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DROPLETS

AmLaw 100 Legal Intelligence — Distilled
Wednesday, September 2, 202641 featured40 also noted34 firms19 practice areasgrade 3–5
Quick Scan — Why It Matters
Perkins CoieRegulatory / Government+ Expand
US Order Targets Foreign Electric Grid Equipment

A new executive order directs the Department of Energy to create a regulatory regime to block the acquisition and use of certain foreign-produced electrical grid components deemed a national security threat.

A new executive order declares a national emergency to protect the U.S. electric grid from threats posed by foreign adversaries. The order authorizes the Secretary of Energy to establish a new regulatory regime restricting transactions involving “bulk-power system electric equipment” (BPSEE) sourced from designated foreign entities.

This action signals heightened federal scrutiny of critical infrastructure supply chains and could significantly impact energy companies, equipment manufacturers, and major electricity consumers. The order’s scope is broad, covering equipment from generation facilities to transmission control systems, and may even apply to previously installed components. While not self-executing, it directs the Department of Energy (DoE) to develop implementing regulations, which will likely include a licensing and mitigation process.

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Perkins CoieInternational Trade / Tariffs+ Expand
FCC Adds Power Inverters, Advanced Robotics to National Security 'Covered List'

Companies in the energy, manufacturing, agriculture, and mining sectors must now scrutinize their supply chains after the FCC banned new approvals for foreign-made power inverters and advanced robotics, citing national security risks.

The Federal Communications Commission (FCC) has added foreign-produced advanced robotic devices and power inverters to its "Covered List," blocking any new models from receiving the authorization required for importation and sale in the United States. The commission cited unacceptable risks to national security for the move, which follows similar recent restrictions on foreign-produced drones and routers. Existing models that received FCC authorization before July 28, 2026, are not affected and can continue to be imported, sold, and receive software updates.

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Vinson & ElkinsEnergy / Renewables+ Expand
US Declares National Emergency to Secure Bulk-Power System

A new executive order empowers the Department of Energy to block transactions involving foreign-made electric grid equipment, with implementing rules due by late December 2026.

On August 26, 2026, the White House issued Executive Order 14420, declaring a national emergency to secure the U.S. bulk-power system from foreign threats. The order revives and expands a similar 2020 framework, authorizing the Secretary of Energy to prohibit, condition, or unwind transactions involving electric grid equipment tied to a 'Covered Foreign Entity.' The measure is a response to perceived risks of sabotage and supply-chain disruption from foreign-made components, particularly amid growing electricity demand from data centers, AI, and advanced manufacturing.

Sophisticated counsel and clients across the energy, infrastructure, and technology sectors must take immediate note. The order's reach is extensive, affecting utilities, renewable-energy developers, equipment manufacturers, and their lenders. The prohibition is not self-executing but will be defined by forthcoming rules. Crucially, the Energy Secretary can also impose conditions on already-installed equipment, potentially requiring its monitoring, isolation, or replacement.

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McDermott Will & EmeryEnvironment / ESG / Climate+ Expand
EU Packaging Regulation Imposes New Product Compliance Duties

The EU's new Packaging and Packaging Waste Regulation is now in effect, imposing immediate obligations on restricted substances, conformity assessment, and extended producer responsibility for packaged goods sold in the EU.

The EU's Packaging and Packaging Waste Regulation (PPWR) became generally applicable on August 12, 2026, fundamentally changing compliance for any business shipping packaged goods to the European Union. The framework treats packaging as an integral part of the product, subject to a comprehensive compliance regime, rather than just a post-sale waste concern. Key obligations are already active, including strict limits on PFAS and heavy metals in packaging and a new requirement for manufacturers to conduct conformity assessments, prepare detailed technical documentation, and issue an EU Declaration of Conformity. Importers are now responsible for verifying these steps, while Extended Producer Responsibility (EPR) obligations continue to be managed at the Member State level. Companies should immediately assess all packaging formats and supply chains for EU sales. They must gather data from suppliers to support conformity documents and confirm that importers and distributors are fulfilling their verification roles. Commercial agreements should be reviewed and updated to clearly allocate P

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Shook, Hardy & BaconEnvironment / ESG / Climate+ Expand
DC Circuit Upholds EPA’s CERCLA ‘Hazardous Substance’ Listing for PFOA/PFOS

A federal appeals court unanimously affirmed the EPA's 2024 rule designating two common 'forever chemicals' as hazardous substances under the Superfund law, confirming the agency's authority to compel investigation and cleanup.

The U.S. Court of Appeals for the D.C. Circuit has unanimously upheld the Environmental Protection Agency's 2024 designation of PFOA and PFOS as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and liability Act (CERCLA). The decision in Chamber of Commerce v. EPA affirms the agency’s authority to require reporting of releases of these two common “forever chemicals” and to compel potentially responsible parties to investigate and remediate contamination at Superfund sites nationwide.

This ruling creates significant new liabilities for a broad spectrum of clients, impacting not only chemical manufacturers but also downstream users and property owners where these substances may be present. The court found the EPA reasonably explained its decision despite scientific uncertainties and properly interpreted its authority. It held that the statutory standard, “may present a substantial risk of harm,” requires only a “scientifically possible substantial risk.”

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Wilmer Cutler Pickering Hale and DorrSecurities / Capital Markets+ Expand
SEC Proposes 'Regulation Crypto Assets' Offering Framework

The SEC has proposed 'Regulation Crypto Assets,' a framework creating new registration exemptions for certain digital asset offerings and establishing a conditional safe harbor from the 'investment contract' definition.

The US Securities and Exchange Commission has released a proposed 'Regulation Crypto Assets,' its first formal rulemaking designed to establish a regulatory framework for offerings of investment contracts tied to crypto assets. The proposal introduces two new exemptions from Securities Act registration: a 'Startup Exemption' for offerings up to $5 million over four years and a 'Fundraising Exemption,' modeled on Regulation A, for offerings up to $75 million annually.

This development is critical for an industry that has long navigated legal uncertainty and SEC enforcement actions based on doctrines established long before digital assets existed. The proposed rules would provide clearer pathways for capital formation, with tailored, principles-based disclosure requirements. A key feature is a conditional safe harbor that would deem an investment contract to have ceased to exist once the issuer fulfills its essential managerial promises, potentially providing a long-sought regulatory off-ramp for projects that become sufficiently decentralized.

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DLA PiperSanctions / Export Controls+ Expand
US Sanctions Target Ecuador Maritime Network for Cartel Ties

The US Treasury has designated 15 Ecuadorian persons and entities and 10 vessels for allegedly providing logistical support for maritime cocaine trafficking by major cartels.

The US Treasury's Office of Foreign Assets Control (OFAC) has designated 15 individuals and entities and identified 10 vessels in Ecuador as blocked property. The US government alleges the network used a commercial fishing operation to provide fuel and logistical support for maritime cocaine shipments on behalf of major transnational cartels, including the Sinaloa Cartel, CJNG, Los Choneros, and Los Lobos.

Sophisticated counsel should advise clients that this action creates significant compliance risks for any company involved in Ecuador's maritime, fishing, insurance, finance, or logistics sectors. The risk is magnified because two of the cartels implicated, Los Choneros and Los Lobos, are designated as Foreign Terrorist Organizations (FTOs). This exposes companies to severe potential penalties for providing 'material support,' a broad term that can include services like transport, insurance, or financing. OFAC violations can result in strict civil liability.

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Ballard SpahrFinancial Regulation+ Expand
NY Bill Targets Interest Rate Exportation by Out-of-State Banks

A New York bill would opt the state out of the federal DIDMCA law, aiming to apply its own usury caps to loans made to residents by out-of-state, state-chartered banks.

A New York state senator has introduced legislation that would opt the state out of the Depository Institutions Deregulation and Monetary Control Act (DIDMCA), a key federal law allowing state-chartered banks to export their home-state interest rates nationwide. Although the bill cannot pass in 2026 because it was filed after the legislative session ended, it is expected to be reintroduced in January 2027, representing a significant escalation in the battle over federal preemption of state usury laws. If passed, the law would subject loans to New York residents by out-of-state banks to New York’s own interest-rate caps, including its 25% criminal usury ceiling. This could severely disrupt established interstate consumer lending models, particularly bank-fintech partnership programs. The bill's broad definition of a loan "made in" New York is already being contested in federal courts challenging similar opt-out laws in Colorado and Oregon. Financial institutions with national lending programs should monitor the bill's reintroduction and the progression of related cases.

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Alston & BirdEnvironment / ESG / Climate+ Expand
DC Circuit Backs EPA on PFOA/PFOS Hazardous Substance Designation

The D.C. Circuit has upheld the EPA's designation of PFOA and PFOS as hazardous substances under the Superfund law, confirming expanded liability for a wide range of industries with historic ties to the chemicals.

A U.S. Court of Appeals for the D.C. Circuit panel unanimously upheld the Environmental Protection Agency's rule designating PFOA and PFOS—two widely used PFAS chemicals—as "hazardous substances" under the Comprehensive Environmental Response, Compensation, and liability Act (CERCLA). Industry groups had challenged the rule, arguing the EPA exceeded its authority and conducted a flawed cost-benefit analysis. The court rejected these arguments, finding the agency can regulate substances based on a plausible, substantial risk of danger without needing to prove certain harm.

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Hogan LovellsInternational Trade / Tariffs+ Expand
UK Considers Digital Product Rules, Flagging EU Divergence Risk

The UK government has opened a call for evidence on a potential digital product record framework, creating uncertainty over future alignment with the EU's Digital Product Passport system.

The UK government has initiated a call for evidence to assess the potential introduction of a domestic digital product record (DPR) framework, a move that parallels the EU’s established Digital Product Passport (DPP) system. The inquiry, open for stakeholder input until September 21, 2026, seeks to determine how digital records could enhance product transparency, streamline compliance, and support market surveillance.

For businesses operating across Europe, this development raises critical questions about future regulatory alignment. While the EU’s DPP requirements are already being implemented and apply in Northern Ireland under the Windsor Framework, the UK’s approach for Great Britain remains undecided. A divergent UK standard could create a separate compliance track, complicating product data management, labeling, and supply chain logistics for manufacturers and retailers.

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Morrison & FoersterTechnology / AI+ Expand
States Bake Federal Interoperability Into New Frontier AI Laws

New 'frontier AI' laws in California, New York, and Illinois permit developers to satisfy state obligations by complying with future, equivalent federal standards, a novel approach to potential federal preemption.

In a novel approach to the looming issue of federal preemption, California, New York, and Illinois have embedded 'interoperability' provisions into their new laws governing frontier AI. These clauses allow a developer to satisfy key state-level compliance obligations, such as critical safety incident reporting, by adhering to future federal standards. State agencies retain discretion to determine if a federal law or regulation is 'substantially equivalent to or more stringent than' the state's own requirements. For clients developing or deploying advanced AI, this model offers a potential pathway to avoid a patchwork of duplicative state-by-state compliance burdens if a comprehensive federal framework emerges. It represents a strategic move by states to preserve their regulatory authority while acknowledging the need for national uniformity. Counsel should monitor how state agencies might operationalize their authority to approve federal standards and watch whether this interoperability model influences the ongoing congressional debate over express preemption in federal AI legislatio

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Goodwin ProcterInternational Trade / Tariffs+ Expand
DOJ Launches New Global Trade Fraud Enforcement Section

The US Department of Justice has created a permanent Global Trade & Commerce Enforcement Section and released a new guide with DHS, signaling heightened focus on customs fraud, tariff evasion, and supply-chain integrity.

The U.S. Department of Justice has established the permanent Global Trade & Commerce Enforcement Section to investigate and prosecute criminal import and trade fraud. Working with the Department of Homeland Security, the DOJ also released A Resource Guide to Trade Fraud Enforcement, described as the first comprehensive framework of its kind for these matters. The guide and new section signal a heightened federal priority on combating conduct that undermines US industries, evades tariffs, or introduces illicit goods into supply chains. For corporate counsel, the development highlights increased enforcement risk, particularly through the False Claims Act, which allows for treble damages and is a key tool for pursuing customs fraud and duty underpayments. The governments guidance emphasizes the importance of robust corporate compliance programs, including active supply-chain auditing and verification of partner representations. Companies involved in international trade should review their compliance and disclosure policies in light of the specific priorities and authorities outlined in

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CooleyAntitrust / Competition+ Expand
FTC Forces Divestitures in $3.9B Ascension/AmSurg Healthcare Deal

The Federal Trade Commission finalized a consent order requiring Ascension to divest seven surgery centers to resolve antitrust concerns in its acquisition of AmSurg, signaling continued focus on local healthcare market concentration.

The Federal Trade Commission (FTC) gave final approval to a consent order resolving antitrust concerns in Ascension Health Alliance’s $3.9 billion acquisition of AmSurg. The order requires Ascension to divest seven AmSurg ambulatory surgery centers across five metropolitan areas where the agency found the deal would substantially reduce competition for specific outpatient surgical services, including gastroenterology, ophthalmology, and orthopedics.

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VenableIP / Patent+ Expand
Takeda Launches First Patent Suit Over Entyvio Biosimilar

Takeda has filed the first patent infringement lawsuit under the BPCIA against a proposed biosimilar version of its blockbuster inflammatory bowel disease drug, Entyvio.

Takeda Pharmaceuticals has initiated the first patent litigation under the Biologics Price Competition and Innovation Act (BPCIA) concerning a proposed biosimilar for its blockbuster drug Entyvio (vedolizumab). The lawsuit, filed in the U.S. District for New Jersey, targets Polpharma's proposed biosimilar, PB016, and alleges infringement of six of Takeda's method-of-treatment patents.

This litigation is a significant development for clients in the life sciences sector, as Entyvio generated approximately $3.9 billion in U.S. sales for Takeda in its last fiscal year. The case will be the first to test the patent portfolio protecting this major revenue stream. According to the complaint, Polpharma declined to participate in the BPCIA's pre-litigation information exchange, known as the "patent dance," a strategic decision that shapes the early phases of such disputes. Counsel should monitor the litigation, as its outcome will influence the timeline for biosimilar market entry. A second biosimilar application, from Alvotech and Teva, has also been accepted by the FDA, suggesting further

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Goodwin ProcterCorporate / M&A+ Expand
Activism Risk Looms for 'Digital Asset Treasury' Companies

Public companies holding significant digital assets are becoming attractive targets for shareholder activists due to trading discounts, governance gaps, and complex capital structures.

A new analysis warns that public companies repositioning their strategy around holding digital assets—so-called "digital asset treasury" (DAT) or "crypto-pivot" companies—are becoming prime targets for shareholder activists. Sophisticated counsel should care because these companies exhibit characteristics that have historically attracted activist campaigns, creating a novel risk environment for clients in this sector.

The key vulnerabilities include stock prices trading at a persistent discount to the net asset value (NAV) of the company's crypto holdings, complex capital structures resulting from frequent fundraising, and governance concerns, such as boards that may lack an appropriate mix of public-company and digital-asset expertise. Activists are likely to pressure these companies to close the NAV discount through share buybacks, asset sales, or strategic M&A. Boards should proactively review their composition, strengthen governance and risk oversight, and prepare for potential engagement on these emerging issues.

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LittlerEmployment / Labor+ Expand
Reports: EEOC to Cut Employer Response Time to 15 Days

The U.S. Equal Employment Opportunity Commission is reportedly shortening its standard 30-day deadline for position statements, a nationwide change that will require employers to accelerate internal investigations.

The U.S. Equal Employment Opportunity Commission (EEOC) is reportedly preparing to implement a nationwide procedural change that will cut the standard response time for employers from 30 days to just 15. According to law firm reports, the agency is already applying these shorter deadlines in some matters and is expected to adopt a much more restrictive approach to granting extensions. While the EEOC has not yet formally announced the new policy, the shift appears to be underway.

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Arnold & PorterFDA / Life Sciences Regulatory+ Expand
FDA Seeks Input on Regulating AI-Enabled Medical Devices

The US Food and Drug Administration has released a discussion paper seeking public comment on a new regulatory framework for medical devices enabled by generative AI.

On August 18, 2026, the FDA's Digital Health Center of Excellence issued a discussion paper initiating a public dialogue on regulating medical devices that incorporate generative AI. The paper does not propose new rules but rather seeks stakeholder feedback on a range of issues, from ensuring algorithm safety and effectiveness to addressing potential bias and managing the entire product lifecycle of these rapidly evolving tools. For medical device manufacturers, software developers, and healthcare providers, this is a critical, early opportunity to shape future US regulatory policy in a high-growth sector. BigLaw clients in the life sciences and technology spaces are directly impacted, as their input can influence the direction of future draft guidance or formal rulemaking. The immediate action is for counsel to analyze the paper and advise clients on submitting comments to the FDA docket, which can help create a more predictable and innovation-friendly regulatory landscape.

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Baker BottsFinancial Regulation+ Expand
CFTC Signals Rules for Derivatives on AI Compute

The U.S. Commodity Futures Trading Commission has issued a public request for comment on a framework for listing derivatives contracts based on AI compute power, the first formal step toward regulating this emerging asset class.

The U.S. Commodity Futures Trading Commission (CFTC) has issued a Request for Comment (RFC) exploring a regulatory framework for derivatives based on "compute," the processing power underlying the artificial intelligence economy. This is the agency's first formal step toward creating a regulated market for a new asset class tied to what it calls a "scarce, capital-intensive commodity." The compute market, estimated to be worth hundreds of billions annually, currently has fragmented and opaque pricing, making it difficult for companies to hedge against cost volatility.

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Ballard SpahrConsumer Protection+ Expand
Doxo Settles FTC 'Junk Fee' and Misleading Ad Complaint for $2.1M

The FTC's settlement with online bill-pay service Doxo signals a continued crackdown on misleading search ads, hidden 'junk fees,' and deceptive subscription models.

Online bill payment company Doxo will pay $2.1 million and is subject to strict marketing prohibitions to settle an FTC complaint alleging deceptive practices. The FTC claimed Doxo and its co-founders used misleading search advertisements, including billers' names and logos, to impersonate official payment channels. The complaint also focused on the company adding undisclosed 'junk fees' to transactions and deceptively enrolling consumers into a recurring subscription service.

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Orrick, Herrington & SutcliffeFintech / Crypto+ Expand
CFTC Eyes Crypto Market Rules as Legislation Stalls

The derivatives regulator has directed staff to begin exploring rulemaking options for digital asset market structure, citing continued congressional deadlock on the CLARITY Act.

In response to concerns that the bipartisan CLARITY Act may not pass Congress, CFTC Chairman Michael Selig has instructed agency staff to explore creating rules for the crypto asset market using the commission's existing authority. This move signals a potential shift from waiting on legislators to proactive regulation by the agency. Sophisticated clients and counsel care because this could create the first comprehensive federal market structure for digital assets in the United States, impacting exchanges, DeFi protocols, and institutional investors. Selig's remarks suggest options like creating a new registration category for crypto exchanges—a "crypto asset market"—which could bring them under direct CFTC oversight for leveraged or margined trading. For DeFi projects, the CFTC has been directed to engage with developers on potential compliance pathways.

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Vinson & ElkinsWhite Collar / Investigations+ Expand
SEC Enforcement Shifts From Volume to Targeted Actions

With a new task force focused on financial reporting fraud, the SEC signals a strategic move away from high-volume, compliance-based cases to target core investor protection matters.

The Securities and Exchange Commission is recalibrating its enforcement program, shifting from a high volume of cases to fewer, more targeted actions. This 'back to basics' approach prioritizes core issues like financial fraud, market manipulation, and insider trading over technical compliance matters. Underscoring this change, the agency in August 2026 created a new Financial Reporting and Accounting Unit within its Enforcement Division specifically to pursue complex accounting and auditing misconduct.

This strategic pivot means the SEC is dedicating expert resources to building stronger, more significant cases in areas of fundamental risk for public companies. Boards and senior management face heightened scrutiny over financial controls, internal reporting, and auditing processes, as recent settlements involving accounting irregularities and inadequate materiality analyses demonstrate. The new specialized task force signals that accounting-related conduct will be a top enforcement priority, likely leading to more sophisticated investigations.

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King & SpaldingEnergy / Renewables+ Expand
Executive Order 14420 Declares Bulk-Power System National Emergency

President invokes IEEPA/NEA to bar or condition purchases of foreign-made bulk-power equipment from China, Iran, Russia, and other Covered Foreign Entities, with DOE implementing regulations and FAR amendments to follow.

On August 26, 2026, the President issued Executive Order 14420, declaring a national emergency over foreign threats to the U.S. bulk-power system. Citing the rise of data centers, advanced manufacturing, AI, and defense production, the Order invokes IEEPA and the National Emergencies Act to create a new security-review regime for foreign-made grid equipment. Section 2(a) prohibits transactions involving bulk-power system electric equipment (defined to include substation hardware, large transformers, utility-scale inverters, and associated software and remote-access capabilities) designed, developed, manufactured, or supplied by persons linked to a Covered Foreign Entity—countries subject to a U.S. arms embargo or sanctions (including China, Iran, Russia) or others designated by the Secretary of Energy. Section 2(b) authorizes conditioning continued use of legacy foreign equipment already on the grid, with phased compliance possible. The Order also directs DOE to recommend FAR revisions within 180 days to favor U.S.-manufactured energy infrastructure, with the FAR Council to propose a

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Jackson LewisEmployment / Labor+ Expand
EEOC Releases Strategic Plan, Shifts Enforcement Focus

The EEOC's new strategic plan for 2026-2030 directs resources to National Enforcement Plan priorities, focusing on intentional discrimination and moving away from disparate impact claims.

The US Equal Employment Opportunity Commission (EEOC) has published its strategic plan for fiscal years 2026-2030, aligning its operational goals with its recently issued National Enforcement Plan (NEP). The new plan directs the agency to focus its resources on stated NEP priorities, such as certain DEI initiatives, religious accommodation, protections for vulnerable workers, systemic harassment, and the Pregnant Workers Fairness Act. In a significant policy shift, the plan also states the EEOC will no longer pursue litigation based on disparate impact claims, instead prioritizing matters involving intentional discrimination. For sophisticated employers, this signals a change in the agency's enforcement risk profile, particularly for broad-based employment policies. The plan also sets a high bar for resolutions, with a goal that 97% of conciliation agreements contain non-monetary relief like mandatory training, policy revisions, and external monitoring. Systemic investigations will now be prioritized for cases affecting at least 10 employees. Counsel should review current employment

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Skadden, Arps, Slate, Meagher & FlomConsumer Protection+ Expand
FTC Proposes Enforcement Policy on Personalized Pricing

The agency plans to use its Section 5 authority against unfair or deceptive dynamic pricing, citing failure to disclose the practice as a potential violation.

The U.S. Federal Trade Commission has proposed a new enforcement policy statement targeting personalized pricing, also known as "surveillance pricing," where companies use consumer data to set individualized prices. The FTC plans to use its authority under Section 5 of the FTC Act to challenge practices it deems deceptive or unfair. According to the proposal, failing to clearly and conspicuously disclose that prices are personalized based on user data could be considered a deceptive act, particularly when consumers reasonably expect static pricing. The policy also notes that misrepresenting a personalized price as a discount could be misleading. This federal initiative adds a significant layer of risk for companies employing algorithmic pricing, complementing a growing patchwork of state laws that already restrict or require disclosure of such practices. A final FTC policy could also guide interpretations of state consumer protection statutes, potentially increasing private litigation exposure. Companies using these technologies should evaluate their customer disclosures and data-col

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Hogan LovellsInternational Trade / Tariffs+ Expand
CFIUS CY2025 Report Signals Scrutiny, Slower Reviews

The U.S. foreign-investment committee's latest annual report reveals a significant drop in the success rate for short-form declarations, signaling longer and more uncertain timelines for cross-border transactions.

The Committee on Foreign Investment in the United States (CFIUS) has released its annual report for calendar year 2025, revealing important trends for cross-border dealmakers. While total filings increased, driven by a 21% rise in short-form declarations, the committee's willingness to quickly clear them has fallen sharply. The proportion of declarations cleared within the 30-day assessment period dropped to 66% from 78% in 2024. Correspondingly, CFIUS more frequently requested parties to file a longer, more detailed notice after reviewing a declaration, a trend that can add significant delays to transaction timelines.

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Akin GumpFDA / Life Sciences Regulatory+ Expand
FDA Signals New Regulatory Approach for AI Medical Devices

A new FDA discussion paper on generative AI in medical devices abandons familiar terminology and proposes a "competency-based" evaluation model, signaling a potential overhaul of its regulatory framework.

The US Food and Drug Administration has released a discussion paper outlining a potential new framework for regulating generative AI-enabled medical devices. The paper is notable for omitting established terminology, such as 'software as a medical device' (SaMD), and introducing novel concepts for evaluating the technology’s unique risks and benefits. Sophisticated counsel should note the proposal for a 'competency-based approach' to evaluation, which the agency likens to the credentialing of human clinicians, focusing on underlying knowledge rather than exhaustive testing of every possible scenario. This represents a potential paradigm shift from current review processes and could fundamentally alter the pathway to market for AI-driven medical technology. The FDA acknowledges that implementing such a framework would likely require statutory changes. Stakeholders have an opportunity to shape the future of this regulation, with the FDA seeking feedback on 26 specific questions until October 19, 2026.

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Holland & KnightEnvironment / ESG / Climate+ Expand
Federal Court Upholds Oregon EPR Law After Constitutional Challenge

A federal court rejected Dormant Commerce Clause and Due Process challenges to Oregon's extended producer responsibility law, dissolving an injunction and providing a key victory for state-level recycling programs.

The U.S. District Court for the District of Oregon has upheld the state's Plastic Pollution and Recycling Modernization Act, rejecting a constitutional challenge to the comprehensive extended producer responsibility (EPR) framework. A trade group, the National Association of Wholesaler-Distributors, argued the law violated the Dormant Commerce Clause and the Due Process Clause. The court disagreed, finding the law does not discriminate against or unduly burden interstate commerce and that the state retains sufficient oversight over the private Producer Responsibility Organizations tasked with implementation.

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Hogan LovellsPrivacy / Data Security+ Expand
Indonesia Finalizes Data Protection Law With Implementing Regulation

Indonesia's long-awaited implementing regulation for its Personal Data Protection Law sets specific operational requirements for consent, documentation, and data transfers, with a January 2027 effective date.

Indonesia has enacted Government Regulation No. 33 of 2026, the implementing regulation for its 2022 Personal Data Protection (PDP) Law, which will take effect on January 16, 2027. The regulation provides the detailed operational rules that were missing since the parent law was passed, creating specific new compliance obligations for organizations processing personal data in the country.

Sophisticated clients and counsel care because the regulation introduces concrete, GDPR-like requirements that may necessitate localizing existing global privacy programs. Key provisions detail the conditions for obtaining explicit consent, prescribe minimum content for records of processing activities and data-retention policies, and mandate data protection impact assessments (DPIAs) for high-risk processing, expressly including AI and machine learning. It also establishes a three-tier legal framework for cross-border data transfers, which will depend on adequacy decisions, binding safeguards, or, as a last resort, explicit consent.

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Mayer BrownEnergy / Renewables+ Expand
US Issues New Restrictions on Foreign Power Equipment

Executive Order 14420 creates new prohibitions and restrictions on the acquisition and use of foreign-sourced bulk-power system equipment, requiring review by developers, sponsors, and suppliers.

The White House has issued Executive Order 14420, creating new restrictions on the acquisition, importation, transfer, or installation of certain foreign-sourced electrical equipment used in the US bulk-power system. The order is intended to mitigate national security risks posed by equipment sourced from foreign adversaries, which could be exploited to create catastrophic effects on the nation's critical infrastructure.

For developers, project sponsors, and equipment suppliers in the energy sector, this order has immediate and significant implications. It will require a thorough review of existing and planned supply chains to ensure compliance and avoid disruption. Projects may face delays, increased costs, or the need to re-source key components from approved domestic or allied suppliers. Counsel should advise affected clients to analyze the specific technologies and countries of origin targeted by the order and any forthcoming implementing regulations from the Department of Energy. Proactive supply-chain diligence and contract review will be critical to navigating the new procure

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VenableRegulatory / Government+ Expand
1st Circ: APA Halts Funding Freeze But Won’t Compel Payment

The First Circuit held that an across-the-board freeze on IIJA and IRA funds was likely an unlawful final agency action but found that the district court exceeded its authority by ordering the government to disburse specific funds.

In 'Woonasquatucket River Watershed Council v. USDA', the First Circuit affirmed a preliminary injunction halting a federal freeze on funds awarded under the Infrastructure Investment and Jobs Act and the Inflation Reduction Act, but it vacated the part of the order compelling the government to make payments. The court found that a broad directive to pause funding was likely a reviewable “final agency action” under the Administrative Procedure Act (APA) and that the agencies’ “freeze first, ask questions later” approach likely violated the APA by failing to consider grant recipients’ significant reliance interests.

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Ballard SpahrFinancial Regulation+ Expand
House Panel to Weigh Bill Clarifying Bank Rate Preemption

A House committee will consider legislation to resolve whether states can cap interest rates on loans from out-of-state, state-chartered banks, a key issue for interstate lenders and their FinTech partners.

The House Financial Services Committee will hold a hearing on H.R. 7866, the American Lending Fairness Act of 2026, which aims to clarify a contentious provision of the Depository Institutions Deregulation and Monetary Control Act of 1980 (DIDMCA). At issue is whether a state's decision to "opt out" of federal interest-rate preemption allows it to impose its own usury caps on loans made by out-of-state, state-chartered banks to its residents.

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SteptoeIP / Patent+ Expand
AI-Designed Drug Nears Approval With Human Inventors Only

A drug designed using artificial intelligence has entered late-stage clinical trials, and its associated patents strategically sidestep the AI inventorship debate by naming only human scientists.

An AI-designed drug has entered Phase III clinical trials, a late and costly stage of human testing before a company can seek regulatory approval. The patents on the candidate name only human scientists as inventors, deliberately sidestepping the contentious legal question of whether an AI can be an inventor under patent law. This real-world development provides a pragmatic industry response to a question courts and patent offices worldwide are still grappling with. While litigation like the Thaler case has sought to establish AI inventorship, the USPTO and EPO have consistently held that only natural persons can be inventors. This company's approach offers a viable path for securing protection for AI-assisted discoveries without challenging the status quo. Counsel should note this emerging practice for mitigating risk while leveraging AI in R&D.

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Alston & BirdTax+ Expand
Fifth Circuit Creates New Test for Limited Partner SE Tax

The court replaced its prior bright-line rule with a new, fact-intensive standard focused on whether a partner plays a significant role in managing or running the business.

In a substitute opinion for 'K Alain L.L.L.P. v. Commissioner', the U.S. Court of Appeals for the Fifth Circuit withdrew its January 2026 decision that had created a bright-line test for the limited partner exception to self-employment tax. The prior ruling held that a partner's status as a limited partner under state law was sufficient to qualify for the exception. The new opinion rejects that test, as well as the Tax Court’s stricter “passive investor” standard from 'Soroban v. Commissioner'.

Instead, the court adopted an intermediate, management-based standard, holding that the exception is for partners who play no “significant role in managing or running a business.” This creates considerable uncertainty for partnerships and their advisors, as the court did not define the threshold for a "significant role." The decision directly affects tax structuring and reporting for limited partnerships, particularly investment funds and service partnerships.

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Alston & BirdConsumer Protection+ Expand
FTC Proposes Enforcement Policy on Personalized Pricing

The Federal Trade Commission is seeking public comment on a proposed policy statement that signals its intent to use Section 5 of the FTC Act to police unfair or deceptive personalized pricing practices.

The U.S. Federal Trade Commission has announced a proposed enforcement policy statement regarding personalized pricing, clarifying its intent to scrutinize the practice under Section 5 of the FTC Act. The proposal, which follows a multi-year agency study, asserts that failing to clearly disclose that prices are personalized based on consumer data can be an unfair or deceptive practice. Sophisticated clients across retail, travel, and technology sectors should care because this signals a new enforcement priority for the FTC. The commission provided examples of practices it views as problematic, such as charging more for food delivery to consumers deemed less mobile or increasing hotel prices for a user whose data suggests travel for a family emergency. While the policy statement is not a formal rule and does not ban the practice outright, it provides a clear roadmap of the agency's legal theories for future enforcement actions. Businesses using dynamic or personalized pricing should review their consumer disclosures and data consent practices ahead of the policy's finalization, as a 3

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DLA PiperFDA / Life Sciences Regulatory+ Expand
Court Orders USDA to Revise Bioengineered Food Labeling Rule

A federal court found the USDA acted arbitrarily by exempting highly refined ingredients from GMO disclosure rules, expanding labeling requirements for many processed foods.

A federal court has invalidated a key US Department of Agriculture (USDA) regulation that exempted many processed foods from bioengineered-disclosure requirements. The US District Court for the Northern District of California affirmed a 2025 ruling that the USDA acted arbitrarily when it excluded highly refined ingredients from the National Bioengineered Food Disclosure Standard simply because modified genetic material is undetectable after processing. The exemption had shielded an estimated 70% to 80% of genetically modified foods from labeling rules. The court also ruled against the USDA's policy allowing QR codes as a stand-alone method for disclosure. This decision has broad implications for the food and beverage industry, as many products previously exempt will likely now require new labeling. The court has ordered the USDA to revise its regulations by January 1, 2028, after rejecting the agency’s request for a longer extension. Food manufacturers and retailers should monitor the forthcoming rulemaking and re-evaluate their products and supply chains to ensure compliance with th

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Skadden, Arps, Slate, Meagher & FlomCorporate / M&A+ Expand
Delaware Reaffirms High Bar for Director Oversight Claims

The Delaware Court of Chancery dismissed a stockholder lawsuit against Boeing's board, reinforcing the formidable pleading standard for claims alleging a conscious failure of director oversight.

A Delaware Court of Chancery decision has dismissed a stockholder failure-of-oversight lawsuit filed against the board of Boeing. The 'Caremark' claim arose from a 2024 incident where a door plug detached from a jet in-flight. Plaintiffs alleged the board breached its duties by failing to adequately oversee the company's safety and quality control programs.

The court, however, found that the plaintiffs' own complaint detailed a board that was attentive to its duties. It highlighted the existence of a board-level Aerospace Safety Committee and a separate safety organization that reported to it, concluding that the board received "copious reporting on numerous manufacturing and compliance risks." The opinion, authored by Justice Morgan Zurn, now on the state's Supreme Court, forcefully reiterated that Delaware law protects boards from liability merely because a risk materialized. To succeed, a plaintiff must plead specific facts showing a conscious dereliction of duty, a high bar this case failed to meet. The ruling signals that Delaware remains a predictable and director-friendly jur

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K&L GatesFinancial Regulation+ Expand
CFTC Proposes Strict New Rules for Vertically Integrated Markets

The CFTC has proposed new regulations to manage conflicts of interest in vertically integrated derivatives markets, including a general ban on affiliates trading on their own exchanges and new third-party oversight requirements.

The US Commodity Futures Trading Commission has proposed extensive new rules targeting conflicts of interest in vertically integrated derivatives markets. The proposal reflects a significant shift toward more prescriptive safeguards, addressing concerns that exchanges or clearinghouses might favor affiliated trading firms or misuse non-public information. Key provisions include a general prohibition on a principal trading firm trading on an affiliated designated contract market (DCM), with a narrow exception for market makers who would be subject to strict conditions like order-priority subordination and independent third-party oversight. The rules would also mandate enhanced operational separation, information barriers, and new conflict-of-interest procedures for DCMs, swap execution facilities, and clearinghouses with affiliated intermediaries. Futures commission merchants would face new obligations to disclose affiliate relationships to customers. These changes, if adopted, will require significant compliance overhauls across the industry and may particularly affect digital asset

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Hogan LovellsEnvironment / ESG / Climate+ Expand
Oregon EPR Law Survives First Constitutional Challenge

A federal district court rejected dormant Commerce Clause and due process claims against Oregon's packaging waste law in a landmark decision expected to heavily influence similar challenges to EPR statutes in California and Colorado.

A federal judge in Oregon upheld the state's pioneering Recycling Modernization Act, rejecting the first major constitutional challenge to a U.S. Extended Producer Responsibility (EPR) law for packaging. The ruling, from the U.S. District Court for the District of Oregon, found the law did not violate the dormant Commerce Clause or the Due Process Clause. The plaintiff, a national trade association, argued the program's costs and complexity unconstitutionally burdened interstate commerce and that the state improperly delegated regulatory power to a private Producer Responsibility Organization (PRO).

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Morgan, Lewis & BockiusFinancial Regulation+ Expand
UK FCA's New Non-Financial Misconduct Rule Now In Force

The UK Financial Conduct Authority's new rule and guidance expanding the scope of its conduct rules to cover serious non-financial misconduct at non-banking firms took effect September 1.

The UK Financial Conduct Authority's new rule and guidance on serious non-financial misconduct (NFM) at non-banking firms became effective September 1, 2026. The change extends the scope of the Code of Conduct (COCON) to more explicitly cover misconduct such as harassment or other behavior that violates a person's dignity or creates a hostile environment, even if not linked to a protected characteristic under equality law.

This development is important for sophisticated counsel and clients because it aligns standards for non-banking firms with those already governing banks, signaling a heightened regulatory focus on workplace culture and individual accountability. The guidance also clarifies that serious NFM in an employee's private life may be relevant to their fitness and propriety (FIT) assessment if it undermines public confidence or shows a disregard for ethical obligations.

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Arnold & PorterAntitrust / Competition+ Expand
FTC Proposes Unwinding Zillow-Redfin Multifamily Ad Deal

The FTC and five state AGs seek a court-approved order forcing Zillow and Redfin to unwind a $100 million exit deal that allegedly sidelined Redfin from multifamily rental advertising for nine years.

The FTC and five state attorneys general filed a proposed settlement in the Eastern District of Virginia that would unwind core terms of Zillow's $100 million arrangement with Redfin. The complaint alleges the deal paid Redfin to exit the multifamily rental-advertising market, transfer customers and employees to Zillow, and refrain from competing for up to nine years. Under the proposed order, Redfin must rebuild an independent multifamily rental marketplace within six months; Zillow must lift re-entry restrictions, facilitate customer and employee transitions, and abandon specified hiring restraints. The action signals that the FTC and state enforcers will scrutinize competitor partnerships and licensing arrangements under Section 7 and the Sherman Act even when the transaction falls below HSR thresholds. The conduct remedies, including mandatory divestiture-style rebuild of a competing platform, show enforcers' willingness to reconstruct lost competition rather than rely solely on financial disgorgement. Sophisticated counsel advising on strategic alliances, data-sharing deals, and

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Wilmer Cutler Pickering Hale and DorrHealthcare+ Expand
DOJ Hits Medicare Advantage Providers With $558M+ in FCA Settlements

Three recent DOJ settlements totaling over $558 million target Medicare Advantage providers for allegedly causing false diagnosis codes, signaling heightened FCA scrutiny of risk-sharing arrangements.

DOJ announced three False Claims Act settlements against Medicare Advantage providers for allegedly causing the submission of unsupported diagnosis codes that inflated CMS risk-adjustment payments. The Villages Health agreed to pay $541.5 million—the largest of the three—after self-disclosing under the HHS-OIG Health Care Fraud Self-Disclosure Protocol and receiving substantial cooperation credit. Monogram Health paid $2.4 million and Complete Health paid $14.2 million; both matters originated in qui tam suits in which DOJ partially intervened. All three settlements featured risk-sharing arrangements that allegedly incentivized providers to inflate risk scores, expanding DOJ's enforcement lens beyond the Medicare Advantage plans themselves to their provider partners. Counsel advising MA plans, provider groups, and risk-bearing entities should evaluate diagnosis-coding controls, governance over value-based contracts, and the comparative benefits of proactive self-disclosure. The settlements come as DOJ's new National Fraud Enforcement Division signals continued prioritization of manag

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DIG DEEPER
MOST CONSEQUENTIALUS Order Targets Foreign Electric Grid Equipment

A new executive order directs the Department of Energy to create a regulatory regime to block the acquisition and use of certain foreign-produced electrical grid components deemed a national security threat.

A new executive order declares a national emergency to protect the U.S. electric grid from threats posed by foreign adversaries. The order authorizes the Secretary of Energy to establish a new regulatory regime restricting transactions involving “bulk-power system electric equipment” (BPSEE) sourced from designated foreign entities.

This action signals heightened federal scrutiny of critical infrastructure supply chains and could significantly impact energy companies, equipment manufacturers, and major electricity consumers. The order’s scope is broad, covering equipment from generation facilities to transmission control systems, and may even apply to previously installed components. While not self-executing, it directs the Department of Energy (DoE) to develop implementing regulations, which will likely include a licensing and mitigation process.

Perkins CoieRegulatory / Government
national-securitycritical-infrastructureenergysupply-chaindepartment-of-energyieepaexecutive-ordergovernment-contracts
AR
Today's Curator
Arthur Rodrigues. Corporate Counsel & Corporate Secretary at Teachable, Inc. Founder of Cicero Intelligent Minds. Former BigLaw (O'Melveny, Weil, Hughes Hubbard). JD/LLM Michigan Law.
Full Analysis — The Details
01 — ANTITRUST / COMPETITION2
Cooley+ Expand
FTC Forces Divestitures in $3.9B Ascension/AmSurg Healthcare Deal

The Federal Trade Commission finalized a consent order requiring Ascension to divest seven surgery centers to resolve antitrust concerns in its acquisition of AmSurg, signaling continued focus on local healthcare market concentration.

The Federal Trade Commission (FTC) gave final approval to a consent order resolving antitrust concerns in Ascension Health Alliance’s $3.9 billion acquisition of AmSurg. The order requires Ascension to divest seven AmSurg ambulatory surgery centers across five metropolitan areas where the agency found the deal would substantially reduce competition for specific outpatient surgical services, including gastroenterology, ophthalmology, and orthopedics.

ftcmerger-reviewantitrusthealthcaredivestitureconsent-decree
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Arnold & Porter+ Expand
FTC Proposes Unwinding Zillow-Redfin Multifamily Ad Deal

The FTC and five state AGs seek a court-approved order forcing Zillow and Redfin to unwind a $100 million exit deal that allegedly sidelined Redfin from multifamily rental advertising for nine years.

The FTC and five state attorneys general filed a proposed settlement in the Eastern District of Virginia that would unwind core terms of Zillow's $100 million arrangement with Redfin. The complaint alleges the deal paid Redfin to exit the multifamily rental-advertising market, transfer customers and employees to Zillow, and refrain from competing for up to nine years. Under the proposed order, Redfin must rebuild an independent multifamily rental marketplace within six months; Zillow must lift re-entry restrictions, facilitate customer and employee transitions, and abandon specified hiring restraints. The action signals that the FTC and state enforcers will scrutinize competitor partnerships and licensing arrangements under Section 7 and the Sherman Act even when the transaction falls below HSR thresholds. The conduct remedies, including mandatory divestiture-style rebuild of a competing platform, show enforcers' willingness to reconstruct lost competition rather than rely solely on financial disgorgement. Sophisticated counsel advising on strategic alliances, data-sharing deals, and

ftczillowredfinantitrustsection-7non-competemultifamilyhsr
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02 — CONSUMER PROTECTION3
Ballard Spahr+ Expand
Doxo Settles FTC 'Junk Fee' and Misleading Ad Complaint for $2.1M

The FTC's settlement with online bill-pay service Doxo signals a continued crackdown on misleading search ads, hidden 'junk fees,' and deceptive subscription models.

Online bill payment company Doxo will pay $2.1 million and is subject to strict marketing prohibitions to settle an FTC complaint alleging deceptive practices. The FTC claimed Doxo and its co-founders used misleading search advertisements, including billers' names and logos, to impersonate official payment channels. The complaint also focused on the company adding undisclosed 'junk fees' to transactions and deceptively enrolling consumers into a recurring subscription service.

ftcconsumer-protectionjunk-feesdeceptive-advertisingnegative-optionrosca
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Skadden, Arps, Slate, Meagher & Flom+ Expand
FTC Proposes Enforcement Policy on Personalized Pricing

The agency plans to use its Section 5 authority against unfair or deceptive dynamic pricing, citing failure to disclose the practice as a potential violation.

The U.S. Federal Trade Commission has proposed a new enforcement policy statement targeting personalized pricing, also known as "surveillance pricing," where companies use consumer data to set individualized prices. The FTC plans to use its authority under Section 5 of the FTC Act to challenge practices it deems deceptive or unfair. According to the proposal, failing to clearly and conspicuously disclose that prices are personalized based on user data could be considered a deceptive act, particularly when consumers reasonably expect static pricing. The policy also notes that misrepresenting a personalized price as a discount could be misleading. This federal initiative adds a significant layer of risk for companies employing algorithmic pricing, complementing a growing patchwork of state laws that already restrict or require disclosure of such practices. A final FTC policy could also guide interpretations of state consumer protection statutes, potentially increasing private litigation exposure. Companies using these technologies should evaluate their customer disclosures and data-col

ftcconsumer-protectionpersonalized-pricingalgorithmic-pricingsection-5udap
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Alston & Bird+ Expand
FTC Proposes Enforcement Policy on Personalized Pricing

The Federal Trade Commission is seeking public comment on a proposed policy statement that signals its intent to use Section 5 of the FTC Act to police unfair or deceptive personalized pricing practices.

The U.S. Federal Trade Commission has announced a proposed enforcement policy statement regarding personalized pricing, clarifying its intent to scrutinize the practice under Section 5 of the FTC Act. The proposal, which follows a multi-year agency study, asserts that failing to clearly disclose that prices are personalized based on consumer data can be an unfair or deceptive practice. Sophisticated clients across retail, travel, and technology sectors should care because this signals a new enforcement priority for the FTC. The commission provided examples of practices it views as problematic, such as charging more for food delivery to consumers deemed less mobile or increasing hotel prices for a user whose data suggests travel for a family emergency. While the policy statement is not a formal rule and does not ban the practice outright, it provides a clear roadmap of the agency's legal theories for future enforcement actions. Businesses using dynamic or personalized pricing should review their consumer disclosures and data consent practices ahead of the policy's finalization, as a 3

ftcconsumer-protectionpersonalized-pricingsection-5unfair-trade-practicesdata-privacy
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03 — CORPORATE / M&A2
Goodwin Procter+ Expand
Activism Risk Looms for 'Digital Asset Treasury' Companies

Public companies holding significant digital assets are becoming attractive targets for shareholder activists due to trading discounts, governance gaps, and complex capital structures.

A new analysis warns that public companies repositioning their strategy around holding digital assets—so-called "digital asset treasury" (DAT) or "crypto-pivot" companies—are becoming prime targets for shareholder activists. Sophisticated counsel should care because these companies exhibit characteristics that have historically attracted activist campaigns, creating a novel risk environment for clients in this sector.

The key vulnerabilities include stock prices trading at a persistent discount to the net asset value (NAV) of the company's crypto holdings, complex capital structures resulting from frequent fundraising, and governance concerns, such as boards that may lack an appropriate mix of public-company and digital-asset expertise. Activists are likely to pressure these companies to close the NAV discount through share buybacks, asset sales, or strategic M&A. Boards should proactively review their composition, strengthen governance and risk oversight, and prepare for potential engagement on these emerging issues.

shareholder-activismcryptodigital-assetscorporate-governancenet-asset-valuema
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Skadden, Arps, Slate, Meagher & Flom+ Expand
Delaware Reaffirms High Bar for Director Oversight Claims

The Delaware Court of Chancery dismissed a stockholder lawsuit against Boeing's board, reinforcing the formidable pleading standard for claims alleging a conscious failure of director oversight.

A Delaware Court of Chancery decision has dismissed a stockholder failure-of-oversight lawsuit filed against the board of Boeing. The 'Caremark' claim arose from a 2024 incident where a door plug detached from a jet in-flight. Plaintiffs alleged the board breached its duties by failing to adequately oversee the company's safety and quality control programs.

The court, however, found that the plaintiffs' own complaint detailed a board that was attentive to its duties. It highlighted the existence of a board-level Aerospace Safety Committee and a separate safety organization that reported to it, concluding that the board received "copious reporting on numerous manufacturing and compliance risks." The opinion, authored by Justice Morgan Zurn, now on the state's Supreme Court, forcefully reiterated that Delaware law protects boards from liability merely because a risk materialized. To succeed, a plaintiff must plead specific facts showing a conscious dereliction of duty, a high bar this case failed to meet. The ruling signals that Delaware remains a predictable and director-friendly jur

corporate-governancedirector-liabilitycaremark-claimsfiduciary-dutiesdelaware-chanceryshareholder-litigationbusiness-judgment-rule
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04 — EMPLOYMENT / LABOR2
Littler+ Expand
Reports: EEOC to Cut Employer Response Time to 15 Days

The U.S. Equal Employment Opportunity Commission is reportedly shortening its standard 30-day deadline for position statements, a nationwide change that will require employers to accelerate internal investigations.

The U.S. Equal Employment Opportunity Commission (EEOC) is reportedly preparing to implement a nationwide procedural change that will cut the standard response time for employers from 30 days to just 15. According to law firm reports, the agency is already applying these shorter deadlines in some matters and is expected to adopt a much more restrictive approach to granting extensions. While the EEOC has not yet formally announced the new policy, the shift appears to be underway.

eeocemployment-discriminationlitigationhrregulatoryinvestigations
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Jackson Lewis+ Expand
EEOC Releases Strategic Plan, Shifts Enforcement Focus

The EEOC's new strategic plan for 2026-2030 directs resources to National Enforcement Plan priorities, focusing on intentional discrimination and moving away from disparate impact claims.

The US Equal Employment Opportunity Commission (EEOC) has published its strategic plan for fiscal years 2026-2030, aligning its operational goals with its recently issued National Enforcement Plan (NEP). The new plan directs the agency to focus its resources on stated NEP priorities, such as certain DEI initiatives, religious accommodation, protections for vulnerable workers, systemic harassment, and the Pregnant Workers Fairness Act. In a significant policy shift, the plan also states the EEOC will no longer pursue litigation based on disparate impact claims, instead prioritizing matters involving intentional discrimination. For sophisticated employers, this signals a change in the agency's enforcement risk profile, particularly for broad-based employment policies. The plan also sets a high bar for resolutions, with a goal that 97% of conciliation agreements contain non-monetary relief like mandatory training, policy revisions, and external monitoring. Systemic investigations will now be prioritized for cases affecting at least 10 employees. Counsel should review current employment

eeocemployment-discriminationstrategic-planenforcement-priorities
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05 — ENERGY / RENEWABLES3
Vinson & Elkins+ Expand
US Declares National Emergency to Secure Bulk-Power System

A new executive order empowers the Department of Energy to block transactions involving foreign-made electric grid equipment, with implementing rules due by late December 2026.

On August 26, 2026, the White House issued Executive Order 14420, declaring a national emergency to secure the U.S. bulk-power system from foreign threats. The order revives and expands a similar 2020 framework, authorizing the Secretary of Energy to prohibit, condition, or unwind transactions involving electric grid equipment tied to a 'Covered Foreign Entity.' The measure is a response to perceived risks of sabotage and supply-chain disruption from foreign-made components, particularly amid growing electricity demand from data centers, AI, and advanced manufacturing.

Sophisticated counsel and clients across the energy, infrastructure, and technology sectors must take immediate note. The order's reach is extensive, affecting utilities, renewable-energy developers, equipment manufacturers, and their lenders. The prohibition is not self-executing but will be defined by forthcoming rules. Crucially, the Energy Secretary can also impose conditions on already-installed equipment, potentially requiring its monitoring, isolation, or replacement.

executive-ordernational-emergencybulk-power-systemenergy-regulationsupply-chaincritical-infrastructure
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King & Spalding+ Expand
Executive Order 14420 Declares Bulk-Power System National Emergency

President invokes IEEPA/NEA to bar or condition purchases of foreign-made bulk-power equipment from China, Iran, Russia, and other Covered Foreign Entities, with DOE implementing regulations and FAR amendments to follow.

On August 26, 2026, the President issued Executive Order 14420, declaring a national emergency over foreign threats to the U.S. bulk-power system. Citing the rise of data centers, advanced manufacturing, AI, and defense production, the Order invokes IEEPA and the National Emergencies Act to create a new security-review regime for foreign-made grid equipment. Section 2(a) prohibits transactions involving bulk-power system electric equipment (defined to include substation hardware, large transformers, utility-scale inverters, and associated software and remote-access capabilities) designed, developed, manufactured, or supplied by persons linked to a Covered Foreign Entity—countries subject to a U.S. arms embargo or sanctions (including China, Iran, Russia) or others designated by the Secretary of Energy. Section 2(b) authorizes conditioning continued use of legacy foreign equipment already on the grid, with phased compliance possible. The Order also directs DOE to recommend FAR revisions within 180 days to favor U.S.-manufactured energy infrastructure, with the FAR Council to propose a

executive-order-14420bulk-power-systemieepasupply-chaincovered-foreign-entityfederal-procurementenergy-securitycritical-infrastructure
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Mayer Brown+ Expand
US Issues New Restrictions on Foreign Power Equipment

Executive Order 14420 creates new prohibitions and restrictions on the acquisition and use of foreign-sourced bulk-power system equipment, requiring review by developers, sponsors, and suppliers.

The White House has issued Executive Order 14420, creating new restrictions on the acquisition, importation, transfer, or installation of certain foreign-sourced electrical equipment used in the US bulk-power system. The order is intended to mitigate national security risks posed by equipment sourced from foreign adversaries, which could be exploited to create catastrophic effects on the nation's critical infrastructure.

For developers, project sponsors, and equipment suppliers in the energy sector, this order has immediate and significant implications. It will require a thorough review of existing and planned supply chains to ensure compliance and avoid disruption. Projects may face delays, increased costs, or the need to re-source key components from approved domestic or allied suppliers. Counsel should advise affected clients to analyze the specific technologies and countries of origin targeted by the order and any forthcoming implementing regulations from the Department of Energy. Proactive supply-chain diligence and contract review will be critical to navigating the new procure

executive-orderenergypower-gridsupply-chaininfrastructurenational-security
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06 — ENVIRONMENT / ESG / CLIMATE5
McDermott Will & Emery+ Expand
EU Packaging Regulation Imposes New Product Compliance Duties

The EU's new Packaging and Packaging Waste Regulation is now in effect, imposing immediate obligations on restricted substances, conformity assessment, and extended producer responsibility for packaged goods sold in the EU.

The EU's Packaging and Packaging Waste Regulation (PPWR) became generally applicable on August 12, 2026, fundamentally changing compliance for any business shipping packaged goods to the European Union. The framework treats packaging as an integral part of the product, subject to a comprehensive compliance regime, rather than just a post-sale waste concern. Key obligations are already active, including strict limits on PFAS and heavy metals in packaging and a new requirement for manufacturers to conduct conformity assessments, prepare detailed technical documentation, and issue an EU Declaration of Conformity. Importers are now responsible for verifying these steps, while Extended Producer Responsibility (EPR) obligations continue to be managed at the Member State level. Companies should immediately assess all packaging formats and supply chains for EU sales. They must gather data from suppliers to support conformity documents and confirm that importers and distributors are fulfilling their verification roles. Commercial agreements should be reviewed and updated to clearly allocate P

ppwreupackagingsustainabilityproduct-compliancesupply-chainpfasenvironment
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Shook, Hardy & Bacon+ Expand
DC Circuit Upholds EPA’s CERCLA ‘Hazardous Substance’ Listing for PFOA/PFOS

A federal appeals court unanimously affirmed the EPA's 2024 rule designating two common 'forever chemicals' as hazardous substances under the Superfund law, confirming the agency's authority to compel investigation and cleanup.

The U.S. Court of Appeals for the D.C. Circuit has unanimously upheld the Environmental Protection Agency's 2024 designation of PFOA and PFOS as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and liability Act (CERCLA). The decision in Chamber of Commerce v. EPA affirms the agency’s authority to require reporting of releases of these two common “forever chemicals” and to compel potentially responsible parties to investigate and remediate contamination at Superfund sites nationwide.

This ruling creates significant new liabilities for a broad spectrum of clients, impacting not only chemical manufacturers but also downstream users and property owners where these substances may be present. The court found the EPA reasonably explained its decision despite scientific uncertainties and properly interpreted its authority. It held that the statutory standard, “may present a substantial risk of harm,” requires only a “scientifically possible substantial risk.”

pfaspfoa-pfoscerclasuperfundepadc-circuitenvironmental-litigationhazardous-substances
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Alston & Bird+ Expand
DC Circuit Backs EPA on PFOA/PFOS Hazardous Substance Designation

The D.C. Circuit has upheld the EPA's designation of PFOA and PFOS as hazardous substances under the Superfund law, confirming expanded liability for a wide range of industries with historic ties to the chemicals.

A U.S. Court of Appeals for the D.C. Circuit panel unanimously upheld the Environmental Protection Agency's rule designating PFOA and PFOS—two widely used PFAS chemicals—as "hazardous substances" under the Comprehensive Environmental Response, Compensation, and liability Act (CERCLA). Industry groups had challenged the rule, arguing the EPA exceeded its authority and conducted a flawed cost-benefit analysis. The court rejected these arguments, finding the agency can regulate substances based on a plausible, substantial risk of danger without needing to prove certain harm.

pfascerclasuperfundepaenvironmental-litigationdc-circuithazardous-substances
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Holland & Knight+ Expand
Federal Court Upholds Oregon EPR Law After Constitutional Challenge

A federal court rejected Dormant Commerce Clause and Due Process challenges to Oregon's extended producer responsibility law, dissolving an injunction and providing a key victory for state-level recycling programs.

The U.S. District Court for the District of Oregon has upheld the state's Plastic Pollution and Recycling Modernization Act, rejecting a constitutional challenge to the comprehensive extended producer responsibility (EPR) framework. A trade group, the National Association of Wholesaler-Distributors, argued the law violated the Dormant Commerce Clause and the Due Process Clause. The court disagreed, finding the law does not discriminate against or unduly burden interstate commerce and that the state retains sufficient oversight over the private Producer Responsibility Organizations tasked with implementation.

extended-producer-responsibilityeprenvironment-esg-climatedormant-commerce-clauseoregonrecycling
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Hogan Lovells+ Expand
Oregon EPR Law Survives First Constitutional Challenge

A federal district court rejected dormant Commerce Clause and due process claims against Oregon's packaging waste law in a landmark decision expected to heavily influence similar challenges to EPR statutes in California and Colorado.

A federal judge in Oregon upheld the state's pioneering Recycling Modernization Act, rejecting the first major constitutional challenge to a U.S. Extended Producer Responsibility (EPR) law for packaging. The ruling, from the U.S. District Court for the District of Oregon, found the law did not violate the dormant Commerce Clause or the Due Process Clause. The plaintiff, a national trade association, argued the program's costs and complexity unconstitutionally burdened interstate commerce and that the state improperly delegated regulatory power to a private Producer Responsibility Organization (PRO).

eprpackagingrecyclingdormant-commerce-clausedue-processoregoncaliforniacolorado
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07 — FDA / LIFE SCIENCES REGULATORY3
Arnold & Porter+ Expand
FDA Seeks Input on Regulating AI-Enabled Medical Devices

The US Food and Drug Administration has released a discussion paper seeking public comment on a new regulatory framework for medical devices enabled by generative AI.

On August 18, 2026, the FDA's Digital Health Center of Excellence issued a discussion paper initiating a public dialogue on regulating medical devices that incorporate generative AI. The paper does not propose new rules but rather seeks stakeholder feedback on a range of issues, from ensuring algorithm safety and effectiveness to addressing potential bias and managing the entire product lifecycle of these rapidly evolving tools. For medical device manufacturers, software developers, and healthcare providers, this is a critical, early opportunity to shape future US regulatory policy in a high-growth sector. BigLaw clients in the life sciences and technology spaces are directly impacted, as their input can influence the direction of future draft guidance or formal rulemaking. The immediate action is for counsel to analyze the paper and advise clients on submitting comments to the FDA docket, which can help create a more predictable and innovation-friendly regulatory landscape.

fdagenerative-aimedical-devicesregulatorydigital-healthlife-sciences
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Akin Gump+ Expand
FDA Signals New Regulatory Approach for AI Medical Devices

A new FDA discussion paper on generative AI in medical devices abandons familiar terminology and proposes a "competency-based" evaluation model, signaling a potential overhaul of its regulatory framework.

The US Food and Drug Administration has released a discussion paper outlining a potential new framework for regulating generative AI-enabled medical devices. The paper is notable for omitting established terminology, such as 'software as a medical device' (SaMD), and introducing novel concepts for evaluating the technology’s unique risks and benefits. Sophisticated counsel should note the proposal for a 'competency-based approach' to evaluation, which the agency likens to the credentialing of human clinicians, focusing on underlying knowledge rather than exhaustive testing of every possible scenario. This represents a potential paradigm shift from current review processes and could fundamentally alter the pathway to market for AI-driven medical technology. The FDA acknowledges that implementing such a framework would likely require statutory changes. Stakeholders have an opportunity to shape the future of this regulation, with the FDA seeking feedback on 26 specific questions until October 19, 2026.

fdagenerative-aimedical-devicesregulatorysoftware-as-a-medical-devicelife-scienceshealthcare
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DLA Piper+ Expand
Court Orders USDA to Revise Bioengineered Food Labeling Rule

A federal court found the USDA acted arbitrarily by exempting highly refined ingredients from GMO disclosure rules, expanding labeling requirements for many processed foods.

A federal court has invalidated a key US Department of Agriculture (USDA) regulation that exempted many processed foods from bioengineered-disclosure requirements. The US District Court for the Northern District of California affirmed a 2025 ruling that the USDA acted arbitrarily when it excluded highly refined ingredients from the National Bioengineered Food Disclosure Standard simply because modified genetic material is undetectable after processing. The exemption had shielded an estimated 70% to 80% of genetically modified foods from labeling rules. The court also ruled against the USDA's policy allowing QR codes as a stand-alone method for disclosure. This decision has broad implications for the food and beverage industry, as many products previously exempt will likely now require new labeling. The court has ordered the USDA to revise its regulations by January 1, 2028, after rejecting the agency’s request for a longer extension. Food manufacturers and retailers should monitor the forthcoming rulemaking and re-evaluate their products and supply chains to ensure compliance with th

food-labelingusdagmobioengineered-foodadministrative-procedure-actfood-and-beverage
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08 — FINANCIAL REGULATION5
Ballard Spahr+ Expand
NY Bill Targets Interest Rate Exportation by Out-of-State Banks

A New York bill would opt the state out of the federal DIDMCA law, aiming to apply its own usury caps to loans made to residents by out-of-state, state-chartered banks.

A New York state senator has introduced legislation that would opt the state out of the Depository Institutions Deregulation and Monetary Control Act (DIDMCA), a key federal law allowing state-chartered banks to export their home-state interest rates nationwide. Although the bill cannot pass in 2026 because it was filed after the legislative session ended, it is expected to be reintroduced in January 2027, representing a significant escalation in the battle over federal preemption of state usury laws. If passed, the law would subject loans to New York residents by out-of-state banks to New York’s own interest-rate caps, including its 25% criminal usury ceiling. This could severely disrupt established interstate consumer lending models, particularly bank-fintech partnership programs. The bill's broad definition of a loan "made in" New York is already being contested in federal courts challenging similar opt-out laws in Colorado and Oregon. Financial institutions with national lending programs should monitor the bill's reintroduction and the progression of related cases.

didmcainterest-rate-exportationusurypreemptionnew-yorkconsumer-lendingfintech-partnership
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Baker Botts+ Expand
CFTC Signals Rules for Derivatives on AI Compute

The U.S. Commodity Futures Trading Commission has issued a public request for comment on a framework for listing derivatives contracts based on AI compute power, the first formal step toward regulating this emerging asset class.

The U.S. Commodity Futures Trading Commission (CFTC) has issued a Request for Comment (RFC) exploring a regulatory framework for derivatives based on "compute," the processing power underlying the artificial intelligence economy. This is the agency's first formal step toward creating a regulated market for a new asset class tied to what it calls a "scarce, capital-intensive commodity." The compute market, estimated to be worth hundreds of billions annually, currently has fragmented and opaque pricing, making it difficult for companies to hedge against cost volatility.

cftcderivativesfinancial-regulationtechnology-aicommoditiesrequest-for-commentcompute-power
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Ballard Spahr+ Expand
House Panel to Weigh Bill Clarifying Bank Rate Preemption

A House committee will consider legislation to resolve whether states can cap interest rates on loans from out-of-state, state-chartered banks, a key issue for interstate lenders and their FinTech partners.

The House Financial Services Committee will hold a hearing on H.R. 7866, the American Lending Fairness Act of 2026, which aims to clarify a contentious provision of the Depository Institutions Deregulation and Monetary Control Act of 1980 (DIDMCA). At issue is whether a state's decision to "opt out" of federal interest-rate preemption allows it to impose its own usury caps on loans made by out-of-state, state-chartered banks to its residents.

didmcainterest-rate-preemptionusurybanking-regulationfintech-lendingdual-banking-system
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K&L Gates+ Expand
CFTC Proposes Strict New Rules for Vertically Integrated Markets

The CFTC has proposed new regulations to manage conflicts of interest in vertically integrated derivatives markets, including a general ban on affiliates trading on their own exchanges and new third-party oversight requirements.

The US Commodity Futures Trading Commission has proposed extensive new rules targeting conflicts of interest in vertically integrated derivatives markets. The proposal reflects a significant shift toward more prescriptive safeguards, addressing concerns that exchanges or clearinghouses might favor affiliated trading firms or misuse non-public information. Key provisions include a general prohibition on a principal trading firm trading on an affiliated designated contract market (DCM), with a narrow exception for market makers who would be subject to strict conditions like order-priority subordination and independent third-party oversight. The rules would also mandate enhanced operational separation, information barriers, and new conflict-of-interest procedures for DCMs, swap execution facilities, and clearinghouses with affiliated intermediaries. Futures commission merchants would face new obligations to disclose affiliate relationships to customers. These changes, if adopted, will require significant compliance overhauls across the industry and may particularly affect digital asset

cftcderivativesvertical-integrationconflicts-of-interestrulemakingdcmfcm
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Morgan, Lewis & Bockius+ Expand
UK FCA's New Non-Financial Misconduct Rule Now In Force

The UK Financial Conduct Authority's new rule and guidance expanding the scope of its conduct rules to cover serious non-financial misconduct at non-banking firms took effect September 1.

The UK Financial Conduct Authority's new rule and guidance on serious non-financial misconduct (NFM) at non-banking firms became effective September 1, 2026. The change extends the scope of the Code of Conduct (COCON) to more explicitly cover misconduct such as harassment or other behavior that violates a person's dignity or creates a hostile environment, even if not linked to a protected characteristic under equality law.

This development is important for sophisticated counsel and clients because it aligns standards for non-banking firms with those already governing banks, signaling a heightened regulatory focus on workplace culture and individual accountability. The guidance also clarifies that serious NFM in an employee's private life may be relevant to their fitness and propriety (FIT) assessment if it undermines public confidence or shows a disregard for ethical obligations.

fcasmcrnon-financial-misconductworkplace-culturefinancial-regulationuk
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09 — FINTECH / CRYPTO1
Orrick, Herrington & Sutcliffe+ Expand
CFTC Eyes Crypto Market Rules as Legislation Stalls

The derivatives regulator has directed staff to begin exploring rulemaking options for digital asset market structure, citing continued congressional deadlock on the CLARITY Act.

In response to concerns that the bipartisan CLARITY Act may not pass Congress, CFTC Chairman Michael Selig has instructed agency staff to explore creating rules for the crypto asset market using the commission's existing authority. This move signals a potential shift from waiting on legislators to proactive regulation by the agency. Sophisticated clients and counsel care because this could create the first comprehensive federal market structure for digital assets in the United States, impacting exchanges, DeFi protocols, and institutional investors. Selig's remarks suggest options like creating a new registration category for crypto exchanges—a "crypto asset market"—which could bring them under direct CFTC oversight for leveraged or margined trading. For DeFi projects, the CFTC has been directed to engage with developers on potential compliance pathways.

cftccryptocurrencydigital-assetsfinancial-regulationrulemakingdeficlarity-act
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10 — HEALTHCARE1
Wilmer Cutler Pickering Hale and Dorr+ Expand
DOJ Hits Medicare Advantage Providers With $558M+ in FCA Settlements

Three recent DOJ settlements totaling over $558 million target Medicare Advantage providers for allegedly causing false diagnosis codes, signaling heightened FCA scrutiny of risk-sharing arrangements.

DOJ announced three False Claims Act settlements against Medicare Advantage providers for allegedly causing the submission of unsupported diagnosis codes that inflated CMS risk-adjustment payments. The Villages Health agreed to pay $541.5 million—the largest of the three—after self-disclosing under the HHS-OIG Health Care Fraud Self-Disclosure Protocol and receiving substantial cooperation credit. Monogram Health paid $2.4 million and Complete Health paid $14.2 million; both matters originated in qui tam suits in which DOJ partially intervened. All three settlements featured risk-sharing arrangements that allegedly incentivized providers to inflate risk scores, expanding DOJ's enforcement lens beyond the Medicare Advantage plans themselves to their provider partners. Counsel advising MA plans, provider groups, and risk-bearing entities should evaluate diagnosis-coding controls, governance over value-based contracts, and the comparative benefits of proactive self-disclosure. The settlements come as DOJ's new National Fraud Enforcement Division signals continued prioritization of manag

false-claims-actmedicare-advantagerisk-adjustmentdiagnosis-codesqui-tamdoj-settlementvalue-based-careself-disclosure
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11 — INTERNATIONAL TRADE / TARIFFS4
Perkins Coie+ Expand
FCC Adds Power Inverters, Advanced Robotics to National Security 'Covered List'

Companies in the energy, manufacturing, agriculture, and mining sectors must now scrutinize their supply chains after the FCC banned new approvals for foreign-made power inverters and advanced robotics, citing national security risks.

The Federal Communications Commission (FCC) has added foreign-produced advanced robotic devices and power inverters to its "Covered List," blocking any new models from receiving the authorization required for importation and sale in the United States. The commission cited unacceptable risks to national security for the move, which follows similar recent restrictions on foreign-produced drones and routers. Existing models that received FCC authorization before July 28, 2026, are not affected and can continue to be imported, sold, and receive software updates.

fcccovered-listnational-securityinternational-tradesupply-chainroboticspower-invertersenergy
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Hogan Lovells+ Expand
UK Considers Digital Product Rules, Flagging EU Divergence Risk

The UK government has opened a call for evidence on a potential digital product record framework, creating uncertainty over future alignment with the EU's Digital Product Passport system.

The UK government has initiated a call for evidence to assess the potential introduction of a domestic digital product record (DPR) framework, a move that parallels the EU’s established Digital Product Passport (DPP) system. The inquiry, open for stakeholder input until September 21, 2026, seeks to determine how digital records could enhance product transparency, streamline compliance, and support market surveillance.

For businesses operating across Europe, this development raises critical questions about future regulatory alignment. While the EU’s DPP requirements are already being implemented and apply in Northern Ireland under the Windsor Framework, the UK’s approach for Great Britain remains undecided. A divergent UK standard could create a separate compliance track, complicating product data management, labeling, and supply chain logistics for manufacturers and retailers.

ukeudigital-product-passportproduct-regulationsupply-chaininternational-traderegulatory-divergence
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Goodwin Procter+ Expand
DOJ Launches New Global Trade Fraud Enforcement Section

The US Department of Justice has created a permanent Global Trade & Commerce Enforcement Section and released a new guide with DHS, signaling heightened focus on customs fraud, tariff evasion, and supply-chain integrity.

The U.S. Department of Justice has established the permanent Global Trade & Commerce Enforcement Section to investigate and prosecute criminal import and trade fraud. Working with the Department of Homeland Security, the DOJ also released A Resource Guide to Trade Fraud Enforcement, described as the first comprehensive framework of its kind for these matters. The guide and new section signal a heightened federal priority on combating conduct that undermines US industries, evades tariffs, or introduces illicit goods into supply chains. For corporate counsel, the development highlights increased enforcement risk, particularly through the False Claims Act, which allows for treble damages and is a key tool for pursuing customs fraud and duty underpayments. The governments guidance emphasizes the importance of robust corporate compliance programs, including active supply-chain auditing and verification of partner representations. Companies involved in international trade should review their compliance and disclosure policies in light of the specific priorities and authorities outlined in

dojtrade-fraudenforcementfalse-claims-actcustomstariffssupply-chaindhs
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Hogan Lovells+ Expand
CFIUS CY2025 Report Signals Scrutiny, Slower Reviews

The U.S. foreign-investment committee's latest annual report reveals a significant drop in the success rate for short-form declarations, signaling longer and more uncertain timelines for cross-border transactions.

The Committee on Foreign Investment in the United States (CFIUS) has released its annual report for calendar year 2025, revealing important trends for cross-border dealmakers. While total filings increased, driven by a 21% rise in short-form declarations, the committee's willingness to quickly clear them has fallen sharply. The proportion of declarations cleared within the 30-day assessment period dropped to 66% from 78% in 2024. Correspondingly, CFIUS more frequently requested parties to file a longer, more detailed notice after reviewing a declaration, a trend that can add significant delays to transaction timelines.

cfiusforeign-investmentnational-securitym-across-border-transactionsregulatorytreasury-department
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12 — IP / PATENT2
Venable+ Expand
Takeda Launches First Patent Suit Over Entyvio Biosimilar

Takeda has filed the first patent infringement lawsuit under the BPCIA against a proposed biosimilar version of its blockbuster inflammatory bowel disease drug, Entyvio.

Takeda Pharmaceuticals has initiated the first patent litigation under the Biologics Price Competition and Innovation Act (BPCIA) concerning a proposed biosimilar for its blockbuster drug Entyvio (vedolizumab). The lawsuit, filed in the U.S. District for New Jersey, targets Polpharma's proposed biosimilar, PB016, and alleges infringement of six of Takeda's method-of-treatment patents.

This litigation is a significant development for clients in the life sciences sector, as Entyvio generated approximately $3.9 billion in U.S. sales for Takeda in its last fiscal year. The case will be the first to test the patent portfolio protecting this major revenue stream. According to the complaint, Polpharma declined to participate in the BPCIA's pre-litigation information exchange, known as the "patent dance," a strategic decision that shapes the early phases of such disputes. Counsel should monitor the litigation, as its outcome will influence the timeline for biosimilar market entry. A second biosimilar application, from Alvotech and Teva, has also been accepted by the FDA, suggesting further

bpciabiosimilarspatent-litigationpharmatakedaentyviovedolizumab
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Steptoe+ Expand
AI-Designed Drug Nears Approval With Human Inventors Only

A drug designed using artificial intelligence has entered late-stage clinical trials, and its associated patents strategically sidestep the AI inventorship debate by naming only human scientists.

An AI-designed drug has entered Phase III clinical trials, a late and costly stage of human testing before a company can seek regulatory approval. The patents on the candidate name only human scientists as inventors, deliberately sidestepping the contentious legal question of whether an AI can be an inventor under patent law. This real-world development provides a pragmatic industry response to a question courts and patent offices worldwide are still grappling with. While litigation like the Thaler case has sought to establish AI inventorship, the USPTO and EPO have consistently held that only natural persons can be inventors. This company's approach offers a viable path for securing protection for AI-assisted discoveries without challenging the status quo. Counsel should note this emerging practice for mitigating risk while leveraging AI in R&D.

aiinventorshippatentspharmabiotech
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13 — PRIVACY / DATA SECURITY1
Hogan Lovells+ Expand
Indonesia Finalizes Data Protection Law With Implementing Regulation

Indonesia's long-awaited implementing regulation for its Personal Data Protection Law sets specific operational requirements for consent, documentation, and data transfers, with a January 2027 effective date.

Indonesia has enacted Government Regulation No. 33 of 2026, the implementing regulation for its 2022 Personal Data Protection (PDP) Law, which will take effect on January 16, 2027. The regulation provides the detailed operational rules that were missing since the parent law was passed, creating specific new compliance obligations for organizations processing personal data in the country.

Sophisticated clients and counsel care because the regulation introduces concrete, GDPR-like requirements that may necessitate localizing existing global privacy programs. Key provisions detail the conditions for obtaining explicit consent, prescribe minimum content for records of processing activities and data-retention policies, and mandate data protection impact assessments (DPIAs) for high-risk processing, expressly including AI and machine learning. It also establishes a three-tier legal framework for cross-border data transfers, which will depend on adequacy decisions, binding safeguards, or, as a last resort, explicit consent.

indonesiadata-privacydata-protectioncompliancecross-border-data-transfersconsent
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14 — REGULATORY / GOVERNMENT2
Perkins Coie+ Expand
US Order Targets Foreign Electric Grid Equipment

A new executive order directs the Department of Energy to create a regulatory regime to block the acquisition and use of certain foreign-produced electrical grid components deemed a national security threat.

A new executive order declares a national emergency to protect the U.S. electric grid from threats posed by foreign adversaries. The order authorizes the Secretary of Energy to establish a new regulatory regime restricting transactions involving “bulk-power system electric equipment” (BPSEE) sourced from designated foreign entities.

This action signals heightened federal scrutiny of critical infrastructure supply chains and could significantly impact energy companies, equipment manufacturers, and major electricity consumers. The order’s scope is broad, covering equipment from generation facilities to transmission control systems, and may even apply to previously installed components. While not self-executing, it directs the Department of Energy (DoE) to develop implementing regulations, which will likely include a licensing and mitigation process.

national-securitycritical-infrastructureenergysupply-chaindepartment-of-energyieepaexecutive-ordergovernment-contracts
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Venable+ Expand
1st Circ: APA Halts Funding Freeze But Won’t Compel Payment

The First Circuit held that an across-the-board freeze on IIJA and IRA funds was likely an unlawful final agency action but found that the district court exceeded its authority by ordering the government to disburse specific funds.

In 'Woonasquatucket River Watershed Council v. USDA', the First Circuit affirmed a preliminary injunction halting a federal freeze on funds awarded under the Infrastructure Investment and Jobs Act and the Inflation Reduction Act, but it vacated the part of the order compelling the government to make payments. The court found that a broad directive to pause funding was likely a reviewable “final agency action” under the Administrative Procedure Act (APA) and that the agencies’ “freeze first, ask questions later” approach likely violated the APA by failing to consider grant recipients’ significant reliance interests.

administrative-procedure-actfirst-circuitfederal-fundingpreliminary-injunctionsovereign-immunityinflation-reduction-actiija
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15 — SANCTIONS / EXPORT CONTROLS1
DLA Piper+ Expand
US Sanctions Target Ecuador Maritime Network for Cartel Ties

The US Treasury has designated 15 Ecuadorian persons and entities and 10 vessels for allegedly providing logistical support for maritime cocaine trafficking by major cartels.

The US Treasury's Office of Foreign Assets Control (OFAC) has designated 15 individuals and entities and identified 10 vessels in Ecuador as blocked property. The US government alleges the network used a commercial fishing operation to provide fuel and logistical support for maritime cocaine shipments on behalf of major transnational cartels, including the Sinaloa Cartel, CJNG, Los Choneros, and Los Lobos.

Sophisticated counsel should advise clients that this action creates significant compliance risks for any company involved in Ecuador's maritime, fishing, insurance, finance, or logistics sectors. The risk is magnified because two of the cartels implicated, Los Choneros and Los Lobos, are designated as Foreign Terrorist Organizations (FTOs). This exposes companies to severe potential penalties for providing 'material support,' a broad term that can include services like transport, insurance, or financing. OFAC violations can result in strict civil liability.

ofacsanctionsecuadormaritimesupply-chain-riskforeign-terrorist-organizationsanti-money-laundering
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16 — SECURITIES / CAPITAL MARKETS1
Wilmer Cutler Pickering Hale and Dorr+ Expand
SEC Proposes 'Regulation Crypto Assets' Offering Framework

The SEC has proposed 'Regulation Crypto Assets,' a framework creating new registration exemptions for certain digital asset offerings and establishing a conditional safe harbor from the 'investment contract' definition.

The US Securities and Exchange Commission has released a proposed 'Regulation Crypto Assets,' its first formal rulemaking designed to establish a regulatory framework for offerings of investment contracts tied to crypto assets. The proposal introduces two new exemptions from Securities Act registration: a 'Startup Exemption' for offerings up to $5 million over four years and a 'Fundraising Exemption,' modeled on Regulation A, for offerings up to $75 million annually.

This development is critical for an industry that has long navigated legal uncertainty and SEC enforcement actions based on doctrines established long before digital assets existed. The proposed rules would provide clearer pathways for capital formation, with tailored, principles-based disclosure requirements. A key feature is a conditional safe harbor that would deem an investment contract to have ceased to exist once the issuer fulfills its essential managerial promises, potentially providing a long-sought regulatory off-ramp for projects that become sufficiently decentralized.

seccrypto-assetssecurities-regulationcapital-formationinvestment-contractsafe-harbordigital-assets
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17 — TAX1
Alston & Bird+ Expand
Fifth Circuit Creates New Test for Limited Partner SE Tax

The court replaced its prior bright-line rule with a new, fact-intensive standard focused on whether a partner plays a significant role in managing or running the business.

In a substitute opinion for 'K Alain L.L.L.P. v. Commissioner', the U.S. Court of Appeals for the Fifth Circuit withdrew its January 2026 decision that had created a bright-line test for the limited partner exception to self-employment tax. The prior ruling held that a partner's status as a limited partner under state law was sufficient to qualify for the exception. The new opinion rejects that test, as well as the Tax Court’s stricter “passive investor” standard from 'Soroban v. Commissioner'.

Instead, the court adopted an intermediate, management-based standard, holding that the exception is for partners who play no “significant role in managing or running a business.” This creates considerable uncertainty for partnerships and their advisors, as the court did not define the threshold for a "significant role." The decision directly affects tax structuring and reporting for limited partnerships, particularly investment funds and service partnerships.

self-employment-taxlimited-partnerpartnership-taxationfifth-circuittax-litigationk-alainsoroban
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18 — TECHNOLOGY / AI1
Morrison & Foerster+ Expand
States Bake Federal Interoperability Into New Frontier AI Laws

New 'frontier AI' laws in California, New York, and Illinois permit developers to satisfy state obligations by complying with future, equivalent federal standards, a novel approach to potential federal preemption.

In a novel approach to the looming issue of federal preemption, California, New York, and Illinois have embedded 'interoperability' provisions into their new laws governing frontier AI. These clauses allow a developer to satisfy key state-level compliance obligations, such as critical safety incident reporting, by adhering to future federal standards. State agencies retain discretion to determine if a federal law or regulation is 'substantially equivalent to or more stringent than' the state's own requirements. For clients developing or deploying advanced AI, this model offers a potential pathway to avoid a patchwork of duplicative state-by-state compliance burdens if a comprehensive federal framework emerges. It represents a strategic move by states to preserve their regulatory authority while acknowledging the need for national uniformity. Counsel should monitor how state agencies might operationalize their authority to approve federal standards and watch whether this interoperability model influences the ongoing congressional debate over express preemption in federal AI legislatio

ai-regulationpreemptioninteroperabilitystate-lawfederalism
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19 — WHITE COLLAR / INVESTIGATIONS1
Vinson & Elkins+ Expand
SEC Enforcement Shifts From Volume to Targeted Actions

With a new task force focused on financial reporting fraud, the SEC signals a strategic move away from high-volume, compliance-based cases to target core investor protection matters.

The Securities and Exchange Commission is recalibrating its enforcement program, shifting from a high volume of cases to fewer, more targeted actions. This 'back to basics' approach prioritizes core issues like financial fraud, market manipulation, and insider trading over technical compliance matters. Underscoring this change, the agency in August 2026 created a new Financial Reporting and Accounting Unit within its Enforcement Division specifically to pursue complex accounting and auditing misconduct.

This strategic pivot means the SEC is dedicating expert resources to building stronger, more significant cases in areas of fundamental risk for public companies. Boards and senior management face heightened scrutiny over financial controls, internal reporting, and auditing processes, as recent settlements involving accounting irregularities and inadequate materiality analyses demonstrate. The new specialized task force signals that accounting-related conduct will be a top enforcement priority, likely leading to more sophisticated investigations.

secenforcementwhite-collarinvestigationsaccounting-fraudcorporate-governanceinsider-trading
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