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References from High-risk without safeguards? The EU AI Act and the push for deregulation of medical AI. Local targets link to admitted publications; unresolved targets remain external evidence.
The AI cycle of health inequity and digital ageism: mitigating biases through the EU regulatory framework on medical devices
10.1093/jlb/lsad031 · 2023 · External reference
Does “AI” stand for augmenting inequality in the era of covid-19 healthcare?
10.1136/bmj.n304 · 2021 · External reference
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The EU Artificial Intelligence Act (2024): Implications for healthcare
10.1016/j.healthpol.2024.105152 · 2024 · External reference
The AI Cycle of Health Inequity and Digital Ageism: Mitigating Biases through the EU Regulatory Framework on Medical Devices
10.1093/jlb/lsad031 · 2023 · External reference
10.1093/jlb/lsae007
10.1093/jlb/lsae007 · External reference
A systematic literature review on mammography: deep learning techniques for breast cancer detection with global and Asian perspectives
10.1186/s12885-025-14876-5 · 2025 · External reference
Assessing artificial intelligence in breast screening with stratified results on 306 839 mammograms across geographic regions, age, breast density and ethnicity: A Retrospective Investigation Evaluating Screening (ARIES) study
10.1136/bmjhci-2024-101318 · 2025 · External reference
Disparities in dermatology AI performance on a diverse, curated clinical image set
10.1126/sciadv.abq6147 · 2022 · External reference
The need for a system view to regulate artificial intelligence/machine learning-based software as medical device
10.1038/s41746-020-0262-2 · 2020 · External reference
10.1016/s2589-7500(22)00063-2
10.1016/s2589-7500(22)00063-2 · External reference
Health AI for good rather than evil? The need for a new regulatory framework for AI-based medical devices
2021 · External reference
A “True Lifecycle Approach” towards governing healthcare AI with the GCC as a global governance model
2025 · External reference
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Regulating Artificial Intelligence and Machine Learning-Enabled Medical Devices in Europe and the United Kingdom
10.5204/lthj.3073 · 2023 · External reference
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The EU AI Act: Between the rock of product safety and the hard place of fundamental rights
10.54648/cola2025004 · 2025 · External reference
The European Union’s Artificial Intelligence Act and trust: towards an AI Bill of Rights in healthcare?
10.1080/17579961.2025.2469986 · 2025 · External reference
Towards an EU Charter of Digital Patients’ Rights in the Age of Artificial Intelligence
10.1007/s44206-025-00159-w · 2025 · External reference
The Fundamental Rights Impact Assessment (FRIA) in the AI Act: Roots, legal obligations and key elements for a model template
10.1016/j.clsr.2024.106020 · 2024 · External reference
What problems is the AI act solving? Technological solutionism, fundamental rights, and trustworthiness in European AI policy
10.1080/19460171.2024.2373786 · 2025 · External reference
The Algorithmic Divide: A Systematic Review on AI-Driven Racial Disparities in Healthcare
10.1007/s40615-024-02237-0 · 2026 · External reference
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Sources of bias in artificial intelligence that perpetuate healthcare disparities—A global review
10.1371/journal.pdig.0000022 · 2022 · External reference
10.1016/j.ejrad.2024.111867
10.1016/j.ejrad.2024.111867 · External reference
10.1056/aip2400223
10.1056/aip2400223 · External reference
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Scaling medical AI across clinical contexts
10.1038/s41591-025-04184-7 · 2026 · External reference
Hype vs Reality in the Integration of Artificial Intelligence in Clinical Workflows
10.2196/70921 · 2025 · External reference
10.4337/9781839108990.00043
10.4337/9781839108990.00043 · External reference
The need for transparency of clinical evidence for medical devices in Europe
10.1016/s0140-6736(18)31270-4 · 2018 · External reference
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Global Health in the Age of AI: Charting a Course for Ethical Implementation and Societal Benefit
10.1007/s11023-025-09730-3 · 2025 · External reference
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Really Responsive Regulation
10.1111/j.1468-2230.2008.00681.x · 2008 · External reference
A theory of risk colonization: The spiralling regulatory logics of societal and institutional risk
10.1080/03085140500465865 · 2006 · External reference
A Critical Take on the Policy Recommendations of the EU High-Level Expert Group on Artificial Intelligence
10.1017/err.2019.65 · 2020 · External reference
Emerging shadow health systems: regulating health-focused generative AI chatbots from a European perspective
10.3389/fpubh.2026.1830068 · 2026 · External reference
The proposed EU Directives for AI liability leave worrying gaps likely to impact medical AI
10.1038/s41746-023-00823-w · 2023 · External reference
Artificial intelligence in the EU Safe Hearts Plan: prediction alone is not enough
10.1016/j.lanepe.2026.101784 · 2026 · External reference
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10.1111/rego.12512
10.1111/rego.12512 · External reference