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European Union
The EU AI Act, GDPR's collision with AI training data, the Digital Services Act, and the AI Office's enforcement role are tracked here daily — see also the dedicated EU AI Act tracker.
EuropeMedQA Study Protocol: A Multilingual, Multimodal Medical Examination Dataset for Language Model Evaluation
While Large Language Models (LLMs) have demonstrated high proficiency on English-centric medical examinations, their performance often declines when faced with non-English languages and multimodal diagnostic tasks. This study protocol describes the development of EuropeMedQA, the first comprehensive, multilingual, and multimodal medical examination dataset sourced from official regulatory exams in Italy, France, Spain, and Portugal. Following FAIR data principles and SPIRIT-AI guidelines, we des
Making AI Compliance Evidence Machine-Readable
AI Assurance -- producing the machine-readable evidence required to demonstrate compliance with AI governance frameworks -- has mature policy scaffolding but lacks the infrastructure to operationalize it. Organizations building high-risk AI systems under the EU AI Act face a gap: frameworks such as the EU AI Act, ISO/IEC 42001, and NIST AI RMF specify what to assure but provide no executable format for how. This paper proposes OSCAL -- the NIST standard adopted for FedRAMP cybersecurity complian
Operationalising the Right to be Forgotten in LLMs: A Lightweight Sequential Unlearning Framework for Privacy-Aligned Deployment in Politically Sensitive Environments
Large Language Models (LLMs) are increasingly deployed in politically sensitive environments, where memorisation of personal data or confidential content raises regulatory concerns under frameworks such as the GDPR and its Right to be Forgotten. Translating such legal principles into large-scale generative systems presents significant technical challenges. We introduce a lightweight sequential unlearning framework that explicitly separates retention and suppression objectives. The method first s
From Reactive to Proactive: A Multi-Regulatory Empirical Analysis of 480 AI Incidents and a Data-Driven Governance Compliance Framework
Artificial intelligence systems are increasingly deployed in high-stakes domains, yet it remains unclear whether existing governance frameworks ensure accountability after deployment. This study makes two contributions. First, it presents a cross-regulatory empirical analysis of 480 real-world AI incidents from the AI Incident Database (AIID), evaluating their alignment with post-deployment provisions in three major governance frameworks: the EU AI Act (Articles 72-73), the NIST AI Risk Manageme
Assessing the Added Value of Onboard Earth Observation Processing with the IRIDE HEO Service Segment
Current operational Earth Observation (EO) services, including the Copernicus Emergency Management Service (CEMS), the European Forest Fire Information System (EFFIS), and the Copernicus Land Monitoring Service (CLMS), rely primarily on ground-based processing pipelines. While these systems provide mature large-scale information products, they remain constrained by downlink latency, bandwidth limitations, and limited capability for autonomous observation prioritisation. The International Report
UGAF-ITS: A Standards Harmonization Framework and Validation Tool for Multi-Framework AI Governance in Distributed Intelligent Transportation Systems
Organizations deploying AI-enabled Intelligent Transportation Systems face fragmented governance: ISO/IEC 42001 demands a certifiable management system, the EU AI Act imposes binding high-risk obligations from August 2026, and the NIST AI Risk Management Framework structures voluntary practice. Each instrument is internally coherent, yet they drive different control vocabularies, evidence expectations, and audit rhythms. In distributed ITS deployments where vehicle manufacturers, roadside integr
AI Agents Under EU Law
AI agents - i.e. AI systems that autonomously plan, invoke external tools, and execute multi-step action chains with reduced human involvement - are being deployed at scale across enterprise functions ranging from customer service and recruitment to clinical decision support and critical infrastructure management. The EU AI Act (Regulation 2024/1689) regulates these systems through a risk-based framework, but it does not operate in isolation: providers face simultaneous obligations under the GDP
AI Agents for Sustainable SMEs: A Green ESG Assessment Framework
This study presents a novel, AI-driven framework for assessing Environmental, Social, and Governance (ESG) performance in European small and medium-sized enterprises (SMEs). An initial phase established expert-validated ESG baseline scores from a subset of the Flash Eurobarometer FL549 survey data. In the second phase, a scalable AI agent system, built on the n8n automation platform, applied these baselines to perform automated ESG classification and generate contextual recommendations using lar
A CEFR-Inspired Classification Framework with Fuzzy C-Means To Automate Assessment of Programming Skills in Scratch
Context: Schools, training platforms, and technology firms increasingly need to assess programming proficiency at scale with transparent, reproducible methods that support personalized learning pathways. Objective: This study introduces a pedagogical framework for Scratch project assessment, aligned with the Common European Framework of Reference (CEFR), providing universal competency levels for students and teachers alongside actionable insights for curriculum design. Method: We apply Fuzzy C-M
EuraGovExam: A Multilingual Multimodal Benchmark from Real-World Civil Service Exams
We present EuraGovExam, a multilingual and multimodal benchmark sourced from real-world civil service examinations across five representative Eurasian regions: South Korea, Japan, Taiwan, India, and the European Union. Designed to reflect the authentic complexity of public-sector assessments, the dataset contains over 8,000 high-resolution scanned multiple-choice questions covering 17 diverse academic and administrative domains. Unlike existing benchmarks, EuraGovExam embeds all question content
Mind The Gap: How The Technical Mechanism Of Agentic AI Outpace Global Legal Frameworks
This article presents the first systematic comparative survey of how public bodies, international organisations, national regulators, and the private sector define agentic artificial intelligence, identifying the technical inaccuracies pervading each definition. Analysing eleven regulatory instruments and industry frameworks -- including the EU AI Act, the OECD/G7 Principles, NIST, the UK ICO, and the European Commission -- alongside six leading developer architectures, this study demonstrates a
DAOnt: A Formal Ontology for EU Data Act Compliance
The EU Data Act establishes comprehensive rules governing data access and sharing across business-to-consumer (B2C), business-to-business (B2B), and business-to-government (B2G) contexts. This paper presents a comprehensive ontology for the EU Data Act, enabling reasoning over data sharing agreements through machine-readable representations. The DAOnt ontology reuses elements from three established ontologies, LKIF-Core, ODRL, and DPV, to capture the normative structure of the Data Act. The onto
Regulating AI Agents
AI agents -- systems that can independently take actions to pursue complex goals with only limited human oversight -- have entered the mainstream. These systems are now being widely used to produce software, conduct business activities, and automate everyday personal tasks. While AI agents implicate many areas of law, ranging from agency law and contracts to tort liability and labor law, they present particularly pressing questions for the most globally consequential AI regulation: the European
Algorithmic Administration and the EU AI Act: Legal Principles for Public Sector Use of AI
The increasing use of artificial intelligence (AI) by public authorities introduces both opportunities for innovation and significant challenges for the administrative rule of law. This article examines how the EU AI Act interacts with the fundamental principles of administrative law, with a particular focus on administrative discretion, the duty to state reasons, and proportionality. It analyses the regulatory obligations imposed by the AI Act on public sector deployers of high-risk systems, es
The EU AI Act and the Rights-based Approach to Technological Governance
The EU AI Act constitutes an important development in shaping the Union's digital regulatory architecture. The Act places fundamental rights at the heart of a risk-based governance framework. The article examines how the AI Act institutionalises a human-centric approach to AI and how the AI Act's provisions explicitly and implicitly embed the protection of rights enshrined in the EU Charter of Fundamental Rights. It argues that fundamental rights function not merely as aspirational goals, but as
From the AI Act to a European AI Agency: Completing the Union's Regulatory Architecture
As artificial intelligence (AI) technologies continue to advance, effective risk assessment, regulation, and oversight are necessary to ensure that AI development and deployment align with ethical principles while preserving innovation and economic competitiveness. The adoption of the EU AI Act marks an important step in this direction, establishing a harmonised legal framework that includes detailed provisions on AI governance, as well as the creation of the European AI Office. This paper revis
AEGIS: An Operational Infrastructure for Post-Market Governance of Adaptive Medical AI Under US and EU Regulations
Machine learning systems deployed in medical devices require governance frameworks that ensure safety while enabling continuous improvement. Regulatory bodies including the FDA and European Union have introduced mechanisms such as the Predetermined Change Control Plan (PCCP) and Post-Market Surveillance (PMS) to manage iterative model updates without repeated submissions. This paper presents AI/ML Evaluation and Governance Infrastructure for Safety (AEGIS), a governance framework applicable to a
Bielik-Minitron-7B: Compressing Large Language Models via Structured Pruning and Knowledge Distillation for the Polish Language
This report details the creation of Bielik-Minitron-7B, a compressed 7.35B parameter version of the Bielik-11B-v3.0 model, specifically optimized for European languages. By leveraging a two-stage compression methodology inspired by the NVIDIA Minitron approach, we combined structured hybrid pruning and knowledge distillation to reduce the model's parameter count by 33.4%, from 11.04B to 7.35B. We utilized the NVIDIA Model Optimizer for structural pruning and the NVIDIA NeMo Framework for logit-b
Is your AI Model Accurate Enough? The Difficult Choices Behind Rigorous AI Development and the EU AI Act
Technical and legal debates frequently suggest that "accuracy" is an objective, measurable, and purely technical property. We challenge this view, showing that evaluating AI performance fundamentally depends on context-dependent normative decisions. These techno-normative choices are crucial for rigorous AI deployment, as they determine which errors are prioritised, how risks are distributed, and how trade-offs between competing objectives are resolved. This paper provides a legal-technical anal
Ethical Implications of Training Deceptive AI
Deceptive behavior in AI systems is no longer theoretical: large language models strategically mislead without producing false statements, maintain deceptive strategies through safety training, and coordinate deception in multi-agent settings. While the European Union's AI Act prohibits deployment of deceptive AI systems, it explicitly exempts research and development, creating a necessary but unstructured space in which no established framework governs how deception research should be conducted
The European Health Data Space: an opportunity to strengthen citizen rights and engage citizens in health data governance
Introduction: The European Health Data Space (EHDS), the European Union's new regulatory framework for health data use and reuse, will have important implications for citizens across the Union. While the regulation aims to empower citizens in the primary use of their health data-such as by giving them access to their electronic health records-their role in the secondary use of health data remains less clearly defined. Methods: To explore this, we interviewed health data experts across 23 Europea
Discrimination, artificial intelligence, and algorithmic decision-making
Artificial intelligence (AI) has a huge impact on our personal lives and also on our democratic society as a whole. While AI offers vast opportunities for the benefit of people, its potential to embed and perpetuate bias and discrimination remains one of the most pressing challenges deriving from its increasing use. This new study, which was prepared by Prof. Frederik Zuiderveen Borgesius for the Anti-discrimination Department of the Council of Europe, elaborates on the risks of discrimination c
Navigating the Global Regulatory Landscape for Exosome-Based Therapeutics: Challenges, Strategies, and Future Directions
Extracellular vesicle (EV)-based therapies have attracted considerable attention as a novel class of biologics with broad clinical potential. However, their clinical translation is impeded by the fragmented and rapidly evolving regulatory landscape, with significant disparities between the United States, European Union, and key Asian jurisdictions. In this review, we systematically analyze regional guidelines and strategic frameworks governing EV therapeutics, emphasizing critical hurdles in qua
Guiding AI in radiology: ESR’s recommendations for effective implementation of the European AI Act
This statement has been produced within the European Society of Radiology AI Working Group and identifies the key policies of the EU AI Act as they pertain to medical imaging. It offers specific recommendations to policymakers and the professional community for the effective implementation of the legislation, addressing potential gaps and uncertainties. Key areas include AI literacy, classification rules for high-risk AI systems, data governance, transparency, human oversight, quality management
Advances on the Global Human Settlement Layer by joint assessment of Earth Observation and population survey data
The Global Human Settlement Layer (GHSL) project fosters an enhanced, public understanding of the human presence on Earth. A decade after its inception in the Digital Earth 2020 vision, GHSL is an established project of the European Commission’s Joint Research Centre and an integral part of the Copernicus Emergency Management Service. The 2023 GHSL edition, a result of rigorous research on Earth Observation data and population censuses, contributes significantly to understanding worldwide human
A Review of Renewable Energy Communities: Concepts, Scope, Progress, Challenges, and Recommendations
In recent times, there has been a significant shift from centralized energy systems to decentralized ones. These systems aim to satisfy local energy needs using renewable resources within the community. This approach leads to decreased complexity and costs, improved efficiency, and enhanced local resilience and supports energy independence, thereby advancing the transition toward zero carbon emissions. Community energy plays a pivotal role globally, particularly in European countries, driven by
Regulating ChatGPT and other Large Generative AI Models
Large generative AI models (LGAIMs), such as ChatGPT, GPT-4 or Stable Diffusion, are rapidly transforming the way we communicate, illustrate, and create. However, AI regulation, in the EU and beyond, has primarily focused on conventional AI models, not LGAIMs. This paper will situate these new generative models in the current debate on trustworthy AI regulation, and ask how the law can be tailored to their capabilities. After laying technical foundations, the legal part of the paper proceeds in
The environmental effects of the “twin” green and digital transition in European regions
This study explores the nexus between digital and green transformations-the so-called "twin" transition-in European regions in an effort to identify the impact of digital and environmental technologies on the greenhouse gas (GHG) emissions originating from industrial production. We conduct an empirical analysis based on an original dataset that combines information on environmental and digital patent applications with information on GHG emissions from highly polluting plants for the period 2007-
Drivers of Digital Transformation in SMEs
This study aims to identify and analyze factors determining the adoption of digital technologies in SMEs. Drawing on the technology–organization–environment framework, the study highlights enabling factors from three different contexts and hypothesizes their relationship with digital technology adoption. The data used were collected from 15 346 European Union and non-European Union SMEs to test an ordered logit regression model that highlights the factors associated with an increased level of di
The 2022 Europe report of the Lancet Countdown on health and climate change: towards a climate resilient future
In the past few decades, major public health advances have happened in Europe, with drastic decreases in premature mortality and a life expectancy increase of almost 9 years since 1980. European countries have some of the best health-care systems in the world. However, \nEurope is challenged with unprecedented and overlapping crises that are detrimental to human health and livelihoods and threaten adaptive capacity, including the COVID-19 pandemic, the Russian invasion of Ukraine, the fastes
Future Directions of Intelligent Vehicles: Potentials, Possibilities, and Perspectives
This is the brief report of the first IEEE Distributed/Decentralized Hybrid Workshop on Future Directions of Intelligent Vehicles (IEEE DHW-FDIV), part of the IEEE Distributed/Decentralized Hybrid Symposia on Intelligent Vehicles (IEEE DHS-IV) organized by the IEEE Transactions on Intelligent Vehicles (TIV). This DHW was conducted through two events on January 12 and February 7, 2022 with 23 and 12 participants from Asia, Europe, and North America, respectively. Various issues related to the cur
The Fight for Digital Sovereignty: What It Is, and Why It Matters, Especially for the EU
In AI We Trust: Ethics, Artificial Intelligence, and Reliability
One of the main difficulties in assessing artificial intelligence (AI) is the tendency for people to anthropomorphise it. This becomes particularly problematic when we attach human moral activities to AI. For example, the European Commission's High-level Expert Group on AI (HLEG) have adopted the position that we should establish a relationship of trust with AI and should cultivate trustworthy AI (HLEG AI Ethics guidelines for trustworthy AI, 2019, p. 35). Trust is one of the most important and
Review: Recent advances in bovine in vitro embryo production: reproductive biotechnology history and methods
In vitro production (IVP) of embryos and associated technologies in cattle have shown significant progress in recent years, in part driven by a better understanding of the full potential of these tools by end users. The combination of IVP with sexed semen (SS) and genomic selection (GS) is being successfully and widely used in North America, South America and Europe. The main advantages offered by these technologies include a higher number of embryos and pregnancies per unit of time, and a wider
Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2019
1: ESGE suggests that high definition endoscopy, and dye or virtual chromoendoscopy, as well as add-on devices, can be used in average risk patients to increase the endoscopist's adenoma detection rate. However, their routine use must be balanced against costs and practical considerations.Weak recommendation, high quality evidence. 2: ESGE recommends the routine use of high definition systems in individuals with Lynch syndrome.Strong recommendation, high quality evidence. 3: ESGE recommends the
Ethics of Artificial Intelligence in Radiology: Summary of the Joint European and North American Multisociety Statement
This is a condensed summary of an international multisociety statement on ethics of artificial intelligence (AI) in radiology produced by the ACR, European Society of Radiology, RSNA, Society for Imaging Informatics in Medicine, European Society of Medical Imaging Informatics, Canadian Association of Radiologists, and American Association of Physicists in Medicine. AI has great potential to increase efficiency and accuracy throughout radiology, but it also carries inherent pitfalls and biases. W
Association Between Surgical Skin Markings in Dermoscopic Images and Diagnostic Performance of a Deep Learning Convolutional Neural Network for Melanoma Recognition
IMPORTANCE: Deep learning convolutional neural networks (CNNs) have shown a performance at the level of dermatologists in the diagnosis of melanoma. Accordingly, further exploring the potential limitations of CNN technology before broadly applying it is of special interest. OBJECTIVE: To investigate the association between gentian violet surgical skin markings in dermoscopic images and the diagnostic performance of a CNN approved for use as a medical device in the European market. DESIGN AND SET
The EU Approach to Ethics Guidelines for Trustworthy Artificial Intelligence
As part of its European strategy for Artificial Intelligence (AI), and as a response to the increasing ethical questions raised by this technology, the European Commission established an independent High-Level Expert Group on Artificial Intelligence (AI HLEG) in June 2018. The group was tasked to draft two deliverables: AI Ethics Guidelines and Policy and Investment Recommendations. Nine months later, its first deliverable was published, putting forward a comprehensive framework to achieve “Trus
Violent video game engagement is not associated with adolescents' aggressive behaviour: evidence from a registered report
= 1004) aged 14 and 15 years and an equal number of their carers were interviewed. Young people provided reports of their recent gaming experiences. Further, the violent contents of these games were coded using official EU and US ratings, and carers provided evaluations of their adolescents' aggressive behaviours in the past month. Following a preregistered analysis plan, multiple regression analyses tested the hypothesis that recent violent game play is linearly and positively related to carer
Soft ethics, the governance of the digital and the General Data Protection Regulation
The article discusses the governance of the digital as the new challenge posed by technological innovation. It then introduces a new distinction between soft ethics , which applies after legal compliance with legislation, such as the General Data Protection Regulation in the European Union, and hard ethics , which precedes and contributes to shape legislation. It concludes by developing an analysis of the role of digital ethics with respect to digital regulation and digital governance. This arti