Action Items for U.S. Public Companies for 2025
Rapid rulemaking and aggressive enforcement by the SEC, combined with legislative, judicial, and regulatory developments, have created new requirements and expectations for U.S. public companies.
NHTSA Proposes Sweeping Voluntary Program for Vehicles With Automated Driving Systems
On December 19, 2024, the Chief Counsel of the U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA or the Agency) signed a notice of proposed rulemaking (NPRM) in which the Agency proposed a sweeping voluntary program relating to the evaluation and oversight of motor vehicles equipped with automated driving systems (ADS). NHTSA defines ADS-equipped vehicles, which can also be called autonomous vehicles (AVs), as vehicles designed to fully perform the driving task without any expectation of an attentive human driver.
Looking Ahead to 2025 in EU Cybersecurity Developments
As 2024 draws to a close, we look ahead to notable upcoming cyber developments in the new year. From the adoption of new cyber laws to the initiation of infringement proceedings by the European Commission against a number of EU Member States for alleged failures to adequately implement the EU Network and Information Systems Security 2 Directive, the EU continues to emphasize cybersecurity in a rapidly evolving legal and technological environment. There are no signs of this momentum slowing down in 2025.
CMS Proposes Artificial Intelligence Limits and Utilization Management Guardrails for Medicare Advantage
On December 10, 2024, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule with technical changes for the Medicare Advantage (MA) Program and the Medicare Prescription Drug Benefit Program for Calendar Year 2026 (Proposed Rule). Citing the growing use of Artificial Intelligence (AI) within the healthcare sector and reports that the use of AI may lead to “algorithmic discrimination” that exacerbates inequalities within healthcare, CMS proposes, for the first time, new guardrails that must be adopted by MA plans when using AI to manage patient care. CMS also proposes several reforms addressing utilization management (UM) techniques adopted by MA plans, including requirements for such plans to conduct and report detailed analyses on the use of prior authorizations. Notably, the Proposed Rule primarily modifies MA regulations, without direct application to the Medicare Part D prescription drug program.
Post-Election Landscape: New Risks, New Opportunities
Sidley thought leaders explored risks and opportunities of a second Trump administration in a “lightning round”, covering key practice areas. Change is coming and along with it, new and fast-paced risks and opportunities.
EU AI Act: Are You Prepared for the “AI Literacy” Principle?
The EU AI Act is the world’s first horizontal and standalone law governing the commercialization and use of AI, and a landmark piece of legislation for the EU. Among the various provisions of the EU AI Act, the “AI literacy” principle is an often overlooked but key obligation which requires organizations to ensure that staff who are involved in the operation and use of AI have the necessary skills, knowledge and understanding to adequately assess AI-related risks and opportunities (e.g., through training and hiring staff with the appropriate background and skillset). This obligation – which applies from February 2, 2025 – is one of the few obligations under the EU AI Act that applies to all AI systems i.e., irrespective of the level of risk that the AI system presents. Indeed, by introducing AI literacy as one of the first provisions of the AI Act (Article 4), the EU legislators appear to underscore the significance of this requirement.
U.S. Treasury Issues Final Rule Restricting Outbound Investments in Chinese-Affiliated Entities
On October 28, 2024, the U.S. Department of the Treasury (Treasury) released the Final Rule for its new regulations prohibiting or requiring notification of U.S. outbound investments in certain Chinese-affiliated companies in the semiconductor and microelectronics, quantum information technology, and artificial intelligence (AI) sectors. The Final Rule will take effect on January 2, 2025.
Rising AI Enforcement: Insights From State Attorney General Settlement and U.S. FTC Sweep for Risk Management and Governance
Recent enforcement actions by both state and federal law enforcement signal that companies that make or use artificial intelligence products are facing increased scrutiny under existing unfair and deceptive acts and practices laws. Several late-2024 examples present important insights for companies navigating how to effectively and legally implement artificial intelligence technologies in their businesses.
FY2024 in Review: SEC Enforcement Actions Against Investment Advisers to Private Funds, Registered Funds, and Retail Clients
In its 2024 fiscal year, the U.S. Securities and Exchange Commission brought over 130 enforcement actions against investment advisers and their representatives. This post highlights the key areas of focus and notable actions and litigation from the past fiscal year.
Top Trends in the European Digital Health/AI Market
Digital health AI technologies are transforming the advancement of drug development and healthcare delivery at an unprecedented speed, backed by governments facilitating the momentum to improve healthcare for their growing populations. Sidley’s European life sciences lawyers Josefine Sommer, Eva von Mühlenen, and Francesca Blythe share a timely take on the top 5 life sciences industry trends being shaped by pioneering digital technologies. We are delighted to present a series of insightful interviews with leaders from a diverse digital health ecosystem giving their perspectives from Roche, Origen Genetics, FemTech Insights, Verge, Steto, and Clario.
