EDPB Adopts Report on GDPR Right of Access Following 2024 Coordinated Enforcement Action
On January 20, 2025, the European Data Protection Board (EDPB) adopted a report on the implementation of the right of access by controllers under the GDPR (the Report). The right of access was the subject of the EDPB’s third coordinated enforcement action (CEF) in 2024 which involved 1,185 controllers of varying size, industry, and sectors. The Report provides useful recommendations for controllers on how to comply with access requests, including guidance on how long access request documentation should be retained, the importance of maintaining internal documentation, and how to avoid a ‘one size fits all’ approach. The Report emphasizes that access requests should be handled on a case-by-case basis, considering the broad scope of the right and the limited exemptions.
Artificial Intelligence: U.S. Securities and Commodities Guidelines for Responsible Use
Despite recent focus on artificial intelligence (AI) by U.S. financial regulators, the Securities and Exchange Commission (SEC), Commodity Futures Trading Commission (CFTC), and Financial Industry Regulatory Authority (FINRA) have not yet issued new regulations specifically addressing the use of AI. Nonetheless, during the Biden administration, guidance from these agencies emphasized the necessity of responsible use of AI within existing regulatory frameworks, urging market participants to exercise additional diligence to navigate compliance risks associated with AI usage.
U.S. Copyright Office Issues Report on Artificial Intelligence and Copyrightability
On January 29, 2025, the U.S. Copyright Office issued the second part of its Report on Copyright and Artificial Intelligence, following a Notice of Inquiry (NOI) the Office issued in 2023. The first part of the Office’s Report, released in July 2024, addressed digital replicas. This second part addresses copyrightability, an issue that attracted considerable interest from authors, artists, and the media and technology industries — approximately half of the more than 10,000 comments that the Office received in response to the NOI addressed copyrightability questions.
CMS Seeks Comments on Proposed Guidance Addressing Study Protocols That Use Real-World Data
On January 17, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed guidance document on study protocols that use real-world data (RWD). The proposed guidance focuses on studies with RWD sources in the context of Medicare National Coverage Determinations (NCDs) using CMS’s Coverage with Evidence Development (CED) paradigm. It presents a proposed standardized template for manufacturers or other sponsors to use when developing CED study protocols using RWD. The proposed guidance could also have broader implications with respect to RWD studies and coverage considerations. Comments on the proposed guidance are due by March 18, 2025.
U.S. Department of Commerce Finalizes Connected Vehicles Supply Chain Restrictions
On January 16, 2025, the U.S. Department of Commerce Bureau of Industry and Security (BIS) Office of Information and Communications Technology and Services (OICTS) published a Final Rule formalizing prohibitions on certain connected vehicles (CVs) transactions involving hardware and software linked to the People’s Republic of China (China) and Russia.1 The Final Rule is scheduled to take effect on March 17, 2025. However, given that the Final Rule is one of several new regulatory frameworks on trade issued in the final days of the Biden administration, it remains to be seen what will happen with these regulations after January 20.
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.
U.S. Department of Commerce Seeks to Protect Drones Supply Chain From Foreign Adversaries
On January 3, 2025, the U.S. Department of Commerce Bureau of Industry and Security (BIS) Office of Information and Communications Technology and Services (OICTS) published an Advance Notice of Proposed Rulemaking (ANPRM) on the national security risks posed by foreign adversary involvement in the supply chain for unmanned aerial systems (UAS) (i.e., drones), including risks to critical infrastructure and U.S. sensitive data. BIS seeks public input to inform regulations on the supply of certain UAS components developed by entities linked to the People’s Republic of China (China) and Russia.
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.
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.
Advisor to the CJEU Confirms GDPR Fines For Subsidiary Infringements Should Reflect Group Turnover
On 12 September 2024, Advocate General Medina issued their Opinion in Case C-383/23 in which they confirmed that supervisory data protection authorities must, when calculating the fine for a GDPR infringement committed by a subsidiary, take into account the total annual turnover of the entire group—a concept known as parental liability.
