The EU AI Act’s Alignment within the European Union’s Regulatory Framework on Artificial Intelligence

Authors

  • Şaban İbrahim Göksal Tallin University of Technology, Estonia Author
  • Maria Claudia Solarte Vasquez Tallin University of Technology, Estonia Author
  • Archil Chochia Tallin University of Technology, Estonia Author

DOI:

https://doi.org/10.5507/

Keywords:

artificial intelligence, European Union, EU AI Act, trstworthy AI, regulatory frameworks, institutional analysis, consistency assessment

Abstract

The European Union (EU) Artificial Intelligence (AI) Act is the first horizontal regulation on AI, aiming to regulate the development, placement on the market, and use of AI systems in the EU. The initial proposal was published by the European Commission (EC) in April 2021, and after an intensive three-year period of discussions, revisions, and negotiations, on December 9, 2023, a provisional agreement was reached on the final text. This marked the culmination of a series of ethical policy and legislative foundations that have created a broad and highly influential regulatory framework on AI in the EU. However, the consistency of the final draft within this established institutional environment on AI merits a close examination. This paper studies the AI Act text and its alignment within this framework. It will use the partial institutional analysis method to map the regulatory landscape, identify the most important sources within the said scope, and critically assess their consistency.

References

Journal Articles and Papers

ALI, Gabriele Spina, YU, Ronald. Artificial Intelligence between Transparency and Secrecy: From the EC Whitepaper to the AIA and Beyond. European Journal of Law and Technology, 2021, vol. 12, no. 3, pp. 1–25.

ALMADA, Marco, RADU, Anca. The Brussels Side-Effect: How the AI Act Can Reduce the Global Reach of EU Policy. German Law Journal, 2024, pp. 1–18. https://doi.org/10.1017/glj.2023.108

ANDRADA, Gloria, CLOWES, Robert W., SMART, Paul R., Varieties of transparency: Exploring agency within AI systems. AI & SOCIETY, 2023, vol. 38, no. 4, pp. 1321–1331. https://doi. org/10.1007/s00146-021-01326-6

ANDRAŠKO, Jozef, MESARČÍK, Matúš; HAMUĽÁK, Ondrej. The regulatory intersections between artificial intelligence, data protection and cyber security: Challenges and opportunities for the EU legal framework. AI & SOCIETY, 2021, vol. 36, no. 2, pp. 623–636. https://doi.org/10.1007/ s00146-020-01125-5

ANTONOV, Alexander, KERIKMÄE, Tanel. Trustworthy AI as a Future Driver for Competitiveness and Social Change in the EU. In RAMIRO TROITIÑO, David, et al. (eds). The EU in the 21st Century: Challenges and Opportunities for the European Integration Process. Springer International Publishing, 2020, pp. 135–154. https://doi.org/10.1007/978-3-030-38399-2_9

BIEGA, Asia J., FINCK, Michèle. Reviving Purpose Limitation and Data Minimisation in Data-Driven Systems. Technology and Regulation, 2021, pp. 44-61. https://doi.org/10.26116/techreg.2021.004

BROWN, Rafael; TRUBY, John; IBRAHIM, Imad Antoine. Mending Lacunas in the EU’s GDPR and Proposed Artificial Intelligence Regulation. European Studies – the Review of European law, Economics and Politics. 2022, vol. 9, no. 1, pp. 61–90, DOI: 10.2478/eustu-2022-0003.

BUTCHER, James, BERIDZE, Irakli. What is the State of Artificial Intelligence Governance Globally? The RUSI Journal, 2019, vol. 164, no. 5–6, pp. 88–96. https://doi.org/10.1080/03071847.2019.169 4260

CARTER, J. Adam. Trust and trustworthiness. Philosophy and Phenomenological Research, 2023, vol. 107, no. 2, pp. 377–394. https://doi.org/10.1111/phpr.12918

CACHAT-ROSSET, Gaelle, KLARSFELD, Alain. Diversity, Equity, and Inclusion in Artificial Intelligence: An Evaluation of Guidelines. Applied Artificial Intelligence, 2023, vol. 37, no. 1, pp. 1–29. https://doi.org/10.1080/08839514.2023.2176618

CHATILA, Raja, et al. Trustworthy AI. In BRAUNSCHWEIG, Bertrand, GHALLAB, Malik (eds). Reflections on Artificial Intelligence for Humanity. Springer International Publishing, 2021 pp. 13–39. https://doi.org/10.1007/978-3-030-69128-8_2

CHOUNG, Hyesun, DAVID, Prabu, ROSS, Arun. Trust and ethics in AI. AI & SOCIETY, 2023, vol. 38, no. 2, pp. 733–745. https://doi.org/10.1007/s00146-022-01473-4

CUBIE, Dug, NATOLI, Tommaso. Coherence, Alignment and Integration: Understanding the Legal Relationship Between Sustainable Development, Climate Change Adaptation and Disaster Risk Reduction. In FLOOD, Stephen, et al. (eds). Creating Resilient Futures: Integrating Disaster Risk Reduction, Sustainable Development Goals and Climate Change Adaptation Agendas. Springer International Publishing, 2022, pp. 45–64. https://doi.org/10.1007/978-3-030-80791-7_3

DE COOMAN, Jerome. Humpty Dumpty and High-Risk AI Systems: The Ratione Materiae Dimension of the Proposal for an EU Artificial Intelligence Act. Market and Competition Law Review, 2022, vol. 6, no. 1, pp. 49–88.

DIGNUM, Virginia. Taking Responsibility. In DIGNUM, Virginia (Ed). Responsible Artificial Intelligence: How to Develop and Use AI in a Responsible Way. Springer International Publishing, 2019, pp. 47–69. https://doi.org/10.1007/978-3-030-30371-6_4

EDWARDS, Lilian. The EU AI Act: A summary of its significance and scope. Ada Lovelace Institute, 2022.

FANNI, Rosanna, et al. Enhancing human agency through redress in Artificial Intelligence Systems. AI & SOCIETY, 2023, vol. 38, no. 2, pp. 537–547. https://doi.org/10.1007/s00146-022-01454-7

FELZMANN, Heike, et al. Towards Transparency by Design for Artificial Intelligence. Science and Engineering Ethics, 2020, vol. 26 no. 6, pp. 3333–3361. https://doi.org/10.1007/s11948-020-00276-4

FELZMANN, Heike, et al. Transparency you can trust: Transparency requirements for artificial intelligence between legal norms and contextual concerns. Big Data & Society, 2019, vol. 6, no 1, pp. 1-14. https://doi.org/10.1177/2053951719860542

FLORIDI, Luciano. Establishing the Rules for Building Trustworthy Ai. Nature Machine Intelligence, 2019, vol. 1, pp. 261–262.

FLORIDI, Luciano. The European Legislation on AI: A Brief Analysis of its Philosophical Approach. Philosophy & Technology, 2021, vol. 34, no. 2, pp. 215–222. https://doi.org/10.1007/s13347-021- 00460-9

FLORIDI, Luciano, et al. capAI – A Procedure for Conducting Conformity Assessment of AI Systems in Line with the EU Artificial Intelligence Act. SSRN Scholarly Paper, 2022, pp. 1–82. https://doi. org/10.2139/ssrn.4064091

GREENSTEIN, Stanley. Preserving the rule of law in the era of artificial intelligence (AI). Artificial Intelligence and Law, 2022, vol. 30, no. 3, pp. 291–323. https://doi.org/10.1007/s10506-021-09294-4

HAGENDORFF, Thilo. The Ethics of AI Ethics: An Evaluation of Guidelines. Minds and Machines, 2020, vol. 30, no. 1, pp. 99–120. https://doi.org/10.1007/s11023-020-09517-8

HOHMA, Ellen, et al. Investigating accountability for Artificial Intelligence through risk governance: A workshop-based exploratory study. Frontiers in Psychology, 2023, vol 14, pp. 1–17. https://doi. org/10.3389/fpsyg.2023.1073686

HUPONT, Isabelle, et al. The landscape of facial processing applications in the context of the European AI Act and the development of trustworthy systems. Scientific Reports, 2022, vol. 12, no. 1, pp. 1–14. https://doi.org/10.1038/s41598-022-14981-6

JHA, Ashish K., LEAHY, Eoghan. The European Union’s Artificial Intelligence Act: An Analysis of Preliminary Perceptions and Responses of Irish SMEs. SHARMA, Sujeet K., et al. (eds). Transfer, Diffusion and Adoption of Next-Generation Digital Technologies. Springer Nature Switzerland, 2024, pp. 14–23. https://doi.org/10.1007/978-3-031-50188-3_2

JOAMETS, Kristi, CHOCHIA, Archil. Access to Artificial Intelligence for Persons with Disabilities: Legal and Ethical Questions Concerning the Application of Trustworthy Ai. Acta Baltica Historiae Et Philosophiae Scientiarum, 2021, vol. 9, no. 1, pp. 51–66. https://doi.org/10.11590/ abhps.2021.1.04

JOAMETS, Kristi, VASQUEZ, Maria Claudia Solarte. Regulatory Framework of the Research- Based Approach to Education in the EU. TalTech Journal of European Studies, 2020, vol. 10, no. 3, pp. 109–136.

JOHNSON, James. Automating the OODA loop in the age of intelligent machines: Reaffirming the role of humans in command-and-control decision-making in the digital age. Defence Studies, 2023, vol. 23, no. 1, pp. 43–67. https://doi.org/10.1080/14702436.2022.2102486

JUSTO-HANANI, Ronit. The politics of Artificial Intelligence regulation and governance reform in the European Union. Policy Sciences, 2022, vol. 55, no. 1, pp. 137–159. https://doi.org/10.1007/ s11077-022-09452-8

KALE, Amruta. Provenance documentation to enable explainable and trustworthy AI: A literature review. Data Intelligence, 2023, vol. 5, no. 1, pp. 139–162. https://doi.org/10.1162/dint_a_00119

KERIKMÄE, Tanel; MÜÜRSEP, Peeter; PIHL, Henri Mert; HAMUĽÁK, Ondrej; KOCHARYAN, Hovsep. Legal Person or Agenthood of Artificial Intelligence Technologies. Acta Baltica Historiae et Philosophiae Scientiarum, 2020, vol. 8, no. 2, pp. 73–92. ISSN 2228-2009. DOI 10.11590/ abhps.2020.2.0.

KOULU, Riikka. Proceduralizing control and discretion: Human oversight in artificial intelligence policy. Maastricht Journal of European and Comparative Law, 2020, vol. 27, no. 6, pp. 720–735. https://doi.org/10.1177/1023263X20978649

LAUX, Johann, WACHTER, Sanda, MITTELSTADT, Brent. Trustworthy artificial intelligence and the European Union AI act: On the conflation of trustworthiness and acceptability of risk. Regulation & Governance, 2024, vol. 18, no. 1, pp. 3–32. https://doi.org/10.1111/rego.12512

LI, Bo, et al. Trustworthy AI: From Principles to Practices. ACM Computing Surveys, 2023, vol. 55, no.9, pp. 177:1–177:46. https://doi.org/10.1145/3555803

LIU, Haochen, et al. Trustworthy AI: A Computational Perspective. ACM Transactions on Intelligent Systems and Technology, 2022, vol. 14, no. 1, pp. 4:1–4:59. https://doi.org/10.1145/3546872

LIU, Fanjue, et al. When citizens support AI policies: The moderating roles of AI efficacy on AI news, discussion, and literacy. Journal of Information Technology & Politics, 2023, vol. 0, no. 0, pp. 1–17. https://doi.org/10.1080/19331681.2023.2294363

MAAS, Matthijs M. Aligning AI Regulation to Sociotechnical Change, SSRN Scholarly Paper, 2021, pp. 1–23. https://doi.org/10.2139/ssrn.3871635

MARTÍNEZ RAMIL, Pablo. Is the EU human rights legal framework able to cope with discriminatory AI? IDP: Revista de Internet, Derecho y Política = Revista d’Internet, Dret i Política, 2021, no. 34, pp. 1–14.

MAZZINI, Gabriele, BAGNI, Filippo. Considerations on the regulation of AI systems in the financial sector by the AI Act. Frontiers in Artificial Intelligence, 2023, vol. 6, pp. 1–7. https://doi. org/10.3389/frai.2023.1277544

MORA-CANTALLOPS, Marçal, et al. Traceability for Trustworthy AI: A Review of Models and Tools. Big Data and Cognitive Computing, 2021, vol. 5, no. 2, pp. 1–14. https://doi.org/10.3390/ bdcc5020020

MOSKALENKO, Viacheslav, et al. Resilience and Resilient Systems of Artificial Intelligence: Taxonomy, Models and Methods. Algorithms, 2023, vol. 16, no. 3, pp. 1–44. https://doi.org/10.3390/ a16030165

MÖKANDER, Jakob, et al. Conformity Assessments and Post-market Monitoring: A Guide to the Role of Auditing in the Proposed European AI Regulation. Minds and Machines, 2022, vol. 32, no. 2, pp. 241–268. https://doi.org/10.1007/s11023-021-09577-4

MUSIKANSKI, Laura, et al. Artificial Intelligence and Community Well-being: A Proposal for an Emerging Area of Research. International Journal of Community Well-Being, 2020, vol. 3, no. 1, pp. 39–55. https://doi.org/10.1007/s42413-019-00054-6

NAHAVANDI, Saeid. Trusted Autonomy Between Humans and Robots: Toward Human-on-the- Loop in Robotics and Autonomous Systems. IEEE Systems, Man, and Cybernetics Magazine, 2017, vol. 3, no. 1, pp. 10–17. https://doi.org/10.1109/MSMC.2016.2623867

NIKOLINAKOS, Nikos Th. A European Approach to Excellence and Trust: The 2020 White Paper on Artificial Intelligence. In NIKOLINAKOS, Nikos Th (ed), EU Policy and Legal Framework for Artificial Intelligence, Robotics and Related Technologies—The AI Act. Springer International Publishing, 2023, pp. 211–280. https://doi.org/10.1007/978-3-031-27953-9_5

NOVELLI, Claudio, et al. Taking AI risks seriously: A new assessment model for the AI Act. AI & SOCIETY, 2023, pp. 1–5. https://doi.org/10.1007/s00146-023-01723-z

NOVELLI, Claudio, et al. AI Risk Assessment: A Scenario-Based, Proportional Methodology for the AI Act. Digital Society, 2024, vol. 3, no. 1, pp. 1–24. https://doi.org/10.1007/s44206-024-00095-1

NOVELLI, Claudio, TADDEO, Mariarosaria, FLORIDI, Luciano. Accountability in artificial intelligence: What it is and how it works. AI & SOCIETY, 2023, pp. 1–12. https://doi.org/10.1007/ s00146-023-01635-y

O’SULLIVAN, Shane, et al. Legal, regulatory, and ethical frameworks for development of standards in artificial intelligence (AI) and autonomous robotic surgery. The International Journal of Medical Robotics and Computer Assisted Surgery, 2019, vol. 15, no. 1, pp. 1–12. https://doi.org/10.1002/ rcs.1968

PATANAKUL, Peerasit, PINTO, Jeffrey K. Examining the roles of government policy on innovation. The Journal of High Technology Management Research, 2014, vol. 25, no. 2, pp. 97–107. https://doi. org/10.1016/j.hitech.2014.07.003

POPA, Elena. Human Goals Are Constitutive of Agency in Artificial Intelligence (AI). Philosophy & Technology, 2021, vol. 34, no. 4, pp. 1731–1750. https://doi.org/10.1007/s13347-021-00483-2

RAJI, Inioluwa Deborah et al. Closing the AI accountability gap: Defining an end-to-end framework for internal algorithmic auditing. Proceedings of the 2020 Conference on Fairness, Accountability, and Transparency, 2020, pp. 33–44. https://doi.org/10.1145/3351095.3372873

RAPOSO, Vera Lúcia. Ex machina: Preliminary critical assessment of the European Draft Act on artificial intelligence. International Journal of Law and Information Technology, 2022, vol. 30, no. 1, pp. 88–109. https://doi.org/10.1093/ijlit/eaac007

RÁDI, V. Gábor. Comparative Analysis of the AI Regulation of the EU, US and China from a Privacy Perspective. 2023 46th MIPRO ICT and Electronics Convention (MIPRO), 2023, pp. 1446–1451. https://doi.org/10.23919/MIPRO57284.2023.10159864

ROBBINS, Scott. A Misdirected Principle with a Catch: Explicability for AI. Minds and Machines, 2019, vol. 29, no. 4, pp. 495–514. https://doi.org/10.1007/s11023-019-09509-3

ROBLES CARRILLO, Margarita. Artificial intelligence: From ethics to law. Telecommunications Policy, 2020, vol. 44, no. 6, pp. 1–16. https://doi.org/10.1016/j.telpol.2020.101937

RUSCHEMEIER, Hannah. AI as a challenge for legal regulation – the scope of application of the artificial intelligence act proposal. ERA Forum, 2023, vol. 23, no. 3, pp. 361–376. https://doi. org/10.1007/s12027-022-00725-6

SCHNEIBERG, Marc, Clemens, Elisabeth S. The Typical Tools for the Job: Research Strategies in Institutional Analysis*. Sociological Theory, 2006, vol. 24, no. 3, pp. 195–227. https://doi. org/10.1111/j.1467-9558.2006.00288.x

SIEGMANN, Charlotte, ANDERLJUNG, Markus. The Brussels Effect and Artificial Intelligence: How EU regulation will impact the global AI market. ArXiv, 2022, pp. 1–97. https://doi.org/10.48550/ arXiv.2208.12645

SIGFRIDS, Anton, et al. Human-centricity in AI governance: A systemic approach. Frontiers in Artificial Intelligence, 2023, vol. 6, pp. 1–9. https://doi.org/10.3389/frai.2023.976887

SMUHA, Nathalie A, et al. How the EU Can Achieve Legally Trustworthy AI: A Response to the European Commission’s Proposal for an Artificial Intelligence Act. SSRN Scholarly Paper, 2021, pp. 1–64. https://doi.org/10.2139/ssrn.3899991

SOLARTE-VASQUEZ, Maria Claudia, HIETANEN-KUNWALD, Petra. Responsibility and Responsiveness in the Design of Digital and Automated Dispute Resolution Processes: Internationales Rechtsinformatik Symposium Iris 2020. Verantwortungsbewusste Digitalisierung / Responsible Digitalization, 2020, pp. 451–459.

USMANI, Usman Ahmad, HAPPONEN, Ari, WATADA, Junzo. Human-Centered Artificial Intelligence: Designing for User Empowerment and Ethical Considerations. 2023 5th International Congress on Human-Computer Interaction, Optimization and Robotic Applications (HORA), 2023, pp. 1–7. https://doi.org/10.1109/HORA58378.2023.10156761

VAN WYNSBERGHE, Aimee. Sustainable AI: AI for sustainability and the sustainability of AI. AI and Ethics, 2021, vol. 1, no. 3, pp. 213–218. https://doi.org/10.1007/s43681-021-00043-6

VAROŠANEC, Ida. On the path to the future: Mapping the notion of transparency in the EU regulatory framework for AI. International Review of Law, Computers & Technology, 2022, vol. 36, no. 2, pp. 95–117. https://doi.org/10.1080/13600869.2022.2060471

VEALE, Michael, BORGESIUS, Frederik Z. Demystifying the Draft EU Artificial Intelligence Act— Analysing the good, the bad, and the unclear elements of the proposed approach. Computer Law Review International, 2021, vol. 22, no. 4, pp. 97–112. https://doi.org/10.9785/cri-2021-220402

VETRÒ, Antonio, TORCHIANO, Marco, MECATI, Mariachiara. A data quality approach to the identification of discrimination risk in automated decision making systems. Government Information Quarterly, 2021, vol. 38, no. 4, pp. 1–17. https://doi.org/10.1016/j.giq.2021.101619

WILLIAMS, Rebecca, et al. From transparency to accountability of intelligent systems: Moving beyond aspirations. Data & Policy, 2022, vol. 4, no. e7, pp. 1–23. https://doi.org/10.1017/ dap.2021.37

ZANZOTTO, Fabio M. Viewpoint: Human-in-the-loop Artificial Intelligence. Journal of Artificial Intelligence Research, 219, vol. 64, pp. 243–252. https://doi.org/10.1613/jair.1.11345

European Union Sources and Regulations:

COUNCIL OF THE EUROPEAN UNION. Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts – General approach. 2022. [Interinstitutional File: 2021/0106(COD)].

COUNCIL OF THE EUROPEAN UNION. Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts. 2024. [Interinstitutional File: 2021/0106(COD)].

EUROPEAN COMMISSION. Artificial Intelligence for Europe. 2018a. COM(2018) 237 final.

EUROPEAN COMMISSION. European Commission Staff Working Document: Liability for Emerging Digital Technologies. 2018b. COM(2018) 237 final.

EUROPEAN COMMISSION. Building trust in human-centric artificial intelligence. 2019. COM(2019) 168 final.

EUROPEAN COMMISSION. White Paper on Artificial Intelligence: A European approach to excellence and trust. 2020. COM(2020) 65 final.

EUROPEAN COMMISSION. Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) and amending certain Union legislative acts. 2021a. COM (2021a) 206 final.

EUROPEAN COMMISSION. Commission Staff Working Document: Impact Assessment Accompanying the Proposal for a Regulation of the European Parliament and of the Council Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) and Amending Certain Union Legislative Acts. 2021b. SWD(2021b) 84 final.

EUROPEAN COMMISSION. Coordinated Plan on Artificial Intelligence 2021c Review. 2021c. COM(2021) 205 final.

EUROPEAN COMMISSION. Proposal for a Directive of the European Parliament and of the Council on adapting non-contractual civil liability rules to artificial intelligence (AI Liability Directive). 2022. COM(2022) 496 final.

INDEPENDENT HIGH-LEVEL EXPERT GROUP ON ARTIFICIAL INTELLIGENCE SET UP BY THE EUROPEAN COMMISSION. Ethics guidelines for trustworthy AI. 2019a.

INDEPENDENT HIGH-LEVEL EXPERT GROUP ON ARTIFICIAL INTELLIGENCE SET UP BY THE EUROPEAN COMMISSION. Policy and Investment Recommendations for Trustworthy AI. 2019b.

INDEPENDENT HIGH-LEVEL EXPERT GROUP ON ARTIFICIAL INTELLIGENCE SET UP BY THE EUROPEAN COMMISSION. Sectoral Considerations on the Policy and Investment Recommendations for Trustworthy Artificial Intelligence. 2020.

REGULATION (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation), OJ L119, 4.5.2016, pp. 1–88.

REGULATION (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a single market for digital services (Digital Services Act) and amending Directive 2000/31/EC, OJ, L277/1, pp. 1–102.

REGULATION (EU) 2022/1925 of the European Parliament and of the Council of 14 September 2022 on contestable and fair markets in the digital sector and amending Directives (EU) 2019/1937 and (EU) 2020/1828 (Digital Markets Act), OJ, L 265/1, pp. 1–66.

REGULATION (EU) 2022/863 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act), OJ, L 152/1, pp. 1–44.

REGULATION (EU) 2023/988 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and of the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC, OJ, L135/1.

REGULATION (EU) 2023/2854 on harmonised rules on fair access to and use of data and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act), OJ, L.

Websites

MERRIAM-WEBSTER. (2024) Excellence. [online]. Available at: <https://www.merriam-webster. com/dictionary/excellence> Accessed: 13.03.2024

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2025-03-27

How to Cite

The EU AI Act’s Alignment within the European Union’s Regulatory Framework on Artificial Intelligence. (2025). International and Comparative Law Review, 24(2), 25-53. https://doi.org/10.5507/