The US Food & Drug Administration (FDA) has released final guidance on decentralised clinical trials. It has been heavily amended from its draft version further to comments received from clinical experts and industry groups. The key revisions improve clarity and address issues such as removing all mentions of a requirement to create and maintain a local task log of healthcare providers contracted for trial-related services in routine clinical practice, more information about physical inspection requirements, and clarifying challenges around data variability. Decentralised trials are defined as occurring at non-traditional clinical trial locations, such as a participant’s home or in a local healthcare facility. These local providers and clinical laboratory facilities may be used in a trial with decentralised elements to manage trial participants, and use digital health technologies and telehealth to obtain data.

The US Food and Drug Administration (FDA) has recognised the potential of using AI and machine learning (ML) in the drug development life cycle, for example when selecting suitable patient populations for clinical trials and predicting patient outcomes. AI/ML predictive models are also able to identify patients who are more likely to benefit from the treatment or to react adversely, assisting in demonstrating the effectiveness of a drug. For example, for the first time the FDA’s Center for Drug Evaluation and Research (CDER) used AI/ML for a regulatory decision, in this case to identify a population who will likely benefit from a drug therapy in relation to an Emergency Use Authorization of the drug, Anakinra, in its treatment of coronavirus (COVID-19) patients.

Arbitration analysis: The US Court of Appeals for the Fifth Circuit held that the district court erred in refusing to compel arbitration in a dispute involving a subcontract for a Saudi Aramco-related oil-and-gas project. The subcontract included an arbitration clause requiring disputes to be resolved under the DIFC-LCIA Arbitration Centre’s rules. The district court found the arbitration clause unenforceable because the designated forum had ceased to exist in 2021. The Fifth Circuit reversed this decision, holding that, the parties’ objective intent was to arbitrate, and the subcontract’s provisions did not designate DIFC-LCIA as the exclusive arbitral forum. However, the Fifth Circuit refrained from conclusively ruling on whether another arbitration institution served as DIFC-LCIA’s successor and whether selecting DIFC-LCIA rules implicitly established the forum as well. Finally, the Fifth Circuit reiterated that under the Federal Arbitration Act (FAA), doubts regarding the scope of arbitrability should be resolved in favor of arbitration. Written by Dr Gizem Alper, international legal & ADR consultant.

This Practice Note provides an introduction to the US Foreign Corrupt Practices Act (FCPA) and issues related to its applicability. It provides best practices guidance for how your clients can comply with the FCPA, including the creation and implementation of an effective anti-corruption compliance program. This Practice Note also includes information about FCPA enforcement trends. When organisations conduct international business, it is extremely important for them to understand their obligations and limitations under the FCPA. Robust enforcement and unparalleled regulatory scrutiny of transactions make educating organisations about the FCPA a vital service lawyers can provide. For more information about the FCPA, see Practice Notes: Practical steps in a bribery investigation—UK and US perspectives and The US Foreign Corrupt Practices Act 1977 (FCPA 1977) and Bribery Act 2010 (BA 2010) comparison table as well as: Best practices in FCPA investigations—checklist. FCPA—an overview As businesses eagerly expand into new markets looking for growth opportunities, they must proceed cautiously because this can also entail new challenges. Multinational companies especially face a heightened risk that a subsidiary or affiliate,

The US Office of Public Affairs has published a speech given by Deputy Attorney General (DAG) Lisa O. Monaco at the University of Oxford on the ‘Promise and Peril of AI’. In the speech, Monaco talked about how the Department of Justice has deployed AI for its benefit, however did say that AI can also ‘lower the barriers to entry for criminals’ and will also likely play a part in upcoming elections.

The United States Securities and Exchange Commission (SEC) has reported that the Seoul-based KT Corporation (KT Corp) has agreed to pay USD$6.3m to resolve charges that it violated the Foreign Corrupt Practices Act (FCPA) by providing improper payments to benefit government officials in South Korea and Vietnam. KT Corp is South Korea’s largest telecommunications operator and lacked sufficient internal accounting controls over charitable donations, third-party payments, executive bonuses and gift card purchases which enabled slush funds to be generated for gifts and illegal political contributions. KT Corp did not admit nor deny the findings. The South Korean authorities indicted 14 executives for criminal violations related to illegal political contributions in November 2021.

Arbitration analysis: The court held that the World Bank’s International Centre for the Settlement of Investment Disputes (‘ICSID’) does not exercise governmental authority and therefore may not utilize domestic courts to compel discovery under 28 U.S.C. § 1782. Adopting the view of the Supreme Court in ZF Automotive US, Inc v Luxshare, Ltd, 596 US 619, 142 S. Ct. 2078, 213 L. Ed. 2d 163 (2022) (‘ZF Automotive’), the court reiterated that comity is the overarching rationale of 28 U.S.C. § 1782. Therefore, court intervention in discovery requests should be impermissible when used to further the interests of private parties as opposed to foreign governments. Furthermore, foreign or international tribunals must possess governmental or intergovernmental authority to order discovery in U.S. courts under 28 U.S.C. § 1782. Here, the court found that the ICSID tribunal does not meet the necessary requirements of 28 U.S.C. § 1782 outlining an ‘international tribunal’ which has governmental authority because (1) the tribunal was created ad hoc; (2) arbitrators were chosen by the parties to the dispute; (3) Panama and Italy did not intend to grant ICSID governmental authority; and (4) the tribunal did not receive ‘governmental funding’. Written by Charles H. Camp, president; Hagar Sivan, law clerk; and Kale Wright, law clerk; Law Offices of Charles H Camp, PC, Washington, DC.

This Practice Note contains illustrative decisions of applications concerning Section 1782(a) of Title 28 of the United States Code (28 USC § 1782) (Section 1782). Section 1782 empowers US federal district courts to compel discovery of documents, testimony (including depositions) or other evidence for use in (or in aid of) proceedings before a foreign or international tribunal. In the context of applications before the courts of England and Wales to restrain the use or enforcement of a Section 1782 order, the leading authority is the House of Lords decision in South Carolina Insurance Co v Assurantie Maatschappij de Zeven Provincien NV (1986). That decision is explored in detail in Practice Note: US Section 1782 discovery for use in foreign proceedings—principles and making an application, specifically, main section Application to restrain enforcement of a Section 1782 order in England. Note: All references to US and other foreign case law in this Practice Note are not reported by LexisNexis®. For guidance on making an application and the statutory requirements and discretionary

This Practice Note considers Section 1782(a) of Title 28 of the United States Code (28 USC § 1782) (Section 1782), which empowers US federal district courts to compel discovery of documents, testimony, including depositions, or other evidence for use in proceedings before a foreign or international tribunal. It explains the statutory requirements and discretionary factors that US courts consider when deciding whether to grant Section 1782 applications. It also considers the potential impact of making a Section 1782 application in support of proceedings before the courts of England and Wales. This discovery process may also be referred to by any of the following: 28 US Code; obtaining discovery in the US for use in foreign litigation or arbitration (international proceedings); assistance to foreign and international tribunals under Section 1782; Section 1782 proceedings; resisting enforcement of a Section 1782 order before the English courts; attempts to use Section 1782; extraterritorial discovery; US discovery tools; limits on Section 1782 discovery; and, applying for injunctive relief against a Section 1782

This Practice Note considers Section 1782(a) of Title 28 of the United States Code (28 USC § 1782) (Section 1782), which empowers US federal district courts to compel discovery of documents, testimony (including depositions) or other evidence for use in (or in aid of) proceedings before 'a foreign or international tribunal’. The Practice Note discusses the US Supreme Court decisions in Intel Corp v Advanced Micro Devices (2004) and ZF Automotive US, Inc, et al v Luxshare, Ltd (2022). It also provides details on the conflicting US court decisions considering the use of Section 1782 discovery for international arbitration in the years between those two decisions. Note: • Section 1782 may also be referred to as: 28 US Code; obtaining discovery in the US for use in foreign litigation or arbitration (international proceedings); assistance to foreign and international tribunals under Section 1782; Section 1782 proceedings; resisting enforcement of a Section 1782 order before the English courts; attempts to use Section 1782; extraterritorial discovery; US discovery tools; limits on Section 1782 discovery; and,

IP & IT analysis: What are the implications of a recent US Supreme Court ruling for companies that stream TV over the internet or store media in the cloud? Tony Ballard, broadcasting and telecommunications partner at Harbottle & Lewis, considers how this latest US decision fits into the wider debate around communication to the public.

Law360: The US Supreme Court on Monday refused to review two cases relating to the Foreign Sovereign Immunities Act's arbitration exception, allowing the lower court rulings to stand amounting to a decision that clears a path for creditors looking to enforce arbitral awards worth hundreds of millions of dollars against Spain and Russia.