Although the final text of the EU AI Act should enter into force in the next few months, many of its obligations will only start to apply two or more years after that (for further details, see our earlier blog here). To address this gap, the Commission is encouraging industry to take early, voluntary
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Colorado Becomes the First State to Pass Comprehensive AI Legislation
In the absence of congressional action on comprehensive artificial intelligence (AI) legislation, state legislatures are forging ahead with groundbreaking bills to regulate the rapidly advancing technology. On May 8, the Colorado House of Representatives passed SB 205, a far-reaching and comprehensive AI bill, on a 41-22-2 vote. The final vote comes just days…
CEQ Final NEPA Regulations and Department of Energy Actions Aim to Responsibly Accelerate Clean Energy, Transmission, and Other Infrastructure Development
On May 1, 2024, the White House Council on Environmental Quality (“CEQ”) published its final “Phase 2” National Environmental Policy Act (“NEPA”) regulations, formally called the Bipartisan Permitting Reform Implementation Rule (“Final Rule”). Publication of the Final Rule completes a multi-year effort by the Biden Administration that included publication of final, narrower “Phase…
California establishes working guidance for AI procurement
As the 2024 elections approach and the window for Congress to consider bipartisan comprehensive artificial intelligence (AI) legislation shrinks, California officials are attempting to guard against a generative AI free-for-all—at least with respect to state government use of the rapidly advancing technology—by becoming the largest state to issue rules for state procurement of AI technologies. …
March 2024 Developments Under President Biden’s Cybersecurity Executive Order, National Cybersecurity Strategy, and AI Executive Order
This is part of a series of Covington blogs on implementation of Executive Order 14028, “Improving the Nation’s Cybersecurity,” issued by President Biden on May 12, 2021 (the “Cyber EO”). The first blog summarized the Cyber EO’s key provisions and timelines, and the subsequent blogs described the actions taken by various government agencies to implement…
MHRA Outlines New Strategic Approach to Artificial Intelligence
On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”). The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12…
Overview of AI Regulatory Landscape in APAC
With the rapid evolution of artificial intelligence (AI) technology, the regulatory frameworks for AI in the Asia–Pacific (APAC) region continue to develop quickly. Policymakers and regulators have been prompted to consider either reviewing existing regulatory frameworks to ensure their effectiveness in addressing emerging risks brought by AI, or proposing new, AI-specific rules or regulations. Overall,…
EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices
In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS…
EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices
On March 5, 2025, the final text of the European Health Data Space (EHDS) was published in the EU Official Journal (see here). In April 2024,we wrote several blog posts on EHDS based on a provisional compromise text. We have now updated those to reflect the final version and included references to the correct…
EFPIA Issues Statement on Application of the AI Act in the Medicinal Product Lifecycle
On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) issued a statement on the application of the AI Act in the medicinal product lifecycle. The EFPIA statement highlights that AI applications are likely to play an increasing role in the development and manufacture of medicines. As drug development is already governed…