Relevant bibliographies by topics / AI Regulation

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'AI Regulation'

Author: Grafiati
Published: 2 June 2025
Last updated: 31 July 2025

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Journal articles on the topic "AI Regulation"

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ZAVATIN (CHILEA), Iuliana, Ioana Maria POPESCU (IACOBESCU), Rodica LUPU (ȘTEFĂNESCU), and Andra-Elena ORLOSCHI. "AI REGULATION VS. AI STANDARDIZATION." Revista Economica 76, no. 3 (2024): 113–26. https://doi.org/10.56043/reveco-2024-0030.

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The key specificity of Artificial Intelligence today is that it is a fast-evolving field with yet unknown capabilities and potential. In technical research as well as in media there are new emerging AI-related topics almost every day. We hear a lot about risks of AI but also about so many useful AI applications that help people and companies benefit from better lives or enhanced results of their activity. Businesses developing AI solutions worldwide face significant challenges not only in designing processes but also in putting on the market safe, efficient and reliable technologies. Thus, the
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Chilea, Iuliana, Maria Popescu (Iacobescu) Ioana, Rodica Lupu, and Andra ORLOSCHI. "AI REGULATION VS. AI STANDARDIZATION." Revista Economica 76, no. 3 (2024): 113–26. https://doi.org/10.56043/reveco-2024-0030.

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The key specificity of Artificial Intelligence today is that it is a fast-evolving field with yet unknown capabilities and potential. In technical research as well as in media there are new emerging AI-related topics almost every day. We hear a lot about risks of AI but also about so many useful AI applications that help people and companies benefit from better lives or enhanced results of their activity. Businesses developing AI solutions worldwide face significant challenges not only in designing processes but also in putting on the market safe, efficient and reliable technologies. Thus, the
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Çami, Laura, and Av Xhon Skënderi. "The Impact of AI on Determining the Applicable Law in Cross-Border Disputes Under the Rome II Regulation." Global Journal of Politics and Law Research 11, no. 3 (2023): 1–10. http://dx.doi.org/10.37745/gjplr.2013/vol11n3110.

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The rapid advancement of artificial intelligence (AI) has significantly impacted choice of legislation issues in international litigation under the Rome II Regulation. This research paper aims to analyse the impact of AI on the application of the Rome II Regulation and identify the challenges it poses to the current legal framework. The paper will first examine the fundamental principles of the Rome II Regulation and its application to cross-border disputes. It will then explore the role of AI in determining the applicable law, focusing on the challenges faced by courts in applying the Regulat
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Brown, Rafael, Jon Truby, and Imad Antoine Ibrahim. "Mending Lacunas in the EU’s GDPR and Proposed Artificial Intelligence Regulation." European Studies 9, no. 1 (2022): 61–90. http://dx.doi.org/10.2478/eustu-2022-0003.

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Summary The European Union (EU) is leading in the regulation of data privacy and artificial intelligence through the General Data Protection Regulation (GDPR), the proposed European Commission (EC) regulation, and the proposed European Parliament (EP) regulations concerning Artificial Intelligence (AI). The EU also regulates AI through ethical aspects and Intellectual Property Rights as well as the Council of Europe’s conclusions concerning the use of sandboxes regulations and experimentation clauses. This article highlights the EU’s missed opportunities to create synergies between the GDPR an
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Saputra, Beny, Hartati Hartati, and Olivér Bene. "Hungary’s AI Strategy: Lessons for Indonesia’s AI Legal Framework Enhancement." Jambe Law Journal 7, no. 1 (2024): 25–58. http://dx.doi.org/10.22437/home.v7i1.325.

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This study analyses Hungary's approach to regulating artificial intelligence (AI) by analyzing their AI Strategy (2020-2030) and provides insights for improving Indonesia's legal framework. In Hungary, although there is no dedicated legislation for artificial intelligence (AI), the country places a high importance on adhering to current regulations to regulate AI technologies. This paper does a comparative analysis to evaluate the influence of Hungary's approach on the advancement of artificial intelligence (AI), the methods used to enforce regulations, the ethical principles followed, the saf
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Yoo, Sung Hee. "Bioethical Analysis of the EU AI Act : Implications and Challenges for AI Regulation in South Korea." Catholic Institute of Bioethics 15, no. 1 (2025): 71–111. https://doi.org/10.35230/pb.2025.15.1.71.

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This study analyzes the impact of artificial intelligence (AI) advancements on bioethical principles, particularly through a comparative examination of the EU AI Act and South Korea's AI regulations. While AI technology has driven significant innovation across various sectors such as healthcare, law, and public policy, it has also introduced numerous ethical challenges, including data bias, lack of explainability, and unclear legal accountability. These issues pose potential risks to fundamental human rights, necessitating a regulatory approach grounded in bioethical principles. The EU AI Act
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Kuteynikov, Dmitry, Osman Izhaev, Valerian Lebedev, and Sergey Zenin. "Legal regulation of artificial intelligence and robotic systems: review of key approaches." Cuestiones Políticas 40, no. 72 (2022): 690–703. http://dx.doi.org/10.46398/cuestpol.4072.40.

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The aim of the article is to study various approaches to legal regulation of AI artificial intelligence and robotic systems in the European Union, USA, and China. These regions are the world's largest centers of technological development and therefore each of them has perfected a unique approach to legal regulation on the limits, scopes, and proper uses of AI. His achievements are widely used by other countries. The authors used the methods of analysis of scientific documents, laws, and legal regulations. In addition, this article reviews the basic conceptual approaches available in the world
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Katulić, Tihomir. "Towards the Trustworthy AI." Medijska istraživanja 26, no. 2 (2021): 9–28. http://dx.doi.org/10.22572/mi.26.2.1.

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After decades of theoretical deliberations, the rapid development of advanced information technology has allowed machine learning as a first practical step towards artificial intelligence to enter widespread commercial and government use. The transition into a post-industrial, information society has revealed the value of data as an important resource whose processing is the basis of the new innovative information society services. The European Union has enacted several important regulations and directives in the recent past to protect the recognized fundamental rights of individuals and to re
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Liu, Shaoshan. "Navigating AI Regulation in Africa: Challenges and Considerations." ACM SIGCAS Computers and Society 52, no. 3 (2023): 8. http://dx.doi.org/10.1145/3656033.3656035.

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While most discussions about Artificial Intelligence (AI) regulations focus on advanced economies, such as OECD countries [1,2], this series of articles systematically examines the AI regulation challenges in emerging economies of the Global South. In this piece, we navigate AI regulation challenges and considerations in Africa [3].
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Abbott, Ryan, and Brinson S. Elliott. "Putting the Artificial Intelligence in Alternative Dispute Resolution." Amicus Curiae 4, no. 3 (2023): 685–706. http://dx.doi.org/10.14296/ac.v4i3.5627.

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This article argues that the evolving regulatory and governance environment for artificial intelligence (AI) will significantly impact alternative dispute resolution (ADR). Very recently, AI regulation has emerged as a pressing international policy issue, with jurisdictions engaging in a sort of regulatory arms race. In the same way that existing ADR regulations impact the use of AI in ADR, so too will new AI regulations impact ADR, among other reasons, because ADR is already utilizing AI and will increasingly utilize AI in the future. Appropriate AI regulations should thus benefit ADR, as the
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Dissertations / Theses on the topic "AI Regulation"

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WIEHLER, Lukas. "How can AI regulation be effectively enforced? : comparing compliance mechanisms for AI regulation with a multiple-criteria decision analysis." Doctoral thesis, European University Institute, 2022. http://hdl.handle.net/1814/74805.

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Award date: 17 June 2022. Supervisor: Professor Andrea Renda (European University Institute)<br>Newly emerging AI regulations need effective and innovative enforcement and compliance mechanisms to assure that fundamental and human rights are protected when using an AI system. This study compares four different compliance mechanisms namely ‘Real-Time and Automated Conformity Assessment’, ‘Standardization and Certification’, ‘Algorithmic Impact Assessment’ and ‘Algorithmic Auditing’ as well as three different assurers of compliance namely deployers, notified bodies and civil society organisation
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McDougald, S. Diane School of Microbiology &amp Immunology UNSW. "Regulation of starvation and nonculturability in the marine pathogen, Vibrio vulnificus." Awarded by:University of New South Wales. School of Microbiology and Immunology, 2000. http://handle.unsw.edu.au/1959.4/19118.

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Vibrio vulnificus is a model environmental organism exhibiting a classical starvation response during nutrient limitation as well as a non-culturable state when exposed to low temperatures. In addition to these classic global responses, this organism is an opportunistic pathogen that exhibits numerous virulence factors. This organism was chosen as the model organism for the identification of regulators of the viable but nonculturable response (VBNC) and the starvation-induced maintenance of culturability (SIMC) that occurs when cells are starved prior to low temperature incubation. In order
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DUNI, DANIELA. "Le azioni dell’UE per l’informatizzazione. Dagli strumenti di base ai procedimenti telematici." Doctoral thesis, Università degli Studi di Cagliari, 2016. http://hdl.handle.net/11584/266714.

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In the EC and EU Treaties (at present Lisbon Treaty that includes TEU and TEUF), the ICT is not the subject of specific provisions. However it has been held in high regard by the European Institutions. This study therefore examined the provisions of the above mentioned Treaties considered more or less directly or indirectly linked to the computerization in general and that of P.A. in particular, on the basis of which have been issued documents of various types, programmatic or binding. The European Union has p
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Franzin, Fernanda Maria 1981. "Papel do sistema AI-3/epinefrina/norepinefrina na regulação da expressão gênica de Escherichia coli enteropatogênica atípica." [s.n.], 2013. http://repositorio.unicamp.br/jspui/handle/REPOSIP/317064.

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Orientador: Marcelo Palma Sircili<br>Tese (doutorado) - Universidade Estadual de Campinas, Instituto de Biologia<br>Made available in DSpace on 2018-08-24T04:50:38Z (GMT). No. of bitstreams: 1 Franzin_FernandaMaria_D.pdf: 6490379 bytes, checksum: facd90d2115a20d8eccb498865503103 (MD5) Previous issue date: 2013<br>Resumo: Escherichia coli enteropatogênica atípica (aEPEC) faz parte de um grupo de patógenos capazes de formar um tipo de lesão em células epiteliais denominada Attaching and Effacing (A/E). Os genes requeridos para a formação da lesão A/E estão localizados em uma ilha de patogenici
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Ellis, Tammy Lynn. "Modulation of apolipoprotein AI gene expression by oxidative stress, regulation by both the pro-oxidant H¦2O¦2 and the antioxidant DMSO." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1997. http://www.collectionscanada.ca/obj/s4/f2/dsk2/ftp04/mq20631.pdf.

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Yıldız, Melih Burak. "EU’s Proposed AI Regulation in the context of Fundamental Rights : Analysing the Swedish approach through the lens of the principles of good administration." Thesis, Södertörns högskola, Juridik, 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:sh:diva-46517.

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AI has become one of the most powerful drivers of social change, transforming economies, impacting politics and wars, and reshaping how citizens live and interact. Nevertheless, the implementation of AI can have adverse effects on peoples’ lives. This dissertation first examines the relationship between artificial intelligence and public law, mainly in two domains, administrative law and criminal law. It also provides a clear insight into the potential impact of AI applications on fundamental rights in the legal context of the European Union. Four selected fundamental rights, Human Dignity, Da
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KOH, THONG CHUAN EUGENE. "Down regulation of NLK by MIR-221/222 modulates chemosensitivity to glucocorticoids in pediatric normal karyotype b-cell precursor acute lymphoblastic leukemia. La downregolazione di nemo-like kinase indotta dai MIR-221/222 modula chemiosensibilità ai glucocorticoidi nella pediatrico b-cell precursor leucemia linfattica acuta." Doctoral thesis, Università degli Studi di Milano-Bicocca, 2012. http://hdl.handle.net/10281/30498.

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Normal karyotype pediatric B-cell precursor ALL patients are heterogeneous with respect to chemotherapy response, relapse rates and prognosis and the reason is unknown. These patients are treated with a standard protocol, and stratified using MRD methodology that shows they have variable responses and predicted outcomes. This study aims to determine the reasons behind such heterogeneity. This study shows that through miRNA profiling, miR-221/222 are differentially expressed in normal karyotype patients and are up regulated in Poor Responder patients. Through proliferation, apoptosis, viability
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Björklund, Pernilla. "The curious case of artificial intelligence : An analysis of the relationship between the EU medical device regulations and algorithmic decision systems used within the medical domain." Thesis, Uppsala universitet, Juridiska institutionen, 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-442122.

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The healthcare sector has become a key area for the development and application of new technology and, not least, Artificial Intelligence (AI). New reports are constantly being published about how this algorithm-based technology supports or performs various medical tasks. These illustrates the rapid development of AI that is taking place within healthcare and how algorithms are increasingly involved in systems and medical devices designed to support medical decision-making.  The digital revolution and the advancement of AI technologies represent a step change in the way healthcare may be deliv
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Parginos, Konstantinos. "Advanced Methods for Enhancing the Interpretability of AI tools in the Energy Sector." Electronic Thesis or Diss., Université Paris sciences et lettres, 2025. http://www.theses.fr/2025UPSLM006.

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La prise de décision en énergie repose sur des modèles complexes intégrant de nombreuses incertitudes. L'essor des énergies renouvelables (ENR) accroît cette complexité en raison de leur dépendance météorologique. Bien que l'IA améliore la prévision et l'optimisation, son manque d'interprétabilité freine son adoption. Cette recherche clarifie l'explicabilité des modèles, développe une IA symbolique pour les enchères ENR, applique des modèles à règles pour la prévision de l'adéquation réseau et utilise les cartes cognitives floues à flux d'information (IF-FCMs) pour la prévision des surcharges
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Cabral, Tiago Sérgio. "AI Regulation in the European Union: democratic trends, current instruments and future initiatives." Master's thesis, 2019. http://hdl.handle.net/1822/74323.

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Dissertação de mestrado em Direito da União Europeia<br>It is expected that the development of AI will create plenty of opportunities for economic and social progress. However, with it will also come numerous challenges. To properly reap the benefits of this world changing technology new legal concepts, principles, rules and interpretations are needed. The European Union, in particular, is aiming for a position as a leader in AI development and the world’s standard-setter for future AI Regulation. Therefore, studying this question from the European perspective is of extreme practical and
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Books on the topic "AI Regulation"

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W, Brender, Takefman J, and Boivin J, eds. Psychological evaluation of infertile couples participating in GIFT (Gamete Intrafallopian Transfer, AI (Artificial Insemination) and Ovulation Induction: Final report. Sexuality and Reproductive Health Lab, Dept. of Psychology, Concordia University, 1992.

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Salza, Isabella. La riforma dello sportello unico per le attività produttive dopo la SCIA: Commento organico ai DD.PP.RR. 9 luglio 2010, n. 159, e 7 settembre 2010, n. 160. Dike giuridica, 2010.

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Liebowitz, Jay. Regulating Hate Speech Created by Generative AI. Auerbach Publications, 2024. http://dx.doi.org/10.1201/9781032654829.

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Guariniello, Raffaele. La sicurezza del lavoro ai videoterminali: Le nuove norme, i soggetti, gli obblighi. IPSOA, 2001.

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Odincov, Boris. Models and intelligent systems. INFRA-M Academic Publishing LLC., 2020. http://dx.doi.org/10.12737/1060845.

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The monograph consists of three chapters, the first of which outlines the theoretical foundations of intelligent information systems. Special attention is paid to the disclosure of the term "model" as the intended meaning depends on the understanding of the material. Introduces and examines the new concepts such as the associative and intuitive knowledge while in the creation of intellectual information systems are not used. &#x0D; The second Chapter contains the analysis of problems of development of artificial intelligence (AI), developed in two directions: classical and statistical. Discuss
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Bhutan. Electronic voting machine (EVM) rules and regulations of the Kingdom of Bhutan =: ʼBrug gi tshogs rgyan phrul chas (Ai wi aem) bcaʼ yig daṅ sgrig bźi. Election Commission of Bhutan, 2007.

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Wong, Willow. AI and Big Data: Disruptive Regulation. Elgar Publishing Limited, Edward, 2023.

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AI Fairness and Beyond: Law, Regulation, and Technology. Bloomsbury Publishing Plc, 2024.

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Shaw, Patricia, and Ali G. Hessami. Factoring Ethics in Technology, Policy Making, Regulation and AI. IntechOpen, 2021.

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Reed, Chris. AI Fairness and Beyond. Hart Publishing, 2024. http://dx.doi.org/10.5040/9781509976843.

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This book proposes a regulatory system for ensuring that AI makes fair decisions. No one wants to be the subject of an unfair decision made by an AI, and fairness is so important to society that we are likely to want to regulate to demand it. But how? This book attempts to answer that question. The aim of regulation must be for an AI’s decisions to match the human conception of fairness. To understand what that is, the book proposes a holistic understanding of fairness, which tells us what regulation must try to achieve. However, regulation is not an abstract activity – it regulates how humans
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Book chapters on the topic "AI Regulation"

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Sharma, Rohan. "AI Regulation." In AI and the Boardroom. Apress, 2024. http://dx.doi.org/10.1007/979-8-8688-0796-1_3.

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Tamò-Larrieux, Aurelia, Clement Guitton, and Simon Mayer. "Automatically Processable Regulation." In AI and Law. CRC Press, 2025. https://doi.org/10.1201/9781003386919-3.

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Sheikh, Haroon, Corien Prins, and Erik Schrijvers. "Regulation." In Research for Policy. Springer International Publishing, 2023. http://dx.doi.org/10.1007/978-3-031-21448-6_8.

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AbstractEmbedding or integrating AI into society depends on the existence of frameworks, and therefore regulation. Now that the technology is making the transition from the lab to society, its effects on the economy and the society are subject to widespread scrutiny. This has led to debate about the nature of the regulatory measures needed to ensure that AI is properly embedded in society and government processes.
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Timan, Tjerk, Charlotte van Oirsouw, and Marissa Hoekstra. "The Role of Data Regulation in Shaping AI: An Overview of Challenges and Recommendations for SMEs." In The Elements of Big Data Value. Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-68176-0_15.

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AbstractIn recent debates around the regulation of artificial intelligence, its foundations, being data, are often overlooked. In order for AI to have any success but also for it to become transparent, explainable and auditable where needed, we need to make sure the data regulation and data governance around it is of the highest quality standards in relation to the application domain. One of the challenges is that AI regulation might – and needs to – rely heavily on data regulation, yet data regulation is highly complex. This is both a strategic problem for Europe and a practical problematic:
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Campbell, Catriona. "Current State of AI Governance & Regulation." In AI by Design. Chapman and Hall/CRC, 2022. http://dx.doi.org/10.1201/9781003267003-4.

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Israr, Mohammad, Saba Khan, Venya Gupta, Abhishek Sharma, and Devanshu Tiwari. "Responsible AI Governance and Regulation." In A Compendium of Responsible Artificial Intelligence. CRC Press, 2025. https://doi.org/10.1201/9781003514497-8.

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Myers, Cayce. "AI, Ethics, and Industry Regulation." In Artificial Intelligence and Law in the Communication Professions. Routledge, 2025. https://doi.org/10.4324/9781003426561-8.

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O’Connor, Arthur J. "Regulation and Compliance." In Organizing for Generative AI and the Productivity Revolution. Apress, 2024. http://dx.doi.org/10.1007/979-8-8688-0959-0_7.

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Eke, Damian Okaibedi, Kutoma Wakunuma, Simisola Akintoye, and George Ogoh. "African Perspectives of Trustworthy AI: An Introduction." In Trustworthy AI. Springer Nature Switzerland, 2025. https://doi.org/10.1007/978-3-031-75674-0_1.

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Abstract In 2024, the EU AI Act became the first-ever comprehensive legal framework on AI in the world as Regulation (EU) 2024/1689 of the European Parliament and of the Council. The fundamental aim of this Act and other policy measures such as EU AI innovation Package and the Coordinated Plan on AI, is to foster Trustworthy AI in Europe and beyond; to ensure that Europeans can trust what AI can offer.
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Rigotti, Carlotta. "The AI Act and feminist epistemology." In The Regulation of Sex Robots. Routledge, 2025. https://doi.org/10.4324/9781003560685-7.

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Conference papers on the topic "AI Regulation"

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Meza, Jaime, María Fernanda Linzan Saltos, Elkin Uday Velastegui Campoverde, Mercedes Carolina Navarro Cejas, and Valeria Carolina Argüello Castro. "AI Regulation for Ecuador." In 2025 Eleventh International Conference on eDemocracy & eGovernment (ICEDEG). IEEE, 2025. https://doi.org/10.1109/icedeg65568.2025.11081572.

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Sun, Feng, Jinhai Shen, Bangbing Zhu, Haiguang Lai, Jianhua Chen, and Jiashun Tang. "Feedback Circuit Regulation Inspired Loop Filter Coefficient Regulation Algorithm in Satellite Internet of Things." In 2024 5th International Conference on Computer, Big Data and Artificial Intelligence (ICCBD+AI). IEEE, 2024. https://doi.org/10.1109/iccbd-ai65562.2024.00046.

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D, Malathi, Feisal Alaswad, Batoul Aljaddouh, Leela Ranganayagi, and Sangeetha R. "AI-Powered Traffic Management: Improving Congestion Detection and Signal Regulation." In 2025 International Conference on Multi-Agent Systems for Collaborative Intelligence (ICMSCI). IEEE, 2025. https://doi.org/10.1109/icmsci62561.2025.10894186.

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Corazza, Michele, Generoso Longo, Leonardo Zilli, Emanuele Di Sante, Salvatore Sapienza, and Monica Palmirani. "Hybrid AI Enhancing European Drafting Legislation for a Better Regulation." In 2025 Eleventh International Conference on eDemocracy & eGovernment (ICEDEG). IEEE, 2025. https://doi.org/10.1109/icedeg65568.2025.11081650.

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Haas, Lukas, Johann Zedelmeier, Florian Bindges, et al. "Data Protection Regulation Compliant Dataset Generation for LiDAR-Based People Detection Using Neural Networks." In 2024 Conference on AI, Science, Engineering, and Technology (AIxSET). IEEE, 2024. https://doi.org/10.1109/aixset62544.2024.00019.

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Pope, Tia, and Ahmad Patooghy. "BioChk: A Regulation-Aligned Quality Assurance Framework for AI-Generated Biologics." In 2025 IEEE Conference on Artificial Intelligence (CAI). IEEE, 2025. https://doi.org/10.1109/cai64502.2025.00253.

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Gao, Di Kevin, Sudip Mittal, Jiming Wu, Hongwei Du, Jingdao Chen, and Shahram Rahimi. "The AI Pentad, the CHARME2D Model, and an Assessment of Current-State AI Regulation." In 2024 International Conference on Sustainable Technology and Engineering (i-COSTE). IEEE, 2024. https://doi.org/10.1109/i-coste63786.2024.11025113.

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Vagnoni, Simone, and Monica Palmirani. "Detecting Transitional Provisions in EU Legislation with Hybrid AI for Better Regulation." In 2025 Eleventh International Conference on eDemocracy & eGovernment (ICEDEG). IEEE, 2025. https://doi.org/10.1109/icedeg65568.2025.11081693.

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Leofante, Francesco, Hamed Ayoobi, Adam Dejl, et al. "Contestable AI Needs Computational Argumentation." In 21st International Conference on Principles of Knowledge Representation and Reasoning {KR-2023}. International Joint Conferences on Artificial Intelligence Organization, 2024. http://dx.doi.org/10.24963/kr.2024/83.

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AI has become pervasive in recent years, but state-of-the-art approaches predominantly neglect the need for AI systems to be contestable. Instead, contestability is advocated by AI guidelines (e.g. by the OECD) and regulation of automated decision-making (e.g. GDPR). In this position paper we explore how contestability can be achieved computationally in and for AI. We argue that contestable AI requires dynamic (human-machine and/or machine-machine) explainability and decision-making processes, whereby machines can 1. interact with humans and/or other machines to progressively explain their out
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Subramnyam, Sreelatha Aihloor, Deevyansh Khadria, and Amjad Anvari-Moghaddam. "AI-Driven Flexibility Market Platform for Dynamic Demand Regulation in Eco-Industrial Cluster." In 2025 21st International Conference on the European Energy Market (EEM). IEEE, 2025. https://doi.org/10.1109/eem64765.2025.11050220.

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Reports on the topic "AI Regulation"

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Hooker, Reece. Finding a balance on AI regulation. Monash University, 2023. http://dx.doi.org/10.54377/ce0a-e090.

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Shaffer Shane, Tommy. AI incident reporting: Addressing a gap in the UK’s regulation of AI. The Centre for Long-Term Resilience, 2024. https://doi.org/10.71172/ahvt-9xy7.

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Perdana, Arif. Going back to the future for AI regulation. Edited by Ria Ernunsari, Reece Hooker, and Chris Bartlett. Monash University, 2023. http://dx.doi.org/10.54377/d093-4185.

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Brione, Patrick, and Devyani Gajjar. Artificial intelligence: ethics, governance and regulation. Parliamentary Office of Science and Technology, 2024. http://dx.doi.org/10.58248/hs51.

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Wagner, Rudolf. AI, EHR, SaMD and Hospitals — US, German and Australian regulation make AI immediately available with non-SaMD pathway for Hospitals and Doctors. ADHOCON, 2024. http://dx.doi.org/10.70317/2024.24rw09.

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In the evolving healthcare landscape, hospitals are increasingly developing in-house AI tools and EHR systems to improve patient care while avoiding the regulatory burden associated with Software as a Medical Device (SaMD) classification. This paper explores the regulatory frameworks in the U.S., Germany, and Australia governing hospitals’ use of AI-based tools, EHR systems, and the relevant governmental oversight. We analyze how hospitals and EHR providers can strategically position AI to offer informational insights without triggering SaMD regulation. By reviewing international regulations a
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Zheng, Cindy. Southeast Asia needs to balance AI innovation and regulation. East Asia Forum, 2024. http://dx.doi.org/10.59425/eabc.1712700000.

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Marsden, Chris, and George Christou. What Europe's AI regulation moment will mean for the world. Edited by Reece Hooker. Monash University, 2023. http://dx.doi.org/10.54377/7550-5812.

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Segelke, B., S. Hok, V. Lao, M. Corzett, and E. Garcia. Regulation of Yersina pestis Virulence by AI-2 Mediated Quorum Sensing. Office of Scientific and Technical Information (OSTI), 2010. http://dx.doi.org/10.2172/978400.

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Stern, Ariel Dora. The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives. National Bureau of Economic Research, 2022. http://dx.doi.org/10.3386/w30639.

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Wagner, Rudolf. Enforcing Software and AI as Medical Devices: Expert Witness Insights on Civil Lawsuits, Regulation, and Legal Liability Pathways. ADHOCON UG (haftungsbeschränkt), 2024. http://dx.doi.org/10.70317/2024.13rw10.

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As an expert witness to German courts (Landgerichte, Oberlandesgerichte) and federal courts for Medical Devices and IVDs the number of expert statements has constantly increased, especially for Software and AI in Healthcare and focusing on their Medical Device classification. The paper also examines how competition and insurers may respond to claims arising from the use of improper classified software, artificial intelligence including Large Language Models (LLMs) with denial of coverage, increased premiums, and subrogation actions against hospitals or AI developers. Regulatory challenges are
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