When is an AI system high-risk?
Table of references
s. 44–50pp. 44–50 · PDF 48–54
Literature
- Couneson, Guillaume. 2024. “Article 6: Classification Rules for High-Risk AI Systems.” In Pehlivan, Forgó, and Valcke (eds) (2024), 193–218.
- Crootof, Rebecca, Margot E. Kaminski, and W. Nicholson Price II. 2023. “Humans in the Loop.” Vanderbilt Law Review 76 (2): 429–510. https://scholarship.law.vanderbilt.edu/vlr/vol76/iss2/2.
- Ebers, Martin. 2024. “Truly Risk-Based Regulation of Artificial Intelligence: How to Implement the EU's AI Act.” European Journal of Risk Regulation 16 (2): 684–703. doi:10.1017/err.2024.78.
- Enarsson, Therese, Lena Enqvist, and Markus Naarttijärvi. 2022. “Approaching the Human in the Loop: Legal Perspectives on Hybrid Human/Algorithmic Decision-Making in Three Contexts.” Information & Communications Technology Law 31 (1): 123–153. doi:10.1080/13600834.2021.1958860
- Floridi, Luciano. 2011. The Philosophy of Information. Oxford: Oxford University Press. doi:10.1093/acprof:oso/9780199232383.001.0001
- Gallagher, Daniel. 2024. “Article 26: Obligations of Deployers of High-Risk AI Systems.” In Pehlivan, Forgó, and Valcke (eds) (2024), 537–552.
- Gasiola, Gustavo Gil. 2025. “Rebuilding the Pyramid: The AI Act's Risk-Based Approach Using a Binary Decision Diagram.” Computer Law & Security Review 58: 106189. doi:10.1016/j.clsr.2025.106189.
- Granmar, C.G. 2024. “AI-Based Decision-Making and the Human Oversight Requirement Under the AI Act.” In: Gill-Pedro, E. and A. Moberg (eds). YSEC Yearbook of So-cio-Economic Constitutions, vol 2023. Springer, Cham. doi:10.1007/16495_2024_68
- Hanif, Hilmy, Jorge Constantino, Marie-Therese Sekwenz, Michel van Eeten, Jolien Ubacht, Ben Wagner, and Yury Zhauniarovich. 2024. “Navigating the EU AI Act Maze Using a Decision-Tree Approach.” ACM Journal on Responsible Computing 1 (3): 1–16. doi:10.1145/3677174
- Laux, Johann, and Hannah Ruschemeier. 2025. “Automation Bias in the AI Act: On the Legal Implications of Attempting to De-Bias Human Oversight of AI.” European Journal of Risk Regulation 16 (4): 1519–1534. doi:10.1017/err.2025.10033
- Lazcoz, Guillermo, and Paul de Hert. 2023. “Humans in the GDPR and AIA Governance of Automated and Algorithmic Systems: Essential Pre-Requisites Against Abdicating Responsibilities.” Computer Law & Security Review 50: 105833. doi:10.1016/j.clsr.2023.105833
- Lenaerts, Koen, and José A. Gutiérrez-Fons. 2013. “To Say What the Law of the EU Is: Methods of Interpretation and the European Court of Justice.” EUI AEL Distinguished Lectures of the Academy 2013/09. Florence: European University Institute. https://hdl.handle.net/1814/28339
- Levitina, Anna. 2024. “Humans in Automated Decision-Making Under the GDPR and AI Act.” Revista CIDOB d'Afers Internacionals 138: 121–143. doi:10.24241/rcai.2024.138.3.121/ English text: https://www.cidob.org/en/publications/humans-automated-decision-making-under-gdpr-and-ai-act
- Mahler, Tobias. 2022. “Between Risk Management and Proportionality: The Risk-Based Approach in the EU's Artificial Intelligence Act Proposal.” In The Swedish Law and Informatics Research Institute, 247–270. doi:10.53292/208f5901.38a67238. Also available at SSRN: https://ssrn.com/abstract=4001444
- Mahler, Tobias, and Sebastian Felix Schwemer. 2024. “Article 80: Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III.” In Pehlivan, Forgó, and Valcke (eds) (2024), 1140– 1148.
- Tosoni, Luca, and Samson Y. Esayas. 2024. “Article 81: Union Safeguard Procedure.” In Pehlivan, Forgó, and Valcke (eds) (2024), 1149–1157.
- Panezi, Argyri. 2024. “Article 14: Human Oversight.” In Pehlivan, Forgó, and Valcke (eds) (2024), 351–371.
- Parasuraman, Raja, and Dietrich H. Manzey. 2010. “Complacency and Bias in Human Use of Automation: An Attentional Integration.” Human Factors 52, no. 3: 381–410. doi:10.1177/0018720810376055
- Pehlivan, Ceyhun Necati, Nikolaus Forgó, and Peggy Valcke (eds.). 2024. The EU Artificial Intelligence (AI) Act: A Commentary. Alphen aan den Rijn: Wolters Kluwer. ISBN 978-94-035-3227-1.
- Riede, Lutz, and Oliver Talhoff. 2024. “Article 25: Responsibilities Along the AI Value Chain.” In Pehlivan, Forgó, and Valcke (eds) (2024), 524–536.
- Smuha, Nathalie A., and Karen Yeung. 2025. “The European Union's AI Act: Beyond Motherhood and Apple Pie?” In The Cambridge Handbook of the Law, Ethics, Policy and Artificial Intelligence, edited by Nathalie A. Smuha, 228–258. Cambridge: Cambridge University Press. doi:10.1017/9781009367783.015
- Veale, Michael, and Frederik Zuiderveen Borgesius. 2021. “Demystifying the Draft EU Artificial Intelligence Act.” Computer Law Review International 22 (4): 97–112. doi:10.9785/cri-2021-220402. arXiv:https://arxiv.org/abs/2107.03721
- Wachter, Sandra, Brent Mittelstadt, and Luciano Floridi. 2017. “Why a Right to Explanation of Automated Decision-Making Does Not Exist in the General Data Protection Regulation.” International Data Privacy Law 7 (2): 76–99. doi:10.2139/ssrn.2903469
Legal sources
Legislation and treaties
- Consolidated Version of the Treaty on European Union. OJ C 326, 26.10.2012. https://eur-lex.europa.eu/eli/treaty/teu_2012/oj/eng
- Consolidated Version of the Treaty on the Functioning of the European Union. OJ C 326, 26.10.2012. http://data.europa.eu/eli/treaty/tfeu_2012/oj
- 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 L 119, 4.5.2016. https://eurlex.europa.eu/eli/reg/2016/679/oj/
- Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act). OJ L 2024/1689. http://data.europa.eu/eli/reg/2024/1689/oj
Case law
- Case 283/81, CILFIT and Lanificio di Gavardo SpA v Ministry of Health, ECLI:EU:C:1982:335. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:61981CJ0283
- Case 66/85, Lawrie-Blum v Land Baden-Württemberg, ECLI:EU:C:1986:284. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:61985CJ0066
- Case C-162/97, Criminal Proceedings Against Nilsson and Others, ECLI:EU:C:1998:554. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:61997CJ0162
- Case C-268/06, Impact v Minister for Agriculture and Food and Others, ECLI:EU:C:2008:223. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62006CJ0268
- Case C-226/11. Expedia Inc. v Autorité de la concurrence and Others, ECLI:EU:C:2012:795. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62011CJ0226
- Case C-201/13, Deckmyn and Vrijheidsfonds v Vandersteen and Others, ECLI:EU:C:2014:2132. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:62013CJ0201
- Case C-634/21, OQ v Land Hessen (SCHUFA Holding), ECLI:EU:C:2023:957. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:62021CJ0634
Institutional documents and official guidance
- Article 29 Data Protection Working Party. 2018. “Guidelines on Automated Individual Decision-Making and Profiling for the Purposes of Regulation 2016/679.” WP251rev.01. Adopted 3 October 2017; last revised 6 February 2018. Brussels. https://ec.europa.eu/newsroom/article29/items/612053
- Council of the European Union. 2022. “Proposal for a Regulation Laying Down Harmonised Rules on Artificial Intelligence—General Approach.” ST 14954/22. Brussels, 25 November 2022. https://data.consilium.europa.eu/doc/document/ST-14954-2022-INIT/en/pdf
- Council of the European Union. 2024. “Proposal for a Regulation Laying Down Harmonised Rules on Artificial Intelligence—Analysis of the Final Compromise Text with a View to Agreement.” ST 5662/24. Brussels, 26 January 2024. https://data.consilium.europa.eu/doc/document/ST-5662-2024-INIT/en/pdf
- Council of the European Union. 2026. “Proposal for a Regulation Amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as Regards the Simplification of the Implementation of Harmonised Rules on Artificial Intelligence (Digital Omnibus on AI)—Mandate for Negotiations with the European Parliament.” ST 7322/26. Brussels, 13 March 2026.https://data.consilium.europa.eu/doc/document/ST-7322-2026-INIT/en/pdf
- European Commission. 2025. “Proposal for a Regulation Amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as Regards the Simplification of the Implementation of Harmonised Rules on Artificial Intelligence (Digital Omnibus on AI).” COM(2025) 836 final. Brussels. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52025PC0836
- European Data Protection Board and European Data Protection Supervisor. 2026. “EDPB–EDPS Joint Opinion 1/2026 on the Proposal for a Regulation as Regards the Simplification of the Implementation of Harmonised Rules on Artificial Intelligence (Digital Omnibus on AI).” 21 January 2026.https://www.edpb.europa.eu/our-work-tools/our-documents/edpbedps-joint-opinion/edpb-edps-joint-opinion-12026-proposal_en
- European Parliament. 2023. “Draft Compromise Amendments on the Proposal for a Regulation on Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act).” Consolidated compromise text, IMCO-LIBE. Brussels, 9 May 2023. https://www.europarl.europa.eu/meetdocs/2014_2019/plmrep/COMMIT-TEES/CJ40/DV/2023/05-11/ConsolidatedCA_IMCOLIBE_AI_ACT_EN.pdf
- European Parliament. 2026. "Amendments adopted by the European Parliament on 26 March 2026 on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI) (COM(2025)0836 – C10-0304/2025 – 2025/0359(COD)).” 26 March 2026. https://www.europarl.europa.eu/doceo/document/TA-10-2026-0098_EN.html
Websites and online materials
- Microsoft. 2025. “Enterprise AI Services Code of Conduct.” https://learn.microsoft.com/en-us/legal/ai-code-of-conduct
- Oxford English Dictionary. 2025. Entries cited: “assessment (n.), sense 5.a,” doi:10.1093/OED/8740411998 “narrow (adj.), sense 3.a,” doi:10.1093/OED/8863877943 “preparatory (adj.), sense 1,” doi:10.1093/OED/7056784451 “procedure (n.), sense 1.a,” doi:10.1093/OED/3805511077 “task (n.), sense 2.a,” doi:10.1093/OED/8723383921