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Regulatory Research Priorities for AI Use in the Medicine Lifecycle: A European Perspective with Global Relevance

Regulatory bodies play a central role in providing guidance that enables safe and effective use of artificial intelligence tools in medicine development and evaluation. Regulators can also act as catalysts for regulatory science research. To inform these efforts, a European-wide survey was conducted to solicit stakeholder perspectives on the priority areas for regulatory science research related to the use of artificial intelligence in the medicine lifecycle. Twenty-eight regulatory science research questions we…

Clinical Pharmacology & Therapeutics · Policy

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Reframing risk management for AI-enabled medical devices: A dual-layer risk governance framework

BackgroundAI-enabled medical devices introduce dynamic, data-dependent risks that challenge traditional safety-risk management frameworks. While ISO 14971, AAMI CR34971, and the EU Artificial Intelligence Act each address elements of device safety and algorithmic governance, they remain fragmented when applied. This review examines conceptual and operational gaps in current approaches and proposes an integrated governance model for AI-specific safety-risk management.MethodsA structured narrative review was condu…

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Regulating Manipulative Design Is Not Preempted by CDA 230 or the First Amendment

For over two decades, there has been a heated debate among legal scholars, activists, judges, and others about the scope of Section 230 of the Communications Decency Act. A persistent theme in those debates has been hyperbolic claims about the necessity of immunity from state laws for digital tech platforms and fearmongering that anything less than maximum immunity will destroy the Internet. This Article argues that states retain considerable discretion to regulate digital platforms’ design and engineering decis…

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Evidence-backed problem

German media regulator says Google's AI Overviews subject to German media law

Germany's media regulator said on Tuesday that Google's AI Overviews and Perplexity AI are subject to the country's media laws, stepping up scrutiny of AI-generated content after a German court found Google liable ‌for inaccurate information produced by the feature.

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Evidence-backed gain

Financial regulation reforms in China – can artificial intelligence be a gamechanger to more sustainable financial regulations

Over the past few years, China has seen a substantial change in financial rules. The country’s recent fundamental redesign of its supervision structure has resulted in a dramatically altered regulatory framework for banks and other financial services organizations operating in China. The National Financial Regulatory Administration (NFRA), China’s new super financial regulator, is revolutionizing regulating the financial sector. Except for the securities industry, all financial sectors are regulated by the centr…

Policy

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When Is a Decision Automated? A Taxonomy for a Fundamental Rights Analysis

Abstract This Article addresses the pressing issues surrounding the use of automated systems in public decision-making, specifically focusing on migration, asylum, and mobility. Drawing on empirical data, this Article examines the potential and limitations of the General Data Protection Regulation and the Artificial Intelligence Act in effectively addressing the challenges posed by automated decision-making (ADM). The Article argues that the current legal definitions and categorizations of ADM fail to capture th…

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The Impact of Artificial Intelligence on Public Sector Decision- Making: Benefits, Challenges, and Policy Implications

Artificial intelligence (AI) is increasingly transforming government decision-making processes. This article presents a systematic literature review of 43 studies (2020-2025) examining AI’s impact on public-sector decision-making, delineating its advantages, disadvantages, policy implications, technical aspects, and ethical concerns. The findings indicate that AI technologies offer significant benefits for government decision-making, including improved efficiency, data-driven insights, and enhanced service deliv…

Policy

Disinformation, AI and regulation in Ecuador’s 2025 presidential election

Introduction This research analyses Ecuadorians’ perceptions of the use of generative artificial intelligence (AI) in the dissemination of disinformation during the 2025 presidential elections. In light of the growing use of synthetic technologies in political campaigns, it examines the impact of AI on electoral integrity, public trust and the need for regulation. Methodology Mixed explanatory approach, based on two surveys ( n = 201 and n = 64), nine semi-structured interviews with experts after the elections,…

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Disinformation, AI and regulation in Ecuador’s 2025 presidential election

The impact of generative artificial intelligence on socioeconomic inequalities and policy making

Abstract Generative artificial intelligence (AI) has the potential to both exacerbate and ameliorate existing socioeconomic inequalities. In this article, we provide a state-of-the-art interdisciplinary overview of the potential impacts of generative AI on (mis)information and three information-intensive domains: work, education, and healthcare. Our goal is to highlight how generative AI could worsen existing inequalities while illuminating how AI may help mitigate pervasive social problems. In the information d…

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Justitia ex machina: The impact of an AI system on legal decision-making and discretionary authority

Governments increasingly use algorithms to inform or supplant decision-making. Artificial Intelligence systems in particular are considered objective, consistent and efficient decision-makers, but have also been shown to be fallible. Furthermore, the adoption of artificial intelligence (AI) in government is fraught with challenges which are only partly understood and rarely studied in practice. In this paper, we draw on science and technology studies and human computer interaction and report on a critical case s…

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Justitia ex machina: The impact of an AI system on legal decision-making and discretionary authority

Regulating AI-powered consumer contracts: risks, remedies, and global legal responses|Regolamentazione dei contratti dei consumatori basati sull’Intelligenza Artificiale: rischi, rimedi e risposte giuridiche globali

Artificial Intelligence (AI) has reshaped consumer contracts by enabling automated drafting, personalization, and enforcement at scale, with limited human intervention. While this increases efficiency, it also introduces risks, including bias, opacity, privacy violations, and power asymmetries. This article offers a comparative legal analysis of regulatory responses and case studies, focusing on the EU AI Act and contrasting it with approaches in the US, Canada, Brazil, and emerging frameworks in Asia-Pacific. T…

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Regulating AI-powered consumer contracts: risks, remedies, and global legal responses|Regolamentazione dei contratti dei consumatori basati sull’Intelligenza Artificiale: rischi, rimedi e risposte giuridiche globali

The EU's AI act: A framework for collaborative governance

In February 2024, the Council and the European Parliament (EP) agreed on the Artificial Intelligence Regulation (usually known as AI Act, AIA) .2 This regulation evaluates AI applications to ensure they are used ethically and responsibly, promoting the development of safe and lawful AI across the EU's single market. It establishes a comprehensive legal framework with a risk-based approach, aiming to achieve a balance between protecting the health, safety, and fundamental rights of European citizens and ensuring…

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The EU's AI act: A framework for collaborative governance

AI-driven corporate governance: a regulatory perspective

The use of AI-driven or AI-assisted systems in corporate compliance is a novel topic in the business and management literature, only marginally considered by legal academia. While some scholarly pieces have explored the use of artificial intelligence (AI) systems to support compliance in the financial sector (eg, for anti-money laundering purposes), the legal implications of deploying AI systems to fulfil corporate compliance tasks has not yet received the attention it deserves. This article approaches the use o…

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AI-driven corporate governance: a regulatory perspective

Elon Musk’s xAI sues Colorado over new rules for artificial intelligence

Elon Musk’s artificial intelligence company, xAI, has filed a lawsuit against the state of Colorado over a new AI law set to take effect in June. The suit seeks to block the state from enforcing the law, which would impose new requirements on AI systems to protect state residents from “algorithmic discrimination” in sectors such as education, employment, healthcare, housing and financial services. Colorado was the first state to pass a comprehensive bill to regulate AI. The company claims the law infringes on it…

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Elon Musk’s xAI sues Colorado over new rules for artificial intelligence

Algorithmic Justice and Responsible AI Journalism: A Comparative Communication Policy Perspective in East Asia

As generative artificial intelligence and automated content curation rapidly reshape the global media landscape, the intersection of algorithmic justice and media governance has become a critical frontier for sustainable development. This study provides a comparative communication policy analysis of China and South Korea, focusing explicitly on how their distinct regulatory toolkits address the tension between algorithmic fairness and platform accountability in AI journalism. While China utilizes a top-down, sta…

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