THE EU ARTIFICIAL INTELLIGENCE ACT: THE NECESSARY TOOL TO GUARANTEE THE FUNDAMENTAL RIGHTS OF CITIZENS
Keywords:
artificial intelligence, healthcare, medicine, European Union, legislationAbstract
In recent years, the growing trend of introducing artificial intelligence (AI) into various spheres of public life has caused strong concern among international, European, and national bodies and institutions. They have come to realize that the practical application of AI is outpacing its legal regulation, creating a real danger of infringing upon numerous basic human rights and freedoms. The need to adopt explicit regulatory rules regarding the use of AI is particularly significant in medicine and healthcare, as these sensitive fields encompass one of the citizens‘ most important subjective rights the right to health. The exceptional importance of this right is predetermined by the fact that the individual's ability to fully exercise their civil, economic, social, and other rights is conditioned by the presence of appropriate conditions to achieve the best possible health status. This inherent human rights is not only associated with individuals‘ well being, but also with the well being of the entire population, economic progress, and the advancement of the state. Health is a basic public good, the key role of which was recognized by the international community, the EU, and sovereign states already decades ago, which is why they are striving to adopt adequate instruments for its protection. In the current stage of development of modern society, artificial intelligence could be considered as a tool with the potential to raise the standard of living, including by providing better quality and affordable healthcare for the population. However, to achieve this effect, efficient guarantees for the safe use of AI should be created, especially in the field of medicine and healthcare. The first step in this direction should be the adoption of an adequate regulatory framework with clearly defined legal rules and mechanisms for their implementation. Given the global importance of the question of AI applicability, the best approach would be to create a universal legal framework that introduces harmonized rules for the use of AI. At present, the international community is extensively deliberating the necessity of adopting legal regulation of AI but has failed to reach a unified position, delaying the adoption of universal binding rules. In recent years, the European Union has coordinated its efforts in this area, leading to a preliminary agreement between the Council and the European Parliament in December 2023 regarding the adoption of the AI Act. The new legislative act will be the first legal document in EU law that delineates explicit harmonized rules in this complex matter.
References
Европейски съвет. Заседание на Европейския съвет (19 октомври 2017 г.) – Заключения; EUCO 14/17, 2017 г., стр. 7;
Европейска комисия. Съобщение за медиите: Изкуствен интелект: Комисията очертава европейски подход за стимулиране на инвестициите и задава насоки в областта на етиката, Брюксел, 25 април 2018, https://ec.europa.eu/commission/presscorner/detail/bg/IP_18_3362;
Европейска комисия. Високи постижения и доверие в изкуствения интелект. Надеждният ИИ може да донесе много ползи, като например по-добро здравно обслужване, по-безопасен и чист транспорт, https://www.consilium.europa.eu/bg/policies/artificial-intelligence/#AI%20act;
Мавров, М. (2023). Правни аспекти на общественото здравеопазване в условията на пандемичните ефекти при заразните болести. Анализ на нормативната база и практиката. Предложения за оптимизация, С., Сиела;
Съвет на Европейския съюз. Политики. Изкуствен интелект, https://www.consilium.europa.eu/bg/policies/artificial-intelligence/#AI%20act;
Съвет на ЕС. Съобщение за печата. 9 декември 2023 г. Законодателен акт за изкуствения интелект: Съветът и Парламентът постигат споразумение относно първите правила за ИИ в света. https://www.consilium.europa.eu/bg/policies/artificial-intelligence/timeline-artificial-intelligence/;
Amisha, Malik, P., Pathania, M., & Rathaur, V. K. (2019). Overview of artificial intelligence in medicine. Journal of family medicine and primary care, 8(7), 2328-2331, https://doi.org/10.4103/jfmpc.jfmpc_440_19;
Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level ST/6569/2022/INIT, OJ L 314, 6.12.2022, p. 64–78
Council of Europe.Commissioner for Human Rights (2019). Unboxing Artificial Intelligence: 10 steps to protect Human Rights., рр. 1-29;
European Commission. A Europe fit for the digital age, https://commission.europa.eu/strategy-and-policy/priorities-2019-2024_en;
European Commission. Proposal for a Regulation оf The European Parliament and of The Council Laying Down Harmonised Rules On Artificial Intelligence (Artificial Intelligence Act) And Amending Certain Union Legislative Acts, COM/2021/206 final;
European Commission. Al Act. 2024, https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai;
European Commission, Communication To The Commission. Artificial Intelligence in the European Commission (AI@EC) A strategic vision to foster the development and use of lawful, safe and trustworthy Artificial Intelligence systems in the European Commission, Brussels, 24.1.2024 C(2024) 380 final;
European Council. EUCO 13/20. Special meeting of the European Council (1 and 2 October 2020) – Conclusions, Brussels, 2 October 2020 (OR. en);
European Parliament, P9_TA(2023)0236. Amendments adopted by the European Parliament on 14 June 2023 on the proposal for a regulation of the European Parliament and of the Council on laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts (COM(2021)0206 – C9-0146/2021–2021/0106(COD);
Frankish K., Ramsey W.M., editors. (2014). The Cambridge Handbook of Artificial Intelligence. Cambridge University Press; Cambridge, UK, Introduction, pp. 1–14;
Gunn A. (1976). The diagnosis of acute abdominal pain with computer analysis. J. R. Coll. Surg. Edinb., 21:170–172;
Hellwig, J., Huggett, S., Siebert, M., & Jayabalasingham, B. (2019). Artificial Intelligence: How knowledge is created, transferred, and used, https://doi.org/10.17632/7ydfs62gd6.2;
Hellwig, J., Huggett, S., & Siebert, M. (2024), „Data for report „Artificial Intelligence: How knowledge is created, transferred, and used““, Elsevier Data Repository, V3, doi: 10.17632/7ydfs62gd6.3;
Nuffield Council on Bioethics (2018). Bioethics Briefing Notes: Artificial Intelligence (AI) in Healthcare and Research, аvailable online: http://nuffieldbioethics.org/wp-content/uploads/Artificial-Intelligence-AI-in-healthcare-and-research.pdf;
Ramesh, A.N., Kambhampati, C., Monson, J.R.T., & Drew, P.J. (2004). Artificial intelligence in medicine. Ann. R. Coll. Surg. Engl., 86:334–338, doi: 10.1308/147870804290;
Raycheva, R., Kostadinov, K., Mitova, E., Bogoeva, N., Iskrov, G., Stefanov, G., & Stefanov, R. (2023).Challenges in mapping European rare disease databases, relevant for ML-based screening technologies in terms of organizational, FAIR and legal principles: scoping review. Front. Public Health 11:1214766., doi: 10.3389/fpubh.2023.1214766;
Valcheva, A. (2022). Human rights and artificial intelligence. KNOWLEDGE - International Journal , 52(1), 121–126, https://ikm.mk/ojs/index.php/kij/article/view/5169;
Tran, B. X., Vu, G. T., Ha, G. H., Vuong, Q. H., Ho, M. T., Vuong, T. T., La, V. P., Ho, M. T., Nghiem, K. P., Nguyen, H. L. T., Latkin, C. A., Tam, W. W. S., Cheung, N. M., Nguyen, H. T., Ho, C. S. H., & Ho, R. C. M. (2019). Global Evolution of Research in Artificial Intelligence in Health and Medicine: A Bibliometric Study. Journal of clinical medicine, 8(3), 360. https://doi.org/10.3390/jcm8030360