On August 22, 2023, the Spanish Council of Ministers approved the Statute of the Spanish Agency for the Supervision of Artificial Intelligence (“AESIA”) thus creating the first AI regulatory body in the EU. The AESIA will start operating from December 2023, in anticipation of the upcoming EU AI Act  (for

Continue Reading Spain Creates AI Regulator to Enforce the AI Act

The field of artificial intelligence (“AI”) is at a tipping point. Governments and industries are under increasing pressure to forecast and guide the evolution of a technology that promises to transform our economies and societies. In this series, our lawyers and advisors provide an overview of the policy approaches and

Continue Reading Spotlight Series on Global AI Policy — Part I: European Union

On September 28, 2023, the Cyberspace Administration of China (“CAC”) issued draft Provisions on Standardizing and Promoting Cross-Border Data Flows (Draft for Comment) (规范和促进数据跨境流动规定(征求意见稿)) (draft “Provisions”) (Chinese version available here) for a public consultation, which will conclude on October 15, 2023. 

The draft Provisions propose

Continue Reading China Proposes Significant Changes to Cross-Border Transfer Rules

Unless Congress reaches an agreement to keep the lights on, the U.S. government appears headed for a shutdown at midnight on October 1.  As the deadline looms, stakeholders should not let the legislative jockeying overshadow another consequence of a funding lapse: regulatory delay.  Under normal circumstances, federal agencies publish thousands of rules per year, covering agriculture, health care, transportation, financial services, and a host of other issues.  In a shutdown, however, most agency proceedings to develop and issue these regulations would grind to a halt, and a prolonged funding gap would lead to uncertainty for stakeholders, particularly as the 2024 elections approach.  Another consequence is that more regulations could become vulnerable to congressional disapproval under the Congressional Review Act (CRA).

The Administrative Procedure Act (APA) provides that “General notice of proposed rulemaking shall be published in the Federal Register,” and prescribes requirements for the contents of an agency rulemaking notice.  To initiate or finalize a rulemaking, agencies must submit rules to the Office of the Federal Register (OFR)—the National Archives and Records Administration agency that publishes the Federal Register, the government’s daily journal of rules, regulations, and other activities.

When government funding lapses, however, publication of critical rulemaking documents slows.  Under the Antideficiency Act, both an agency seeking to publish documents and OFR are prohibited from spending or obligating funds during a shutdown.  Government agencies are also prohibited from accepting voluntary services for government work—except in cases of “emergencies involving the safety of human life or the protection of property.”

These restrictions significantly curtail the ability of agencies to initiate new rulemakings that don’t qualify for the exception, or to advance rulemakings that began before a shutdown.  Federal employees are not allowed to draft or submit rules for publication, accept or review public comments, or revise or publish final rules while their agency is unfunded. 

Likewise, because the APA and other statutes require certain executive actions to be published in the Federal Register—OFR must also be funded and operational to publish most agency documents, even if the agency publishing the document has not experienced a funding lapse.

To account for this issue, OFR has set forth guidelines in advance of prior shutdowns that detail when agencies—funded or not—may submit documents for publication in the Federal Register, and when OFR will publish those documents.

First, for unfunded agencies—which, as of today, would include all federal agencies whose budgets are subject to annual appropriations—OFR will only publish documents that are necessary to safeguard human life, protect property, or “provide other emergency services consistent with the performance of functions and services exempted under the Antideficiency Act.”   Agency materials related to “ongoing, regular functions of government” that pose no “imminent threat” to human safety or property protection are not permissible activities for unfunded agencies, and therefore inappropriate for OFR publication. 

This restriction would have significant implications for agency regulatory efforts across the government, with impact on a wide range of regulated sectors.  In one notable example, the rulemaking to implement the President’s recent outbound investment executive order (which we and our colleagues have discussed here) would likely stall for the duration of the shutdown.  Nothing in the order or the Treasury Department’s advance notice of proposed rulemaking (ANPRM) suggests that the order—despite being issued under the International Emergency Economic Powers Act (IEEPA)—involves imminent threats to human safety or property.  Thus, while public comments on the ANPRM are due on September 28, before the end of the fiscal year, a subsequent lapse in the Treasury Department’s funding would prohibit agency staff from reviewing public comments, scheduling and taking meetings with stakeholders, and revising and finalizing the proposed rule.Continue Reading Looming Shutdown Elevates Congressional Review Act Threat for New Regulations

We’ve seen this movie before. Conservatives, eager to bend the curve on federal outlays, are preparing to use the only leverage they have (their votes) while Senate Majority Leader Charles Schumer is talking about “House Republican extremists” causing a government shutdown. In most people’s eyes, Republicans have “lost” every shutdown fight since 1995. So why are conservatives back at it again?

Beyond their preference for a smaller government, conservatives are not alone in seeing runaway spending as a dire threat and will admit that their own party shares the blame. Our political system is structurally ill-equipped to turn off spending once it begins. A new estimate that the deficit will double to $2 trillion this year and Fitch Ratings’ recent downgrade of government credit are the most recent reminders that the problem is real. Efforts to rein in the deficit date back at least to the Gramm-Rudman-Hollings agreement in 1985 and include proposed Constitutional amendments, the Budget Enforcement Act of 1990 (PAYGO), the Line Item Veto Act of 1996, the Balanced Budget Act of 1997, a “sustainable growth rate” for Medicare reimbursements, George W. Bush’s plan to make Social Security sustainable, the 2010 Simpson-Bowles Commission, the 2011 ‘Supercommittee,’ sequestration, the discretionary spending caps in the Budget Control Act of 2011, revenue-producing tax increases, and growth-generating tax cuts.

None of it worked and the government is $32 trillion in debt. Congress rarely makes tough decisions without an action-forcing mechanism and conservatives want to be that mechanism. The House’s two conservative caucuses, the Freedom Caucus and the larger Republican Study Committee have identified similar priorities. Most broadly, they do not want the Covid-era surge in spending to serve as the baseline for future spending. The FY 2023 omnibus, which was called a “monstrosity” by Speaker Kevin McCarthy, passed the House with almost no GOP support in the very last days of the Democrats’ majority. Conservatives want to return to pre-Covid levels or lower. With $115 billion in rescissions, House appropriators have offered budgetary authority at pre-pandemic (FY 2022) levels, but conservatives say this is a gimmick that won’t reduce actual outlays. On this point, the Heritage Foundation says, ‘This represents an unprecedented expansion of rescissions as a budgetary tool to add spending within appropriations caps.’ Many conservatives also see the President’s emergency supplemental request as an end-run around the debt-limit agreement and have a longstanding position that supplementals should be offset.Continue Reading What Conservatives Want From the Spending Spat

Last week, Ethiopia hosted the 2nd regional African Forum on Business and Human Rights. This year’s Forum focused on local perspectives and solutions to implementing the UN Guiding Principles on Business and Human Rights (UNGPs), including in the context of operationalising the African Continental Free Trade Area (AfCFTA). Participants included a range of stakeholders including business enterprises and associations, governments, civil society, Indigenous Peoples groups, labour organisations, international and regional organizations and national human rights institutions. Dialogue touched on critical issues including the intersection between environmental and social impacts and the importance of developing and implementing business and human rights (BHR) frameworks that are appropriate for Africa.

In this post, we distil several considerations for businesses operating in Africa:

  1. Stakeholders are committed to establishing BHR frameworks tailored to Africa

An underlying theme of the Forum — “For Africa, From Africa” — was the implementation of the UNGPs through African perspectives. Participants discussed the extra-territorial reach of the EU’s proposed Corporate Sustainability Due Diligence Directive (CSDDD), through which the EU seeks to play a critical role in global standard setting on human rights due diligence. There was a clear recognition that the CSDDD and a plethora of other EU ESG laws are likely to apply directly or indirectly to businesses and significantly impact many businesses in the region. The EU is currently piloting projects in several African states to develop frameworks to assist states and businesses in preparing for CSDDD implementation and mitigate the risk of the law negatively impacting value chains. Despite this, there was some criticism regarding a perceived limited engagement with stakeholders in the Global South in the CSDDD drafting process and the potential risks and implications that could flow from that, including for example, a concern that costs of meeting due diligence standards could ultimately be pushed down to small-holding farmers and SMEs within the value chain.Continue Reading 2023 African Forum on Business and Human Rights: What do companies need to know?

On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role of Congress related to the deployment of artificial intelligence (AI) in areas under the HELP Committee’s jurisdiction, including health and life sciences.  In the white paper, Senator Cassidy disfavors a one-size-fits-all approach to the regulation of AI and instead calls for a flexible approach that leverages existing frameworks depending on the particular context of use of AI.  “[O]nly if our current frameworks are unable to accommodate . . . AI, should Congress look to create new ones or modernize existing ones.”  The Senator seeks public feedback on the white paper by September 22, 2023.  Health care and life sciences stakeholders should consider providing comments. 

This blog outlines five key takeaways from the white paper from a health care and life sciences perspective. Note that beyond health and life sciences issues, the white paper also addresses considerations for other areas, such as use of AI in educational settings and labor/employment implications created by use of AI.


5 Key Takeaways for AI in Health Care and Life Sciences

The white paper – entitled “Exploring Congress’ Framework for the Future of AI: The Oversight and Legislative Role of Congress Over the Integration of Artificial Intelligence in Health, Education, and Labor” – describes the “enormous good” that AI in health care presents, such as “the potential to help create new cures, improve care, and reduce administrative burdens and overall health care spending.”  At the same time, Senator Cassidy notes that AI presents risks that legal frameworks should seek to minimize.  Five key takeaways from the white paper include:Continue Reading Framework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public Feedback

On September 6, 2023, U.S. Senator Bill Cassidy, ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, published a white paper addressing artificial intelligence (AI) and its potential benefits and risks in the workplace, as well as in the health care  context, which we discuss here.

Continue Reading Senate Whitepaper Addresses AI in the Workplace

On 11 July 2023 the National Security Act 2023 (the Act) received royal assent and became law. The Act addresses trade secret misappropriation in the context of industrial espionage by a foreign government, making the unauthorised conduct of obtaining, copying, recording or retaining a trade secret, or disclosing or providing access to a trade secret, under certain circumstances, a criminal offence. The maximum penalty is 14 years imprisonment and/or a fine (section 2 of the Act).

The trade secrets provision is part of a broader regime introduced by the UK government to address national security threats such as espionage, sabotage and foreign interference. 

One of the conditions that has to be met in relation to the person’s conduct is the “foreign power condition”. The foreign power condition is defined in section 31(1) of the Act as:

(a)the conduct in question, or a course of conduct of which it forms part, is carried out for or on behalf of a foreign power, and

(b)the person knows, or having regard to other matters known to them ought reasonably to know, that to be the case.

In order for section 31(1) to be triggered it is for example sufficient if the conduct is under direction or control of the foreign power or even just carried out with the financial or otherwise assistance provided by a foreign power for that purpose.

It will be interesting to see how the foreign power condition will be applied in practice, in particular where governments have extensive control and ownership over corporations.Continue Reading Trade secrets misappropriation: a new criminal offence in the UK

Following our recent overview of key topics to watch in the National Defense Authorization Act (“NDAA”) for Fiscal Year (“FY”) 2024, available here, we continue our coverage with a “deep dive” into NDAA provisions related to the People’s Republic of China (“China” or “PRC”) in each of the House and Senate bills.  DoD’s focus on strengthening U.S. deterrence and competitive positioning vis-à-vis China features prominently in the 2022 National Defense Strategy (“NDS”) and in recent national security discourse.  This focus is shared by the Select Committee on Strategic Competition Between the United States and the Chinese Communist Party (“Select Committee”), led by Chairman Mike Gallagher (R-WI) and Ranking Member Raja Krishnamoorthi (D-IL). 

It is no surprise, then, that House and Senate versions of the NDAA include hundreds of provisions—leveraging all elements of national power—intended to address what the NDS brands as China’s “pacing” challenge, including many grounded in Select Committee policy recommendations.  Because the NDAA is viewed as “must-pass” legislation, it has served in past years as a vehicle through which other bills not directly related to DoD are enacted in law.  In one respect, this year is no different—the Senate version of the NDAA incorporates both the Department of State and Intelligence 2024 Authorization bills, each of which includes provisions related to China. 

To get a flavor of the approach to China in this year’s NDAA, look no further than the “Ending China’s Developing Nation Status Act” in Section 1399L of the Senate bill, which would require U.S. opposition to granting China “developing nation” status in treaties under negotiation and by international organizations of which the U.S. and China are members, such as the World Trade Organization.  Classification as a “developing nation” affords China access to preferential loans and other economic benefits intended to increase trading opportunities, notwithstanding its current status as an upper-middle income country (as determined by the World Bank), and the world’s second largest economy, trailing only the U.S.  Not to be outdone, Section 155 of the House bill contains a provision mandating expedited deployment of advanced radars to track high-altitude balloons and other potential threats to the U.S., in direct response to the incident earlier this year in which a Chinese balloon flew across the U.S. before being shot down by the Air Force.

Given these provisions, and many more (some we discuss below), this year’s NDAA strikes us as different.  It incorporates many more China-related provisions and many of these would impose greater obligations on government contractors to limit their interactions with the PRC and entities affiliated with the PRC Government.  Whether the laundry list of China-related provisions in the current NDAA survive, and in what form, will be determined by the conference process currently underway.  But these provisions have the potential to impose significant near-term burdens on contractors—requiring them to assess their obligations and make adjustments to ensure compliance.  Indeed, these provisions may be far more disruptive than requirements imposed by prior year NDAA China provisions that contractors have navigated by reassessing supply chains and increasing due diligence.  All government contractors and suppliers to government contractors with any connection to China would be well advised to monitor how the NDAA conference approaches resolution of this legislation over the coming months.Continue Reading Not to Be Outpaced: NDAA Presents Measures Addressing China