DROPLETS
Federal agencies finalize sweeping amendments to the Transparency in Coverage regulations, broadening disclosure obligations for health insurers.
On October 16, 2026, the Department of Labor, the Department of Treasury, and the Department of Health and Human Services jointly announced substantial revisions to the Transparency in Coverage (TIC) regulations. The amendments broaden required disclosure, obligating health plans to provide more granular pricing information for covered services and to publicly post this data in a standardized format. The changes aim to empower consumers and level the playing field in health‑networks negotiations. Law firms advising insurers, brokers, and health‑plan sponsors will need to audit compliance, update data feeds, train staff, and counsel clients on impacts on network design and pricing strategy. Anticipate forthcoming enforcement guidance and potential litigation that will shape future transparency law, underscoring the need to address these changes promptly.
The Bipartisan American Affordability and Jobs Act of 2026 introduces sweeping reforms to speed up project permitting, potentially reshaping the U.S. infrastructure and energy development landscape.
The Bipartisan American Affordability and Jobs Act—announced on September 30, 2026 by Senate Environment and Public Works (EPW) and Energy and Natural Resources (ENR) Committee leaders—heralds a major overhaul of the federal permitting process. The bill amends statutes to shorten approvals for infrastructure and energy projects, establishing a consolidated review framework, clarifying agency responsibilities, and expanding use of digital permitting portals. For counsel and clients, the reforms could reduce project lead times by up to 30 % and lower compliance costs, especially for large‐scale renewable and grid‑upgrade ventures. Firms handling complex project finance or cross‑state developments should scrutinize the new statutory language, assess whether their current permitting strategies align with the proposed expedited timelines, and consider updating internal compliance workflows. The Act’s provisions will likely be implemented over the first 12–18 months, so monitoring federal agency guidance and any court challenges will be essential to anticipate operational changes and p
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CMS issued a proposal to overhaul Medicare Advantage and Part D while a House bill aims to delay the finalization of the 340B rebate model, creating uncertainty for insurers, pharma, and providers.
CMS’s proposed rule, part of the Consolidated Appropriations Act, 2026 implementation, intends to rethink how Medicare Advantage plans reimburse providers and to reshape Part D drug benefit structures, potentially tightening premiums and altering benefit tiers for beneficiaries.
A concurrent bipartisan House bill would delay the finalization of the 340B rebate model, giving manufacturers and hospitals additional time to adjust to the new pricing framework. The combination of a CMS proposal and congressional action creates a period of regulatory uncertainty for all stakeholders—plans, pharmacy benefit managers, manufacturers, and covered entities—who must prepare for possible changes in data submissions, reimbursement formulas, and compliance timelines.
Lawyers should advise clients on scenario planning, risk assessment, and early engagement with CMS technical assistance programs to mitigate exposure. The roadmap for the rule’s approval and the bill’s passage will affect strategic decisions early next year, making this development a priority for all large‑firm healthcare practices.
The ruling clarifies how existing Chinese laws apply to disputes involving AI, potentially reshaping litigation strategies for businesses.
China’s Supreme People’s Court released its first comprehensive judicial guidance outlining how courts are expected to apply existing legal principles to artificial‑intelligence‐related disputes. The guidance addresses a wide range of issues, from contractual interpretation and liability for autonomous systems to the admissibility of AI‑generated evidence and data‑protection considerations. For attorneys and multinational clients operating in China, the ruling signals that the court will impose a stricter scrutiny on AI claims and will consider the precise nature of the technology – e.g., algorithmic decision‑making versus simple tool usage – when evaluating fault and damages. Practically, firms should review their AI governance policies, assess the exposure of their contractual structures, and anticipate that court rulings will now explicitly reference the guidance provisions. Clients ought to engage Chinese counsel early, update risk assessments, and consider local regulatory alignment. Watching subsequent trial rulings will reveal how the courts interpret the guidance and whether
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The General Court's Booking/Etraveli judgment tightens how dominance is shown in network-effect industries, giving complainants a stronger route to challenge concentrated mergers.
Alston & Bird's European antitrust team reports that the EU General Court's ruling in the Booking/Etraveli case may raise the risk of blocked mergers for dominant companies operating in industries defined by network effects. As described in the source, the significance concerns how dominance and market power are established and sustained where a platform's position rests on two-sided network effects rather than conventional switching costs or market-share arithmetic.
Why sophisticated counsel should care: network-effect markets are precisely those where a dominant incumbent is most likely to acquire a nascent rival, and where authorities most often challenge. If complainants' theory of dominance evidence gains traction, expect parallel theories to appear in transactional challenges, in national proceedings, and in strategic joint-venture and interoperability disputes spanning several jurisdictions.
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A bipartisan coalition of 40 attorneys general has filed an amicus brief supporting New Jersey's petition asking the Supreme Court to review whether Kalshi may offer sports betting contracts without state gaming authorization.
A bipartisan group of 40 state attorneys general has filed an amicus brief in the U.S. Supreme Court supporting New Jersey's petition for certiorari in a case asking whether prediction market operator Kalshi may offer sports betting contracts without state gaming authorization. The filing signals unusually broad state interest in how far federal commodities-market authority reaches into sports betting, and it places a large coalition of regulators behind one state's procedural push to have the question heard.
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The SEC's October 1, 2026 release would let advisers and regulated funds self-custody crypto assets under conditions and would overhaul existing adviser, registered fund and BDC custody rules.
The SEC published a release on October 1, 2026 proposing, subject to conditions, that investment advisers and regulated funds — including registered funds and business development companies — be permitted to self-custody crypto assets, alongside a broader overhaul of the existing custody framework for advisers, registered funds and BDCs.
Why sophisticated counsel should care: custody rules sit at the intersection of fiduciary duty, safekeeping liability, segregation and recordkeeping obligations. A shift from third-party custody toward self-custody, even conditioned on safeguards, would redraw the boundary between a manager's investment discretion and its asset-protection obligations, and would likely ripple into fund documentation, administrator and auditor scopes of work, insurance and indemnity provisions, and investor disclosures. Advisers and fund boards will want to assess whether current sub-custody arrangements, control environments and vendor contracts remain fit for purpose before any compliance period matures.
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The first appellate fair use decision on generative AI training reportedly went against ROSS Intelligence, leaving core AI-training copyright questions open across circuits.
On September 29, 2026, the U.S. Court of Appeals for the Third Circuit decided Thomson Reuters v. ROSS Intelligence, applying copyright fair use to the use of legal headnotes and related material in training generative AI. According to a King & Spalding client alert (the only source in this cluster; the full opinion was not available for review here), the panel ruled against ROSS and characterized the use as something other than "ordinary," leaving broader generative AI training questions unresolved.
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The UK Competition and Markets Authority has closed three more DMCCA investigations with fines totalling £6 million, signalling that its new direct consumer-enforcement fining powers are now operating in practice.
On 14 October 2026, the Competition and Markets Authority announced the conclusion of three further consumer protection investigations under the Digital Markets, Competition and Consumers Act 2024, with penalties totalling £6 million across the matters. Reporting is from Bryan Cave Leighton Paisner; the individual undertakings, sectors and total per-company penalty breakdown have not been verified from the CMA's own release here.
Why it matters: the DMCCA gave the CMA direct fining powers over consumer law breaches, removing the need to pursue enforcement through the courts and lifting the previous £5,000 cap that constrained in-house investigations. Three closures in a single announcement indicate the regime is being used at volume rather than sporadically, which changes the enforcement-risk calculus for any business selling to UK consumers.
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The SEC's October 9, 2026 proposal would broaden when registered funds and BDCs may cross trade with affiliates, reopening compliance analysis for asset managers, advisers and broker-dealers.
The SEC proposed amendments to Rule 17a-7 under the Investment Company Act of 1940 on October 9, 2026, according to a Skadden client alert. The rule governs cross trading between registered investment companies and business development companies and their affiliates, and the proposal would expand the universe of transactions that qualify for the exemption from Section 17(a) affiliate dealing restrictions, with attendant conditions and disclosure.
Why sophisticated counsel should care: Rule 17a-7 has been the main pathway for internal liquidity, securities lending and portfolio rebalancing between fund complexes and affiliated trading desks. Broadening permitted cross trading could unlock new efficiencies for large fund sponsors and their affiliated broker-dealers, but it also resets the documentation posture for trading arrangements, agency and best-execution analysis, allocation among participating funds, and the disclosures investors receive. The compliance burden lands unevenly across complexes depending on current affiliate-trading practices and existing exemptive relief.
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Treasury's October 1 action against an alleged Russia-linked shadow banking network, paired with a FinCEN proposed rule, extends sanctions exposure to banks and correspondent channels tied to Iran evasion.
On October 1, Treasury announced coordinated actions against a Russia-linked shadow banking network it alleged helped the Iranian regime evade sanctions, as part of an operation Treasury describes as Operation Economic Outcast. FinCEN concurrently issued a notice of proposed rulemaking, indicating the package pairs designations with prospective anti-money-laundering or reporting obligations rather than enforcement action alone.
Why sophisticated counsel should care: shadow banking designations typically reach beyond the named entities to the institutions that transact with them. Financial institutions, payment processors, and non-US intermediaries with correspondent exposure may find themselves facing de-risking decisions, blocked-property and reporting questions, and heightened diligence expectations well before any penalty. The proposed rule is also a comment-period opportunity — a defined window for banks and trade-finance participants to shape forthcoming AML obligations before they bind.
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The CFTC's October 5 advance notice of proposed rulemaking would apply CEA section 2(c)(2)(D) to leveraged retail crypto transactions, signaling a path toward registered-exchange or FCM intermediation.
On October 5, the CFTC issued an advance notice of proposed rulemaking previewing two rules, "Regulation Crypto Asset Transactions" and "Regulation Crypto Asset Markets." The proposals would apply section 2(c)(2)(D) of the Commodity Exchange Act to leveraged retail crypto, a provision the agency has previously read as the hook for asserting jurisdiction over off-exchange retail derivatives in digital assets.
Why sophisticated counsel should care now: the ANPRM is a solicitation of comment rather than a rule, but it signals that the agency sees a statutory route to pulling leveraged retail crypto products inside the registered swaps, FCM and designated contract market architecture. Exchange operators, trading venues, market makers and broker-dealers with retail distribution channels should assess whether their current product menus, customer agreements, disclosure documents and segregation arrangements survive a future registration model — and their largest bank and institutional counterparties should price the possibility of volume migrating on-exchange. Firms with non-US retail cry
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Treasury's first civil penalty under the Outbound Investment Security Program — $200,000 against Amidi, LLC for a failure to file — turns the national security investment program's reporting duties into an enforceable obligation.
On October 7, 2026, the U.S. Department of the Treasury announced its first civil penalty under the Outbound Investment Security Program: a $200,000 assessment on Amidi, LLC for failing to submit a required notification. The action is the first reported use of enforcement authority under a regime built to address national security risks from certain U.S.-person outbound investments, and it shifts the program's filing obligations from guidance into a line counsel can be penalized on.
The dollar figure is modest; the signaling value is not. Clients with U.S. persons in the covered transaction space should assume Treasury may examine filing scope and timeliness independently of any concern about the counterparty, and should review whether historic and pending covered deals were correctly classified and reported.
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FinCEN has identified about $17.5 billion in potentially suspicious health‑care fraud activity, signaling a sharp uptick in enforcement focus toward the medical‑service sector.
FinCEN announced on September 9 that it has identified roughly $17.5 billion in suspicious financial activity that “potentially” involves health‑care fraud. The Treasury’s enforcement action signals that the regulator is expanding its focus beyond traditional money‑laundering cases to high‑profile fraudulent schemes in the medical‑service sector. Firms advising health‑care providers, insurers and pharmaceutical companies must review their AML policies, transaction‑monitoring systems, and reporting obligations to ensure compliance with FinCEN’s guidelines. The announcement also highlights the importance of robust due‑diligence on billing partners, pay‑or‑return arrangements, and third‑party intermediaries. While the exact entities targeted remain undisclosed, the magnitude of the suspected fraud underscores the potential scope of liability and the risk of self‑reporting penalties. Clients should assess whether their current controls are aligned with FinCEN’s evolving enforcement priorities and consider independent audits or enhanced training. Monitoring further FinCEN guidance or enfo
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The agencies are seeking public input on competition in agricultural equipment manufacturing and distribution, including repair access, putting manufacturers and dealer networks on notice.
The Federal Trade Commission and the U.S. Department of Agriculture have opened a joint public inquiry into competition in agricultural equipment manufacturing and distribution, according to a Cozen O'Connor client alert. The agencies are soliciting public comment on potential anticompetitive conduct and on barriers that limit farmers' access to equipment and repair services, including parts, diagnostic software and independent servicing.
Why it matters: an FTC inquiry of this kind signals where agency attention is heading, and the right-to-repair dimension adds a consumer-protection and legislative overlay to what is otherwise a core competition question. Comments submitted through the public process will build the factual record that later enforcement, if any, would draw on. Manufacturers, dealer networks, aftermarket parts suppliers, and repair platforms should assume the agencies' review will reach beyond price and output into contracting practices, data access and service-channel restrictions.
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The guidance sets a new methodology for determining U.S. content in mobile industrial equipment that qualifies under the US‑MCA, potentially shifting the tariff burden for firms importing or exporting such goods.
The U.S. Bureau of Industry and Security released guidance on Oct 14 2026 that revises how to calculate the “U.S. content” of mobile industrial equipment and machinery subject to Section 232 metal tariffs and falling within the USMCA qualifying list. The new methodology includes specific break‑downs of component percentages, recent shipment data, and updated weight‑based formulas. Firms engaged in importing or exporting mobile equipment will need to reassess their tariff calculations, as the guidance may lower the audit threshold for certain items and alter duty amounts. Compliance teams should review the new weightings and update internal procurement reports accordingly. The guidance has yet to be tested in real‑world customs cases, so stakeholders should monitor enforcement actions for further clarification as regulators adapt and anticipate.
Orrick reports that Baker v. Seattle Children's Hospital held the Washington Privacy Act does not reach tracking pixels on public-facing pages, a ruling defense counsel will test against wiretap class actions elsewhere.
Orrick reports that the Washington Supreme Court decided Baker v. Seattle Children's Hospital, holding that the Washington Privacy Act does not reach the website-operator conduct at issue involving tracking pixels on a public-facing page. The firm frames the ruling as a significant win amid a growing wave of pixel-tracking and "wiretap" class actions. Because the available account is a defense-side summary and the quoted holding is truncated, the precise scope — what conduct was excluded, and whether the court addressed consent, data-security duties, or vendor arrangements — should be confirmed against the opinion itself.
The decision matters well beyond Washington. State privacy statutes with private rights of action have increasingly been used to allege that third-party analytics, chat and pixel scripts effect unauthorized "captures" of communications. Defense counsel will mine the reasoning for dismissal and narrowing arguments in other forums, and plaintiffs will test its limits in Washington.
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State Department's DDTC has issued a proposed rule amending ITAR, including removal of certain items from the U.S. Munitions List, signaling a significant shift in defense-trade controls now open for public comment.
According to the Holland & Knight alert, the U.S. Department of State's Directorate of Defense Trade Controls has published proposed amendments to the International Traffic in Arms Regulations, described as an "omnibus" package. The headline element is removal of certain items from the U.S. Munitions List, which would move those articles out of ITAR jurisdiction and into Commerce Department export controls administered under the EAR. The rule reportedly also clarifies several key ITAR definitions.
For export-control and trade-compliance counsel, a USML deletion is not a housekeeping edit. Items leaving the USML change licensing authorities, registration obligations, jurisdiction-of-manufacture and Country-of-Origin rules, and the triggers for U.S. persons to handle technology or manufacturing data. Defense primes, component suppliers, and dual-use exporters with mixed portfolios need to map which lines shift regimes before the rule is final, and to check downstream effects on licenses, ITAR end-use statements, and pending authorization requests.
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Signed September 2, 2026 and effective January 1, 2027, Delaware's privacy amendments lower coverage thresholds, add a "resident" category for vendor-sourced candidate reports, and impose profiling duties on AI-assisted hiring.
Per Ogletree Deakins, Governor Matt Meyer signed amendments to the Delaware Personal Data Privacy Act on September 2, 2026, with an effective date of January 1, 2027. Two changes matter most for major-firm clients. First, coverage thresholds drop sharply: the law reaches those processing personal data of 10,000 or more Delaware residents, or 5,000 where at least 20 percent of revenue comes from selling personal data. Second, while employees remain outside the "consumer" definition, a new "resident" category captures personal data processed in connection with profiling and vendor-produced reports used to decide whether to offer employment opportunities — closing the gap around automated sourcing, screening, and ranking tools used before FCRA-regulated background checks.
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The U.S. Department of Health and Human Services plans a short‑term rule that would let certain compounding pharmacies provide peptides previously restricted by the FDA, potentially reshaping the wellness and specialty drug market.
In early October 2026, HHS issued a notice that a temporary regulatory change would permit a limited set of compounding pharmacies to dispense specific peptides that had been covered by the FDA’s controlled substance or prescription drug classifications. The measure is intended as a bridge while the FDA develops a more comprehensive framework for these products amid growing demand from wellness and specialty care practices. The rule’s scope, which includes only peptides meeting certain potency and purity criteria, will require pharmacies to meet new labeling and record‑keeping obligations. For counsel advising compounding firms, the change provides an early opportunity to review compliance gaps and adjust operational protocols. For wellness providers and insurers, the decision signals a potential shift in the supply chain, with implications for pricing, coverage, and patient access. Over the next six months, the FDA is expected to release a draft guidance that will either formalize or sunset the temporary measure, making it crucial for affected clients to monitor the next federa
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The agency is withdrawing its enforcement guidance that required employers to conduct individualized assessments of arrest and conviction records, easing concerns over disparate‑impact claims.
The U.S. Equal Employment Opportunity Commission (EEOC) announced that it will rescind its 2012 enforcement guidance on the consideration of arrest and conviction records in employment decisions under Title VII of the Civil Rights Act. The guidance had instructed employers that a neutral criminal‑background‑check policy could have a disparate impact on protected classes and urged the use of a nine‑factor individualized‑assessment framework. By withdrawing the guidance, the EEOC signals a shift away from the disparate‑impact theory as a basis for liability and a broader deference to employers’ neutral policies. Employers should re‑evaluate onboarding and personnel‑screening protocols and consult counsel for compliance. A review of the final rule’s text will provide further clarity on record‑keeping requirements under the new framework. Guidance revisions will also affect wage‑hour analyses and anti‑discrimination training programs.
The U.S. Treasury announced on October 7, 2026 its first civil penalty under the Outbound Investment Security Program, converting the regime's penalty authority from dormant statute into an enforced compliance regime.
Treasury announced on October 7, 2026 that it had issued its first civil penalty under the Outbound Investment Security Program (OISP), a Treasury-run national-security investment screening regime covering certain transactions involving covered persons in sensitive technology sectors. Until now, the program's penalty authority existed on the books without a public enforcement exemplar; the announcement identified the penalized party as Amidi. The source material is a single law-firm alert, so the penalty amount, the charged violation, and whether any settlement admission or litigation posture accompanies the order are not confirmed here and should be verified against the Treasury release or any public order.
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The en banc Eleventh Circuit overruled decades-old precedent requiring administrative exhaustion before ERISA statutory claims, removing a threshold gating step for benefit litigation in the circuit.
On October 13, 2026, the en banc Eleventh Circuit decided Bolton v. Inland Fresh Seafood Corp. of America, Inc., overruling its own long-standing line of decisions requiring claimants to exhaust a plan's internal claims and administrative-appeal procedure before suing under ERISA's statutory provisions. The available reporting is a single firm alert and describes the holding only in outline; the opinion's precise scope — whether any residual exhaustion requirement survives, and how the ruling sits alongside Supreme Court and out-of-circuit treatment — is not established by this source and should be checked against the slip opinion.
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The Fed asked for public comment on September 24, 2026 on two proposed rules implementing its GENIUS Act oversight of bank-issued payment stablecoin issuers, opening a comment window ahead of finalization.
What happened: on September 24, 2026 the Federal Reserve Board asked for public comment on two proposed rules implementing the Board's responsibilities under the GENIUS Act. The proposals set out a supervisory framework for payment stablecoin issuers that are, in the Fed's framing, directly supervised by the Board rather than by another federal prudential regulator.
Why sophisticated counsel should care: stablecoin regime design is now moving from statute to operating rules. Reserve requirements, redemption and disclosure standards, custody and segregation, and the supervisory examination and enforcement perimeter all become concrete for institutions weighing whether to issue or distribute a bank-permitted stablecoin. For banks, fintech distributors, merchant acquirers, and corporate treasury teams, the proposals will shape product design, partner selection, and how stablecoin settlement is documented in commercial agreements. The two-rule structure also suggests a division of subject matter between the Board and other agencies, which matters for clients operating across both perime
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Federal agencies finalize sweeping amendments to the Transparency in Coverage regulations, broadening disclosure obligations for health insurers.
On October 16, 2026, the Department of Labor, the Department of Treasury, and the Department of Health and Human Services jointly announced substantial revisions to the Transparency in Coverage (TIC) regulations. The amendments broaden required disclosure, obligating health plans to provide more granular pricing information for covered services and to publicly post this data in a standardized format. The changes aim to empower consumers and level the playing field in health‑networks negotiations. Law firms advising insurers, brokers, and health‑plan sponsors will need to audit compliance, update data feeds, train staff, and counsel clients on impacts on network design and pricing strategy. Anticipate forthcoming enforcement guidance and potential litigation that will shape future transparency law, underscoring the need to address these changes promptly.
The General Court's Booking/Etraveli judgment tightens how dominance is shown in network-effect industries, giving complainants a stronger route to challenge concentrated mergers.
Alston & Bird's European antitrust team reports that the EU General Court's ruling in the Booking/Etraveli case may raise the risk of blocked mergers for dominant companies operating in industries defined by network effects. As described in the source, the significance concerns how dominance and market power are established and sustained where a platform's position rests on two-sided network effects rather than conventional switching costs or market-share arithmetic.
Why sophisticated counsel should care: network-effect markets are precisely those where a dominant incumbent is most likely to acquire a nascent rival, and where authorities most often challenge. If complainants' theory of dominance evidence gains traction, expect parallel theories to appear in transactional challenges, in national proceedings, and in strategic joint-venture and interoperability disputes spanning several jurisdictions.
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The agencies are seeking public input on competition in agricultural equipment manufacturing and distribution, including repair access, putting manufacturers and dealer networks on notice.
The Federal Trade Commission and the U.S. Department of Agriculture have opened a joint public inquiry into competition in agricultural equipment manufacturing and distribution, according to a Cozen O'Connor client alert. The agencies are soliciting public comment on potential anticompetitive conduct and on barriers that limit farmers' access to equipment and repair services, including parts, diagnostic software and independent servicing.
Why it matters: an FTC inquiry of this kind signals where agency attention is heading, and the right-to-repair dimension adds a consumer-protection and legislative overlay to what is otherwise a core competition question. Comments submitted through the public process will build the factual record that later enforcement, if any, would draw on. Manufacturers, dealer networks, aftermarket parts suppliers, and repair platforms should assume the agencies' review will reach beyond price and output into contracting practices, data access and service-channel restrictions.
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The UK Competition and Markets Authority has closed three more DMCCA investigations with fines totalling £6 million, signalling that its new direct consumer-enforcement fining powers are now operating in practice.
On 14 October 2026, the Competition and Markets Authority announced the conclusion of three further consumer protection investigations under the Digital Markets, Competition and Consumers Act 2024, with penalties totalling £6 million across the matters. Reporting is from Bryan Cave Leighton Paisner; the individual undertakings, sectors and total per-company penalty breakdown have not been verified from the CMA's own release here.
Why it matters: the DMCCA gave the CMA direct fining powers over consumer law breaches, removing the need to pursue enforcement through the courts and lifting the previous £5,000 cap that constrained in-house investigations. Three closures in a single announcement indicate the regime is being used at volume rather than sporadically, which changes the enforcement-risk calculus for any business selling to UK consumers.
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The agency is withdrawing its enforcement guidance that required employers to conduct individualized assessments of arrest and conviction records, easing concerns over disparate‑impact claims.
The U.S. Equal Employment Opportunity Commission (EEOC) announced that it will rescind its 2012 enforcement guidance on the consideration of arrest and conviction records in employment decisions under Title VII of the Civil Rights Act. The guidance had instructed employers that a neutral criminal‑background‑check policy could have a disparate impact on protected classes and urged the use of a nine‑factor individualized‑assessment framework. By withdrawing the guidance, the EEOC signals a shift away from the disparate‑impact theory as a basis for liability and a broader deference to employers’ neutral policies. Employers should re‑evaluate onboarding and personnel‑screening protocols and consult counsel for compliance. A review of the final rule’s text will provide further clarity on record‑keeping requirements under the new framework. Guidance revisions will also affect wage‑hour analyses and anti‑discrimination training programs.
The U.S. Department of Health and Human Services plans a short‑term rule that would let certain compounding pharmacies provide peptides previously restricted by the FDA, potentially reshaping the wellness and specialty drug market.
In early October 2026, HHS issued a notice that a temporary regulatory change would permit a limited set of compounding pharmacies to dispense specific peptides that had been covered by the FDA’s controlled substance or prescription drug classifications. The measure is intended as a bridge while the FDA develops a more comprehensive framework for these products amid growing demand from wellness and specialty care practices. The rule’s scope, which includes only peptides meeting certain potency and purity criteria, will require pharmacies to meet new labeling and record‑keeping obligations. For counsel advising compounding firms, the change provides an early opportunity to review compliance gaps and adjust operational protocols. For wellness providers and insurers, the decision signals a potential shift in the supply chain, with implications for pricing, coverage, and patient access. Over the next six months, the FDA is expected to release a draft guidance that will either formalize or sunset the temporary measure, making it crucial for affected clients to monitor the next federa
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FinCEN has identified about $17.5 billion in potentially suspicious health‑care fraud activity, signaling a sharp uptick in enforcement focus toward the medical‑service sector.
FinCEN announced on September 9 that it has identified roughly $17.5 billion in suspicious financial activity that “potentially” involves health‑care fraud. The Treasury’s enforcement action signals that the regulator is expanding its focus beyond traditional money‑laundering cases to high‑profile fraudulent schemes in the medical‑service sector. Firms advising health‑care providers, insurers and pharmaceutical companies must review their AML policies, transaction‑monitoring systems, and reporting obligations to ensure compliance with FinCEN’s guidelines. The announcement also highlights the importance of robust due‑diligence on billing partners, pay‑or‑return arrangements, and third‑party intermediaries. While the exact entities targeted remain undisclosed, the magnitude of the suspected fraud underscores the potential scope of liability and the risk of self‑reporting penalties. Clients should assess whether their current controls are aligned with FinCEN’s evolving enforcement priorities and consider independent audits or enhanced training. Monitoring further FinCEN guidance or enfo
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The SEC's October 1, 2026 release would let advisers and regulated funds self-custody crypto assets under conditions and would overhaul existing adviser, registered fund and BDC custody rules.
The SEC published a release on October 1, 2026 proposing, subject to conditions, that investment advisers and regulated funds — including registered funds and business development companies — be permitted to self-custody crypto assets, alongside a broader overhaul of the existing custody framework for advisers, registered funds and BDCs.
Why sophisticated counsel should care: custody rules sit at the intersection of fiduciary duty, safekeeping liability, segregation and recordkeeping obligations. A shift from third-party custody toward self-custody, even conditioned on safeguards, would redraw the boundary between a manager's investment discretion and its asset-protection obligations, and would likely ripple into fund documentation, administrator and auditor scopes of work, insurance and indemnity provisions, and investor disclosures. Advisers and fund boards will want to assess whether current sub-custody arrangements, control environments and vendor contracts remain fit for purpose before any compliance period matures.
…
The CFTC's October 5 advance notice of proposed rulemaking would apply CEA section 2(c)(2)(D) to leveraged retail crypto transactions, signaling a path toward registered-exchange or FCM intermediation.
On October 5, the CFTC issued an advance notice of proposed rulemaking previewing two rules, "Regulation Crypto Asset Transactions" and "Regulation Crypto Asset Markets." The proposals would apply section 2(c)(2)(D) of the Commodity Exchange Act to leveraged retail crypto, a provision the agency has previously read as the hook for asserting jurisdiction over off-exchange retail derivatives in digital assets.
Why sophisticated counsel should care now: the ANPRM is a solicitation of comment rather than a rule, but it signals that the agency sees a statutory route to pulling leveraged retail crypto products inside the registered swaps, FCM and designated contract market architecture. Exchange operators, trading venues, market makers and broker-dealers with retail distribution channels should assess whether their current product menus, customer agreements, disclosure documents and segregation arrangements survive a future registration model — and their largest bank and institutional counterparties should price the possibility of volume migrating on-exchange. Firms with non-US retail cry
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The Fed asked for public comment on September 24, 2026 on two proposed rules implementing its GENIUS Act oversight of bank-issued payment stablecoin issuers, opening a comment window ahead of finalization.
What happened: on September 24, 2026 the Federal Reserve Board asked for public comment on two proposed rules implementing the Board's responsibilities under the GENIUS Act. The proposals set out a supervisory framework for payment stablecoin issuers that are, in the Fed's framing, directly supervised by the Board rather than by another federal prudential regulator.
Why sophisticated counsel should care: stablecoin regime design is now moving from statute to operating rules. Reserve requirements, redemption and disclosure standards, custody and segregation, and the supervisory examination and enforcement perimeter all become concrete for institutions weighing whether to issue or distribute a bank-permitted stablecoin. For banks, fintech distributors, merchant acquirers, and corporate treasury teams, the proposals will shape product design, partner selection, and how stablecoin settlement is documented in commercial agreements. The two-rule structure also suggests a division of subject matter between the Board and other agencies, which matters for clients operating across both perime
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CMS issued a proposal to overhaul Medicare Advantage and Part D while a House bill aims to delay the finalization of the 340B rebate model, creating uncertainty for insurers, pharma, and providers.
CMS’s proposed rule, part of the Consolidated Appropriations Act, 2026 implementation, intends to rethink how Medicare Advantage plans reimburse providers and to reshape Part D drug benefit structures, potentially tightening premiums and altering benefit tiers for beneficiaries.
A concurrent bipartisan House bill would delay the finalization of the 340B rebate model, giving manufacturers and hospitals additional time to adjust to the new pricing framework. The combination of a CMS proposal and congressional action creates a period of regulatory uncertainty for all stakeholders—plans, pharmacy benefit managers, manufacturers, and covered entities—who must prepare for possible changes in data submissions, reimbursement formulas, and compliance timelines.
Lawyers should advise clients on scenario planning, risk assessment, and early engagement with CMS technical assistance programs to mitigate exposure. The roadmap for the rule’s approval and the bill’s passage will affect strategic decisions early next year, making this development a priority for all large‑firm healthcare practices.
The Bipartisan American Affordability and Jobs Act of 2026 introduces sweeping reforms to speed up project permitting, potentially reshaping the U.S. infrastructure and energy development landscape.
The Bipartisan American Affordability and Jobs Act—announced on September 30, 2026 by Senate Environment and Public Works (EPW) and Energy and Natural Resources (ENR) Committee leaders—heralds a major overhaul of the federal permitting process. The bill amends statutes to shorten approvals for infrastructure and energy projects, establishing a consolidated review framework, clarifying agency responsibilities, and expanding use of digital permitting portals. For counsel and clients, the reforms could reduce project lead times by up to 30 % and lower compliance costs, especially for large‐scale renewable and grid‑upgrade ventures. Firms handling complex project finance or cross‑state developments should scrutinize the new statutory language, assess whether their current permitting strategies align with the proposed expedited timelines, and consider updating internal compliance workflows. The Act’s provisions will likely be implemented over the first 12–18 months, so monitoring federal agency guidance and any court challenges will be essential to anticipate operational changes and p
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Federal agencies finalize sweeping amendments to the Transparency in Coverage regulations, broadening disclosure obligations for health insurers.
On October 16, 2026, the Department of Labor, the Department of Treasury, and the Department of Health and Human Services jointly announced substantial revisions to the Transparency in Coverage (TIC) regulations. The amendments broaden required disclosure, obligating health plans to provide more granular pricing information for covered services and to publicly post this data in a standardized format. The changes aim to empower consumers and level the playing field in health‑networks negotiations. Law firms advising insurers, brokers, and health‑plan sponsors will need to audit compliance, update data feeds, train staff, and counsel clients on impacts on network design and pricing strategy. Anticipate forthcoming enforcement guidance and potential litigation that will shape future transparency law, underscoring the need to address these changes promptly.
The guidance sets a new methodology for determining U.S. content in mobile industrial equipment that qualifies under the US‑MCA, potentially shifting the tariff burden for firms importing or exporting such goods.
The U.S. Bureau of Industry and Security released guidance on Oct 14 2026 that revises how to calculate the “U.S. content” of mobile industrial equipment and machinery subject to Section 232 metal tariffs and falling within the USMCA qualifying list. The new methodology includes specific break‑downs of component percentages, recent shipment data, and updated weight‑based formulas. Firms engaged in importing or exporting mobile equipment will need to reassess their tariff calculations, as the guidance may lower the audit threshold for certain items and alter duty amounts. Compliance teams should review the new weightings and update internal procurement reports accordingly. The guidance has yet to be tested in real‑world customs cases, so stakeholders should monitor enforcement actions for further clarification as regulators adapt and anticipate.
A bipartisan coalition of 40 attorneys general has filed an amicus brief supporting New Jersey's petition asking the Supreme Court to review whether Kalshi may offer sports betting contracts without state gaming authorization.
A bipartisan group of 40 state attorneys general has filed an amicus brief in the U.S. Supreme Court supporting New Jersey's petition for certiorari in a case asking whether prediction market operator Kalshi may offer sports betting contracts without state gaming authorization. The filing signals unusually broad state interest in how far federal commodities-market authority reaches into sports betting, and it places a large coalition of regulators behind one state's procedural push to have the question heard.
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The en banc Eleventh Circuit overruled decades-old precedent requiring administrative exhaustion before ERISA statutory claims, removing a threshold gating step for benefit litigation in the circuit.
On October 13, 2026, the en banc Eleventh Circuit decided Bolton v. Inland Fresh Seafood Corp. of America, Inc., overruling its own long-standing line of decisions requiring claimants to exhaust a plan's internal claims and administrative-appeal procedure before suing under ERISA's statutory provisions. The available reporting is a single firm alert and describes the holding only in outline; the opinion's precise scope — whether any residual exhaustion requirement survives, and how the ruling sits alongside Supreme Court and out-of-circuit treatment — is not established by this source and should be checked against the slip opinion.
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Orrick reports that Baker v. Seattle Children's Hospital held the Washington Privacy Act does not reach tracking pixels on public-facing pages, a ruling defense counsel will test against wiretap class actions elsewhere.
Orrick reports that the Washington Supreme Court decided Baker v. Seattle Children's Hospital, holding that the Washington Privacy Act does not reach the website-operator conduct at issue involving tracking pixels on a public-facing page. The firm frames the ruling as a significant win amid a growing wave of pixel-tracking and "wiretap" class actions. Because the available account is a defense-side summary and the quoted holding is truncated, the precise scope — what conduct was excluded, and whether the court addressed consent, data-security duties, or vendor arrangements — should be confirmed against the opinion itself.
The decision matters well beyond Washington. State privacy statutes with private rights of action have increasingly been used to allege that third-party analytics, chat and pixel scripts effect unauthorized "captures" of communications. Defense counsel will mine the reasoning for dismissal and narrowing arguments in other forums, and plaintiffs will test its limits in Washington.
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Signed September 2, 2026 and effective January 1, 2027, Delaware's privacy amendments lower coverage thresholds, add a "resident" category for vendor-sourced candidate reports, and impose profiling duties on AI-assisted hiring.
Per Ogletree Deakins, Governor Matt Meyer signed amendments to the Delaware Personal Data Privacy Act on September 2, 2026, with an effective date of January 1, 2027. Two changes matter most for major-firm clients. First, coverage thresholds drop sharply: the law reaches those processing personal data of 10,000 or more Delaware residents, or 5,000 where at least 20 percent of revenue comes from selling personal data. Second, while employees remain outside the "consumer" definition, a new "resident" category captures personal data processed in connection with profiling and vendor-produced reports used to decide whether to offer employment opportunities — closing the gap around automated sourcing, screening, and ranking tools used before FCRA-regulated background checks.
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Treasury's October 1 action against an alleged Russia-linked shadow banking network, paired with a FinCEN proposed rule, extends sanctions exposure to banks and correspondent channels tied to Iran evasion.
On October 1, Treasury announced coordinated actions against a Russia-linked shadow banking network it alleged helped the Iranian regime evade sanctions, as part of an operation Treasury describes as Operation Economic Outcast. FinCEN concurrently issued a notice of proposed rulemaking, indicating the package pairs designations with prospective anti-money-laundering or reporting obligations rather than enforcement action alone.
Why sophisticated counsel should care: shadow banking designations typically reach beyond the named entities to the institutions that transact with them. Financial institutions, payment processors, and non-US intermediaries with correspondent exposure may find themselves facing de-risking decisions, blocked-property and reporting questions, and heightened diligence expectations well before any penalty. The proposed rule is also a comment-period opportunity — a defined window for banks and trade-finance participants to shape forthcoming AML obligations before they bind.
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Treasury's first civil penalty under the Outbound Investment Security Program — $200,000 against Amidi, LLC for a failure to file — turns the national security investment program's reporting duties into an enforceable obligation.
On October 7, 2026, the U.S. Department of the Treasury announced its first civil penalty under the Outbound Investment Security Program: a $200,000 assessment on Amidi, LLC for failing to submit a required notification. The action is the first reported use of enforcement authority under a regime built to address national security risks from certain U.S.-person outbound investments, and it shifts the program's filing obligations from guidance into a line counsel can be penalized on.
The dollar figure is modest; the signaling value is not. Clients with U.S. persons in the covered transaction space should assume Treasury may examine filing scope and timeliness independently of any concern about the counterparty, and should review whether historic and pending covered deals were correctly classified and reported.
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State Department's DDTC has issued a proposed rule amending ITAR, including removal of certain items from the U.S. Munitions List, signaling a significant shift in defense-trade controls now open for public comment.
According to the Holland & Knight alert, the U.S. Department of State's Directorate of Defense Trade Controls has published proposed amendments to the International Traffic in Arms Regulations, described as an "omnibus" package. The headline element is removal of certain items from the U.S. Munitions List, which would move those articles out of ITAR jurisdiction and into Commerce Department export controls administered under the EAR. The rule reportedly also clarifies several key ITAR definitions.
For export-control and trade-compliance counsel, a USML deletion is not a housekeeping edit. Items leaving the USML change licensing authorities, registration obligations, jurisdiction-of-manufacture and Country-of-Origin rules, and the triggers for U.S. persons to handle technology or manufacturing data. Defense primes, component suppliers, and dual-use exporters with mixed portfolios need to map which lines shift regimes before the rule is final, and to check downstream effects on licenses, ITAR end-use statements, and pending authorization requests.
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The U.S. Treasury announced on October 7, 2026 its first civil penalty under the Outbound Investment Security Program, converting the regime's penalty authority from dormant statute into an enforced compliance regime.
Treasury announced on October 7, 2026 that it had issued its first civil penalty under the Outbound Investment Security Program (OISP), a Treasury-run national-security investment screening regime covering certain transactions involving covered persons in sensitive technology sectors. Until now, the program's penalty authority existed on the books without a public enforcement exemplar; the announcement identified the penalized party as Amidi. The source material is a single law-firm alert, so the penalty amount, the charged violation, and whether any settlement admission or litigation posture accompanies the order are not confirmed here and should be verified against the Treasury release or any public order.
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The SEC's October 9, 2026 proposal would broaden when registered funds and BDCs may cross trade with affiliates, reopening compliance analysis for asset managers, advisers and broker-dealers.
The SEC proposed amendments to Rule 17a-7 under the Investment Company Act of 1940 on October 9, 2026, according to a Skadden client alert. The rule governs cross trading between registered investment companies and business development companies and their affiliates, and the proposal would expand the universe of transactions that qualify for the exemption from Section 17(a) affiliate dealing restrictions, with attendant conditions and disclosure.
Why sophisticated counsel should care: Rule 17a-7 has been the main pathway for internal liquidity, securities lending and portfolio rebalancing between fund complexes and affiliated trading desks. Broadening permitted cross trading could unlock new efficiencies for large fund sponsors and their affiliated broker-dealers, but it also resets the documentation posture for trading arrangements, agency and best-execution analysis, allocation among participating funds, and the disclosures investors receive. The compliance burden lands unevenly across complexes depending on current affiliate-trading practices and existing exemptive relief.
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The ruling clarifies how existing Chinese laws apply to disputes involving AI, potentially reshaping litigation strategies for businesses.
China’s Supreme People’s Court released its first comprehensive judicial guidance outlining how courts are expected to apply existing legal principles to artificial‑intelligence‐related disputes. The guidance addresses a wide range of issues, from contractual interpretation and liability for autonomous systems to the admissibility of AI‑generated evidence and data‑protection considerations. For attorneys and multinational clients operating in China, the ruling signals that the court will impose a stricter scrutiny on AI claims and will consider the precise nature of the technology – e.g., algorithmic decision‑making versus simple tool usage – when evaluating fault and damages. Practically, firms should review their AI governance policies, assess the exposure of their contractual structures, and anticipate that court rulings will now explicitly reference the guidance provisions. Clients ought to engage Chinese counsel early, update risk assessments, and consider local regulatory alignment. Watching subsequent trial rulings will reveal how the courts interpret the guidance and whether
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The first appellate fair use decision on generative AI training reportedly went against ROSS Intelligence, leaving core AI-training copyright questions open across circuits.
On September 29, 2026, the U.S. Court of Appeals for the Third Circuit decided Thomson Reuters v. ROSS Intelligence, applying copyright fair use to the use of legal headnotes and related material in training generative AI. According to a King & Spalding client alert (the only source in this cluster; the full opinion was not available for review here), the panel ruled against ROSS and characterized the use as something other than "ordinary," leaving broader generative AI training questions unresolved.
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Grade 3 — worth a glance, not the full analysis.
- Investor Checklist for AI‑Enabled Medtech Products
Foley & Lardner outlines key regulatory questions investors must ask before funding an AI‑based medical device.
- NY Attorney General Secures $35M Settlement, Permanent Ban on Former Crypto Lending CEO
The New York AG boxed a former crypto‑lending CEO, granting up to $35 million in contingent payments and imposing a permanent industry bar.
- Federal Circuit’s PTAB Take on Range of Motion v. Armaid
The court’s ruling could shape how PTAB motions are framed and challenged.
- Ofgem Connect reform: weighing self-build and transfer against self-build and own
Bryan Cave's analysis of the two routes developers can take on new transmission demand projects under Ofgem's proposed Connect reforms explains the commercial trade‑offs for grid connection applicants.
- Auto Care Moves to Join Colorado EPR Suit Over Dual PRO Fees
Auto Care Association moved to intervene in the federal Colorado EPR suit, claiming producers face duplicate fees from two separate PROs.
- Missouri AG sues Temu over privacy and consumer protection allegations
Missouri's attorney general has sued Temu in state court alleging deceptive practices, Missouri residents' privacy violations, harm to state brands and possible CCP ties, following a multi-year investigation.
- EC issues €40 million merger-review procedure fine
A law firm alert says the European Commission and national competition authorities have grown more active in fining procedural breaches of merger control, with the Commission's latest penalty reaching €40 million.
- Guide: Economic Sanctions Self‑Check for Multinationals
This guide outlines a self‑check framework for reviewing supply‑chain contracts to identify and manage economic‑sanctions risks faced by multinationals.
- Nasdaq Eliminates $2 & $3 Initial Listing Options, Imposes $4 Minimum
The exchange’s new rule removes low‑price listing alternatives, forcing issuers to meet a higher minimum share price.
- UK Government Consults on Whistleblowing Reform and New Employer Duties
The UK Government has opened a consultation on changing the whistleblowing protections framework and creating new compliance duties for employers, a signal for employment and compliance teams tracking future UK labor regulation.
- NYC Fair Chance Act Final Rules Adopted, Effective October 30
The NYC Commission on Human Rights adopted amended Fair Chance Act rules effective October 30, 2026, codifying per se violations, a five-business-day response window and a five-day presumption on unpaid leave.
- Illinois AG's Equinox Suit Sharpens Non-Compete Compliance Risk
Seyfarth Shaw's analysis of the Illinois Attorney General's action against Equinox frames systemic Freedom to Work Act noncompliance as a concrete enforcement risk for Illinois employers.
- White House AI Task Force Seeks Provider Incident Disclosures
Axios reports the super intelligence task force has demanded AI providers immediately disclose and remediate AI incidents, though no formal rule text appears in evidence.
- Washington DFI Settles with Crypto Kiosk Operator for $2.5 Million
The Washington State Department of Financial Institutions finalized a multistate consent order resolving alleged violations by a money‑transmitter and crypto kiosk operator.
- CFPB Opens Inquiry Into Debanking Practices at Largest U.S. Banks
The Consumer Financial Protection Bureau announced on October 14 a new initiative targeting potentially unlawful debanking of consumers and small businesses by the nation's largest banks.
- Massachusetts Updates Paid Family Leave Law
The state released new PFML rules that take effect in Q1 2027, altering employer compliance requirements.
- FHA Letter 2026-11 Allows Alternative Credit Score Models for Minimum Decision Score
Per Orrick, the FHA issued Mortgagee Letter 2026-11 on October 8 allowing mortgagees to use alternative credit score models, including FICO 10T and VantageScore, in determining minimum decision credit scores.
- FDA Opens Rare Disease Review Framework to Comment, Meeting Oct. 28
The agency's October 14 Rare Disease Framework Initiative white paper and request for information invite comment on how rare disease products are reviewed, with a public meeting set for October 28.
- OCC Interpretive Letter 1194 Clears Banks to Offer Guarantee Insurance
A September 3 OCC interpretive letter concludes that personal guarantee insurance for loan guarantors is a permissible credit-related insurance activity for national banks.
- NYDFS Issues Guidance on Cybersecurity Risk Assessments
The New York Department of Financial Services released new instructions on how regulated entities must conduct and use cybersecurity risk assessments under 23 NYCRR Part 500.
- FMC Proposes $200,000 Fees on Spanish-Flagged Vessels, Curbs on Spanish Imports
The Federal Maritime Commission proposed fees on Spanish-flagged vessels and limits on Spanish imports after Spain denied port access to certain U.S.-flagged ships; scope details are unclear from one report.
- California Expands Financing Law to Small Business Commercial Lending
California's AB 2116 broadens the California Financing Law to cover providers of small business commercial financing, adding licensing, disclosure and data-reporting obligations for non-bank lenders.
- Pennsylvania AG sues insulin makers and PBMs over alleged price fixing
Pennsylvania Attorney General Dave Sunday filed suit against Eli Lilly, Novo Nordisk, Sanofi-Aventis USLLC and several pharmacy benefit managers, alleging collusion around insulin pricing.
- Eleventh Circuit vacates injunction on Georgia social media law
The appeals court's vacatur leaves Georgia's under-16 social media statute, effective July 1, 2025, free to be enforced again, though the source does not set out the court's reasoning.
- De-Banking Cases Raise the Stakes for AML Accountability
Perkins Coie reviews recent de-banking cases, as banks' exits from customer relationships over regulatory or reputational risk become a growing legal and political flashpoint.
- UK Employment Rights Act 2025 reforms phase in during October 2026
UK employers face a new tranche of Employment Rights Act 2025 changes in October 2026, including longer Employment Tribunal claim time limits, expanded harassment-prevention duties and broader trade union rights.
- EEOC sues Bollinger Shipyards over blanket Suboxone ban in hiring
The EEOC's second ADA suit in two years against the same employer alleges a blanket ban on Suboxone for safety-sensitive roles replaced the individualized direct-threat assessment the ADA requires.
- 45-State Coalition Seeks Court Approval of Three Generic Drug Settlements
Connecticut AG William Tong reports that a 45-state coalition is asking a court to approve settlements with Ascend Laboratories, Citron Pharma and Mayne Pharma resolving generic-drug conspiracy allegations.
- Manhattan DA Bragg launches Corporate Crime and Antitrust Task Force
The Manhattan District Attorney's office announced a new Corporate Crime and Antitrust Task Force, signalling heightened prosecutorial focus on price-fixing, no-poach and bid-rigging conduct in New York courts.
- Countdown to go-live: implementing the ISDA 2026 FX Definitions
Hogan Lovells flags the run-up to the ISDA 2026 FX Definitions replacing the prior definitions booklet, a documentation change affecting how FX derivatives trades, confirmations and disputes are constructed and performed.
- Colorado Moves to Partially Dismiss EPR Challenge
On Oct. 13, Colorado’s CDPHE adopted an Oregon‑style tactic to dismiss portions of a lawsuit challenging the state’s Extended Producer Responsibility law, shifting the compliance landscape for distributors.
- Finra fines broker‑dealer $800K over AML lapses tied to foreign small‑cap IPOs
A New York broker‑dealer was penalized for AML and supervisory failures after several foreign‑issued small‑cap IPOs it handled.