LEGAL ANALYSIS OF EU ARTIFICIAL INTELLIGENCE ACT (2024): INSIGHTS FROM PERSONAL DATA GOVERNANCE AND HEALTH POLICY
1. Introduction. – 2. Literature Review on EU policy regarding personal data and health policy in artificial intelligence (AI) management and governance. – 3. Methodology and research methods. – 4. Results and discussions. – 4.1. EU new legal trilogue (2024): Generative AI, European Artificial Intelligence Office (EU AIO) and Council Regulation (EU) 2024/1732. – 4.2. General overview of Artificial Intelligence Act. – 4.3. Ethical AI. – 4.4. Legal areas and high risks AI systems. – 4.5. Medical Devices Regulation and Artificial Intelligence Act: legal and policy considerations. – 4.6. Research and development (R&D) in Artificial Intelligence Act. – 4.7. Latest legal reform and regulations of AI sector: Case-Law in Ukraine (2024) and Republic of Moldova (2024). – 4.7.1. Legal provisions of non-original objects and sui generis right in Law of Ukraine “On Copyright and Related Rights” (2022). – 4.7.2. Scope of application and regulation of AI in the Republic of Moldova (2024). – 4.7.3. Scope of application and regulation of AI in Ukraine (2024). – 5. Conclusions.
Abstract
Background: This study correlates the up-to-date ethical, functional and legal evaluations related to the management and governance of artificial intelligence (AI) under European Union (EU) law, particularly impacting the health data sector and medical standards as provided by the Artificial Intelligence Act within the Regulation adopted by the European Council in May 2024. The initial proposal for the management and governance of the AI sector was submitted in April 2021. Three years later, on 13 March 2024, the European Union Artificial Intelligence Act (EU AIA) was adopted by the European Parliament. Subsequently, on 21 May 2024, the Council adopted an innovative legislative framework that harmonises the standards and rules for AI regulation. This framework is set to take effect in May 2026, with
Methods: The current legal analysis focuses on the European Union’s new institutional governance involving a multistage approach to managing health data, ethical artificial intelligence, generative artificial intelligence and classification of types of AI by considering the degree of risk (e.g. artificial intelligence systems with limited risk and systems with high risk) and medical devices. It outlines the legal framework for AI regulation and governance in the EU by focusing on compliance with the previously adopted legislation in the Medical Devices Regulation (2017) and the In-Vitro Diagnostic Regulation (2017). The paper also examines the application of the newly adopted EU Artificial Intelligence Act in relation to national justice
Results and conclusions: The present research facilitates the exploration of the real benefits of managing innovative AI systems for medical data, research, and development, as well as within the medical technology industry.
the central objective of stimulating and motivating a fair, safe, legal single market that respects the principles of ethics and the fundamental rights of the human person.
Methods: The current legal analysis focuses on the European Union’s new institutional governance involving a multistage approach to managing health data, ethical artificial intelligence, generative artificial intelligence and classification of types of AI by considering the degree of risk (e.g. artificial intelligence systems with limited risk and systems with high risk) and medical devices. It outlines the legal framework for AI regulation and governance in the EU by focusing on compliance with the previously adopted legislation in the Medical Devices Regulation (2017) and the In-Vitro Diagnostic Regulation (2017). The paper also examines the application of the newly adopted EU Artificial Intelligence Act in relation to national justice
systems, previous EU regulations on medical devices and personal data protection regulation, and its correlation with the European Court of Human Rights jurisprudence. This opens up complex discussions related to judicial reform and access to justice. For this purpose, as a research objective, the legal analysis includes an innovative perspective following an integrative
discussion on the latest legal reforms and regulations of the AI sector in Eastern Europe launched in 2024 with a special focus on the latest developments in the EU Candidate Countries namely Ukraine and the Republic of Moldova.
Results and conclusions: The present research facilitates the exploration of the real benefits of managing innovative AI systems for medical data, research, and development, as well as within the medical technology industry.
About Authors
Anca Parmena Olimid
Ph.D. (History), Associate Professor, Faculty of Social Sciences, Department of History, Political Sciences and International Relations, University of Craiova, Craiova, Romania
anca.olimid@edu.ucv.ro
Corresponding author, responsible for conceptualization, writing – original draft, data curation, software, supervision and writing – review & editing.
Ph.D. (Managment), Lecturer, Faculty of Social Sciences, Department of History, Political Sciences and International Relations, University of Craiova, Craiova, Romania
catalina.georgescu@edu.ucv.ro
daniel.olimid@edu.ucv.ro
Ph.D. (History), Associate Professor, Faculty of Social Sciences, Department of History, Political Sciences and International Relations, University of Craiova, Craiova, Romania
anca.olimid@edu.ucv.ro
Corresponding author, responsible for conceptualization, writing – original draft, data curation, software, supervision and writing – review & editing.
Cătălina Maria Georgescu,
Ph.D. (Managment), Lecturer, Faculty of Social Sciences, Department of History, Political Sciences and International Relations, University of Craiova, Craiova, Romania
catalina.georgescu@edu.ucv.ro
Co-author, responsible for conceptualization, methodology, resources, investigation and formal analysis and writing – review & editing.
Daniel Alin Olimid
Ph.D. (Medicine), Lecturer, Department Biology and Environmental Engineering, University of Craiova, Craiova, Romania
daniel.olimid@edu.ucv.ro
Co-author, responsible for conceptualization and writing – original draft, data curation and formal analysis.
Competing interests: No competing interests were disclosed.
Disclaimer: The authors declare that their opinion and views expressed in this manuscript are free of any impact of any organizations.
Copyright: © 2024 Anca Parmena Olimid, Cătălina Maria Georgescu and Daniel Alin
Olimid. This is an open access article distributed under the terms of the Creative Commons Attribution License, (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
References
1. Brownsword R, ‘Law, Authority, and Respect: Three Waves of Technological
Disruptionʼ (2022) 14(1) Law Innovation and Technology 5, doi:10.1080/
17579961.2022.2047517.
2. Buocz T, Pfotenhauer S and Eisenberger I, ‘Regulatory Sandboxes in the AI Act:
Reconciling Innovation and Safety?ʼ (2023) 15(2) Law, Innovation and Technology 357,
doi:10.1080/17579961.2023.2245678.
3. Cupać J and Sienknecht M, ‘Regulate Against the Machine: How the EU Mitigates AI
Harm to Democracyʼ (2024) 31(5) Democratization 1067, doi:10.1080/
13510347.2024.2353706.
4. Enqvist L, ‘“Human Oversight” in the EU Artificial Intelligence Act: What, When and
by Whom?’ (2023) 15(2) Law, Innovation and Technology 508, doi:10.1080/
17579961.2023.2245683.
5. Ervo L, ‘Debtors Protection and Enforcement Efficiency According to Finnish Law’
(2020) 3(4) Access to Justice in Eastern Europe 265, doi:10.33327/AJEE-18-3.4-
a000039.
6. Fabiano N, ‘AI Act and Large Language Models (LLMs): When Critical Issues and
Privacy Impact Require Human and Ethical Oversightʼ (31 March 2024) arXiv preprint
arXiv:2404.00600 [cs.CY] <https://arxiv.org/html/2404.00600v1> accessed 05 July 2024.
7. Friedl P, ‘Dis/similarities in the Design and Development of Legal and Algorithmic
Normative Systems: The Case of Perspective APIʼ (2023) 15(1) Law, Innovation and
Technology 25, doi:10.1080/17579961.2023.2184134.
8. Gamito MC, ‘The Role of ETSI in the EU’s Regulation and Governance of Artificial
Intelligenceʼ [2024] Innovation: The European Journal of Social Science Research 1,
doi:10.1080/13511610.2024.2349627.
9. Gasser U, ‘An EU Landmark for AI Governanceʼ (2023) 380(6651) Science 1203,
doi:10.1126/science.adj1627.
10. Gilbert S, ‘The EU Passes the AI Act and its Implications for Digital Medicine are
Unclear’ (2024) 7(1) NPJ Digital Medicine 135, doi:10.1038/s41746-024-01116-6.
11. Gilbert S and others, ‘Learning From Experience and Finding the Right Balance in the
Governance of Artificial Intelligence and Digital Health Technologies’ (2023) 25
Journal of Medical Internet Research e43682, doi:10.2196/43682.
12. Kolfschooten H van, ‘The AI Cycle of Health Inequity and Digital Ageism: Mitigating
Biases Through the EU Regulatory Framework on Medical Devicesʼ (2023) 10(2)
Journal of Law and the Biosciences lsad031, doi:10.1093/jlb/lsad031.
13. Laux J, Wachter S and Mittelstadt B, ‘Trustworthy Artificial Intelligence and the
European Union AI Act: On the Conflation of Trustworthiness and Acceptability of
Riskʼ (2024) 18(1) Regulation & Governance 3, doi:10.1111/rego.12512.
14. Madiega T, ‘Artificial Intelligence Act: Briefing EU Legislation in Processʼ (EPRS
European Parliamentary Research Service, June 2023) <https://superintelligenz.eu/wp-
content/uploads/2023/07/EPRS_BRI2021698792_EN.pdf> accessed 24 June 2024.
15. Maidanyk L, ‘Artificial Intelligence and Sui Generis Right: A Perspective for Copyright
of Ukraine?’ (2021) 4(3) Access to Justice in Eastern Europe 144, doi:10.33327/AJEE-
18-4.3-n000076.
16. McCarthy J, ‘From Childish Things: The Evolving Sandbox Approach in the EU’s
Regulation of Financial Technologyʼ (2023) 15(1) Law, Innovation and Technology 1,
doi:10.1080/17579961.2023.2184131.
17. Onitiu D, ‘The Limits of Explainability & Human Oversight in the EU Commission’s
Proposal for the Regulation on AI- a Critical Approach Focusing on Medical Diagnostic
Systemsʼ (2022) 32(2) Information & Communications Technology Law 170,
doi:10.1080/13600834.2022.2116354.
18. Ozmen Garibay O and others, ‘Six Human-Centered Artificial Intelligence Grand
Challenges’ (2023) 39(3) Journal of Human-Computer Interaction 391,
doi:10.1080/10447318.2022.2153320.
19. Palmieri S and Goffin T, ‘A Blanket That Leaves the Feet Cold: Exploring the AI Act
Safety Framework for Medical AIʼ (2023) 30(4) European Journal of Health Law 406,
doi:10.1163/15718093-bja10104.
20. Pavlidis G, ‘Unlocking the Black Box: Analysing the EU Artificial Intelligence Act’s
Framework for Explainability in AI Lawʼ (2024) 16(1) Innovation and Technology 293,
doi:10.1080/17579961.2024.2313795.
21. Ranjbar A and others, ‘Managing Risk and Quality of AI in Healthcare: Are Hospitals
Ready for Implementation?’ (2024) 17 Risk Manag Healthc Policy 877,
doi:10.2147/RMHP.S452337.
22. Reddy S, ‘Generative AI in Healthcare: An Implementation Science Informed
Translational Path on Application, Integration and Governanceʼ (2024) 19(1)
Implementation Science 27, doi:10.1186/s13012-024-01357-9.
23. Romero-Moreno F, ‘Generative AI and Deepfakes: A Human Rights Approach to
Tackling Harmful Contentʼ [2024] International Review of Law, Computers &
Technology 1, doi:10.1080/13600869.2024.2324540.
24. Schopmans H and Tuncer Ebeturk I, ‘Techno-Authoritarian Imaginaries and the
Politics of Resistance against Facial Recognition Technology in the US and European
Unionʼ (2023) 31(1) Democratization 1, doi:10.1080/13510347.2023.2258803.
25. Sison AJG and others, ‘ChatGPT: More Than a “Weapon of Mass Deception” Ethical
Challenges and Responses from the Human-Centered Artificial Intelligence (HCAI)
Perspectiveʼ [2023] International Journal of Human-Computer Interaction 1,
doi:10.1080/10447318.2023.2225931.
26. Taeihagh A, ‘Governance of Artificial Intelligenceʼ (2021) 40(2) Policy and Society 137,
doi:10.1080/14494035.2021.1928377.
27. Xenidis R, ‘Beyond Bias: Algorithmic Machines, Discrimination Law and the
Analogy Trap’ (2023) 14(4) Transnational Legal Theory 378, doi:10.1080/
20414005.2024.2307200.
Reviews for article
Add a Review
Вступ. Це дослідження зіставляє сучасні етичні, функціональні та правові оцінки,
пов'язані з управлінням і регулюванням штучного інтелекту (ШІ) відповідно до
законодавства Європейського Союзу (ЄС), зокрема з впливом на медичні стандарти та
сектор медичних даних, як це передбачено Законом про штучний інтелект в межах Регламенту, прийнятого Європейською Радою в травні 2024 року. Початкову пропозицію
щодо управління та керування сектором штучного інтелекту було подано в квітні 2021
року. Через три роки, 13 березня 2024 року, Європейський парламент ухвалив Закон
Європейського Союзу про штучний інтелект (EU AIA). Згодом, 21 травня 2024 року, Рада
прийняла інноваційну законодавчу базу, яка гармонізує стандарти і правила регулювання
ШІ. Вона має набути чинності в травні 2026 року, головною метою якої є стимулювання
та мотивація чесного, безпечного, законного єдиного ринку, який поважає принципи етики
та фундаментальні права людини.
Методи. Здійснений правовий аналіз зосереджується на новому інституційному
управлінні Європейського Союзу, що передбачає багатоступеневий підхід до керування
даними про стан здоров’я, етичний штучний інтелект, генеративний штучний
інтелект, класифікацію типів штучного інтелекту з урахуванням ступеня ризику
(наприклад, системи штучного інтелекту з обмеженим ризиком і системи з високим
ризиком) і медичне обладнання. У ньому окреслено законодавчу базу щодо регулювання та
управління штучним інтелектом у ЄС, зокрема зосереджено увагу на дотриманні раніше
прийнятих нормативно-правових актів у Регламенті MDR (The Medical Devices
Regulation) (2017) та Регламенті IVDR (The In Vitro Diagnostic Medical Devices Regulation)
(2017). У статті також досліджується застосування нещодавно ухваленого Закону ЄС
про штучний інтелект щодо національних систем правосуддя, попередні нормативні
акти ЄС щодо медичних пристроїв і регулювання захисту персональних даних, а також
здійснюється їх зіставлення з практикою Європейського суду з прав людини. Це відкриває
складні дискусії щодо судової реформи та доступу до правосуддя. Відповідно до мети
дослідження, правовий аналіз містить інноваційну перспективу, що ґрунтується на
інтегративному обговоренні останніх правових реформ і нормативно-правових актів у
сфері штучного інтелекту в Східній Європі, які були впроваджені у 2024 році, з особливим
акцентом на останні події в країнах-кандидатах на вступ до ЄС, а саме в Україні та
Республіці Молдова.
Результати та висновки. Ця стаття сприяє вивченню реальних переваг управління
інноваційними системами ШІ для медичних даних, досліджень і розробок, а також у галузі
медичних технологій.
Keywords
- artificial intelligence, AI, ethical AI, EU legislation, generative AI, medical data.
Publication history
-
Date of submission: 19 Jul 2024
Date of acceptance: 07 Aug 2024
Date of Online First publication: 02 Sep 2024
Date of publication: 15 Nov 2024
Whether the manuscript was fast tracked? - No
Number of reviewer report submitted in first round: 2 reports
Number of revision rounds: 1 round without revisions
How to cite it?
-
Olimid AP, Georgescu CM and Olimid DA, ‘Legal Analysis of EU Artificial Intelligence
Act (2024): Insights from Personal Data Governance and Health Policy’ (2024) 7(4) Access to Justice in Eastern Europe 120-42 <https://doi.org/10.33327/AJEE-18-7.4-a000103>
