringement limitation-by-limitation.
- Maryland Franchise Law Amendments Take Effect October 1
Maryland has amended its Franchise Registration and Disclosure Law with changes effective October 1, 2026, requiring franchisors to take immediate compliance steps.
- California Employment Law's Extraterritorial Reach Narrowed in Remote Work Case
California's employment statutes do not automatically apply to out-of-state remote workers merely because the employer is headquartered in California, according to a new state appellate ruling offering guidance for multistate employers.
- FDA-SEC MOU Enables Broader Nonpublic Information Sharing
The FDA and SEC's new August 2026 MOU formalizes information sharing, allowing the SEC to use nonpublic FDA data in public company filing reviews and enforcement actions.
- ADA Title III Lawsuits Poised to Break 2026 Record
5,006 federal ADA Title III suits filed in H1 2026 already exceed the five-year average; new plaintiffs' firms entering the space signal continued volume.
- Delaware Amends Privacy Law with Nation's Lowest Thresholds
Delaware's HB 380 lowers consumer data privacy thresholds to 10,000 consumers (5,000 for sellers), expands sensitive data definitions, and adds profiling and automated decision-making requirements effective January 1, 2027.
- Federal Circuit affirms written description for pharma genus claims
Federal Circuit upheld Exelixis patent spec supported genus claims for crystalline cabozantinib salts by disclosing structural features—chemical name, formula, crystalline form—rejecting polymorph challenge.
- DOL unveils mental health parity NQTL enforcement policy
The Department of Labor has announced a new enforcement policy specifically addressing nonquantitative treatment limitation requirements under mental health parity rules, signaling increased scrutiny on employer-sponsored health plans.
- 2nd Circ. Shifts Focus to Motive in Religious Accommodation Cases
The U.S. Court of Appeals for the Second Circuit has revised the prima facie standard for religious accommodation claims, focusing on the employer's discriminatory motive rather than its mere knowledge of an employee's need.
- Beyond the Recall: Expanding Risks of Product Safety Failures
New EU and UK regulations mean a product recall is no longer the end of a safety incident but the start of broader regulatory, litigation, and supply-chain challenges.
- Vietnam two-component electricity tariff: generator implications
Vietnam's pilot two-component retail electricity tariff separating capacity and energy charges creates new considerations for power generators, particularly LNG and peaking plants.
- UK launches corporate reporting reform consultation
The UK Department for Business, Innovation, Science and Trade has published an open consultation on modernising the corporate reporting framework, with a focus on sustainability disclosures and strategic report redesign.
- Connecticut AG Investigates Kik on Privacy, Youth Safety
Connecticut's attorney general is investigating the messaging app Kik for its age-assurance and content moderation practices, citing potential violations of the state's data privacy and unfair trade practices laws.
- 8th Circuit Affirms Key FCRA Defense for Reporting Agencies
A new appellate decision reinforces that consumer reporting agencies act reasonably under the Fair Credit Reporting Act when they rely on official court records.
- EEOC procedural changes may cut employer response times
Employers and counsel should prepare for potentially shorter deadlines when responding to EEOC discrimination charges under upcoming procedural changes.
- DOL Issues New Mental Health Parity Enforcement Guidance
The Department of Labor released a field bulletin and guidance creating a roadmap for employers on Mental Health Parity and Addiction Equity Act compliance.
- FTC Settles with Nuvei for $4.85M Over Merchant Screening Failures
The FTC's settlement with payment processor Nuvei highlights enforcement focus on inadequate merchant due diligence that enabled $30M in tech support scams.
- California GHG Reporting Guidance Released for 2026 SB 253 Compliance
CARB has issued guidance for companies to submit Scope 1 and Scope 2 greenhouse gas emissions reports by November 10, 2026 under SB 253.
- New York Wage Bill Would Reshape Bonus Compensation Practices
New York's legislature passed Senate Bill 2236-A, the Wage Payment Integrity Act, expanding the definition of wages under the NYLL to include most bonus and incentive compensation not explicitly reserved as discretionary.
- VA OIG Identifies Improvements for $25B Federal Supply Schedule Program
The VA OIG's September 2026 report recommends expanded tracking customer requirements and a new vendor self-disclosure process for FSS contract holders.
- France strengthens sports investment review with investor due diligence
France's August 2026 law now requires federation-level regulators to assess prospective investors' five-year financial track record and existing sports holdings before approving acquisitions.
- FinCEN Reissues, Narrows GTO for Southwest Border MSBs
FinCEN renewed and narrowed its order requiring money services businesses in specific southwest border zip codes to report cash transactions between $1,000 and $10,000, responding in part to recent litigation.
- D.C. Medical Debt Law Imposes Collection Bans and Assistance Mandates
D.C.'s Medical Debt Mitigation Amendment Act of 2026 restricts debt collection, prohibits credit reporting of medical debt, and requires free care for patients below 200% of federal poverty level.
- AD/CVD Petition Targets Pizza Boxes From China, Malaysia, Turkey
A coalition of US manufacturers and the United Steelworkers union has petitioned the Commerce Department and ITC to investigate alleged dumping of corrugated pizza boxes from China, Malaysia, and Turkey, and subsidies for Turkish imports.
- Clinical Lab Information Blocking: When Results Must Be Released
Federal information blocking rules generally require clinical laboratories to make completed test results available to patients upon request, with narrow exceptions for specific harm prevention or legally required delays.
- Novo Nordisk Metsera bid rejected over FTC antitrust risk
When Novo Nordisk and Pfizer's final identical bids both reached $86.25/share, Metsera's board chose Pfizer based on deal-closing probability, illustrating how antitrust risk functions as a valuation discount in competitive auctions.
- NIST PQC Patent Licenses: What Implementers Need to Know
NIST secured royalty-free patent licenses for ML-KEM and ML-DSA, but counsel must understand their boundaries before migrating to post-quantum cryptography.
- Advice-of-Counsel Defense Does Not Automatically Waive Privilege
Federal court clarifies that identifying counsel as decision-maker differs from disclosing actual legal advice, with only the latter triggering privilege waiver.
- SEC Proposes Rescinding Political Contributions Rule for Investment Advisers
The SEC has proposed rescinding Rule 206(4)-5 and eliminating related recordkeeping requirements, citing unintended consequences including strict liability for small contributions and barriers to hiring qualified personnel.
- IRS issues Trump Account investment rules, revamps CFC subpart F allocation
Treasury and IRS proposed regulations limit Trump Account investments to low-cost index funds while releasing rules to calculate CFC income daily rather than annually.
- California AB 2577 overhauls Prop 65 settlement approval
California's AB 2577 now requires courts to find settlements provide "public benefit" before approving Prop 65 consent judgments and allows judges to reduce attorney fees over party objections.