Revista de Estudos Constitucionais, Hermenêutica e Teoria do Direito

From Guidelines to Algorithms: How AI is Rewriting the Leges Artis and Medical Liability in Europe

Mario Caterini — 2026-04-29

The integration of artificial intelligence (AI) systems into clinical practice requires a heavy reconsideration of legal categories related to medical liability, not only nationally but also within the increasingly interconnected European framework. This article examines the transition from the traditional lex artis, rooted in national jurisdictions, to a new paradigm shaped by EU governance. Starting from the Italian regulatory framework established by Law No. 24/2017 (“Gelli-Bianco”), the analysis then turns to Regulation (EU) 2024/1689 (the AI Act), which classifies AI systems in healthcare as “high-risk” and imposes obligations of transparency and human oversight. A comparative perspective is then developed, focusing on Italy, Germany, France, and Spain, and revealing different conceptions of the standard of care: from the German fachärztlicher Standard to the Spanish lex artis ad hoc, through the French dualism between fault-based liability and “national solidarity”. Special attention is devoted to explainable artificial intelligence (XAI) as a means to mitigate the opacity of black-box models, together with the implications of the new directive on liability for defective products. The article further explores emerging scenarios from human-machine interaction, such as concordant error and dissent from algorithmic recommendations, assessing them against national approaches. The study reveals a legal landscape in profound transformation, where technological innovation acts as a catalyst for change in diverse national legal cultures, and concludes by sketching a roadmap for governing the possible convergence toward a European model of “augmented medical liability”, in which harmonized EU principles are interwoven with national legal traditions, seeking equilibrium between technological innovation, patient safety, and legal certainty.

Approccio integrato e governance multilevel per le aree urbane nell’Unione europea

Anna Silvia Bruno — 2026-04-29

Abstract: Oggi la politica di coesione attraversa una fase di crisi senza precedenti a causa delle forti tensioni geopolitiche, delle dispute commerciali internazionali e delle emergenze legate alla transizione ecologica e digitale. In un contesto globale dominato dalla necessità di risposte immediate, questa strategia strutturale a lungo termine fatica a trovare il giusto rilievo: nell’attuale processo di integrazione, essa non mira solo all’equilibrio economico, ma punta a sanare le fratture sociali e territoriali attraverso investimenti mirati sia nelle reti infrastrutturali sia nella valorizzazione del capitale umano. L’obiettivo ultimo resta quello di garantire a ogni cittadino dell’Unione prospettive e standard di vita omogenei, indipendentemente dalla propria collocazione geografica o professionale. Il paper si propone di prendere in esame le politiche europee analizzando il ruolo delle autorità locali e delle loro risorse (primo paragrafo) in una governance integrata che aspira a superare le asimmetrie territoriali, sociali, economiche e digitali. Nel secondo e terzo paragrafo, il paper ripercorre le iniziative europee in tema di place based approach e di “città collaborative”, entrambi tentativi di interventi mirati sul territorio, anche attraverso forme di cooperazione tra abitanti, istituzioni e attori del settore non profit. Nel paragrafo finale si evidenzia il ruolo fondamentale del Comitato delle Regioni che ha ribadito l’importanza delle strategie digitali in quanto il successo economico e l’equità sociale dell’Europa dipendono anche da scelte di investimento sub-statali integrate e multilevel.

Principio antropocentrico, riserva di umanità e decisione algoritmica: l’esperienza italiana in comparazione con il Brasile

Davide Ragone — 2026-04-29

This article examines the anthropocentric principle in artificial intelligence and the legal category of the “reserve of humanity” in the Italian experience, tracing its development from European soft law to positive law, with particular reference to the AI Act and Law no. 132 of 2025, and to the administrative case law of the Council of State, from judgment no. 2270 of 2019 to the most recent rulings of 2025 and 2026. Adopting a comparative method, the article compares the Italian approach with the Brazilian framework currently under development, showing how the two legal orders – one already equipped with national legislation on artificial intelligence, the other currently considering Projeto de Lei no. 2338/2023 – address the same structural problem, namely the delegation of public decision-making to algorithms, through solutions that converge in principle while diverging in their modes of legal construction and in the instruments adopted. The analysis leads to a distinction between the reserve of humanity and human oversight: the former does not merely amount to technical supervision, but expresses a substantive limit on the delegability of decisions affecting fundamental rights. On this basis, the article argues that the category of a “meaningful human decision reserve”, while rooted in the international debate on meaningful human control, develops it in a specifically legal direction, and may constitute a criterion suited to translating the anthropocentric principle into verifiable operational guarantees, shifting the focus from process control to the human attribution of the final decision.

Emenda Constitucional Inconstitucional e Reedição: Regras, Escolhas e Consequências

Ousu Mendy — 2026-04-29

In contemporary comparative constitutional studies, one of the most intriguing questions is: is it possible to declare a constitutional amendment unconstitutional? If so, by whom and by what standards? This research investigates unconstitutional constitutional amendments and re-enactments, the choices, rules and consequences that follow. A doctrinal research method is used through secondary legal data in descriptive and prescriptive approaches. In this research, I make a holistic study of three constitutional amendments - successful and unsuccessful amendments in The Gambia, Kenya and Israel - as new questions and use them to draw a conclusion. The formal rules of constitutional amendment are the decisive mechanisms for constitutional enclosure, but constitutional re-enactments tend to deviate from their assumptions and are not aligned with their basic structure, thus destroying the continuity of the legal order. A constitution must be a constitution that responds to the changing society, because there has been a noticeable shift in the overall constitutional debate away from a normative or institutionalist perspective and toward a more analytical and comparative approach in assessing the configuration of constitutional processes. Therefore, changing a significant provision of a constitution that has a direct effect on the status of a state, taking the people out of the basket of progressive realization of a state, is a non sequitur under the rules of constitutional amendment.