Η ρύθμιση των συστημάτων ΤΝ υψηλού κινδύνου στην Πράξη για την Τεχνητή Νοημοσύνη
The regulation of high-risk AI systems in the Artificial Intelligence Act

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Keywords
Τεχνητή Νοημοσύνη ; Πράξη για την Τεχνητή Νοημοσύνη ; Κανονισμός (ΕΕ) 2024/1689 ; Συστήματα Τεχνητής Νοημοσύνης υψηλού κινδύνου ; Προσέγγιση βάσει κινδύνου ; Άρθρο 6 AI Act ; Παράρτημα III AI Act ; Ανθρώπινη εποπτεία ; Διακυβέρνηση δεδομένων ; Εκτίμηση Αντικτύπου στα Θεμελιώδη Δικαιώματα ; Συμμόρφωση ; Artificial Intelligence ; AI Act ; Regulation (EU) 2024/1689 ; High-risk AI systems ; Risk-based approach ; Article 6 AI Act ; Annex III AI Act ; Human oversight ; Data governance ; Fundamental Rights Impact Assessment (FRIA)Abstract
This thesis examines the regulatory framework governing high-risk artificial intelligence systems
under Regulation (EU) 2024/1689 (AI Act), with the aim of assessing whether the new EU
framework ensures effective protection of fundamental rights. The analysis situates the
Regulation within the broader context of the European digital strategy and highlights the
transition from the principles of trustworthy artificial intelligence to a binding legal regime.
Drawing on the legal dogmatic method and qualitative content analysis, the thesis focuses on the
risk-based approach adopted by the Regulation, particularly on the criteria for classifying AI
systems as high-risk and on the main compliance obligations imposed on the actors involved. In
this context, critical questions arise as to whether the Regulation succeeds in defining the notion
of “high-risk” with sufficient clarity, in providing adequate safeguards for the protection of
fundamental rights, and in establishing a functional and enforceable system of obligations.
Against this background, the study explores whether the Regulation can serve as an effective
model for the European governance of artificial intelligence.


