eu ai act
From guardrails to governance: A CEO's guide for securing agentic systems
A practical blueprint for companies and CEOs that shows how to secure agentic systems by shifting from prompt tinkering to hard controls on identity, tools, and data. The previous article in this series, " Rules fail at the prompt, succeed at the boundary," focused on the first AI-orchestrated espionage campaign and the failure of prompt-level control. This article is the prescription. Across recent AI security guidance from standards bodies, regulators, and major providers, a simple idea keeps repeating: treat agents like powerful, semi-autonomous users, and enforce rules at the boundaries where they touch identity, tools, data, and outputs. These steps help define identity and limit capabilities. Today, agents run under vague, over-privileged service identities.
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How Do Companies Manage the Environmental Sustainability of AI? An Interview Study About Green AI Efforts and Regulations
Sampatsing, Ashmita, Vos, Sophie, Beauxis-Aussalet, Emma, Bogner, Justus
With the ever-growing adoption of artificial intelligence (AI), AI-based software and its negative impact on the environment are no longer negligible, and studying and mitigating this impact has become a critical area of research. However, it is currently unclear which role environmental sustainability plays during AI adoption in industry and how AI regulations influence Green AI practices and decision-making in industry. We therefore aim to investigate the Green AI perception and management of industry practitioners. To this end, we conducted a total of 11 interviews with participants from 10 different organizations that adopted AI-based software. The interviews explored three main themes: AI adoption, current efforts in mitigating the negative environmental impact of AI, and the influence of the EU AI Act and the Corporate Sustainability Reporting Directive (CSRD). Our findings indicate that 9 of 11 participants prioritized business efficiency during AI adoption, with minimal consideration of environmental sustainability. Monitoring and mitigation of AI's environmental impact were very limited. Only one participant monitored negative environmental effects. Regarding applied mitigation practices, six participants reported no actions, with the others sporadically mentioning techniques like prompt engineering, relying on smaller models, or not overusing AI. Awareness and compliance with the EU AI Act are low, with only one participant reporting on its influence, while the CSRD drove sustainability reporting efforts primarily in larger companies. All in all, our findings reflect a lack of urgency and priority for sustainable AI among these companies. We suggest that current regulations are not very effective, which has implications for policymakers. Additionally, there is a need to raise industry awareness, but also to provide user-friendly techniques and tools for Green AI practices.
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Embedding Explainable AI in NHS Clinical Safety: The Explainability-Enabled Clinical Safety Framework (ECSF)
Artificial intelligence (AI) is increasingly embedded in NHS workflows, but its probabilistic and adaptive behaviour conflicts with the deterministic assumptions underpinning existing clinical-safety standards. DCB0129 and DCB0160 provide strong governance for conventional software yet do not define how AI-specific transparency, interpretability, or model drift should be evidenced within Safety Cases, Hazard Logs, or post-market monitoring. This paper proposes an Explainability-Enabled Clinical Safety Framework (ECSF) that integrates explainability into the DCB0129/0160 lifecycle, enabling Clinical Safety Officers to use interpretability outputs as structured safety evidence without altering compliance pathways. A cross-regulatory synthesis mapped DCB clauses to principles from Good Machine Learning Practice, the NHS AI Assurance and T.E.S.T. frameworks, and the EU AI Act. The resulting matrix links regulatory clauses, principles, ECSF checkpoints, and suitable explainability outputs. ECSF introduces five checkpoints: global transparency for hazard identification, case-level interpretability for verification, clinician usability for evaluation, traceable decision pathways for risk control, and longitudinal interpretability monitoring for post-market surveillance. Techniques such as SHAP, LIME, Integrated Gradients, saliency mapping, and attention visualisation are mapped to corresponding DCB artefacts. ECSF reframes explainability as a core element of clinical-safety assurance, bridging deterministic risk governance with the probabilistic behaviour of AI and supporting alignment with GMLP, the EU AI Act, and NHS AI Assurance principles.
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Position Paper: If Innovation in AI Systematically Violates Fundamental Rights, Is It Innovation at All?
Castañeira, Josu Eguiluz, Brando, Axel, Laukyte, Migle, Serra-Vidal, Marc
Artificial intelligence (AI) now permeates critical infrastructures and decision-making systems where failures produce social, economic, and democratic harm. This position paper challenges the entrenched belief that regulation and innovation are opposites. As evidenced by analogies from aviation, pharmaceuticals, and welfare systems and recent cases of synthetic misinformation, bias and unaccountable decision-making, the absence of well-designed regulation has already created immeasurable damage. Regulation, when thoughtful and adaptive, is not a brake on innovation -- it is its foundation. The present position paper examines the EU AI Act as a model of risk-based, responsibility-driven regulation that addresses the Collingridge Dilemma: acting early enough to prevent harm, yet flexibly enough to sustain innovation. Its adaptive mechanisms -- regulatory sandboxes, small and medium enterprises (SMEs) support, real-world testing, fundamental rights impact assessment (FRIA) -- demonstrate how regulation can accelerate responsibly, rather than delay, technological progress. The position paper summarises how governance tools transform perceived burdens into tangible advantages: legal certainty, consumer trust, and ethical competitiveness. Ultimately, the paper reframes progress: innovation and regulation advance together. By embedding transparency, impact assessments, accountability, and AI literacy into design and deployment, the EU framework defines what responsible innovation truly means -- technological ambition disciplined by democratic values and fundamental rights.
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AIReg-Bench: Benchmarking Language Models That Assess AI Regulation Compliance
Marino, Bill, Hunter, Rosco, Jamali, Zubair, Kalpakos, Marinos Emmanouil, Kashyap, Mudra, Hinton, Isaiah, Hanson, Alexa, Nazir, Maahum, Schnabl, Christoph, Steffek, Felix, Wen, Hongkai, Lane, Nicholas D.
As governments move to regulate AI, there is growing interest in using Large Language Models (LLMs) to assess whether or not an AI system complies with a given AI Regulation (AIR). However, there is presently no way to benchmark the performance of LLMs at this task. To fill this void, we introduce AIReg-Bench: the first benchmark dataset designed to test how well LLMs can assess compliance with the EU AI Act (AIA). We created this dataset through a two-step process: (1) by prompting an LLM with carefully structured instructions, we generated 120 technical documentation excerpts (samples), each depicting a fictional, albeit plausible, AI system - of the kind an AI provider might produce to demonstrate their compliance with AIR; (2) legal experts then reviewed and annotated each sample to indicate whether, and in what way, the AI system described therein violates specific Articles of the AIA. The resulting dataset, together with our evaluation of whether frontier LLMs can reproduce the experts' compliance labels, provides a starting point to understand the opportunities and limitations of LLM-based AIR compliance assessment tools and establishes a benchmark against which subsequent LLMs can be compared. The dataset and evaluation code are available at https://github.com/camlsys/aireg-bench.
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Navigating the EU AI Act: Foreseeable Challenges in Qualifying Deep Learning-Based Automated Inspections of Class III Medical Devices
Diaz, Julio Zanon, Brennan, Tommy, Corcoran, Peter
As deep learning (DL) technologies advance, their application in automated visual inspection for Class III medical devices offers significant potential to enhance quality assurance and reduce human error. However, the adoption of such AI-based systems introduces new regulatory complexities-particularly under the EU Artificial Intelligence (AI) Act, which imposes high-risk system obligations that differ in scope and depth from established regulatory frameworks such as the Medical Device Regulation (MDR) and the U.S. FDA Quality System Regulation (QSR). This paper presents a high-level technical assessment of the foreseeable challenges that manufacturers are likely to encounter when qualifying DL-based automated inspections -- specifically static models -- within the existing medical device compliance landscape. It examines divergences in risk management principles, dataset governance, model validation, explainability requirements, and post-deployment monitoring obligations. The discussion also explores potential implementation strategies and highlights areas of uncertainty, including data retention burdens, global compliance implications, and the practical difficulties of achieving statistical significance in validation with limited defect data. Disclaimer: This paper presents a technical perspective and does not constitute legal or regulatory advice.
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An Analysis of the New EU AI Act and A Proposed Standardization Framework for Machine Learning Fairness
Teodorescu, Mike, Sun, Yongxu, Bhatia, Haren N., Makridis, Christos
The European Union's AI Act represents a crucial step towards regulating ethical and responsible AI systems. However, we find an absence of quantifiable fairness metrics and the ambiguity in terminology, particularly the interchangeable use of the keywords transparency, explainability, and interpretability in the new EU AI Act and no reference of transparency of ethical compliance. We argue that this ambiguity creates substantial liability risk that would deter investment. Fairness transparency is strategically important. We recommend a more tailored regulatory framework to enhance the new EU AI regulation. Further-more, we propose a public system framework to assess the fairness and transparency of AI systems. Drawing from past work, we advocate for the standardization of industry best practices as a necessary addition to broad regulations to achieve the level of details required in industry, while preventing stifling innovation and investment in the AI sector. The proposals are exemplified with the case of ASR and speech synthesizers.
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SafeEvalAgent: Toward Agentic and Self-Evolving Safety Evaluation of LLMs
Wang, Yixu, Wang, Xin, Yao, Yang, Li, Xinyuan, Teng, Yan, Ma, Xingjun, Wang, Yingchun
The rapid integration of Large Language Models (LLMs) into high-stakes domains necessitates reliable safety and compliance evaluation. However, existing static benchmarks are ill-equipped to address the dynamic nature of AI risks and evolving regulations, creating a critical safety gap. This paper introduces a new paradigm of agentic safety evaluation, reframing evaluation as a continuous and self-evolving process rather than a one-time audit. We then propose a novel multi-agent framework SafeEvalAgent, which autonomously ingests unstructured policy documents to generate and perpetually evolve a comprehensive safety benchmark. SafeEvalAgent leverages a synergistic pipeline of specialized agents and incorporates a Self-evolving Evaluation loop, where the system learns from evaluation results to craft progressively more sophisticated and targeted test cases. Our experiments demonstrate the effectiveness of SafeEvalAgent, showing a consistent decline in model safety as the evaluation hardens. For instance, GPT-5's safety rate on the EU AI Act drops from 72.50% to 36.36% over successive iterations. These findings reveal the limitations of static assessments and highlight our framework's ability to uncover deep vulnerabilities missed by traditional methods, underscoring the urgent need for dynamic evaluation ecosystems to ensure the safe and responsible deployment of advanced AI.
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Safety Compliance: Rethinking LLM Safety Reasoning through the Lens of Compliance
Hu, Wenbin, Jing, Huihao, Shi, Haochen, Li, Haoran, Song, Yangqiu
The proliferation of Large Language Models (LLMs) has demonstrated remarkable capabilities, elevating the critical importance of LLM safety. However, existing safety methods rely on ad-hoc taxonomy and lack a rigorous, systematic protection, failing to ensure safety for the nuanced and complex behaviors of modern LLM systems. To address this problem, we solve LLM safety from legal compliance perspectives, named safety compliance. In this work, we posit relevant established legal frameworks as safety standards for defining and measuring safety compliance, including the EU AI Act and GDPR, which serve as core legal frameworks for AI safety and data security in Europe. To bridge the gap between LLM safety and legal compliance, we first develop a new benchmark for safety compliance by generating realistic LLM safety scenarios seeded with legal statutes. Subsequently, we align Qwen3-8B using Group Policy Optimization (GRPO) to construct a safety reasoner, Compliance Reasoner, which effectively aligns LLMs with legal standards to mitigate safety risks. Our comprehensive experiments demonstrate that the Compliance Reasoner achieves superior performance on the new benchmark, with average improvements of +10.45% for the EU AI Act and +11.85% for GDPR.
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Can AI be Auditable?
Verma, Himanshu, Padh, Kirtan, Thelisson, Eva
Auditability is defined as the capacity of AI systems to be independently assessed for compliance with ethical, legal, and technical standards throughout their lifecycle. The chapter explores how auditability is being formalized through emerging regulatory frameworks, such as the EU AI Act, which mandate documentation, risk assessments, and governance structures. It analyzes the diverse challenges facing AI auditability, including technical opacity, inconsistent documentation practices, lack of standardized audit tools and metrics, and conflicting principles within existing responsible AI frameworks. The discussion highlights the need for clear guidelines, harmonized international regulations, and robust socio-technical methodologies to operationalize auditability at scale. The chapter concludes by emphasizing the importance of multi-stakeholder collaboration and auditor empowerment in building an effective AI audit ecosystem. It argues that auditability must be embedded in AI development practices and governance infrastructures to ensure that AI systems are not only functional but also ethically and legally aligned.
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