european union

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 a summary of the AI Act, see our EMEA Tech Regulation Toolkit). In line with its National Artificial Intelligence Strategy, Spain has been playing an active role in the development of AI initiatives, including a pilot for the EU’s first AI Regulatory Sandbox and guidelines on AI transparency.Continue Reading Spain Creates AI Regulator to Enforce the AI Act

On 9 October 2023, the European Parliament’s Internal Market and Consumer Protection Committee (IMCO) and Committee on Legal Affairs (JURI) agreed revised wording to amend the European Commission’s (the “EC”) proposed new Product Liability Directive (the “Directive”). The vote was passed with 33 votes in favour to 2 against. If adopted, the Directive will replace the existing (almost 40-year old) Directive 85/374/EEC on Liability for Defective Products, which imposes a form of strict liability on product manufacturers for harm caused by their defective products.Continue Reading EU Legislative Update on the New Product Liability Directive

On 31 May 2023, at the close of the fourth meeting of the US-EU Trade & Tech Council (“TTC”), Margrethe Vestager – the European Union’s Executive Vice President, responsible for competition and digital strategy – announced that the EU and US are working together to develop a voluntary AI Code of Conduct in advance of formal regulation taking effect. The goal, according to Vestager, is to develop non-binding international standards on risk audits, transparency and other requirements for companies developing AI systems. The AI Code of Conduct, once finalized, would be put before G7 leaders as a joint transatlantic proposal, and companies would be encouraged to voluntarily sign up.Continue Reading EU and US Lawmakers Agree to Draft AI Code of Conduct

On 11 May 2023, members of the European Parliament’s internal market (IMCO) and civil liberties (LIBE) committees agreed their final text on the EU’s proposed AI Act. After MEPs formalize their position through a plenary vote (expected this summer), the AI Act will enter the last stage of the legislative process: “trilogue” negotiations with the European Commission, Parliament and the Council, which adopted its own amendments in late 2022 (see our blog post here for further details). European lawmakers hope to adopt the final AI Act before the end of 2023, ahead of the European Parliament elections in 2024.

In perhaps the most significant change from the Commission and Council draft, under MEPs’ proposals, providers of foundation models – a term defined as an AI model that is “trained on broad data at scale, is designed for generality of output, and can be adapted to a wide range of distinctive tasks” (Article 3(1c)) – would be subject to a series of obligations. For example, providers would be under a duty to “demonstrate through appropriate design, testing and analysis that the identification, the reduction and mitigation of reasonably foreseeable risks to health, safety, fundamental rights, the environment and democracy and the rule of law prior and throughout development” (Article 28b(2)(a)), as well as to draw up “extensive technical documentation and intelligible instructions for use” to help those that build AI systems using the foundation model (Article 28b(2)(e)).Continue Reading EU Parliament’s AI Act Proposals Introduce New Obligations for Foundation Models and Generative AI

2023 is set to be an important year for developments in AI regulation and policy in the EU. At the end of last year, on December 6, 2022, the Council of the EU (the “Council”) adopted its general approach and compromise text on the proposed Regulation Laying Down Harmonized Rules on Artificial Intelligence (the “AI Act”), bringing the AI Act one step closer to being adopted. The European Parliament is currently developing its own position on the AI Act which is expected to be finalized by March 2023. Following this, the Council, Parliament and European Commission (“Commission”) will enter into trilogue discussions to finalize the Act. Once adopted, it will be directly applicable across all EU Member States and its obligations are likely to apply three years after the AI Act’s entry into force (according to the Council’s compromise text).  Continue Reading EU AI Policy and Regulation: What to look out for in 2023

            On April 28, 2022, Covington convened experts across our practice groups for the Covington Robotics Forum, which explored recent developments and forecasts relevant to industries affected by robotics.  Sam Jungyun Choi, Associate in Covington’s Technology Regulatory Group, and Anna Oberschelp, Associate in Covington’s Data Privacy & Cybersecurity Practice Group, discussed global regulatory trends that

On December 15, 2020, the European Commission published its proposed Regulation on a Single Market for Digital Services, more commonly known as the Digital Services Act (“DSA Proposal”).  In publishing the Proposal, the Commission noted that its goal was to protect consumers and their fundamental rights online, establish an accountability framework for online services, and foster innovation, growth and competitiveness in the single market.  On the same day, the Commission also published its proposal for a Digital Markets Act (“DMA”), which would impose new obligations and restrictions on online services that act as “designated gatekeepers” (see our analysis of the DMA Proposal here).
Continue Reading EU Publishes Proposal For Digital Services Act

In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad concepts and apply generally — but, in places, they specifically mention healthcare and medical devices.

The Commission recognizes the important role that AI and big data analysis can play in improving healthcare, but also notes the specific risks that could arise given the effects that such new technologies may have on individuals’ health, safety, and fundamental rights. The Commission also notes that existing EU legislation already affords a high level of protection for individuals, including through medical devices laws and data protection laws. The Commission’s proposals therefore focus on addressing the gap between these existing rules and the residual risks that remain in respect of new technologies. Note that the Commission’s proposals in the White Paper on AI are open for public consultation until 19 May 2020.Continue Reading AI Update: European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)

On 19 February 2020, the new European Commission published two Communications relating to its five-year digital strategy: one on shaping Europe’s digital future, and one on its European strategy for data (the Commission also published a white paper proposing its strategy on AI; see our previous blogs here and here).  In both Communications, the Commission sets out a vision of the EU powered by digital solutions that are strongly rooted in European values and EU fundamental rights.  Both Communications also emphasize the intent to strengthen “European technological sovereignty”, which in the Commission’s view will enable the EU to define its own rules and values in the digital age.  The Communications set out the Commission’s plans to achieve this vision.
Continue Reading AI Update: European Commission’s plans on data and Europe’s digital future (Part 3 of 4)

The European Commission, as part of the launch of its digital strategy for the next five years, published on 19 February 2020 a White Paper On Artificial Intelligence – A European approach to excellence and trust (the “White Paper”).  (See our previous blog here for a summary of all four of the main papers published by the Commission.)  The White Paper recognizes the opportunities AI presents to Europe’s digital economy, and presents the Commission’s vision for a coordinated approach to promoting the uptake of AI in the EU and addressing the risks associated with certain uses of AI.  The White Paper is open for public consultation until 19 May 2020.
Continue Reading AI Update: European Commission’s White Paper on Artificial Intelligence (Part 2 of 4)