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Regulation & Standards · 28 stories · page 1 of 2

The UK’s G20 presidency will push Andy Burnham to the centre of the global stage. What will he use it for? | Michael Jacobs
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The UK’s G20 presidency will push Andy Burnham to the centre of the global stage. What will he use it for? | Michael Jacobs

Among the many crucial decisions Andy Burnham has to make over the next few weeks, one has gone almost completely unremarked: what Britain’s priorities will be when it assumes the presidency of the G20 next year. Burnham has said he wants to concentrate on domestic policy. But with the world in turmoil, chairing the group of the world’s largest economies will be one of his most important responsibilities. The last time the UK chaired the forum was in 2009, when Gordon Brown presided over the rescue of the global…

The Guardian
Bill Gates says unchecked AI could ‘cause a billion deaths’ in call for regulation
Evidence-backed problem

Bill Gates says unchecked AI could ‘cause a billion deaths’ in call for regulation

Bill Gates has called on the US’s federal legislators and law enforcers to regulate the development of artificial intelligence (AI), saying in an interview airing on Sunday that the technology left unchecked could cause “a billion deaths” and “no one thinks self-regulation is enough”. “You need law enforcement and the politicians to get into the discussion about what safeguards and monitoring look like,” the Microsoft co-founder and philanthropist said to Kristen Welker, the NBC Meet the Press host. “And that ha…

Artificial Intelligence in Pharmaceutical Regulatory Science: Opportunities, Challenges, and Emerging Frameworks
Evidence-backed gain

Artificial Intelligence in Pharmaceutical Regulatory Science: Opportunities, Challenges, and Emerging Frameworks

Digital transformation in pharmaceutical regulatory affairs is accelerating as global submissions grow in complexity and traditional document-based workflows reach their limits. Artificial intelligence (AI), particularly natural language processing (NLP), is increasingly being explored to support regulatory data management, document preparation, and decision support activities. This review examines AI adoption across pharmaceutical regulatory science, including initiatives from major regulatory agencies, AI-supp…

The impact of roadside advertising density on driver visual attention and safety in Kuwait: An AI-driven analysis of simulator and eye-tracking data
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The impact of roadside advertising density on driver visual attention and safety in Kuwait: An AI-driven analysis of simulator and eye-tracking data

Objectives Driver distraction associated with roadside advertising remains a significant road safety concern, yet the precise physiological markers distinguishing stimulus-driven distraction from baseline driving are complex to isolate. This study quantified the impact of roadside advertising density on driver cognitive load and visual attention using a high-fidelity driving simulator and wearable eye-tracking technology. Methods A cohort of 60 licensed drivers navigated simulated environments under three contin…

Policy

Gavin Newsom imposes strict new rules on AI, social media and chatbots for children

California has adopted what Gavin Newsom described as “nation-leading” legislation that bans addictive social media features for young users, regulates companion chatbots and implements new safeguards around AI. The laws, signed by the Democratic California governor on Thursday, include AB 1709, which bars social media companies from using infinite scroll and autoplay for users under 16. “This is about actually addressing the problem, the scrolling, the algorithms. This is about addressing the substantive issue…

Gavin Newsom imposes strict new rules on AI, social media and chatbots for children
Policy

Artificial intelligence in language instruction: impact on English learning achievement, L2 motivation, and self-regulated learning

Introduction: This mixed methods study examines the effects of AI-mediated language instruction on English learning achievement, L2 motivation, and self-regulated learning among English as a Foreign Language (EFL) learners. It addresses the increasing interest in AI-driven educational technologies and their potential to revolutionize language instruction. Methods: Two intact classes, consisting of a total of 60 university students, participated in this study. The experimental group received AI-mediated instructi…

Artificial intelligence in language instruction: impact on English learning achievement, L2 motivation, and self-regulated learning
Policy

AI-Enabled Real-World Evidence in Oncology: A Statistical Perspective for Regulatory Decisions

Artificial intelligence (AI) has the potential to strengthen real-world evidence (RWE) for regulatory decision-making, but its contribution varies by application and methodological maturity. RWE remains limited by challenges in data quality, population selection, treatment characterization, outcome assessment, and statistical methodology. Machine learning and generative AI (genAI), combined with causal inference frameworks, may address these challenges. We review applications, limitations, including reproducibil…

AI-Enabled Real-World Evidence in Oncology: A Statistical Perspective for Regulatory Decisions
Policy

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…

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

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…

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

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…

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