News & Perspectives | Arnold & Porter

Puget Sound Business Journal Interviews Pallavi Mehta Wahi on Arnold & Porter Seattle Growth

Fri, 10 Jul 2026 00:00:00 -0500

Pallavi Mehta Wahi, Arnold & Porter Chair of Western U.S. Strategic Growth and head of the firm’s Seattle office and India practice, was recently quoted in the Puget Sound Business Journal article, “Law firm Arnold & Porter to expand with move to Seattle’s One Union Square,” discussing the firm’s ongoing strategic West Coast growth.

Attempt to Amend in the First UPF Personal Injury Suit Fails to Clear Specific Causation Hurdle

Fri, 10 Jul 2026 00:00:00 -0500

On June 30, 2026, the U.S. District Court for the Eastern District of Pennsylvania denied the plaintiff leave to amend his complaint in Martinez v. Kraft Heinz, reinforcing that private ultra-processed food (UPF) personal injury claims must plausibly allege product-specific but-for causation. The court held that generalized allegations linking UPFs to disease and industry-wide liability theories were insufficient to state a claim, underscoring the significant causation hurdles facing private plaintiffs while leaving the litigation landscape for government enforcement actions largely unchanged.

Capital Snapshot: A Monthly Overview of the Issues, Events, and Timelines Driving Federal Policy Decisions

Fri, 10 Jul 2026 00:00:00 -0500

Our Legislative & Public Policy team is pleased to provide the July 2026 edition of Capital Snapshot, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions.

Anti-Corruption Report Features Daniel Bernstein in Compliance Reps and Warranties Series

Thu, 09 Jul 2026 00:00:00 -0500

Daniel Bernstein, Arnold & Porter White Collar Defense & Investigations counsel, was recently quoted in a four-part Anti-Corruption Report series examining the role of compliance representations and warranties in managing legal and regulatory risk.

Evan Rothstein Quoted in Law360 on Key Midyear Patent Decisions

Thu, 09 Jul 2026 00:00:00 -0500

Evan Rothstein, co-chair of Arnold & Porter’s Intellectual Property practice, was quoted in the Law360 article, “Biggest Rulings For Patent Attys In 2026: A Midyear Report,” which examines several of the year's most significant patent decisions from the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit.

Arnold & Porter Advises Aurobindo Pharma in FTC Clearance for Acquisition of Lannett Company

Thu, 09 Jul 2026 00:00:00 -0500

Arnold & Porter recently represented Aurobindo Pharma Limited in obtaining Federal Trade Commission (FTC) clearance for its acquisition of Lannett Company, Inc., a manufacturer of generic pharmaceutical products, in a transaction valued at approximately $250 million.

Oversight of Laboratory Developed Tests One Year After ACLA v. FDA: Assessing Legislative Proposals in Context

Thu, 09 Jul 2026 00:00:00 -0500

Our latest Advisory examines the current state of laboratory developed test oversight, highlights key developments since the court’s decision, and explores what stakeholders should be watching as policymakers consider future regulatory approaches.

John Elwood Discusses Supreme Court and Federal Appeals Court Decisions in Law360

Wed, 08 Jul 2026 00:00:00 -0500

John Elwood, head of Arnold & Porter’s Appellate and Supreme Court practice, was quoted in the Law360 article, “After Tense Terms, Hints Of High Court Harmony With Circuits,” discussing signs of increasing alignment between the U.S. Supreme Court and the federal courts of appeals during the Court's latest term.

Law360 Quotes Patrick Madden on Third Circuit FLSA Gap Time Decision

Wed, 08 Jul 2026 00:00:00 -0500

Patrick Madden, a partner in the firm’s Labor & Employment group, was quoted in the Law360 article, "5 Major Wage And Hour Rulings So Far In 2026," which examines several significant wage-and-hour decisions issued during the first half of 2026.

Antitrust Agency Insights: Developments at the U.S. Antitrust Enforcement Agencies — Second Quarter 2026

Wed, 08 Jul 2026 00:00:00 -0500

Successfully navigating antitrust agency investigations requires a familiarity with Department of Justice and Federal Trade Commission processes, as well as insight into those agencies and their leaderships’ current priorities for enforcement and competition policy. This Newsletter will provide periodic updates on both, offering an analytical look at how the antitrust agencies are approaching important competition issues and what current investigations may mean for potential future enforcement. We hope our experience — both inside and outside these agencies — will provide insights that help you make more informed decisions for your business.

Law360 Interviews Ron Lee on NDAA Implications for Government Contractors

Tue, 07 Jul 2026 00:00:00 -0500

Ron Lee, senior counsel in Arnold & Porter’s Government Contracts and National Security practices, was recently quoted in the Law360 article, “New Chinese Lobbying Law Raises Q’s For DOD Contractors,” covering how defense contractors are navigating implementation of a provision of the National Defense Authorization Act for Fiscal Year 2025 that prohibits the Secretary of Defense from contracting with companies that contract with a firm that provides lobbying activities for companies on the Department of Defense’s list of Chinese military companies operating in the United States.

Prominent Tech Litigator Sunita Bali Joins Arnold & Porter in San Francisco, Continuing West Coast Expansion

Tue, 07 Jul 2026 00:00:00 -0500

SAN FRANCISCO, July 7, 2026 — Arnold & Porter announced today that Sunita Bali has joined the firm’s Complex Litigation practice as a partner. Sunita will be resident in the firm’s San Francisco office.

Mark Epley Talks Federal Tax Developments with Law360

Tue, 07 Jul 2026 00:00:00 -0500

Arnold & Porter Legislative & Public Policy partner Mark Epley was recently quoted in the Law360 article, “Top Federal Tax Policies Of 2026: Midyear Report,” discussing the most consequential developments in federal tax policy from the first half of 2026.

Legal Strategies for Academic-Industry Research Collaborations

mir.elias@arnoldporter.com — Tue, 07 Jul 2026 00:00:00 -0500

Arnold & Porter’s Trial School Spotlighted in The National Law Journal

Thu, 02 Jul 2026 00:00:00 -0500

The National Law Journal recently featured Arnold & Porter’s annual trial school in the article, “AI-Proof Work: How One Big Law firm's Trial School Trains Associates,” which highlights the firm's long-standing commitment to and continued investment in preparing associates for courtroom training through immersive, hands-on training at a time when artificial intelligence is transforming many aspects of legal practice.

China Imposes Export Control and Government Procurement Restrictions on Designated U.S. Companies

Thu, 02 Jul 2026 00:00:00 -0500

On June 22, 2026, China’s Ministry of Commerce (MOFCOM) and Ministry of Finance (MOF) both announced restrictive measures targeting a total of 56 U.S. entities, likely in response to the U.S. Department of Defense’s (DoD) recent expansion of its list of “Chinese military companies,” also known as the “1260H List.” This Advisory provides an overview of the June 22 announcements, and summarizes the key prohibitions and latest developments.

Daily Journal Names Dipanwita Deb Amar and David Reis to 2026 ‘Top Labor & Employment Lawyers’ List

Wed, 01 Jul 2026 00:00:00 -0500

Arnold & Porter partners Dipanwita Deb Amar and David Reis were named to the Daily Journal's 2026 list of "Top Labor & Employment Lawyers." The annual supplement profiles California's "top labor and employment attorneys specializing in litigation, PAGA matters, unlawful terminations, and workplace investigations."

Artificial Intelligence, Privilege, and Work Product: Emerging Risks in the Life Sciences Industry

Wed, 01 Jul 2026 00:00:00 -0500

As artificial intelligence (AI) use has become prevalent in nearly every stage of litigation, including pre-litigation efforts, courts and litigants alike have encountered challenges applying longstanding doctrine to new technology. Recent decisions indicate that courts disagree on whether communications with generative AI tools are more like disclosures to a third party or more like the use of traditional word-processing tools.

Bobby McMillin Discusses Biosecure Act in STAT

Tue, 30 Jun 2026 00:00:00 -0500

Arnold & Porter Legislative & Public Policy partner Bobby McMillin was recently quoted by STAT discussing the impact of the Biosecure Act and the potential for additional legislative and regulatory measures.

Virtual and Digital Health Digest – June 2026

Tue, 30 Jun 2026 00:00:00 -0500

USDA Proposes Major Overhaul of AFIDA Rules

Tue, 30 Jun 2026 00:00:00 -0500

On June 25, 2026, the U.S. Department of Agriculture (USDA) published a proposed rule (Docket No. USDA-2026-0001; RIN 0560-AI70) that would significantly reshape the regulatory framework under the Agricultural Foreign Investment Disclosure Act of 1978 (AFIDA). The proposed rule would broaden what counts as “agricultural land,” narrow long-standing reporting exemptions, expand beneficial ownership disclosure, increase penalties, and move administration of the program to USDA’s Office of Homeland Security. A wide range of market participants could be affected, including institutional investors in farmland and timberland; commercial and rural-land developers; renewable energy and infrastructure developers; foreign persons and U.S.-organized entities with upstream foreign ownership; and even wholly domestic owners who lease to foreign tenants. Public comments are due August 10, 2026.

Who Counts as a “Foreign Person”?

Before turning to the proposed changes, it is worth pausing on a threshold point that is easy to overlook: AFIDA’s reporting obligations turn on whether a filer is a “foreign person,” and that term is defined far more broadly than many U.S. owners assume. A “foreign person” includes not only foreign individuals, foreign governments, and entities organized outside the United States, but also U.S.-organized entities in which foreign persons hold a “significant interest or substantial control.” A domestic entity can therefore be treated as a foreign person, and be drawn into AFIDA reporting, based solely on its upstream ownership. The proposed rule makes this more likely by lowering the aggregate-ownership threshold from 50% to 10%, and by counting beneficial owners and any interest held by a foreign adversary. A U.S. fund, partnership, or holding company should not assume AFIDA is inapplicable simply because it is organized domestically; the question turns on who holds direct and indirect interests in the entity. Separately, a wholly domestic landlord whose tenant is a foreign person may find that the tenant carries its own independent reporting obligation.

A National Security Initiative

The proposed rule is expressly framed as a national security measure rather than the data-collection exercise AFIDA has historically been. USDA ties the rulemaking to a January 2024 Government Accountability Office report finding that USDA had not shared timely or reliable AFIDA data with the Committee on Foreign Investment in the United States (CFIUS), and to the July 2025 National Farm Security Action Plan, which declares that “farm security is national security” and makes reform of the AFIDA process a top action item. A recurring theme throughout the proposed rule is improving the flow of AFIDA data to CFIUS and applying heightened scrutiny to foreign adversaries. It bears emphasis, however, that AFIDA remains a disclosure statute: it does not authorize USDA to block, condition, or unwind a transaction. National security review of farmland transactions continues to rest with CFIUS, which generally reaches agricultural land only where the land qualifies as “covered real estate” (for example, by proximity to a military installation) or forms part of a covered transaction.

Key Proposed Changes

Expanded Definition of “Agricultural Land”

The proposed rule significantly broadens the definition of “agricultural land,” replacing the decades-old Standard Industrial Classification codes with current North American Industry Classification System (NAICS) codes and adding: solar and wind energy generation on agricultural land; pipeline transportation corridors; farm product warehousing and processing; conservation land that could be used for farming, ranching, forestry, or timber production; and agricultural research and development activities. The proposed rule would also eliminate the current exemption for tracts of 10 acres or less generating under $1,000 in annual receipts and, for the first time, make easements and rights-of-way for non-agricultural use reportable. Importantly, land meeting the definition would be treated as agricultural land regardless of local zoning classification. Owners of farmland, timberland, conservation land, renewable energy and pipeline interests, and path-of-growth real estate holdings may wish to reassess their portfolios for potential filing obligations.

Lease Exemption Dramatically Narrowed

Currently, leaseholds of less than 10 years are exempt from AFIDA reporting. Under the proposed rule, that exemption would be reduced to leases of less than one year for most foreign persons, and eliminated entirely for entities from or controlled by foreign adversary countries (China, Russia, Iran, North Korea, and others designated by the Secretary of State). Short-term agricultural leases, crop production arrangements, and energy site leases that are currently exempt may become reportable.

Enhanced Beneficial Ownership and Structural Disclosure

Foreign persons that are neither individuals nor governments, including funds, partnerships, and corporate entities, would face substantially expanded disclosure requirements. The proposed rule would lower the threshold at which aggregated foreign interests constitute “significant interest or substantial control” from 50% to 10% (USDA has asked for comment on a 5% threshold) and would eliminate the current reporting exemptions for certain shareholders. The proposed rule would require: identification of all persons holding 10% or more of any interest (individually or in aggregate); identification of all “beneficial owners,” defined broadly to include anyone exercising decision-making authority over the land regardless of percentage held; ownership diagrams depicting the relationship between all interest holders; tax identification numbers and passport numbers for all foreign persons; and disclosure of shell corporation structures at all intermediary tiers. Filers would also have to submit a digital, open-source geospatial map delineating the land and its uses, together with current acreage. The proposed definition of “shell corporation” is broadly drawn and may capture holding vehicles common in institutional real estate structures.

Stricter Penalties: Restructured and Increased

The proposed rule significantly increases civil penalties and removes the existing provisions allowing downward adjustment of penalties. It would create three separate late-filing penalty schemes (for acquisitions and holdings, for transfers and inheritances, and for newly reportable holdings), each beginning with an initial $250 penalty assessed on the 91st day. Thereafter, penalties accrue on two tracks: entities designated as foreign adversaries or foreign-adversary-controlled entities would accrue 2.5% of fair market value per week, and all other foreign persons 1.5% per week. For portfolios holding multiple parcels, exposure could compound substantially.

Electronic Filing and New Portal

All AFIDA filings would have to be submitted through USDA’s new online portal (afida.landmark.usda.gov), which requires a Login.gov account. The paper FSA-153 form would be phased out, and the proposed rule removes form-specific references so that USDA can deploy a new electronic form. Filers who cannot access the portal could seek assistance from their local Farm Service Agency (FSA) office.

Administration Transferred to Office of Homeland Security

Administration of AFIDA is moving out of FSA. A separate final rule issued April 13, 2026 already transferred AFIDA authority from FSA to USDA’s Assistant Secretary for Administration, and this proposed rule would codify the sub-delegation of day-to-day administration to USDA’s Office of Homeland Security (OHS), a change that reflects the program’s more explicit national security orientation. FSA would remain the initial point of contact for filers and would assist with fair market value determinations. The proposed rule also overhauls penalty appeals: the response window would shrink from 60 to 30 days; the options to submit a written statement contesting liability or to request a hearing would be eliminated in favor of a single review by the OHS Director; payment would be required electronically through pay.gov; and decisions would be administratively final, with unpaid penalties referred to the U.S. Department of Justice.

Interaction With State Law

AFIDA operates alongside a growing patchwork of state laws. Roughly two dozen states now restrict foreign ownership of agricultural land or impose their own reporting requirements, and these vary widely in scope, triggers, and penalties. Compliance with AFIDA does not satisfy these separate state obligations. The proposed rule states that conflicting state and local laws would be preempted, while also reminding filers that they must continue to comply with applicable state and local restrictions and that USDA will keep sharing filings with state departments of agriculture. That tension, together with pending constitutional challenges to certain state foreign-ownership statutes, leaves the federal-state landscape unsettled.

What This Means for Investors and Landowners

If finalized, the rule would likely require many parties that are currently exempt, or that have never considered themselves subject to AFIDA, to evaluate new disclosure obligations. The proposed rule includes a limited safe harbor period to allow parties time to make compliant filings if deemed necessary. Different categories of market participants could be affected in different ways:

Institutional investors in farmland and timberland: Assess whether holdings fall within the expanded definition of agricultural land and whether fund, joint venture, or trust structures cross the lowered 10% aggregate threshold or trigger the new beneficial-ownership and ownership-diagram disclosures. Also, whether the reduced acreage area and changes to leasehold reporting requirements have expanded prior reporting obligations.
Commercial and rural-land developers: Pre-development or path-of-growth parcels that were farmed or grazed within the prior five years may qualify as agricultural land even if rezoned for another use; this proposed rule clarifies that the filing obligation would apply regardless of local zoning.
Renewable energy and infrastructure developers: Solar, wind, and pipeline interests, as well as easements and rights-of-way, may be reportable, including under site-control leases that were previously exempt.
U.S. entities with upstream foreign ownership: These parties face the most extensive new disclosure, including ownership diagrams, identifiers, and geospatial maps. Where a foreign adversary is involved, they also face the higher penalty track and the loss of lease exemptions.

The proposed rule provides a 90-day window after the final rule’s effective date for newly reportable holdings to come into compliance, along with a one-year reduced-penalty transition period. We are monitoring this rulemaking and can assist with assessing portfolio exposure, preparing public comments, and compliance planning. Comments on the proposed rule are due August 10, 2026.

The proposed changes could have important implications for foreign investors, agribusinesses, lenders, renewable energy companies, and other organizations with interests in U.S. real estate. This alert is for informational purposes only and does not constitute legal advice.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

Washington State’s CEMA Amendment: A Speedbump, Not a Roadblock

Tue, 30 Jun 2026 00:00:00 -0500

Washington State has seen an explosion of lawsuits under its Commercial Electronic Mail Act (CEMA, Ch. 19.190 RCW), stemming from the Washington Supreme Court’s ruling last year in Brown v. Old Navy expanding the scope of “false or misleading” email content. Our latest Advisory examines what the new law changes, what it leaves unchanged, and the practical steps businesses should consider to reduce risk while navigating Washington’s evolving enforcement landscape.

Critical Minerals and Critical Infrastructure Disputes Post-Pax Americana

Bart.Wasiak@arnoldporter.com — Tue, 30 Jun 2026 00:00:00 -0500

James Joseph Quoted in The Chronicle of Philanthropy on Evolving Trends in Major Donor Giving

Mon, 29 Jun 2026 00:00:00 -0500

James Joseph, Arnold & Porter partner and co-chair of the firm's Tax practice, was quoted in The Chronicle of Philanthropy article, "Are Wealthy Donors Giving Big Again? Yes. But It's Complicated," examining how wealthy donors are navigating charitable giving amid continued political and economic uncertainty.

Arnold & Porter Represents Chemours in First Comprehensive Federal PFAS Settlement

Mon, 29 Jun 2026 00:00:00 -0500

Arnold & Porter recently advised The Chemours Company in its settlement to resolve claims asserted by the U.S. Environmental Protection Agency (EPA) relating to per- and polyfluoroalkyl (PFAS) discharges and other alleged non-compliance actions, primarily at the company’s New Jersey, North Carolina, and West Virginia facilities.

Managing IP Names Four Arnold & Porter Lawyers as Western Europe IP Stars

Mon, 29 Jun 2026 00:00:00 -0500

Managing IP recently recognized Arnold & Porter in its 2026 IP Stars Western Europe rankings as an “Other Notable Firm” for IP Transactions in the United Kingdom (England).

Caught up in cost-benefit analysis: CAT refuses certification in Salmon collective proceedings on behalf of consumers

Mon, 29 Jun 2026 00:00:00 -0500

CAT rules against class representative in rail boundary fare case alleging abuse of dominance

Mon, 29 Jun 2026 00:00:00 -0500

Supreme Court provides welcome guidance on collective proceedings as CAT and Court of Appeal at odds

Mon, 29 Jun 2026 00:00:00 -0500

Virtual & Digital Health Digest

Mon, 29 Jun 2026 00:00:00 -0500

This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2026 from the United States, United Kingdom, and European Union.

Staying Current on Payments for Consumer Products & Retail Companies

Thu, 25 Jun 2026 00:00:00 -0500

Join Arnold & Porter’s Consumer Products & Retail industry group for the next program in our Consumer Products & Retail Navigator webinar series, focused on the latest legislative and regulatory developments shaping payments for consumer products and retail companies.

FDA Process 101: An Essential Toolkit for Practicing in FDA-Regulated Products Areas

claire.dennis@arnoldporter.com — Thu, 25 Jun 2026 00:00:00 -0500

Synapse: Arnold & Porter’s Pharma Law Day 2026

Wed, 24 Jun 2026 00:00:00 -0500

Join us on June 24 at The Circle in Zürich for the second edition of Synapse, a focused day of discussion on the most consequential EU, UK and U.S. regulatory and enforcement developments in life sciences, designed for senior in-house counsel navigating complex strategic decisions.

IRS Announces Interpretation of the Expanded Group of Nonprofit Employees Subject to Compensation Limitations Under Section 4960

Wed, 24 Jun 2026 00:00:00 -0500

Under Section 4960 of the Internal Revenue Code, a nonprofit organization is generally subject to a 21% excise tax on compensation paid to “covered employees” in excess of $1 million in any year (and on certain severance and similar “parachute payments” exceeding a defined threshold). Prior to the One Big Beautiful Bill (OBBB), “covered employees” were generally limited to (i) an organization’s top-five most highly compensated employees for the taxable year, and (ii) anyone who was a “covered employee” in a prior taxable year.

The Rise of Big Food Litigation: Is a Landmark Decision in Pennsylvania Only the Beginning?

jocelyn.wiesner@arnoldporter.com — Wed, 24 Jun 2026 00:00:00 -0500

FDA Issues Revised Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drugs and Biological Products

Wed, 24 Jun 2026 00:00:00 -0500

On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States. As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and late-stage clinical development.

FDA Proposes Expedited Investigational New Drug Pilot Program to Drive Early Phase Clinical Research in the United States

Wed, 24 Jun 2026 00:00:00 -0500

On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States.[[N:U.S. Dep’t of Health & Human Servs., Operation TrialBlazer (June 2026); U.S. Dep’t of Health & Human Servs., Press Release, HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials (June 22, 2026).]] As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and late-stage clinical development, including:

The Chemical Compound – Q2 2026

Wed, 24 Jun 2026 00:00:00 -0500

This edition of our quarterly newsletter on chemical regulatory developments provides updates on litigation, regulatory, legislative, and policy developments of importance to our clients. The newsletter focuses on actions affecting chemical substances that are the subject of ongoing regulatory activity or scrutiny by federal, state, and international authorities, as well as developments in related litigation.

Arnold & Porter’s 2026 Seattle Consumer Products, Retail, & Tech Forum

Tue, 23 Jun 2026 00:00:00 -0500

Arnold & Porter invites you to our inaugural Seattle Consumer Products, Retail, & Tech Forum, a half-day program built for legal and business leaders in the consumer products, retail, and tech industries navigating a rapidly shifting state and federal regulatory landscape.

Judicial Foreclosure and Receivership as Alternative Remedies for Washington Lenders After Vargas

Tue, 23 Jun 2026 00:00:00 -0500

On April 30, 2026, the Washington Supreme Court ruled in Vargas v. RRA CP Opportunity Trust 1 that only a “holder” of a negotiable instrument, as contemplated by the Uniform Commercial Code (UCC), can satisfy the prerequisites for conducting a nonjudicial trustee’s sale of property under the Washington Deed of Trust Act (DTA).

U.S. FTO Designations of Brazilian Criminal Organizations: Legal, Compliance, and Geopolitical Implications

Mon, 22 Jun 2026 00:00:00 -0500

Arnold & Porter invites you to a complimentary briefing on a fast-moving development with significant implications for businesses operating in Brazil.

Stephanie Kang Rejoins Arnold & Porter Los Angeles Litigation Team

Mon, 22 Jun 2026 00:00:00 -0500

Arnold & Porter announced today that Stephanie Kang has rejoined the firm’s Complex Litigation practice as counsel, resident in Los Angeles, continuing the firm’s West Coast growth.

Moving At Pace: the CMA’s Use of New UK Consumer Protection Powers and What to Expect In Year 2

Mon, 22 Jun 2026 00:00:00 -0500

In April 2025, the Competition and Markets Authority (CMA) acquired new powers to enforce consumer rights under the Digital Markets, Competition and Consumers Act 2024 (DMCCA). The CMA has deployed these new powers at pace in the first fourteen months. We set out below a short recap of these new powers, a summary of the CMA’s enforcement to date, and what to expect in Year 2.

Pinnacle Women Insights Names Kathleen Harris Among Top 10 Admired Women Leaders

Thu, 18 Jun 2026 00:00:00 -0500

Arnold & Porter partner Kathleen Harris, who heads the firm's London office, was named one of Pinnacle Women Insights’ "Top 10 Admired Women Leaders," recognizing accomplished women leaders driving meaningful impact within their organizations and industries.

China Finalizes Regulations for Pharmaceutical Sales Representatives

Thu, 18 Jun 2026 00:00:00 -0500

China’s 2026 Management Measures for Medical Representatives significantly expand pharmaceutical compliance obligations by imposing stricter oversight on medical representatives, Marketing Authorization Holders, and third-party sales organizations. The regulations strengthen anti-bribery and anti-fraud enforcement, require enhanced monitoring of promotional activities and healthcare institution interactions, and introduce new compliance, registration, and due diligence requirements that pharmaceutical companies operating in China should address before the rules take effect on August 1, 2026.

Good Technology Gone Bad: When Innovation Meets Liability

Wed, 17 Jun 2026 00:00:00 -0500

Please join Arnold & Porter’s Technology & Media industry group for a webinar exploring the legal, regulatory, and reputational risks that can emerge when innovative consumer technologies are allegedly misused

The EU Anti-Corruption Directive Raises Compliance Standard for Businesses

Wed, 17 Jun 2026 00:00:00 -0500

The EU Anti-Corruption Directive, which entered into force on May 31, 2026, creates a harmonized anti-corruption framework across the EU by standardizing corruption offenses, expanding corporate liability, and introducing significant penalties, including fines tied to a company’s global turnover. The directive applies broadly to businesses with EU operations, including non-EU companies, and introduces a new “trading in influence” offense that heightens compliance risks for organizations engaging lobbyists, consultants, or intermediaries. It also incentivizes robust compliance programs, voluntary disclosure, and cooperation with authorities, while signaling a more coordinated and aggressive enforcement environment across EU Member States.

Supreme Court Shuts the Door on ICA Rescission Claims: What Closed-End Fund Managers Need to Know

Wed, 17 Jun 2026 00:00:00 -0500

In FS Credit Opportunities Corp. v. Saba Capital Master Fund, the U.S. Supreme Court held that Section 47(b) of the Investment Company Act does not create an implied private right of action for investors seeking rescission of contracts that allegedly violate the Act. The decision reinforces that enforcement of most ICA provisions remains primarily with the SEC and limits shareholders’ ability to challenge fund governance practices through federal litigation.

Part I: Biotech Deals — Creating Optimal Licensing and Partnering Arrangements

Tue, 16 Jun 2026 00:00:00 -0500

Please join Arnold & Porter for Part I of our in-person series designed for legal and business leaders at biotechnology companies focused on optimizing their licensing and partnering.

It's a DOGE New World: Navigating the Environmental Enforcement Landscape Webinar

benjamin.piper@arnoldporter.com — Tue, 16 Jun 2026 00:00:00 -0500

National Security Controls and the Life Sciences Sector: BIOSECURE Act, Section 1260H, and COINS Act Developments

Tue, 16 Jun 2026 00:00:00 -0500

Following the U.S. Department of Defense’s addition of WuXi AppTec and other biotech companies to its list of Chinese military companies, these entities may soon face restrictions under the BIOSECURE Act, while lawmakers are also pushing to subject biotechnology investments and licensing deals with Chinese firms to outbound investment controls under the COINS Act and proposed BINSA legislation. Companies in the pharmaceutical and biotechnology sectors should closely monitor these developments, assess existing partnerships, and prepare for potential compliance and supply chain impacts.

Arnold & Porter Represents Wiley in Acquisition of Emerald Publishing Limited

Thu, 11 Jun 2026 00:00:00 -0500

Arnold & Porter recently advised Wiley, a content and research intelligence company, in its acquisition of Emerald Publishing Limited from Cambridge Information Group.

Law Times Korea Names Arnold & Porter Best Firm in 2026 Law Firm Consumer Report

Thu, 11 Jun 2026 00:00:00 -0500

Arnold & Porter was recognized in Law Times Korea’s 2026 Law Firm Consumer Report, which surveys in-house counsel on the performance of foreign law firms and joint venture law firms operating in Korea.

Virginia Access to Justice Commission Names Rosa Evergreen a Pro Bono Service Champion

Thu, 11 Jun 2026 00:00:00 -0500

Rosa Evergreen was recently named a Pro Bono Service Champion by the Virginia Access to Justice Commission in recognition of her pro bono service during the 2024-2025 bar year.

Frozen Russian Assets and Ukraine – Legal and Investigative Pathways

Bart.Wasiak@arnoldporter.com — Thu, 11 Jun 2026 00:00:00 -0500

U.S. Expands Cuba Sanctions: Analysis of New Executive Order and Early Designations

Thu, 11 Jun 2026 00:00:00 -0500

President Trump’s Executive Order 14404 significantly expands U.S. sanctions targeting Cuba by creating a new sanctions regime that operates alongside existing Cuba sanctions, broadening the scope of sanctionable activities, and introducing secondary sanctions risks for foreign financial institutions. The executive order, coupled with a series of recent designations of Cuban government entities, officials, and companies, signals a more aggressive U.S. approach toward Cuba and raises important compliance considerations for businesses and financial institutions with Cuba-related operations or counterparties.

The Legal 500 United States 2026 Recognizes Arnold & Porter Lawyers, Practices

Wed, 10 Jun 2026 00:00:00 -0500

The 2026 edition of The Legal 500 United States recognized 50 Arnold & Porter practice areas and 159 lawyers, including 30 lawyers who were distinguished as “Leading Partners,” eight lawyers as “Next Generation Partners,” and one lawyer as a “Leading Associate.” Six Arnold & Porter lawyers were also included in The Legal 500’s “Hall of Fame,” a recognition achieved by lawyers who are “widely regarded as being at the very top of the profession” and who have been consistently ranked as leading individuals by The Legal 500 for a number of years.

Eva Temkin Quoted in BioSpace on FDA’s Expanding Rare Disease Regulatory Framework

Wed, 10 Jun 2026 00:00:00 -0500

Eva Temkin, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Acting Policy Staff Director at the U.S. Food and Drug Administration (FDA)’s Office of Therapeutic Biologics and Biosimilars, was quoted in the BioSpace article, “Busy FDA gives rare disease sector complementary pathways, unanswered questions.”

Bowery Residents’ Committee Recognizes Arnold & Porter

Wed, 10 Jun 2026 00:00:00 -0500

Arnold & Porter was recently honored at the Bowery Residents’ Committee’s 2026 The Way Home Gala, recognizing the firm for its pro bono support.

Financial News Again Names Kathleen Harris One of Europe’s 50 Most Influential Lawyers

Wed, 10 Jun 2026 00:00:00 -0500

Arnold & Porter partner Kathleen Harris, who heads the firm's London office, has been named to Financial News’ list of "Fifty Most Influential Lawyers 2026,” which celebrates the top legal professionals working in Europe.

Algorithmic Pricing: Navigating Antitrust and Consumer Protection Risks

Wed, 10 Jun 2026 00:00:00 -0500

Companies increasingly are turning to artificial intelligence-driven pricing tools to optimize pricing strategies, but regulators and courts are paying closer attention to how those tools use competitor and consumer data. Recent antitrust cases, U.S. Department of Justice enforcement activity, and new state laws are shaping a rapidly evolving legal framework for algorithmic pricing, particularly where algorithms facilitate competitor coordination or enable personalized pricing based on consumer information.

FDA Proposes Revised Payor Communications Draft Guidance to Formally Include Devices and Reflect New Statutory Safe Harbor While Balancing Substantial Government Interests

Wed, 10 Jun 2026 00:00:00 -0500

The U.S. Food and Drug Administration’s 2026 Draft Payor Guidance would update the framework for communications between drug and device manufacturers and payors, including guidance on healthcare economic information, pre-approval communications, and information about unapproved uses of approved or cleared medical products. The draft guidance reflects recent statutory changes under the Pre-Approval Information Exchange Act, extends key protections to medical devices, and offers greater clarity for life sciences companies while leaving some practical implementation questions unresolved.

EU/UK Medical Device & IVD Bootcamp

Tue, 09 Jun 2026 00:00:00 -0500

Join us on Tuesday, 9 June 2026 for a full day bootcamp into the world of medical devices and IVDs! We will discuss the details you need to know, the current EU and UK regulatory landscape, and hot topics.

Law.com International Quotes Kathleen Harris on Evolving Drivers of White Collar Investigations

Tue, 09 Jun 2026 00:00:00 -0500

Arnold & Porter partner Kathleen Harris, who heads firm’s London office, was quoted in the Law.com International article, “How Speak-Up Culture is Keeping White Collar Teams Busy,” discussing changes in the UK investigations landscape.

Law360 Quotes Joel Dahlquist on Investment Treaty Claims Challenging Russia Sanctions

Tue, 09 Jun 2026 00:00:00 -0500

Arnold & Porter International Arbitration Adviser Joel Dahlquist was quoted in the Law360 article, “Claims Over Russia Sanctions Test Investment Treaty Limits,” which examines a growing wave of investor-state arbitration claims brought by sanctioned Russian individuals and entities against European countries that imposed sanctions following Russia’s invasion of Ukraine.

Recent Developments in Cross-Border Restructuring Under Chapter 15 of the Bankruptcy Code

Tue, 09 Jun 2026 00:00:00 -0500

As cross-border restructurings become increasingly common, recognition of foreign insolvency proceedings under Chapter 15 of the U.S. Bankruptcy Code has become a critical tool for protecting assets, binding U.S.-based creditors, and coordinating multinational restructurings. Recent bankruptcy court decisions highlight evolving issues surrounding Chapter 15 recognition, including the treatment of cannabis-related restructurings, the determination of a debtor’s center of main interests (COMI), and the requirement that a debtor have property in the United States to obtain recognition.

Forbes Names Five Arnold & Porter Partners to 2026 America’s Top Women Lawyers List

Mon, 08 Jun 2026 00:00:00 -0500

Five Arnold & Porter partners were recently named to Forbes’ inaugural 2026 America’s Top Women Lawyers list, which recognizes 200 of the nation’s most accomplished women attorneys across a broad range of practice areas whose leadership, influence, and achievements are shaping the future of the legal profession.

Arnold & Porter Named to Dave Thomas Foundation’s 2026 ‘100 Best Adoption-Friendly Workplaces’ List

Mon, 08 Jun 2026 00:00:00 -0500

Arnold & Porter was named to the Dave Thomas Foundation for Adoption's “100 Best Adoption-Friendly Workplaces” list. The firm has been recognized by the Dave Thomas Foundation for its adoption benefits every year since 2015. The list celebrates organizations that offer the most robust leave and adoption benefits in the United States.

Capital Snapshot: A Monthly Overview of the Issues, Events, and Timelines Driving Federal Policy Decisions

Mon, 08 Jun 2026 00:00:00 -0500

Our Legislative & Public Policy team is pleased to provide the June 2026 edition of Capital Snapshot, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions.

New Applicability Dates of Proposed Section 892 Regulations

Mon, 08 Jun 2026 00:00:00 -0500

The U.S. Department of the Treasury (Treasury) and Internal Revenue Service (IRS) have issued proposed regulations providing transition relief for foreign governments and sovereign wealth funds affected by the forthcoming Section 892 rules on debt acquisitions and effective control. The guidance would delay application of key provisions in the regulations published in 2025 and preserve existing treatment for certain preexisting and transitional investments, while Treasury and the IRS continue evaluating comments on the broader Section 892 framework.

Arnold & Porter awarded Deal of the Year (2025) for work on establishing the U.S.–Ukraine Reconstruction Investment Fund

Thu, 04 Jun 2026 00:00:00 -0500

Arnold & Porter is pleased to announce that our work on the transaction establishing the United States–Ukraine Reconstruction Investment Fund has been awarded Deal of the Year (CEE).

Arnold & Porter Advises on Launch of Life Sciences Investment Firm Banyan Bio

Thu, 04 Jun 2026 00:00:00 -0500

Arnold & Porter recently advised Banyan BioInnovations (“Banyan Bio”) in its launch as an investment firm. At the time of its launch, announced on May 5, 2026, Banyan Bio had secured more than $100 million in initial commitments from life sciences investors, including ICON plc, a clinical research organization.

Chambers USA 2026 Ranks 142 Arnold & Porter Lawyers, 75 Practices

Thu, 04 Jun 2026 00:00:00 -0500

The 2026 edition of Chambers USA named Arnold & Porter a “Leading Firm” in 75 practice areas across the nation and recognized 142 lawyers as “Leading Individuals.”

Chambers noted Arnold & Porter’s experience representing “clients on large, high-stakes and complex deals, litigation and investigatory matters,” and highlighted the firm’s “considerable depth and breadth of experience across the board.”

Personal Care Products Council 2026 Legal and Regulatory Conference

raqiyyah.pippins@arnoldporter.com — Wed, 03 Jun 2026 00:00:00 -0500

The conference brings together attorneys, scientists, and regulatory affairs professionals to address the current challenges facing the personal care industry, with sessions covering the latest legal and regulatory developments.

San Francisco Business Times Recognizes Tom Magnani as an Outstanding Voice in the Bay Area

Wed, 03 Jun 2026 00:00:00 -0500

Tom Magnani, head of Arnold & Porter’s Technology Transactions practice and co-chair of the firm’s Technology & Media industry group and Artificial Intelligence (AI) group, has been named one of the San Francisco Business Times’ 2026 Outstanding Voices.

The ICC’s 2026 Arbitration Rules: An Early Preview of the Changes (Part 2)

Wed, 03 Jun 2026 00:00:00 -0500

This article, Part 2, reviews the other significant changes made in the Rules and the practical effects these changes may have for parties, counsel, and arbitrators engaged in disputes at the ICC.

Keeping Pace with Modern Marketing: Practical Claim Substantiation in the Age of AI and Influencers

raqiyyah.pippins@arnoldporter.com — Wed, 03 Jun 2026 00:00:00 -0500

The Expanding Frontier: Product Liability Comes for AI and Digital Platforms

Tue, 02 Jun 2026 00:00:00 -0500

Please join us for a discussion of the evolving product liability landscape affecting generative AI and digital platforms.

Arnold & Porter Advises D. E. Shaw Ventures in Anthropic’s Latest $65B Financing

Tue, 02 Jun 2026 00:00:00 -0500

Arnold & Porter recently advised D. E. Shaw Ventures, the D. E. Shaw group’s venture capital and growth equity arm, in an investment in Anthropic as part of its $65 billion Series H financing.

Critical Deadline Approaching for Taxpayers Entitled to Relief From Penalties and Interest Assessed During Pandemic

Tue, 02 Jun 2026 00:00:00 -0500

A recent federal court decision in Kwong v. United States may entitle millions of taxpayers to refunds or abatements of penalties and interest assessed during the COVID-19 pandemic. Taxpayers who paid late-filing, late-payment, or certain other tax penalties during the pandemic relief period should review their eligibility and consider filing refund, protective refund, or abatement claims before key deadlines, including July 10, 2026.

SEC Proposes to Rescind Climate-Related Disclosure Rules

Tue, 02 Jun 2026 00:00:00 -0500

On May 29, 2026, the SEC proposed to rescind amendments to its rules under the Securities Act and the Exchange Act that would require registrants to provide certain climate-related information in their registration statements and annual reports.

Arnold & Porter Welcomes Corporate Partner Lindsay M. Germano in Denver

Mon, 01 Jun 2026 00:00:00 -0500

DENVER, June 1, 2026 — Arnold & Porter announced today that Lindsay M. Germano has joined the firm’s Corporate & Finance practice as a partner, resident in Denver.

SEC Proposes Significant Amendments to the Registered Offering and Public Company Reporting Framework

Mon, 01 Jun 2026 00:00:00 -0500

The U.S. Securities and Exchange Commission has proposed sweeping amendments that could significantly reshape registered offerings and public company reporting obligations. If adopted, the changes would expand access to Form S-3 and shelf registration, simplify filer classifications, and reduce compliance burdens for many issuers — particularly smaller, newly public, and emerging growth companies.

Virtual and Digital Health Digest – May 2026

Mon, 01 Jun 2026 00:00:00 -0500

Challenge to Oregon’s Packaging Extended Producer Responsibility Law Races to Trial While Other Legal Battles Brew

Mon, 01 Jun 2026 00:00:00 -0500

States are increasingly adopting packaging extended producer responsibility laws that shift recycling and waste-management costs to producers, with Oregon, Colorado, and California emerging as key litigation battlegrounds. Pending challenges may shape how states structure EPR programs, including producer responsibility organization oversight, fee transparency, dispute rights, and compliance obligations for companies that make, distribute, sell, or use packaging.

IAM Patent 1000 2026 Recognizes Arnold & Porter’s Patent Capabilities

Fri, 29 May 2026 00:00:00 -0500

The 15th edition of the IAM Patent 1000 — The World’s Leading Patent Professionals recognized 15 Arnold & Porter lawyers over seven jurisdictions for their outstanding patent work across the United Kingdom, United States, and internationally.

Corporate Criminal Liability Expanded to All Crimes Under the Crime and Policing Act 2026

Fri, 29 May 2026 00:00:00 -0500

The UK Crime and Policing Act 2026 significantly expands corporate criminal liability by making companies potentially liable for any criminal offense committed by senior managers acting within the scope of their authority, extending beyond the economic crimes covered by the Economic Crime and Corporate Transparency Act 2023. Effective June 29, 2026, the Act is expected to increase corporate enforcement activity and underscores the need for businesses to review governance, compliance, and whistleblowing frameworks, identify individuals who may qualify as senior managers, and strengthen training and risk management measures.

UK MHRA Consults on a New Regulatory Framework for Rare Disease Therapies

Fri, 29 May 2026 00:00:00 -0500

Virtual & Digital Health Digest

Fri, 29 May 2026 00:00:00 -0500

This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2026 from the United States, United Kingdom, and European Union.

In this issue, you will find the following:

U.S. News

Health Care Fraud and Abuse Updates
FDA Updates
Privacy and Artificial Intelligence (AI) Updates
Policy Updates

U.S. Featured Content

This month’s edition includes updates on health care fraud and abuse enforcement, U.S. Food and Drug Administration (FDA) artificial intelligence (AI) modernization, AI-enabled medical device regulation, state privacy and AI developments, and federal policy activity. Key items include U.S. Health and Human Services Administration Office of Inspector General’s (HHS-OIG) April 2026 audit identifying $2.3 million in improper Medicare payments for virtual check-ins and e-visits from 2019 to 2022; the sentencing of Reyad Salahaldeen and Mohamad Mustafa for a genetic testing fraud and kickback scheme involving approximately $522 million in false claims; FDA’s launch of Elsa 4.0 and the HALO data platform to support AI-enabled regulatory review and workflow automation; International Medical Device Regulators Forum’s (IMDRF) draft framework for life cycle management of AI-enabled medical devices; Utah’s decision to continue its AI prescription-renewal pilot with physician oversight; Colorado’s proposed bill to replace its existing AI consumer protection law; and several federal AI policy developments, including the American Leadership in AI Act, a congressional investigation into Chinese-developed AI models, reintroduction of the CREATE AI Act, and MACPAC’s recommendation for greater state oversight of automation in Medicaid managed care coverage and authorization processes.

EU/UK Featured Content

Regulatory activity in the EU and UK over the past month has focused on AI in health care, health data access, and digital innovation frameworks. Recent regulatory developments in the EU and UK point to a decisive shift from high level policy ambition to the practical mechanics of enabling AI driven health care, with particular emphasis on health data governance, regulatory pilots, and institutional readiness.

At the EU level, attention is increasingly focused on building durable frameworks to support innovation while maintaining regulatory confidence. The European Medicines Agency is preparing to pilot enhanced regulatory support for breakthrough medical devices and in vitro diagnostics (IVD), an initiative expected to shape future reforms of the EU medical device and IVD regimes. In parallel, the European Commission has taken further steps to operationalize the European Health Data Space (EHDS) through new implementing rules on the governance of the European Health Data Space Board, signaling a move from legislation to execution. The European Data Protection Board (EDPB) has also issued draft guidelines on the application of the General Data Protection Regulation (GDPR) to scientific research, offering long awaited clarification on lawful bases, consent models, and secondary use of data, issues that are central to data intensive research and AI development and likely to influence practice across Member States once finalized.

In the UK, scrutiny has centered on whether existing data and regulatory structures are capable of supporting personalized medicine and AI at scale. Evidence to the House of Lords Science and Technology Committee highlighted the UK’s rich but underexploited health data assets and the persistence of access barriers since the pandemic, with witnesses pointing to fragmented governance and delays in data access as ongoing constraints. At the same time, the expansion of the Medicines and Healthcare products Regulatory Agency’s (MHRA) AI Airlock program, continued work by the National AI Commission, and targeted support for AI driven drug discovery reflect a more iterative, test and learn approach to AI regulation, focused on post market oversight rather than wholesale reform.

U.S. News

Health Care Fraud And Abuse Updates

HHS-OIG Audit on Improper Payments for Virtual Check-In and E-visit Services. On April 23, 2026, HHS-OIG released an audit titled, “CMS Could Strengthen Medicare Program Safeguards To Prevent and Detect Potentially Improper Payments for Virtual Check-in and E-visit Services.” The purpose of the audit was to determine vulnerabilities associated with improper payments for virtual care services. OIG’s audit found that between 2019 and 2022, Centers for Medicare & Medicaid Services (CMS) paid $2.3 million in improper Medicare payments involving virtual check-ins and e-visits. As a result, OIG recommended that (1) CMS develop system edits for billing technology-based Medicare services; (2) CMS strengthen the Healthcare Common Procedure Coding System (HCPCS) code descriptions for virtual check-ins; and (3) CMS educate providers on billing requirements for virtual check-ins and e-visits. CMS concurred with the first and third recommendations.

Two Georgia Men Sentenced for Role in Genetic Testing Fraud and Kickback Scheme. On May 4, 2026, two Georgia men, Reyad Salahaldeen and Mohamad Mustafa, were sentenced for their roles in a Medicare, Medicaid, and private health insurance fraud scheme. Salahaldeen controlled four laboratories, two of which Salahaldeen controlled with Mustafa. From 2018 through August 2020, the two paid kickbacks and bribes to marketers who targeted Medicare and Medicaid beneficiaries and individuals covered by private insurance to obtain health information and DNA samples for genetic tests. The marketers obtained DNA samples via telemarketing and methods of in-person solicitation. Additionally, at the direction of Salahaldeen and Mustafa and in exchange for kickbacks, the marketers obtained fraudulent lab forms for tests from medical providers who did not treat or consult with the patients. Salahaldeen then falsified lab forms, letters for medical necessity, and other medical records.

In total, the four laboratories controlled by the defendants submitted approximately $522 million in false claims, of which Medicare, Medicaid, and private insurers paid approximately $84 million.

FDA Updates

FDA Announces Launch of Updated Elsa AI Platform. On May 6, 2026, FDA announced significant advancements in its agency-wide AI modernization efforts, including the launch of “Elsa 4.0,” an upgraded internal AI platform now available to all FDA staff, and the consolidation of more than 40 applications and submission systems into a unified data platform called HALO (Harmonized AI & Lifecycle Operations for Data). By integrating Elsa with HALO, FDA aims to enable staff to query data, automate workflows, and access agency information more efficiently without manual document uploads. FDA leadership described the initiative as a major step toward embedding AI directly into regulatory operations to accelerate scientific review processes and support faster delivery of treatments to patients.

The updated Elsa platform introduces expanded capabilities such as custom AI agents, document generation, quantitative data analysis and visualization, secure web search functionality, voice-to-text dictation, optical character recognition (OCR), and enhanced search tools for large document repositories. FDA emphasized that Elsa operates within a FedRAMP High Secure Google Cloud environment, does not train on industry-submitted data, and maintains human oversight throughout all AI-assisted processes. FDA characterized these developments as part of a broader strategy to streamline operations, reduce administrative burdens on reviewers and investigators, and advance regulatory science through responsible AI deployment.

IMDRF Releases Technical Framework for AI Management. On April 7, 2026, the IMDRF released a draft technical framework addressing life cycle management for AI-enabled medical devices (Draft Framework), with public comments open through June 10, 2026. The draft document outlines a globally harmonized approach for the design, development, validation, deployment, monitoring, and retirement of AI-enabled medical technologies, building on the IMDRF’s prior Good Machine Learning Practice principles. The Draft Framework addresses key issues, including quality management systems, risk management, cybersecurity, human oversight, data governance, clinical evaluation, and real-world performance monitoring, while emphasizing patient safety, transparency, and responsible innovation.

The Draft Framework also highlights emerging regulatory considerations unique to AI-enabled and machine learning-based medical devices, including risks related to automation bias, data drift, explainability, cybersecurity vulnerabilities, and adaptive or generative AI models. Notably, the Draft Framework places significant emphasis on post-market monitoring, real-world performance evaluation, traceability, and transparency in labeling and user communications. While the document is not intended to establish binding regulatory requirements, it signals increasing international alignment around expectations for AI-enabled medtech products and may help shape future regulatory approaches across jurisdictions, including FDA oversight of AI-driven medical devices.

Privacy and AI Updates

Utah’s Office of Artificial Intelligence Policy Rejects Medical Licensing Board’s Call to Suspend AI Prescription Renewal Pilot. On April 20, 2026, the Utah Medical Licensing Board sent a letter to Utah’s Office of Artificial Intelligence Policy (OAIP) requesting immediate suspension of the state’s AI prescription-renewal pilot program, which was launched in January pursuant to an agreement between the state and health technology startup Doctronic, LLC. Under the pilot program, Doctronic deploys AI to automate guideline-based prescription renewals. In its letter, the Board stated that it was not consulted before the pilot launched and that prescription renewals require individualized clinical reassessment. The OAIP and the Utah Department of Commerce’s Division of Professional Licensing promptly declined the Board’s request, explaining that the OAIP was created by the Utah Legislature under SB 149 with a mandate to operate an AI regulatory mitigation program authorizing temporary waivers of regulatory requirements to test AI technologies in controlled environments, and that the Doctronic pilot was reviewed by medical professionals prior to launch. The agencies further noted that the pilot is currently in Phase One, during which a licensed physician reviews and approves every AI-generated prescription renewal before it is transmitted to a pharmacy, and that the OAIP retains authority to modify or cancel the pilot if safety benchmarks are not met. The agencies invited the Board to collaborate going forward by reviewing pilot data, providing feedback on future proposals, and connecting OAIP with subject matter experts.

Colorado Senate Bill Proposed to Replace the State’s AI Consumer Protection Law. On May 7, 2026, several Colorado Senators introduced state Senate Bill 26-189, which would repeal and replace the Colorado Consumer Protection for Artificial Intelligence Act, which was enacted in May 2024 and is currently scheduled to take effect on June 30, 2026. SB 26-189 is largely based on recommendations from a working group convened by Governor Jared Polis and, unlike the existing law, would not require companies to explain how their AI systems work, but would require developers and deployers to notify consumers when AI is used to make consequential decisions and to provide consumers with an opportunity to appeal and request human review. If enacted, the bill would take effect on January 1, 2027.

Policy Updates

Former Bipartisan Artificial Intelligence Task Force Co-Chairs Introduced the American Leadership in AI Act. On April 27, 2026, former Bipartisan Artificial Intelligence Task Force Co-Chairs Ted Lieu (D-CA) and Jay Obernolte (R-CA) introduced the American Leadership in AI Act (H.R. 8516, text). According to their press release, the bill includes over 20 bipartisan proposals from the House Bipartisan AI Taskforce report published last Congress, including proposals that would codify AI literacy efforts at the National Science Foundation (NSF), establish an AI education scholarship program at NSF, expand research on AI in education, and establish community college and area career and technical education centers of AI excellence. While bipartisan, the bill has no additional cosponsors and is unlikely to make significant progress this Congress. Additionally, we expect Rep. Obernolte to release a separate AI legislative package aligned with Congressional Republican and White House AI priorities.

House Committee Chairs Announce a Joint Investigation Into the National Security and Cybersecurity Risks Posed by Chinese-Developed AI Models. On April 29, 2026, House Select Committee on China Chairman John Moolenaar (R-MI) and House Committee on Homeland Security Chairman Andrew R. Garbarino (R-NY) announced a joint investigation into the national security and cybersecurity risks posed by Chinese-developed AI models, including DeepSeek, Alibaba, Moonshot AI, and MiniMax. The investigation reflects concerns that some China based AI companies may be using unauthorized techniques to derive capabilities from U.S. models and incorporate them into lower cost systems that are subsequently offered to American users, developers, or businesses.

Senators Reintroduce the Creating Resources for Every American to Experiment With Artificial Intelligence Act (CREATE AI Act). On April 29, 2026, Sens. Todd Young (R-IN), Martin Heinrich (D-NM), Mike Rounds (R-SD), and Cory Booker (D-NJ) reintroduced the CREATE AI Act (S. 4441). The bill would establish the National Artificial Intelligence Research Resource (NAIRR), a shared national research infrastructure to connect individuals to tools to advance AI research and development (R&D).

Medicaid and CHIP Payment and Access Commission (MACPAC) Holds May 2026 Public Meetings. On May 7, 2026, MACPAC held its May 2026 Public Meeting featuring a panel titled, “Automation in Medicaid Prior Authorization: Recommendations.” During the session, MACPAC Commissioner Michael Nardone suggested further review is needed to discuss the benefits of AI and the need for federal regulations of Medicaid decision-making that are flexible for AI. He noted that AI is evolving faster than state and federal regulations can be developed and implemented.

The commission voted affirmatively on the following recommendation: State Medicaid agencies should amend their Medicaid managed care plan contracts to require disclosure or other reporting of the use of automation in plans’ coverage and authorization processes. Disclosure should facilitate state visibility into the applications of automation tools and other elements of automation. States should also modify existing reporting requirements and oversight processes to minimize administrative burden.

EU and UK News

Regulatory Updates

European Medicines Agency (EMA) Will Launch Pilot to Support Breakthrough Medical Devices and IVDs. The pilot is expected to be launched in the second quarter of 2026 to support breakthrough medical devices and IVDs, with the objective of testing a pathway that accelerates patient access to highly innovative technologies while maintaining the EU’s high standards for safety and performance. Under the pilot, manufacturers of devices granted designated breakthrough will benefit from enhanced regulatory support, including priority scientific advice from EMA- administered medical device expert panels. The initiative builds on the MDCG 2025-9 Guidance on Breakthrough Devices adopted by the Medical Device Coordination Group (MDCG) in December 2025. Importantly, the pilot is intended to inform and shape a future EU breakthrough devices framework proposed by the European Commission in its December 2025 legislative revisions to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), including the introduction of new Article 52a of the MDR and new Article 48a of the IVDR. As such, the pilot represents a key step in strengthening an innovation friendly regulatory environment for medical technologies within the EU.

IMDRF Opens Public Consultation on a Draft Technical Framework for AI Lifecycle Management.The framework builds on the IMDRF’s previously published Good Machine Learning Practice guiding principles and sets out an internationally harmonized set of considerations and concepts spanning the entire life cycle of AI-enabled medical devices, from design and development through deployment, performance monitoring, and change management. The framework is intended primarily for manufacturers of AI-enabled medical devices, including those incorporating machine learning, and recognizes that devices using generative, autonomous, or adaptive AI technologies may require additional or heightened considerations. It aims to promote harmonized concepts and regulatory considerations across jurisdictions by describing common terminology, risk based concepts, and life cycle practices that authorities may align with their own regulatory frameworks. The document is non-binding and is not intended to serve as regulation or jurisdiction-specific guidance. The IMDRF invites stakeholder feedback on the draft until July 10, 2026.

MHRA Announces Expansion of Its AI Airlock Program, Along With Major Additional Funding. The MHRA has secured a £3.6 million multi-year funding uplift to expand its AI Airlock program, the UK’s first regulatory sandbox for artificial intelligence as a medical device (AIaMD). As reported in the November 2025 Digest, Phase two of the program explored the challenges of regulating AI-powered diagnostics. Following the conclusion of the second phase, the Department of Health and Social Care has committed £1.2 million per year over the next three years (2026 to 2029). The MHRA anticipates that it will be able to support more ambitious and longer-term testing models. Reporting is expected in summer 2026, along with the findings from the pilot phase, informing the design of phase three.

UK National AI Commission Publishes Blog on the Future of AI in Health Care. Professor Henrietta Hughes, the Patient Safety Commissioner, has authored a blog post on the work of the National AI Commission into the regulation of AI in health care. She provides insight into the responses received to the call for evidence, aimed at helping to inform the commission with its recommendations. The post refers to concerns raised in responses to the call for evidence, including the post-market monitoring of AIaMD, uncertainty around liability when AI is involved in clinical decision-making, and the need for strong safeguards alongside innovation. Broader engagement work, including MHRA-led sector roundtables involving over 30 organizations and 117 clinicians, showed that the public is more comfortable with AI supporting clinicians than making high-stakes decisions independently. The commission’s recommendations are on track to be published in Summer 2026.

UK’s Government-Backed Sovereign AI Unit Announces Support for Companies Pioneering AI in Drug Discovery. Sovereign AI is the UK’s £500 million national initiative to support promising AI companies to start, scale, and compete globally from the UK. Designed to operate like a venture capital fund with the backing of the state, the Unit combines direct investment with a comprehensive support package, including fully funded access to the UK’s largest AI supercomputers and hands-on government support navigating data access, procurement, product validation, and routes into new regulatory approaches. The first companies to receive support include a company using AI to tackle brain diseases such as Alzheimer’s and Parkinson’s, and a company developing a foundation model for AI-driven strain design in engineering biology and biomanufacturing. In addition, several startups are receiving access to the AI Research Resource supercomputer network, enabling them to train advanced models and scale cutting edge AI technologies on sovereign UK infrastructure.

UK MHRA Strengthens Its Digital Health and Technology Expertise With New Appointment From the U.S. Centers for Disease Control and Prevention. It has been announced that Jason Bonander will join the MHRA as Chief Digital and Technology Officer from late May 2026, bringing extensive experience from his role as Chief Information Officer at the U.S. Centers for Disease Control and Prevention. In his new role at the MHRA, he will work to modernize the MHRA’s services and platforms to support efficiency, transparency, and faster regulation.

House of Lords Science and Technology Committee Holds Further Oral Evidence Sessions on Personalized Medicine and AI as Part of Its Inquiry Into NHS Innovation. On April 14, 2026, evidence was heard from Professor Andrew Morris (Director of Health Data Research UK) and Professor Cathie Sudlow (Director of the Usher Institute, University of Edinburgh, and author of the 2024 “Uniting the UK’s Health Data” review). Both witnesses highlighted that the UK possesses uniquely rich health data assets but continues to under-utilize their value due to fragmented access arrangements and persistent barriers to the linkage of individual level datasets, which they described as essential to enabling large scale research, innovation, and the effective deployment of AI. The work during the pandemic was praised as a proof-of-concept for how data can be leveraged at scale. However, it was noted that since then, access barriers to health data for bona fide research purposes have become more difficult, with delays, inconsistent decision making, and uncertainty in approval routes deterring researchers and innovators. The newly established Health Data Research Service (HDRS) was broadly welcomed as a potential national coordinating body for data access and governance. Key recommendations included treating health data as critical national infrastructure, streamlining the legal framework for data access, closing the primary care data gap, embedding continuous public engagement, and fostering public trust through transparency.

Privacy Updates

European Data Protection Board Adopts Guidelines 1/2026 on Processing of Personal Data for Scientific Research Purposes. The guidelines provide clarification on how the General Data Protection Regulation (EU) 2016/679 (GDPR) applies for scientific research purposes. In particular, the guidelines clarify the scope of “scientific research” under the GDPR and introduce six indicative factors (e.g., adherence to ethical standards, societal objectives), which, if met, create a presumption that an activity constitutes scientific research under the GDPR. The guidelines also provide guidance on the legal bases for data processing, and confirm that data controllers may rely on broad consent and dynamic consent, or a combination of both, under certain conditions. In addition, the guidelines confirm that further processing of the data for scientific research purposes is presumed compatible with the original purpose of collection under Article 5(1)(b) GDPR, and that personal data may be stored for longer periods of time for scientific research purposes, even if the original purposes for processing the data have been fulfilled. The EDPB has opened a public consultation on the guidelines, which closes on June 25, 2026.

European Commission Adopts Implementing Regulation (EU) 2026/771 on the EHDS. The Implementing Regulation sets out the rules for the implementation of the EHDS Regulation (EU) 2025/327 (see our March 2025 Advisory) in regard to the establishment, management, and functioning of the EHDS Board. The EHDS Board, which will be composed of representatives from EU Member States and the European Commission, will serve as a forum for cooperation and exchange of information among EU Member States. Some responsibilities of the EHDS Board include supporting the consistent implementation of the EHDS Regulation across EU Member States, and issuing guidance and opinions to national competent authorities and other stakeholders involved in the implementation of the EHDS Regulation.

UK Information Commissioner’s Office (ICO) Finalizes Guidance on Storage and Access Technologies (SATs). This guidance covers how the Privacy and Electronic Communications Regulations (PECR) and the UK GDPR apply to cookies, tracking pixels, and device fingerprinting, reflecting changes introduced by the Data (Use and Access) Act 2025. It is intended to provide clarification on the law as it currently stands and is separate from the ICO’s ongoing work to review Regulation 6 of PECR for online advertising purposes. This guidance is relevant to life sciences companies operating patient-facing digital platforms, apps, and wearable device interfaces that use tracking technologies.

Kuran Phull is employed as a trainee solicitor at Arnold & Porter’s London office. Amalia is not admitted to the practice of law.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

The New Yorker Quotes Ambassador Barbara Leaf on Operation Epic Fury in Iran

Thu, 28 May 2026 00:00:00 -0500

Arnold & Porter Senior International Policy Advisor and former U.S. Ambassador Barbara Leaf (Amb. Leaf) was quoted in The New Yorker article, “The Epic Disaster of Operation Epic Fury,” on the strategic and diplomatic consequences of the Trump administration’s war with Iran.

EU Withdrawal Button, UK Subscription Rules, and Data Protection Risks for U.S. Online Sellers

james.castro-edwards@arnoldporter.com — Thu, 28 May 2026 00:00:00 -0500

Regulators are intensifying scrutiny of subscription practices worldwide, as we previously highlighted in our discussion of U.S. developments, and the European Union (EU) and United Kingdom (UK) are now moving aggressively ahead of the United States. In the EU, Directive 2023/2673 comes into force on June 19, 2026, requiring all businesses that sell online to EU consumers to provide a mandatory digital withdrawal function for consumer (B2C) contracts. In the UK, the Digital Markets, Competition and Consumers Act 2024 (DMCCA) will introduce new rules for subscription contracts effective Spring 2027. Together, these represent the most significant overhaul of online consumer law in over a decade. Both also carry data protection implications that may not be immediately obvious.

New York Takes Aim at Self-GRAS: Mandatory Disclosure Law Poised to Reshape Food Ingredient Oversight

Thu, 28 May 2026 00:00:00 -0500

On April 21, 2026, the New York Assembly passed the Food Safety and Chemical Disclosure Act, legislation that would establish the first state-level public disclosure regime for substances deemed “generally recognized as safe” (GRAS). If enacted, the law would require companies to submit detailed scientific support for GRAS determinations before such substances could be sold or used in food in New York, signaling a significant shift toward increased transparency and regulatory scrutiny of food ingredient safety.

Travis Annatoyn Speaks with Law360 on NEPA Reviews on Anniversary of Seven County Decision

Wed, 27 May 2026 00:00:00 -0500

Travis Annatoyn, Arnold & Porter counsel and former Deputy Solicitor for Energy and Mineral Resources at the U.S. Department of the Interior, was quoted in the Law360 article “Seven County’s Legacy Still Unwritten A Year Later,” which examines how the U.S. Supreme Court’s decision in Seven County Infrastructure Coalition v. Eagle County continues to affect federal environmental review and permitting practices under the National Environmental Policy Act (NEPA).

Virtual and Digital Health Digest – April 2026

Tue, 26 May 2026 00:00:00 -0500

Time to Learn the “Canadian Two-Step”?

Tue, 26 May 2026 00:00:00 -0500

Reverse vesting orders (RVOs) have become a significant restructuring mechanism in Canadian insolvency proceedings, allowing unwanted liabilities and assets to be transferred into a separate “ResidualCo” while preserving the debtor’s core business, licenses, and tax attributes for acquisition by a purchaser. In In re Iovate Health Sciences International Inc., the U.S. Bankruptcy Court for the Southern District of New York recognized and enforced a Canadian RVO under Chapter 15, holding that the structure did not violate U.S. public policy, that creditors were sufficiently protected, and that nonconsensual third-party releases approved in Canada could be enforced in the U.S. despite the Supreme Court’s Purdue Pharma decision limiting such releases in Chapter 11 cases. The decision is notable for providing one of the first detailed U.S. analyses of RVOs and for reinforcing the growing view that Chapter 15 proceedings permit broader cross-border restructuring tools than those available under domestic Chapter 11 practice.

The ICC’s 2026 Arbitration Rules: An Early Preview of the Changes (Part 1)

Tue, 26 May 2026 00:00:00 -0500

The International Chamber of Commerce's (ICC) revised 2026 Arbitration Rules, effective June 1, 2026, introduce significant changes aimed at improving transparency, efficiency, and procedural flexibility in ICC arbitrations. Key updates include enhanced arbitrator disclosure obligations, the elimination of mandatory Terms of Reference in most cases, expanded expedited procedures for disputes up to $4 million, and broader emergency arbitration powers that allow urgent relief against a wider range of parties. Collectively, these reforms are expected to streamline proceedings, increase early conflict identification, and provide parties with more flexible and efficient dispute resolution mechanisms.

Navigating Antitrust Compliance for Consumer Products & Retail Companies

Thu, 21 May 2026 00:00:00 -0500

Join Arnold & Porter’s Consumer Products & Retail Industry Group for the next program in our Consumer Products & Retail Navigator webinar series, focused on how to identify and avoid common antitrust traps in your pricing, contracting, and distribution practices.

Daily Journal Names Deborah Fishman and Tom Magnani to 2026 ‘Top Intellectual Property Lawyers’ List

Thu, 21 May 2026 00:00:00 -0500

Arnold & Porter partners Deborah Fishman and Tom Magnani were named to Daily Journal’s list of “Top Intellectual Property Lawyers 2026.”

Massachusetts Lawyers Weekly Recognizes Josh Barlow as a 2026 Leader in the Law

Thu, 21 May 2026 00:00:00 -0500

Arnold & Porter partner Josh Barlow has been selected as a 2026 Massachusetts Leaders in the Law honoree by Massachusetts Lawyers Weekly.

Inside OIG’s New CIA Template: What Kinex Means for Life Sciences and Healthcare Compliance

Thu, 21 May 2026 00:00:00 -0500

The 2026 OIG Corporate Integrity Agreement (CIA) for Kinex Medical Company highlights evolving healthcare compliance expectations, emphasizing stronger compliance officer independence, enhanced board oversight, rigorous fair market value documentation, and proactive auditing and monitoring obligations. The agreement also reflects the growing role of generative AI in healthcare compliance programs, signaling that organizations must implement governance controls around AI-driven decision-making while maintaining robust documentation, training, and risk assessment processes to prepare for potential OIG CIA audits and enforcement scrutiny.

Supreme Court Leaves Price-Anderson Act Split in Place

Wed, 20 May 2026 00:00:00 -0500

On Monday, the Supreme Court rejected a plea to decide a critical question regarding the Price-Anderson Act (the PAA), the federal statute that governs suits stemming from public radiation exposure from nuclear facilities.

California Supreme Court hears Gilead Tenofovir Cases, weighs scope of 'duty to innovate'

Wed, 20 May 2026 00:00:00 -0500

Judah Prero Discusses New Mexico’s PFAS Reporting Requirement with Chemical Watch News & Insight

Tue, 19 May 2026 00:00:00 -0500

Judah Prero, Arnold & Porter Environmental counsel and former Assistant State Attorney General at the Maryland Department of the Environment, was quoted in the Chemical Watch News & Insight article, “Industry braces for New Mexico PFAS product labelling requirements.”

Jonathan Martel Discusses EPA Guidance on Aftermarket Diesel Sensor Removal with Inside EPA

Tue, 19 May 2026 00:00:00 -0500

Jonathan Martel, co-chair of Arnold & Porter’s Environmental practice group and a former attorney at the U.S. Environmental Protection Agency’s (EPA) Office of General Counsel, was quoted in the Inside EPA article “DOJ, EPA Appear Split Over Legality Of Aftermarket Diesel Sensor Removal,” which examines questions surrounding EPA guidance on diesel exhaust fluid (DEF) sensor removal and the government’s ongoing enforcement posture in aftermarket diesel tampering cases.

Claire Reade Discusses U.S.-China Trade Dynamics and Trump-Xi Summit with BBC and Al Jazeera

Mon, 18 May 2026 00:00:00 -0500

Claire Reade, Arnold & Porter senior counsel and former Assistant U.S. Trade Representative for China Affairs, recently spoke with BBC and Al Jazeera to discuss the realistic prospects for U.S.-China trade negotiations ahead of the Trump-Xi summit.

President Trump Signs Executive Order Mandating Fixed-Price Contracting in Federal Procurement

Mon, 18 May 2026 00:00:00 -0500

On April 30, 2026, President Trump signed an Executive Order (EO) titled “Promoting Efficiency, Accountability, and Performance in Federal Contracting,” directing executive branch agencies to make fixed-price contracts the default and preferred method of federal procurement. But the EO not only establishes a priority for fixed-price contracts; it mandates renegotiation of the 10 largest existing cost-type contracts at each agency within 90 days. This advisory covers the EO’s key terms and likely impacts, highlighting what remains to be seen regarding the impacts on federal contractors.

Crying Fowl: What the Agri Stats Settlement Means for Competitor Benchmarking Programs

Mon, 18 May 2026 00:00:00 -0500

On May 7, 2026, the DOJ and several states reached a proposed settlement with Agri Stats, alleging that its meat industry benchmarking reports facilitated unlawful information sharing among competitors and enabled price coordination. The settlement imposes detailed restrictions on how competitively sensitive data may be collected, aggregated, aged, and distributed, reflecting the DOJ’s clearest guidance to date on the limits of permissible benchmarking and signaling a more aggressive enforcement approach toward industry information exchanges.

Arnold & Porter at the Accountants’ Liability 2026 Conference

Thu, 14 May 2026 00:00:00 -0500

Arnold & Porter is co-chairing the annual Accountants’ Liability Conference, the premier CLE event for the profession, bringing together SEC and PCAOB leadership, Big Four and mid-market accounting firms, and outside counsel to discuss enforcement trends, audit litigation, and emerging issues.

DOD Extends Foreign Ownership, Control, or Influence Disclosure Requirements to Unclassified Contracts and Subcontracts Greater Than $5 Million

Thu, 14 May 2026 00:00:00 -0500

On May 6, 2026, the U.S. Department of Defense (DOD) published a proposed rule that would extend the current prohibition on awarding classified contracts to a company subject to foreign ownership, control, or influence (FOCI), absent satisfactory FOCI-mitigation measures, to awards of noncommercial defense contracts valued at $5 million or more, regardless of whether the work requires access to classified information.[[N: Although the proposed rule generally excepts solicitations for commercial DOD contracts, a designated senior DOD official may determine that a commercial contract “involves a risk or potential risk to national security because of sensitive data, systems, or processes,” and for that reason incorporate the new DFARS clause imposing FOCI restrictions.]] To effectuate this new prohibition, the proposed rule would require all contractors bidding on and performing such defense contracts — and subcontractors whose subcontracts are valued at $5 million or more — to submit to the Defense Counterintelligence and Security Agency (DCSA) information regarding any relationships maintained by the contractor with foreign persons, which DOD may use in its evaluation of bids submitted to competitive procurements.

Companies interested in working with the DOD should carefully review the proposed rule and consider what the proposed disclosure obligations mean for their business.

Background

This proposed rule implements Section 847 of the National Defense Authorization Act for Fiscal Year 2020 (FY20 NDAA), which instructed the Secretary of Defense to “improve the process and procedures for the assessment and mitigation of risks related to foreign ownership, control, or influence (FOCI) of contractors and subcontractors doing business with the Department of Defense.” The Joint Explanatory Statement that accompanied the FY20 NDAA explains Section 847’s purpose as follows:

The conferees are concerned by the growing threat to the integrity of the defense industrial base from strategic competitors, like the Russian Federation, the People’s Republic of China, and their proxies, seeking to gain access to sensitive defense information or technology through contractors or subcontractors. The conferees recognize that there are existing efforts underway to understand and mitigate some of these risks as directed by several pilot programs …. However, the acquisition community must have greater visibility into all cleared and uncleared potential contractors and subcontractors seeking to do business with the Department. The Department must ensure that contractors and subcontractors do not pose a risk to the security of sensitive data, systems, or processes such as personally identifiable information, cybersecurity, or national security systems.

To operationalize the above mandates, Section 847 specifically requires the DOD to promulgate new clauses in the Defense Federal Acquisition Regulation Supplement (DFARS) to extend FOCI disclosure and mitigation requirements to nonclassified, noncommercial defense contracts valued at $5 million or more. (Contractors working on classified contracts are already subject to restrictions on beneficial ownership and FOCI disclosure and mitigation procedures.)

Disclosure Requirements

Consistent with Congress’ direction, the proposed rule would establish a new DFARS section 240.27X, Mitigation of Risks Related to Beneficial Ownership or Foreign Ownership, Control, or Influence, that imposes requirements on contractors bidding on DOD applicable contracts, those awarded such contracts, and subcontractors performing similarly valued subcontracts under such contracts.

First, the rule would require solicitations for noncommercial DOD contracts valued at $5 million or more to require offerors to submit Standard Form 328 (SF-328) — the Certificate Pertaining to Foreign Interests — and all required associated documents to DCSA. The SF-328 requires the offeror to report all FOCI that may exist with respect to the company. For example, the SF-328 asks, among other things:

Does any foreign person(s), directly or indirectly, own, beneficially own, or subscribe to 5 percent or more of the outstanding shares of any class of stock, participation interest, units, or total capital commitment for your organization?
Do any foreign persons serve as a member of your organization’s governing body, or hold a management position?
Does your organization have any contracts, agreements, understandings, grants, side letters, or arrangements with a foreign person(s)?
During your organization’s last fiscal year, did it derive 5 percent or more of its total revenue, net income, tuition, gifts, or endowments from any single foreign person?

For any question to which an offeror responds “Yes,” the offeror must submit additional documentation, as outlined in the SF-328.

In addition to submitting the SF-328, the proposed rule requires offerors to provide contact information for each “beneficial owner” of the business in the National Industrial Security System (NISS). A “beneficial owner” is any individual or entity who, directly or indirectly, ultimately owns or controls the business. By submitting an offer under solicitations containing this new clause, offerors will represent that they have submitted the SF-328 to DCSA and beneficial owner contact information to NISS and that the information is current, accurate, and complete.

Second, the disclosure obligation does not end at bid submission — the proposed DFARS clause also requires contractors to provide updates to their FOCI and beneficial ownership disclosures to DCSA throughout the life of the contract whenever a change to such information occurs. Furthermore, in relation to subcontracts exceeding $5 million, prime contractors must flow down the reporting obligation and ensure the subcontractor is listed as “eligible” in the NISS prior to award and for the duration of performance. If a change renders the subcontractor subject to FOCI during contract performance, the contractor is responsible for ensuring that the change is reported and any mitigation is effectuated.

Impact on Evaluations and Mitigation Requirements

Based on information provided in the SF-328 and associated documentation or any update furnished to DCSA, DCSA will determine whether the offeror or contractor is under FOCI by considering whether a “foreign interest” has the power, directly or indirectly, to:

Direct or decide matters affecting the management or operations of that company in a manner that may result in a risk or potential risk to national security or potential compromise of sensitive data, systems, or processes
Otherwise control or influence the business or management of the contractor in a manner that could adversely affect its ability to perform the contract or subcontract

“Foreign interest” is defined broadly to include: any foreign government, agency of a foreign government, or representative of a foreign government; any form of business enterprise or legal entity organized, chartered, or incorporated under the laws of another country; and any person who is not a citizen or national of the United States.

The proposed DFARS clause requires the DOD contracting entity to, before making award and based on input from DCSA, determine whether the offeror “poses a risk or potential risk of compromise to national security … related to FOCI or beneficial ownership,” and if so, determine whether such risk may be mitigated. To be eligible for contract award, the offeror must agree at the time of award to implement any risk mitigation strategy prescribed by the DOD contracting entity within 90 days of award. Relatedly, if the DOD’s contracting entity determines an already-performing contractor is under FOCI based on an update provided to DCSA, the contractor must similarly implement a risk mitigation strategy within 90 days of DOD identifying the risk. Only by implementing such a mitigation strategy — or being found to have no FOCI or beneficial ownership risks — can an offeror receive or maintain “eligible” status in the NISS.

A contracting officer may not award, modify, or exercise an option or otherwise extend a contract, task order, or delivery order unless the offeror or contractor has an “eligible” status in NISS. Neither may a prime contractor award or maintain a subcontract in excess of $5 million without ensuring the subcontractor maintains “eligible” status in NISS.

Conclusion

The proposed rule’s expansion of beneficial ownership and FOCI information disclosure and mitigation requirements are designed to protect sensitive DOD information from foreign influence. By requiring detailed assessments of beneficial ownership information to detect FOCI early in the contracting process, DOD will be better equipped to establish mitigation measures that help reduce the risk of foreign adversaries gaining access to sensitive defense-related information and intellectual property. But these changes also have broad implications for federal defense contractors.

First, defense contractors that have not already been subject to DCSA’s FOCI screening for classified contracts should prepare and have ready for disclosure detailed information about their beneficial ownership and foreign operations. Second, mitigation strategies will not be optional when they are required by DOD. Offerors and contractors must be prepared to work with the DOD contracting entity to mitigate the risk of FOCI or risk losing contracts (and even subcontracts). Third, obligations will not end upon submission of an offer. Contractors will need to stay vigilant throughout the life of a contract, keep DOD informed of pertinent changes to beneficial ownership and FOCI information, and monitor compliance of their subcontractors. Fourth, defense contractors may reasonably conclude that a high risk of FOCI may reduce their competitiveness for future contracts with DOD (even in the commercial sphere). As such, companies may wish to consider the potential follow-on effects of any future foreign ventures or partnerships.

Comments on the proposed rule are due on or before July 6, 2026. Please contact any author of this Advisory or your Arnold & Porter relationship attorney if you would like to submit comments, have questions about the proposed rule, or to seek further guidance or advice.

MHRA Launches Consultation on Modernising the Definition of Gene Therapy Medicinal Products

Thu, 14 May 2026 00:00:00 -0500

10 Months Later: Updates on U.S. Stablecoin Law

kevin.toomey@arnoldporter.com — Wed, 13 May 2026 00:00:00 -0500

Panelists Justin Skidmore and Kevin Toomey will look back at the first 10 months of the GENIUS Act in the U.S., covering obligations across reserves, disclosures, certifications, licensing, and AML.

U.S. Chamber of Commerce and Brazilian National Confederation of Industry Recognize Ambassador Thomas A. Shannon, Jr. with Brazil–U.S. Industry Award

Wed, 13 May 2026 00:00:00 -0500

Arnold & Porter Senior International Policy Advisor and Global Law & Public Policy Practice Co-Chair Ambassador Tom Shannon received the inaugural Brazil–U.S. Industry Award in the Institutional Diplomacy category.

Panel with former U.S. Environmental Protection Agency Office of General Counsel Attorneys

camille.heyboer@arnoldporter.com — Wed, 13 May 2026 00:00:00 -0500

David Kerschner and Rachel Forman Talk Digital Product Liability with Law360

Tue, 12 May 2026 00:00:00 -0500

Arnold & Porter Product Liability Litigation partner David Kerschner and counsel Rachel Forman were quoted in the recent Law360 article, “What To Watch For As Meta Stares Down NM Injunction Trial,” discussing the product liability implications of New Mexico v. Meta Platforms Inc. et al. as the second-phase proceedings begin.

Arnold & Porter Secures Complete Victory for NRCO in LNG Project Arbitration

Tue, 12 May 2026 00:00:00 -0500

Arnold & Porter secured a complete victory for NRCO Engineering, S.A. in an ICDR arbitration in Houston arising from a cross-border liquefied natural gas (LNG) supply venture in Eastern Europe.

The Rise of the AI Arbitrator: Technology, Trust, and the Future of International Arbitration

Bart.Wasiak@arnoldporter.com — Tue, 12 May 2026 00:00:00 -0500

Judge Joseph Greenaway Jr. Shares Appellate Tips and Insights in Law360

Mon, 11 May 2026 00:00:00 -0500

Judge Joseph A. Greenaway Jr., Arnold & Porter partner who formerly served as a judge on both the U.S. Court of Appeals for the Third Circuit and the U.S. District Court for the District of New Jersey, was quoted in the Law360 article, “Know 'The Record Below': Appellate Pros Talk Argument Prep,” following his participation in a panel discussion on preparing for oral arguments at the 2026 Third Circuit Bench and Bar Conference in Hershey, Pennsylvania.

Draft UK Medical Device Amending Regulations: Key Proposals and MHRA Call for Evidence

eleri.abreo@arnoldporter.com — Mon, 11 May 2026 00:00:00 -0500

Aron Estaver Returns to Arnold & Porter as Investment Management Partner in San Francisco

Fri, 08 May 2026 00:00:00 -0500

SAN FRANCISCO, May 8, 2026 — Arnold & Porter announced today that Aron Estaver has rejoined the Investment Management team of the Corporate & Finance practice as a partner, affiliated with the firm’s San Francisco office.

San Francisco Business Times Recognizes Ellen Kaye Fleishhacker as a Most Influential Woman in Bay Area Business

Fri, 08 May 2026 00:00:00 -0500

Global Co-Chair of Arnold & Porter, Ellen Kaye Fleishhacker, has been named one of the Most Influential Women in Bay Area Business by the San Francisco Business Times.

Capital Snapshot: A Monthly Overview of the Issues, Events, and Timelines Driving Federal Policy Decisions

Fri, 08 May 2026 00:00:00 -0500

Our Legislative & Public Policy team is pleased to provide the May 2026 edition of Capital Snapshot, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions. This month’s edition of the Capital Snapshot contains a review of the landscape of the 119th Congress, including upcoming congressional schedules and key dates, and recently-announced retirements, resignations, vacancies, and candidacies.

In the Room: Former Officials on National Security and Other Enforcement Issues and What It Means for Your Business

Thu, 07 May 2026 00:00:00 -0500

Legal risk for contractors and cross-border businesses is not driven solely by statute or regulation — it is shaped by geopolitics, Administration and congressional priorities, and enforcement discretion.

Digital Assets & the GENIUS Act

Thu, 07 May 2026 00:00:00 -0500

This session will address the GENIUS Act and its implications and explore recent developments in the digital asset sector and related opportunities and potential challenges for banking institutions.

Food and Drug Law Institute Recognizes Elizabeth Trentacost as a Rising Star

Thu, 07 May 2026 00:00:00 -0500

Arnold & Porter senior associate Elizabeth Trentacost has been named a Rising Star by the Food and Drug Law Institute (FDLI) at its annual conference.

The Law Commission of England & Wales Announces a Review of a Potential New Class Actions Regime

Thu, 07 May 2026 00:00:00 -0500

Washington Supreme Court Limits Remedy of Nonjudicial Foreclosure to Holders of Negotiable Instruments

Thu, 07 May 2026 00:00:00 -0500

On April 30, 2026, the Washington Supreme Court published a decision in the case of Vargas v. RRA CP Opportunity Trust 1 that may have significant ramifications for residential and commercial real estate lenders in the State of Washington.

EU AI Act Omnibus: Provisional Deal Announced – Initial Reflections for Life Sciences Companies

Thu, 07 May 2026 00:00:00 -0500

EU Implements New Rules on Uniform Procedural Requirements for Notified Body Assessments

Wed, 06 May 2026 00:00:00 -0500

Four Things to Know About the CFPB’s Final Rule Revising Small Business Lending Data Collection Under Regulation B

Wed, 06 May 2026 00:00:00 -0500

The CFPB’s May 2026 final rule revises the Section 1071 small business lending data collection framework under Regulation B by significantly narrowing the scope of institutions, borrowers, transactions, and data points subject to reporting requirements. The rule raises reporting thresholds, excludes certain categories of lending such as merchant cash advances and agricultural loans, and streamlines required data collection obligations, while signaling that the CFPB may expand the framework incrementally through future rulemakings. Financial institutions should evaluate whether they remain covered by the revised rule, continue monitoring ongoing litigation challenging Section 1071 implementation, and assess the operational and compliance implications ahead of the January 1, 2028 compliance date.

Arnold & Porter Expands European Antitrust Litigation Team with Addition of Partner Nicola Chesaites

Tue, 05 May 2026 00:00:00 -0500

LONDON and WASHINGTON, D.C., May 5, 2026 — Arnold & Porter announced today that Nicola Chesaites has joined the firm’s Antitrust/Competition litigation practice as a partner, resident in London.

Arnold & Porter Advises D. E. Shaw Ventures on OpenAI, Anthropic Investments

Tue, 05 May 2026 00:00:00 -0500

Arnold & Porter recently advised D. E. Shaw Ventures, the D. E. Shaw group’s venture capital and growth equity arm, on investments in OpenAI and Anthropic.

Arnold & Porter Defeats Class Certification in the U.S. District Court for the Central District of California

Mon, 04 May 2026 00:00:00 -0500

Arnold & Porter has secured another victory for Epoch Everlasting Play, LLC in a consumer products lawsuit over its Calico Critters toy line.

Arnold & Porter Advises Brazil on Landmark €5B Global Bond Offering, Largest Ever and First Euro Issuance Since 2014

Mon, 04 May 2026 00:00:00 -0500

Arnold & Porter advised the Federative Republic of Brazil on its landmark €5 billion global bond offering, which closed on April 23, 2026.

Constitutional Law: The Safe for Kids Act & The Freedom of Expression

Sun, 03 May 2026 00:00:00 -0500

Virtual & Digital Health Digest

Fri, 01 May 2026 00:00:00 -0500

This digest covers key virtual and digital health regulatory and public policy developments during March and early April 2026 from the United States, United Kingdom, and European Union.

In this issue, you will find the following:

U.S. News

Health Care Fraud and Abuse Updates
FDA Updates
Provider Reimbursement Updates
Privacy and Artificial Intelligence (AI) Updates
Policy Updates

U.S. Featured Content

This month’s edition covers a dynamic landscape at the intersection of health care compliance, technology regulation, and federal policy. On the enforcement front, two notable health care fraud cases, including a Florida pharmacy scheme and a $46 million telemedicine fraud, underscore the government’s continued focus on Medicare abuse. In the regulatory arena, the U.S. Food and Drug Administration (FDA) made headlines by rejecting a deregulatory artificial intelligence (AI) petition from Harrison.ai, reaffirming that premarket review remains essential for AI-powered radiology devices, while simultaneously seeking fresh input on digital health technologies in clinical investigations. Meanwhile, federal health agencies are pushing forward on digital health integration as the Centers for Medicare and Medicaid Services (CMS) launched its Health Tech Ecosystem initiative, introduced the ACCESS model for enhanced digital health reimbursement, and announced the LEAD accountable care model, all while the U.S. Department of Health and Human Services (HHS) restructured its health information technology (IT) offices to sharpen focus on interoperability. On Capitol Hill, lawmakers introduced a wave of AI-related legislation from Sen. Blackburn’s TRUMP AMERICA AI Act to bills addressing AI chatbots in professional services and biodata standardization, signaling that Congress is actively grappling with how to govern artificial intelligence across health care and beyond.

EU and UK News

Regulatory Updates
Privacy Updates
IP Updates
Product Liability Updates

EU/UK Featured Content

Regulatory activity in the EU and UK over the past month has focused on accelerating the alignment of digital, AI, and life sciences regulatory frameworks, alongside increasing scrutiny of data governance and market readiness for emerging technologies.

At the EU level, work to simplify and streamline EU AI-related legislation has advanced, with the Council of the European Union and European Parliament having adopted their positions on the European Commission’s (EC) Digital Omnibus reforms, and now entering trilogue negotiations on the final text. In parallel, MedTech Europe published its response to the EC consultation on the simplification of the EU AI rules as part of the Digital Omnibus, calling for clearer integration between the AI Act and other sectoral legislation, as well as extended implementation timelines. Separately, the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issued a joint opinion on the proposed European Biotech Act, emphasizing the need for clearer safeguards, harmonized legal bases for processing clinical data, and strong protections when health and genetic data are used in biotech and AI contexts.

In the UK, developments have focused on the role of AI-enabled innovation within the health care system. A new parliamentary inquiry into personalized medicine and AI will examine ongoing challenges and barriers to National Health Service (NHS) adoption of new technologies, including procurement, digital infrastructure limitations, and system fragmentation. At the same time, the Medicines and Healthcare products Regulatory Agency (MHRA) has secured multi year funding to expand its AI Airlock Program to support the development of more ambitious AI medical devices. These initiatives signal a continued policy commitment to embedding digital and AI driven innovation into health care delivery and to strengthening the regulatory environment required to support safe deployment at scale.

U.S. News

Health Care Fraud And Abuse Updates

Florida Mother-Daughter Duo Convicted of Health Care Fraud. On March 26, 2026, Cindy Justice, owner and president of PureScience Rx, a Florida pharmacy, and her daughter, Ashleigh Davis, operations manager at PureScience Rx, were convicted by a grand jury for health care fraud, payment of illegal kickbacks, and conspiracy to commit other offenses.

The defendant allegedly paid a telemarketing call center to target Medicare beneficiaries and facilitate medically unnecessary prescriptions, including for drugs that were not FDA-approved or supported by medical evidence. In some instances, prescriptions were issued using stolen provider identities. The scheme resulted in Medicare paying more than $4.9 million on the fraudulent claims.

Telemedicine Company Owner Pleads Guilty in $46 Million Medicare Fraud Scheme. On March 27, 2026, Christopher Harwood, owner of telemedicine company TelevisitMD, pleaded guilty to conspiracy to commit health care fraud and wire fraud in connection with a $46.2 million Medicare scheme.

The defendant allegedly targeted Medicare beneficiaries through aggressive telemarketing practices and paid physicians to approve orders for medically unnecessary orthotic braces and genetic tests without legitimate telehealth encounters or meaningful patient relationships. Harwood and his co-conspirators then sold the signed orders to durable medical equipment suppliers and laboratories, including entities he owned, which billed Medicare for the unnecessary items. Medicare paid approximately $17.9 million on the fraudulent claims, and Harwood personally received more than $10 million.

FDA Updates

FDA Rejects Deregulatory AI Proposal. On April 1, 2026, FDA replied to a petition submitted by Rubrum Advising on behalf of Harrison.ai. In the petition, Harrison.ai requested that FDA partially exempt certain class II radiology computer-aided detection, diagnosis, triage, and notification devices from 510(k) premarket notification requirements when manufacturers met specified conditions, including having prior 510(k) clearances and implementing post-market oversight measures. FDA formally denied the petition, concluding that it did not show that premarket review is unnecessary to assure safety and effectiveness. FDA was not persuaded by the petition’s arguments and rejected the claim that a manufacturer’s prior 510(k) clearance demonstrates “proficiency in processes” that would justify exempting future devices, noting that many other aspects of AI development may not translate across indications, modalities, or device types. FDA also stated the proposal would improperly let manufacturers determine what post-market controls are sufficient “in lieu of FDA review and clearance,” which is “neither consistent with the statute nor in the best interest of public health.” After reviewing public comments and applying the four established factors for Class II exemption, FDA found that the devices still present meaningful risks, that the characteristics necessary for safe and effective performance are not yet well established across all uses, and that changes could materially affect safety, effectiveness, or even classification. FDA acknowledged the petition’s proposals, reiterated its commitment to innovative approaches for digital health regulation, and pointed manufacturers toward Predetermined Change Control Plans as a more appropriate pathway to reduce regulatory burden while maintaining oversight.

Provider Reimbursement Updates

CMS Proposes Telehealth Waivers for New Innovation Center Models. CMS continues to incorporate telehealth waivers in Innovation Center models, emphasizing that such flexibilities can promote continuity of care and support broader access for Medicare beneficiaries. Most recently, CMS proposed incorporating waivers in the Long-term Enhanced ACO Design (LEAD) Model and the Comprehensive Care for Joint Replacement Expanded (CJR-X) Model.

The LEAD Model is a 10-year voluntary ACO model that will launch after the existing ACO model, ACO Realizing Equity, Access, and Community Health (REACH) Model concludes at the end of 2026. According to the recently published Request for Applications (RFA), the LEAD Model will incorporate a “telehealth benefit enhancement” similar to the one included in ACO REACH, in which CMS will waive the rural geographic component of originating site requirements and allow the originating site to include a beneficiary’s home. CMS also will waive the interactive telecommunications system requirement for certain asynchronous dermatology and ophthalmology telehealth services, allowing for digital images to be transmitted to a practitioner and evaluated outside of a real-time interaction.

Additionally, in the fiscal year (FY) 2027 inpatient prospective payment system (IPPS) proposed rule, CMS proposed a nationwide expansion of the CJR Model, which ran from 2016 through 2024. Under the proposed mandatory CJR-X Model, hospitals would be accountable for the cost and quality of care related to lower extremity joint replacement procedures for the period beginning with hospital admission through 90 days post-discharge. Like the CJR Model, CMS proposes that the CJR-X Model will waive the rural geographic component of originating site requirements and allow the originating site to include a beneficiary’s home. Furthermore, CMS proposes to create a new set of HCPCS codes to describe evaluation and management services furnished to CJR-X beneficiaries in their home via telehealth. According to CMS, the telehealth waivers will “maximize the opportunity to improve the quality of care and efficiency for episodes of care in CJR-X.”

In both the LEAD Model RFA and the FY27 IPPS proposed rule, CMS recognized that broad Medicare telehealth waivers are currently in effect, pursuant to the Consolidated Appropriations Act, 2026. But because these waivers are not permanent, CMS concluded that model-specific waivers would “guarantee” telehealth services can continue for model beneficiaries, even if the broad telehealth waivers expire.

Privacy and AI Updates

Information Sought on the Use of Digital Health Technologies in Clinical Investigations. On March 31, 2026, FDA issued a Request for Information (RFI) regarding the use of digital health technologies (DHTs)[[N: “Digital Health Technologies” or “DHTs” are defined by the FDA as “systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses.”]] in clinical investigations for drugs and biological products. The FDA previously issued guidance in this area in 2023, providing recommendations on ways to facilitate the use of DHTs in clinical investigations, including using DHTs to collect data for clinical investigation endpoints (2023 DHT Guidance). In the new RFI, the FDA explains that significant technological advancements have been made since 2023, including in sensors, such as those present in smartwatches and mobile phones, which may be customized for clinical investigations. DHTs are being designed to perform interactive clinical tests of patient functions, such as dynamometers to measure strength, apps to measure coordination and fine motor skills, and accelerometers to measure balance. In light of these developments, the agency is seeking fresh input focused on four specific questions:

What regulatory challenges do DHT manufacturers, sponsors, or other interested parties face regarding the use of DHTs in clinical investigations of drugs and biological products?
What opportunities are there for [the FDA’s Center for Drug Evaluation and Research] and [the Center for Biologics Evaluation and Research] to support and facilitate the adoption of DHTs in clinical investigations of drugs and biological products?
What areas of guidance would support the use of DHTs in clinical investigations?
What specific DHT-related topics, such as digitally derived endpoints in certain disease areas, would benefit from discussion in a public workshop?

The RFI states that information and comments received in response to these questions will inform the FDA’s development of guidance documents, as well as other FDA activities to support the appropriate use of DHTs in clinical investigations of drugs and biological products.

The deadline for submitting responses to the RFI is June 1, 2026.

Policy Updates

HHS Continues To Prioritize AI and Digital Health Tools Across Agency Activities. HHS continues to prioritize integration of AI and digital health technologies across agencies’ priorities and programming. On April 9, 2026, CMS held “Health Tech Ecosystem: Live! First Wave Launch,” during which the agency highlighted digital health tools from 50 companies that have met the Minimum Viable Product requirements deadline for the Health Tech Ecosystem pledge. One of the agency’s initiatives includes allowing patients to share their medical records with their providers via QR code in an effort to “Kill the Clipboard.”

Additionally, the FDA is soliciting additional information from companies interested in participating in its new Technology-Enabled Meaningful Patient Outcomes pilot for digital health devices, which will likely inform the FDA’s approach to regulating AI. Through the pilot, FDA will exercise “appropriate” enforcement discretion with regard to some medical device regulations so that devices can receive Medicare reimbursement under CMS’ Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, which will offer enhanced reimbursement for digital health technologies that improve clinical outcomes. On April 13, 2026, CMS announced the participation of 150 companies in the upcoming launch ACCESS model and extended the deadline for applications until May 15, 2026.

On March 31, 2026, CMS released a Request for Applications for its recently announced Long-term Enhanced ACO Design model, which will launch as a 10-year voluntary model beginning on January 1, 2027. The LEAD model aims to attract more providers, including independent practices and rural providers, to participate in accountable care organizations. According to the RFA, the model will incorporate the use of certified interoperable electronic health records; a telehealth benefit enhancement; and a Tech Enabler Initiative to identify opportunities to enhance patient care navigation, condition management, and connections with community-based services.

Reorganization of the Office of the National Coordinator for Health Information Technology. On March 31, 2026, HHS announced a restructuring of the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) in an effort to align a “focus on nationwide health IT interoperability and data liquidity.” Under the restructuring, ASTP/ONC will now be the Office of the National Coordinator for Health Information Technology. Additionally, the offices of the HHS Chief Technology Officer (CTO), HHS Chief Artificial Intelligence Officer (CAIO), and HHS Chief Data Officer (CDO) will be moved to the Office of the Chief Information Officer (OCIO). The president’s FY27 budget request would provide $50 million in funding to ONC to prioritize advancing interoperability and coordination between health IT stakeholders, including updating payment policies. Of note, ASTP/ONC was funded at $69 million in FY26.

CMS Delays Prior Authorization Implementation for Two Services Under WISeR Model. On April 6, 2026, CMS filed a notice delaying the implementation of prior authorization for two services under the Wasteful and Inappropriate Service Reduction (WISeR) model, including Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease and Percutaneous Image-Guided Lumbar Decompression for Spinal Stenosis.

On March 27, 2026, a group of 35 House Democrats sent a letter to House Appropriations Labor-Health and Human Services (L-HHS) Subcommittee leadership urging the subcommittee to include language in its upcoming FY27 L-HHS appropriations bill to repeal the WISeR Model and prohibit implementation of other models testing prior authorization in traditional Medicare. The lawmakers also expressed concern about incentives for the model’s contractors to deny care for Medicare beneficiaries.

Senator Marsha Blackburn Releases Discussion Draft of AI Legislative Package. On March 18, 2026, Sen. Marsha Blackburn (R-TN) released a discussion draft of The Republic Unifying Meritocratic Performance Advancing Machine Intelligence by Eliminating Regulatory Interstate Chaos Across American Industry (TRUMP AMERICA AI) Act. According to the press release, the legislation is intended to codify President Trump’s December 2025 AI-related executive order; it does not include broad state preemption, unlike past legislative attempts to implement state preemption. Instead, the TRUMP AMERICA AI Act opts for a narrow preemption of state laws that contradict provisions in the legislation. The legislative package combines several pieces of existing bipartisan legislation sponsored or cosponsored by Sen. Blackburn, including the Kids’ Online Safety Act (KOSA, S. 1748) and the NO FAKES Act (S. 1367).

Congress Considers AI in Health Care and Biotechnology. In March, Members of Congress introduced multiple bills at the intersection of AI, health care, and biotechnology, including the following:

On March 19, 2026, Reps. Kevin Mullin (D-CA), Debbie Dingell (D-MI), Doris Matsui (D-CA), Darren Soto (D-FL), Rashida Tlaib (D-MI), Jennifer McClellan (D-VA), and Kim Schrier (D-WA) introduced the CHATBOT Act (H.R. 7985), which would prohibit AI chatbots from providing unauthorized professional advice related to “covered professions” in the health care, financial services, legal, accounting, and other industries. The bill would increase liability for AI companies whose chatbots mislead users or provide harmful guidance, including additional enforcement authority under the Federal Trade Commission.
On March 12, 2026, Sens. Todd Young (R-IN) and Ben Ray Lujan (D-NM) and Reps. Ro Khanna (D-CA) and Jay Obernolte (R-CA) introduced the AI-Ready Bio-Data Standards Act (S. 4069/H.R. 7907). The legislation would direct the National Institute of Standards and Technology to create a national framework for standardizing biological datasets. Additionally, the bill would codify shared priorities of the National Security Commission on Emerging Biotechnology and the Trump administration’s AI Action Plan, including investing in AI-enabled biosecurity and building datasets for genomic sequencing.
On March 4, 2026, Reps. Obernolte, Khanna, Rich McCormick (R-GA), and Jake Auchincloss (D-MA) introduced the Cloud Labs to Advance Biotechnology (LAB) Act (H.R. 7801), which would direct the National Science Foundation to establish a national network of advanced, cloud-enabled laboratories to generate high-quality biological data through AI.

EU and UK News

Regulatory Updates

UK Government Publishes Explanatory Memorandum on Proposed EU MDR and IVDR Reforms. The UK government’s Department of Health and Social Care has published a memorandum explaining the European Commission’s proposal to amend Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The memorandum notes that compliance with the current regulations involves high and often disproportionate compliance costs and delays, in part due to regulatory complexity. It explains that the proposed reforms aim to streamline processes, support innovation, and ensure smoother market functioning. Under the EC’s proposal, certain software-based devices will move to a lower risk class, meaning less stringent standards will apply, and it will become easier for manufacturers to seek authorization to implement planned and regular changes to software. Obligations of manufacturers of AI-based devices, where such devices are classified as high-risk under the EU AI Act, will also be reduced. The memorandum touches on UK aspects of the reforms, noting that the MDR and IVDR will apply in Northern Ireland via the Windsor Framework. It confirms that, currently, CE marked devices will be recognized in Great Britain without additional checks until June 2030 (though indefinite recognition is currently the subject of public consultation, as we have previously reported on).

New UK-U.S. Pharmaceutical Arrangement Includes MedTech. On April 2, 2026, the UK and U.S. finalized the landmark pharmaceutical partnership announced in December, which aims to give NHS patients faster access to innovative medicines while making the UK the first country in the world to secure zero tariff access for its pharmaceutical exports to the U.S. for at least three years. It has been confirmed that no additional U.S. tariffs will apply to UK HealthTech products for at least three years, providing welcome certainty for manufacturers. However, a notable imbalance remains, with HealthTech exports still subject to a 10% tariff, compared with the new zero tariff treatment for pharmaceuticals. Industry groups have stated they will continue to press officials on both sides of the Atlantic to address this discrepancy. Building on this agreement, the MHRA and FDA have also announced a deepening of regulatory cooperation on medical devices, including exploring future mutual recognition mechanisms to reduce duplication, streamline approval pathways, and accelerate access to safe, cutting edge medical technologies for patients in both countries, while maintaining independent, world class safety standards.

Team-NB Publishes Position Paper on Revisions of the EU Medical Devices and In Vitro Diagnostics Regulations. On March 2, 2026, Team-NB (the European association of notified bodies) published a position paper on the EC proposals to amend the MDR and the In Vitro Diagnostic Regulation 2017/746 (see our February 2026 Advisory for details on the proposals). Team-NB supports certain of the proposed measures, including increased digitalization (e.g., electronic documentation and labeling), earlier regulatory dialogue, and measures to support innovation (e.g., regulatory sandboxes for innovative technologies and combined studies). However, it identifies several concerns, in particular, reduced regulatory scrutiny (e.g., extended expiry dates) and implementation challenges in light of multiple ongoing regulatory initiatives. The position paper contributes to the ongoing legislative discussions on the revision of the MDR and IVDR.

Council of the European Union (Council) and European Parliament Each Adopt Their Position on the European Commission Proposal to Simplify the EU AI Rules. The proposal, part of the EU’s Digital Omnibus package, is aimed at simplifying the implementation of harmonized rules on AI under the EU AI Act. Both the EC and the European Parliament propose amendments to streamline various requirements, reduce administrative burdens, and provide more proportionate application of AI rules across EU Member States. Both institutes support the introduction of fixed application dates for high-risk AI tools: December 2, 2027, for standalone high-risk systems and August 2, 2028, for high-risk systems embedded in products subject to EU sectoral legislation. The EC’s position reinstates key compliance safeguards, including mandatory registration of AI systems deemed exempt from high-risk classification and the strict necessity standard for processing sensitive data for bias detection. The Council also requires the EC to issue guidance to support operators of high-risk AI systems in meeting their obligations while minimizing compliance burdens. The European Parliament favors a lighter application of AI Act obligations for products already regulated under sectoral laws (e.g., for medical devices). Interinstitutional negotiations between the European Parliament, the Council, and the European Commission (“trilogue negotiations”) will now commence to agree on the final form of the law.

UK MHRA Expands AI Airlock Program. The MHRA has secured a £3.6 million funding uplift to expand its AI Airlock program, the UK’s first regulatory sandbox for AI as a medical device. Since its launch in 2024, the program has identified several areas where AI medical devices raise new regulatory challenges. Following the completion of its second phase, the Department of Health and Social Care has committed £1.2 million per year over the next three years (2026-2029), allowing the program to move beyond the constraints of annual budgeting. This will enable the program to support more ambitious, longer-term testing models and strengthen the development of sustainable regulatory pathways for future AI medical technologies.

UK Parliament Launches Inquiry Into NHS Personalized Medicine and AI Innovation. The House of Lords Science and Technology Committee has opened an inquiry into innovation in the NHS, using personalized medicine and AI as case studies to understand why the health service struggles to adopt cutting-edge life sciences technologies. The inquiry will examine the scientific and technological foundations of personalized medicine, including developments in genomics, biotechnology, and AI-driven analytics, and will explore the research infrastructure needed to support their development and validation. It will assess gaps between early-stage research, clinical trials, and NHS-wide delivery, including procurement challenges, clinical pathway constraints, interoperability bottlenecks, and the role of regulators and clinical bodies. The committee will also consider whether regulatory and appraisal frameworks are appropriate and proportionate for AI-based and personalized technologies, as well as how NHS structural fragmentation contributes to uneven adoption. In addition, the inquiry will explore issues including the high cost of personalized treatments, the clinical academic workforce, and clinical trials infrastructure needed for rapid implementation across the NHS.

MedTech Europe Publishes Position Paper on the EC’s Proposal to Simplify the EU AI Rules. The position paper was submitted in response to the EC consultation on the Digital Omnibus package. While MedTech Europe supports the European Commission’s objective of improving regulatory coherence and simplifying EU digital legislation, it calls for greater clarity and targeted adjustments to ensure that the framework functions effectively for the medical technology sector. In particular, MedTech Europe calls for: (1) greater alignment with the MDR and the IVDR in relation to risk management, ensuring that AI related obligations do not duplicate or conflict with existing sector specific frameworks; (2) explicit confirmation that investigational devices under the MDR and devices used in performance studies under the IVDR are not considered “placed on the market” or “put into service” under the AI Act, to avoid such devices being subject to AI Act obligations; (3) a harmonized designation pathway for notified bodies, covering both the AI Act and sectoral medical device legislation; and (4) a longer transition period for the application of high-risk AI system obligations, extending the implementation timeline to two years, to allow sufficient time for the development of standards and guidance, and notified body capacity necessary for effective compliance.

UK Government Launches AI Pilots in Barnsley. The UK government has launched two AI pilot schemes in Barnsley, making it the UK’s first “tech town.” The schemes are aimed at improving NHS services and strengthening local AI and digital capacity. The first pilot centers on an £800,000 AI Upskilling Challenge Fund to provide targeted AI training to small- and medium-sized enterprises and residents who may lack digital confidence, with organizations invited to pitch for funding to deliver the training. The second pilot establishes a “Healthcare Living Lab” at Barnsley Hospital NHS Foundation Trust, to trial AI tools designed to cut waiting lists, reduce missed appointments, support clinical decision‑making, and ease administrative pressures on NHS staff. The initiatives are intended to form a blueprint for wider national adoption and are intended to reflect the government’s commitment to ensuring that the benefits of AI reach local communities and key industries across the UK.

Privacy Updates

European Data Protection Board and European Data Protection Supervisor Issue Joint Opinion 3/2026 on the European Commission Proposal for a Biotech Act. While the EDPB and EDPS broadly support the objectives of the EC proposal, they identify significant data protection concerns. In particular, they welcome the introduction of a harmonized legal basis under the General Data Protection Regulation (EU) 2016/679 (GDPR) for processing clinical trial data, which is intended to reduce fragmentation across EU Member States, but call for greater clarity on the scope and application of the legal basis, including more detailed protocol-level documentation, and clearer conditions for the further use of clinical trial data for scientific research.

The EDPB and EDPS also highlight important uncertainties around the allocation of controller roles between sponsors and investigators, and the scope of long-term data retention requirements. They further emphasize that, while regulatory sandboxes may allow for derogations from EU clinical trial requirements, this does not alter the application of existing obligations under the GDPR. The same applies to AI use and biotech data initiatives, which should be accompanied by appropriate safeguards, particularly where health and genetic data are involved. While non-binding, the Joint Opinion is expected to carry significant weight in the legislative negotiations. Find more details on the Joint Opinion in our March 2026 BioSlice Blog.

European Commission Publishes FAQ Guidance on EHDS Regulation Implementation. The EC has published guidance on frequently asked questions on the European Health Data Space (EHDS). The guidance explains that the aims of Regulation (EU) 2025/327 (EHDS Regulation) are to allow patients to have greater control over their health data, ensure secure cross border data sharing, and support health care delivery. The guidance also covers the relationship of the EHDS regulation with other areas of EU law, such as data protection, medical devices, and clinical trials.

IP Updates

EU and UK Copyright and AI Policy Developments. Following the UK government’s consultation on copyright and AI, which we reported on in our January 2025 Digest, the House of Lords Communications and Digital Committee published its report on March 6, 2026, followed by the UK government’s report and impact statement on March 18, 2026. At the EU level, the European Parliament adopted the “Voss Report” on March 10, 2026. Although the copyright and AI landscape remains largely unchanged with no immediate reform to copyright law, there are some notable takeaways:

Text and data mining exception: The UK government confirmed that a broad commercial text and data mining exception with an opt-out mechanism is no longer its preferred option and intends to gather further evidence before a final position is reached.
Licensing models: A licensing-first approach draws consistent support across the EU and the UK, with the Lords Report recommending a model focused on consent and fair remuneration and the Voss Report calling for a sector-based voluntary licensing process.
Transparency: The Lords Report proposes a mandatory transparency framework with granular disclosures on training data enforced by a designated regulator. Meanwhile, the Voss Report advocates itemized lists of all copyrighted works used in training, regardless of the place of training.
Labeling: There is cross-jurisdictional consensus that AI developers, service providers, and platforms should be legally required to label wholly AI-generated content.
Life sciences sector: The UK government expressly referenced the option of a focused exception for science and research to facilitate AI-driven research and accelerate drug discovery.

The copyright and AI landscape await more definitive policy direction.

Fresh Doubts Over Patentability of AI-related Inventions in the UK. On March 27, 2026, the UK Intellectual Property Office (UKIPO) published an Examination Report in relation to the patent application (GB2583455) that was the subject of the Supreme Court judgment in Emotional Perception AI Limited v. Comptroller General of Patents, Designs and Trade Marks [2026] UKSC 3, as covered in our February 2026 Digest. The report confirms that the UKIPO will fully re-examine patentability, and expressed concerns over the application of the “intermediate step,” particularly in the analysis of “mixed-type inventions.” In its assessment that the invention lacks the necessary technical character and inventive step, the report casts new doubt on the UK’s approach to patentability of AI-related and computer-implemented inventions. The applicant, Emotional Perception AI Limited, has until April 27, 2026 to provide its reply.

Product Liability Updates

UK Government Launches Consultations on New Product Safety Framework and Market Surveillance Rules. The UK government has launched two consultations on reforms to the product safety regime, with a strong emphasis on addressing risks arising from digital and AI‑enabled technologies. The first consultation sets out proposals for a new, modernized product safety framework, designed to ensure regulation keeps pace with increasingly complex digital products and connected devices. It highlights that traditional safety models are no longer adequate for technologies featuring software updates, connectivity, data driven functionality, or AI enabled behavior, and invites views on how the regime should identify and manage novel harms linked to digital features and AI enabled products. The second consultation focuses on strengthening the UK’s market surveillance and enforcement framework, proposing to consolidate dispersed enforcement powers into a single statutory instrument, introduce civil monetary penalties as an alternative to criminal prosecution, and ensure regulators have the tools needed to respond effectively to the challenges of digital supply chains and online marketplaces. Both consultations are open until June 23, 2026, and feedback can be submitted for the new product safety framework and for the market surveillance and enforcement consultation.

Amalia White is employed as a trainee solicitor at Arnold & Porter’s London office. Amalia is not admitted to the practice of law.
Jack Chisem is employed as a paralegal at Arnold & Porter’s London office. Jack is not admitted to the practice of law.

China Compliance Update: Anti-Corruption — Spring 2026

Fri, 01 May 2026 00:00:00 -0500

Anti-corruption continued to be a major focus for Chinese regulators in 2026, with the Supreme People’s Court publishing its first new judicial interpretations of China’s corruption and bribery regulations in a decade. Official statistics provided further evidence of regulators’ continued emphasis on both administrative and criminal anti-corruption enforcement.

Are You Ready — California Cybersecurity Audits Are Here!

Fri, 01 May 2026 00:00:00 -0500

The California Privacy Protection Agency’s Executive Director Tom Kemp recently stated that the agency’s new Audits Division will begin conducting audits assessing companies’ compliance with California data privacy laws this year.

How Courts Reviewed FDA Action Before Chevron and May Again After Loper Bright

Jonathan.Trinh@arnoldporter.com — Fri, 01 May 2026 00:00:00 -0500

Beyond the Basics: Mortgage Lending Secured by Leaseholds, Condominiums and Complex Collateral

Thu, 30 Apr 2026 00:00:00 -0500

Arnold & Porter partner Kari Larson and counsel Christian Scarlett will be presenting at the 38th Annual RPTE National CLE Conference.

Deal to Dispute: Managing Risk in M&A and Commercial Transactions

Thu, 30 Apr 2026 00:00:00 -0500

We invite you to join us for a practical webinar on managing litigation risk in commercial transactions.

LACCA Recognizes Arnold & Porter as a Top International Law Firm for Latin America’s Largest Banks

Thu, 30 Apr 2026 00:00:00 -0500

Arnold & Porter was recognized as a top international law firm for Latin America's largest banks in Latin American Corporate Counsel Association (LACCA)'s latest research into “Who represents Latin America's biggest banks?” LACCA's report presents the “banks that make up this year’s top 100 – as well as their preferred external counsel.“

Forbes Highlights Arnold & Porter on Tariff Refund Litigation and Consumer Class Actions

Thu, 30 Apr 2026 00:00:00 -0500

Lori Leskin, head of Arnold & Porter’s consumer products practice, was quoted in the Forbes article, “Consumers Won’t See Tariff Refunds. Smart Retailers Will Turn Them Into Price Cuts,” examining the legal and business implications of $166 billion in tariff refunds owed to U.S. importers following a Supreme Court ruling invalidating Trump-era tariffs.

China Compliance Update: Life Sciences — Spring 2026

Thu, 30 Apr 2026 00:00:00 -0500

In 2026, Chinese regulators have continued their focus on anti-corruption enforcement in the life sciences industry. In addition to long-standing priorities, such as fraud against China’s state-run medical insurance program, regulators appear to be paying greater attention to investigator-initiated studies and patient programs in 2026. This Advisory summarizes recent regulatory developments and enforcement actions.

Women and Diversity in Law Awards Recognize Kathleen Harris as Law Firm Leader of the Year

Wed, 29 Apr 2026 00:00:00 -0500

Head of Arnold & Porter's London office Kathleen Harris has been named Law Firm Leader of the Year – International Law Firm at the Women and Diversity in Law Awards 2026, which honor outstanding women leaders and practitioners across the UK legal profession, as well as legal teams and businesses driving meaningful change.

Earn-Outs and Other Forms of Contingent Consideration: Recent Delaware Decisions and Drafting Takeaways

Wed, 29 Apr 2026 00:00:00 -0500

In our July 2024 Advisory regarding Trifecta Multimedia Holdings Inc. v. WCG Clinical Services LLC, we noted the importance, in the earn-out context, of distinguishing between extra-contractual statements that may be treated as actionable representations and those that may be dismissed as mere “puffery,” and we highlighted the significance of clear anti-reliance language in acquisition agreements. Two more recent Delaware decisions — the Court of Chancery’s post-trial opinion in Camaisa v. Pharmaceutical Research Associates, Inc. and the Delaware Supreme Court’s decision in Fortis Advisors LLC v. Johnson & Johnson — bear on those same subjects and, in the case of Fortis, make Delaware’s position on anti-reliance language particularly clear. The decisions also implicate several other recurring questions in contingent consideration disputes, including efforts-based covenants and the limits of the implied covenant of good faith and fair dealing. We summarize the background of these cases and our principal takeaways below.

U.S. Health and Human Services Tries Again To Improve Availability of Innovative Devices in Medicare

Tue, 28 Apr 2026 00:00:00 -0500

On April 23, 2026, the Centers for Medicare & Medicaid Services and the U.S. Food and Drug Administration (FDA) announced a plan to create a new pathway to expedite Medicare coverage for certain medical devices designated by the FDA as breakthrough devices (the Announcement). Devices travelling the new Regulatory Alignment for Predictable and Immediate Device pathway, which would in effect be run jointly by the two agencies, are expected to experience fewer delays between FDA market authorization and Medicare national coverage determinations than at present, as long as they meet certain requirements.

Implementing the GENIUS Act: FinCEN and OFAC Propose AML and Sanctions Program Requirements

Tue, 28 Apr 2026 00:00:00 -0500

The U.S. Department of the Treasury’s (Treasury) Financial Crimes Enforcement Network (FinCEN) and the Office of Foreign Assets Control (OFAC) recently issued a joint proposed rulemaking (Proposal) that would implement the anti-money laundering and sanctions program requirements of the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act).[[N: Treasury, Treasury Proposes Rule to Implement the GENIUS Act’s Requirements to Counter Illicit Finance (Apr. 8, 2026).]] If adopted as proposed, the new program requirements would apply to “permitted payment stablecoin issuers” (PPSIs) as defined by the GENIUS Act and would become effective 12 months after publication of the final rule. In addition to seeking general comments on the Proposal, FinCEN and OFAC posed nearly 60 specific questions on which they solicited feedback. Comments are due by June 9, 2026.

The Proposal, which follows an advance notice of proposed rulemaking in the fall of 2025,[[N: GENIUS Act Implementation, 90 Fed. Reg. 45159 (Sept. 19, 2026).]] would impose five general categories of obligations on PPSIs, as discussed below.

Written Anti-Money Laundering and Countering the Financing of Terrorism (AML/CFT) Compliance Program

The AML/CFT program would include policies and procedures (including a mandatory risk assessment process), independent testing, ongoing training, and designation of an AML/CFT Officer. The Proposal largely mirrors the proposed revisions to existing BSA/AML program requirements for most financial institutions (including banks and broker dealers) recently issued by FinCEN, including the formalization of the risk-assessment requirement, the incorporation of the previous fifth “pillar” (Customer Due Diligence) into the “policies and procedures” pillar, and the redesignation of the program’s title from “BSA/AML” to “AML/CFT.” PPSIs would also be subject to the due-diligence and enhanced due-diligence requirements applicable to certain private banking and correspondent accounts under the USA PATRIOT Act, as well as any “Special Measures” that FinCEN imposes under Section 311 of that Act. The AML/CFT program would require board-level (or similar) approval.

Significantly, the Proposal would adopt FinCEN’s new approach to supervision and enforcement, whereby neither FinCEN nor the relevant prudential regulator would take a significant enforcement or major supervisory action against a PPSI for an AML/CFT program violation unless the failure constituted “a significant or systemic failure to maintain that program.”

Suspicious Activity Reporting

PPSIs would be required to file suspicious activity reports (SARs) to advise law enforcement of suspected violations of law. Notably, the requirement would apply only to transactions occurring on the PPSI’s primary market (i.e., transactions in which the PPSI is directly involved), not to transactions occurring on the secondary market for the PPSI’s stablecoin offering. A $5,000 threshold would apply.

Recordkeeping; Information Sharing

PPSIs would be subject to recordkeeping requirements similar to those of other financial institutions, including the Recordkeeping Rule and the Travel Rule (regarding certain funds transfers and the conveyance of payment details to other institutions, respectively). Certain cross-border transfers of assets, as well as certain extensions of credit, would also be covered. A five-year retention period would apply.

PPSIs would also be expressly covered by sections 314(a) and (b) of the USA PATRIOT Act. Section 314(a) requires institutions to provide certain information to FinCEN upon request. Section 314(b) permits institutions, on a voluntary basis, to share information among themselves to assist with identifying and reporting possible money laundering or terrorist activity.

Effective Sanctions Compliance Program

PPSIs would be required to adopt and maintain a sanctions compliance program with five key elements:

Senior management and organizational commitment (including that the program be fully integrated in the PPSI’s payment stablecoin operations and apply to all payment stablecoin activity; allow for sufficient authority, autonomy, and resources; and routinely provide updates and testing reports to senior management and other appropriate personnel).
Periodic holistic sanctions-related risk assessments, updated as circumstances warrant, to be used to inform and update the PPSI’s sanctions compliance program.
Risk-based internal controls to identify and take appropriate action in response to payment stablecoin transactions (on both primary and secondary markets) that would violate U.S. sanctions laws.
Independent testing/auditing with appropriate accountability, resources, expertise, and authority.
Ongoing risk-based training tailored to the institution and its relevant personnel and stakeholders. Standard OFAC recordkeeping and reporting requirements would apply.

Ability To Block, Freeze, and Reject Certain Specified or Impermissible Transactions

PPSIs would be required to have “technical capabilities, policies, and procedures to block, freeze, and reject specific or impermissible transactions that violate Federal or State laws, rules, or regulations.” Such capability would need to include the ability to comply with any “lawful order.” As with the sanctions compliance program, and unlike the proposed SARs rule, this requirement covers both a PPSI’s primary and secondary markets.

Takeaways

Although the Proposal incorporates new material such as the formalized risk-assessment process and the mandatory sanctions compliance program, in many ways it adheres to existing regulations and supervisory expectations. However, FinCEN has had to tailor existing regulations significantly to adapt the Proposal to the unique circumstances of PPSIs and payment stablecoins, and industry participants should take particular note of the technical aspects of the Proposal and offer feedback where appropriate. Also, in addition to numerous questions about the Proposal’s specific provisions, FinCEN has asked for comments on how, for PPSIs that are subsidiaries of financial institutions, the proposed requirements will or will not integrate effectively into existing organizational AML/CFT programs, and has also asked whether any of the Proposal’s provisions should be extended to foreign payment stablecoin issuers.

If you have any questions regarding the Proposal or need assistance in determining whether to comment on the Proposal, please contact any of the authors of this Advisory or your usual firm contact.

DOJ Announces Controlled Substances Act Scheduling Changes for FDA-Approved Marijuana and State-Licensed Medical Marijuana Products

Mon, 27 Apr 2026 00:00:00 -0500

On April 23, 2026, the U.S. Department of Justice (DOJ), in conjunction with the Drug Enforcement Administration, announced that pursuant to President Trump’s December 18, 2025, Executive Order “Increasing Medical Marijuana and Cannabidiol Research,” issuance of a final rule by way of Attorney General order that immediately placed both FDA-approved products containing marijuana and marijuana products regulated by a state medical marijuana license in Schedule III of the Controlled Substances Act (CSA). Previously, marijuana products were placed on Schedule I of the CSA, which generally limited its use to tightly controlled research. DOJ did not institute this change through notice and comment rulemaking but instead under 21 U.S.C. 811(d)(1) which allows the attorney general to reschedule substances to carry out the United State’s obligations under the Single Convention on Narcotic Drugs.

John Schmidt Speaks to Global Competition Review on UK Approval of Manx Telecom Sale

Fri, 24 Apr 2026 00:00:00 -0500

John Schmidt, Arnold & Porter Antitrust partner, was quoted in the recent Global Competition Review article, “U.K. conditionally approves sale of Manx Telecom to CVC-backed joint venture,” discussing the conditions attached to the sale of a critical supplier of telecoms services to the British government.

The Legal 500 2026 Recognizes Arnold & Porter's New York Private Wealth Capabilities

Fri, 24 Apr 2026 00:00:00 -0500

The inaugural edition of The Legal 500 Private Client Guide has recognized Arnold & Porter's Private Client Services team in the New York: Private Wealth category.

DOJ Prioritizes Antitrust Enforcement Against Large Health Systems for Payor Contracting Practices

Fri, 24 Apr 2026 00:00:00 -0500

In what is now a trend, on March 26, 2026, the United States Department of Justice Antitrust Division (DOJ) filed an antitrust lawsuit against The New York and Presbyterian Hospital challenging its contracting practices with commercial health insurers (or payors). The lawsuit alleges that the hospital system used its market power to contractually restrict payors from offering health plans featuring lower-cost rival hospitals. The complaint is very similar to one filed by the DOJ and the State of Ohio against OhioHealth, the largest hospital system in central Ohio, in February. This Advisory analyzes the allegations in both complaints and provides takeaways for health systems as they navigate the current antitrust enforcement environment.

Proactive Strategies for Commercial Indemnification Disputes: Managing Recurring Risks

Fri, 24 Apr 2026 00:00:00 -0500

Contractual indemnification claims arising out of an underlying third-party tort or contract claim are a recurring business risk for entities that are parties to commercial contracts. These types of indemnification claims — which can involve indemnification for both liability attributable to the underlying action as well as associated defense costs spent — span many industries, including telecommunications, electronics, life sciences, pharmaceuticals, consumer products, real estate, and financial services. With careful planning and consideration, practitioners can avoid costly litigation or, when necessary, adeptly prosecute or defend these complex disputes.

Competition Bootcamp: Webinar for In-House Life Sciences Lawyers

Thu, 23 Apr 2026 00:00:00 -0500

Following the success of our bootcamp in November, Arnold & Porter is excited to deliver an updated version of the session as a webinar.

SEC Staff Extends Section 16(a) Filing Deadline for Directors and Officers of Certain Foreign Private Issuers Affected by Middle East Hostilities

Thu, 23 Apr 2026 00:00:00 -0500

On April 17, 2026, the Division of Corporation Finance issued a no-action letter to Tower Semiconductor Ltd., an Israeli foreign private issuer (Tower), extending until May 29, 2026 the date through which Tower’s directors and officers may fail to file required Section 16(a) reports without leading the Division of Corporation Finance to recommend enforcement action to the SEC. The Division had previously granted no-action relief for failures to file until April 20, 2026. The new no-action position was based on several facts set forth in Tower’s no action request letter, including the impact of the continuing war among Israel, Lebanon, and Hezbollah, as Tower’s “headquarters, management, parent company and largest fabrication facility (Fab 2) are all located less than 20 miles away from the Israel-Lebanon border, which continues to suffer rocket fires, missile strikes and air raid sirens from Lebanon.” The request letter also noted that wartime restrictions in Israel, especially where Tower’s headquarters, management, and Fab 2 are located, remain ongoing, as do severe disruptions to communications and infrastructure. These conditions continue to impair Tower’s ability to collect, verify, and assist its directors and officers in reporting the required information, including disruptions to notary services required for Form ID, due to rocket strikes and other collateral consequences of military operations in the region.

The Division’s response states that: “This no-action position is available for directors and officers of any other foreign private issuer with a class of equity securities registered under Exchange Act Section 12 that is organized and headquartered in Israel or any other foreign jurisdiction in the geographical region directly affected by the conflict described in your letter, provided they can represent that their ability to comply with the March 18, 2026 filing deadline mandated by the Holding Foreign Insiders Accountable Act has been materially affected by the direct effects of the conflict.”

Part II: Transferring Data Safely: National Security, Privacy, and Emerging Sovereign Rights

Wed, 22 Apr 2026 00:00:00 -0500

Cross-border data flows in the life sciences sector sit at the crossroads of national security enforcement, evolving privacy law, and a new generation of sovereign data rights claims — creating compliance complexity that few organizations are fully prepared for.

Implementing the GENIUS Act: The FDIC Proposes Comprehensive Rulemaking Governing Payment Stablecoins Issuance

Wed, 22 Apr 2026 00:00:00 -0500

The FDIC’s April 2026 proposed rule implements key provisions of the GENIUS Act by establishing a comprehensive, principles-based regulatory framework for payment stablecoin issuance and related activities by FDIC-supervised institutions. The proposal would limit permitted payment stablecoin issuers to core functions like issuance, redemption, reserve management, and custody, while imposing strict requirements on reserves, liquidity, capital, risk management, and operational resilience. It also prohibits paying interest or yield on stablecoins, restricts certain activities like rehypothecation and extending credit, and mandates clear redemption rights, disclosures, and robust reporting and audit obligations. Additionally, the rule clarifies that stablecoin reserve deposits are insured only at the issuer level (not pass-through to holders) and aligns with broader interagency efforts to create a unified federal regulatory regime for stablecoins, with public comments invited on key design questions such as capital standards, redemption timelines, and the scope of permissible activities.

But Wait, There’s Less! Science in Rulemaking: Navigating Challenges and Innovations

Sarah.Grey@arnoldporter.com — Wed, 22 Apr 2026 00:00:00 -0500

Inside EPA Cites Arnold & Porter Advisory on European Union PFAS Restrictions

Tue, 21 Apr 2026 00:00:00 -0500

A recent Inside EPA article, “Lawyers Urge U.S. Industry Comments On Broad EU PFAS Restriction,” cited the Arnold & Porter advisory, “ECHA Committees Advance Broad PFAS Restriction Under REACH,” which was authored by senior counsel Lawrence Culleen; counsels Tom Fox and Judah Prero; and senior attorney Camille Heyboer.

Export Controls for Startups: From Overlooked Risk To Competitive Advantage

Tue, 21 Apr 2026 00:00:00 -0500

U.S. export controls have expanded significantly in recent years, creating growing compliance risks — and potential strategic advantages — for startups in high-tech sectors. A new white paper by Arnold & Porter attorneys Trevor Schmitt and Bell Johnson, in collaboration with Michael Hochberg, explains how these regulations impact everything from hiring to product design and investment decisions. It also offers practical guidance on embedding compliance early to mitigate risk and turn regulatory obligations into a competitive edge.

Arnold & Porter Welcomes White Collar Partner Eric Snyder in New York

Fri, 17 Apr 2026 00:00:00 -0500

NEW YORK, April 17, 2026 — Arnold & Porter announced today that Eric Snyder has joined the firm’s White Collar Defense & Investigations practice as a partner, resident in New York.

Managing IP Americas Awards Recognize Arnold & Porter for IP and Copyright Capabilities

Fri, 17 Apr 2026 00:00:00 -0500

Arnold & Porter was honored with two awards at the Managing IP Americas Awards, which recognize firms’ outstanding intellectual property achievements over the past year.

GreenNY: How New York’s Green Procurement Program Uses Public Purchasing to Decarbonize Supply Chains, Eliminate Toxics, and Build a More Sustainable Marketplace

julia.kindlon@arnoldporter.com — Fri, 17 Apr 2026 00:00:00 -0500

The Midterm Elections Are Coming — Prepare Now for Congressional Investigations

Thu, 16 Apr 2026 00:00:00 -0500

If Democrats regain control of either chamber of Congress in the 2026 midterm elections, we anticipate a substantial increase in congressional investigations beginning in early 2027. Congressional committees wield powerful investigative tools that can expose institutions and individuals to legal, reputational, political, and market risk.

Arnold & Porter Securities Enforcement & Litigation Partners Keynote AI in Finance Summit