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Biodiritto ed ecosistemi globali: le nuove sfide delle tecnologie emergenti e profonde
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Sulla parziale, totale o assente coincidenza tra chi decide e chi dovrebbe decidere. Riflessioni in chiave comparata a partire da alcune decisioni in materia di giustizia climatica
No full textThis contribution aims to examine the relationship between climate litigation and the principle of separation of powers, questioning about the partial, total, or absent alignment between those who decide and those who ought to decide on climate matters. To address this issue, the analysis will focus on the landmark Klimaseniorinnen judgment delivered by the European Court of Human Rights (ECtHR) in April 2024. This ruling offers valuable insights into the dynamics of the separation of powers principle in this specific field and can also serve as a lens to analyze two climate disputes adjudicated by “domestic courts”: the Italian Giudizio Universale and the French Affaire du Siècle.Il contributo si propone di esaminare il rapporto tra contenzioso climatico e separazione, interrogandosi sulla parziale, totale o assente coincidenza tra chi decide e chi dovrebbe decidere in materia climatica. Per tentare di rispondere a questo quesito verrà presa in esame la nota sentenza Klimaseniorinnen pronunciata ad aprile 2024 dalla Corte EDU, che fornisce interessanti spunti di riflessione sulla dinamica del principio di separazione di poteri in questo specifico ambito e può essere inoltre essere utilizzata come lente per guardare a due controversie climatiche decise da due “corti domestiche”, il Giudizio Universale italiano e l’Affaire du Siècle francese
Regulating the use of artificial intelligence in the doctor-patient relationship? A primer on supranational and national legal frameworks
No full textThe paper aims at giving a general overview on the current regulatory frameworks concerning the use of AI systems within the doctor-patient relationship, assessing their effectiveness in minimising opacity and automation bias risks. The first section will focus on the supranational regulatory approach promoted by the Regulation (EU) n° 2024/1689 and will examine its applicative scope in the field of care relationship. The second part will analyse the regulatory solutions adopted at the national level, comparing the French and Italian normative approaches and the specific provision adopted to define doctors’ duties and patients’ rights. Finally, the paper will discuss the integration of various regulatory levels examined to establish a comprehensive regulatory framework for the use of AI in the doctor-patient relationship.The paper aims at giving a general overview on the current regulatory frameworks concerning the use of AI systems within the doctor-patient relationship, assessing their effectiveness in minimising opacity and automation bias risks. The first section will focus on the supranational regulatory approach promoted by the Regulation (EU) n° 2024/1689 and will examine its applicative scope in the field of care relationship. The second part will analyse the regulatory solutions adopted at the national level, comparing the French and Italian normative approaches and the specific provision adopted to define doctors’ duties and patients’ rights. Finally, the paper will discuss the integration of various regulatory levels examined to establish a comprehensive regulatory framework for the use of AI in the doctor-patient relationship
Consenso (a fasi progressive), interesse pubblico per l’IA, opt-out per l’uso secondario: le nuove regole per la ricerca scientifica sui dati sanitari
No full textThis paper contributes to the debate on European and Italian regulations, both de iure condito and de iure condendo, regarding the construction of subjective legal positions, the balancing of legally relevant interests (both private and public), and the allocation of risks associated with scientific research on health data. The analysis focuses on the following rules: Article 110 of the Italian Data Protection Code, recently amended; Article 8 of the proposed Italian AI Law; and Article 71 EHDS, which introduces the right to opt-out for secondary use. These pages explore their impact on scientific research, highlighting the shortcomings of consent and the risk of regulatory fragmentation.Queste pagine intendono contribuire al dibattito sulle regole europee e nazionali, de iure condito e condendo, relative alla costruzione di situazioni giuridiche soggettive, alla composizione degli interessi giuridicamente rilevanti (privati e pubblici), all’allocazione dei rischi connessi all’attività di ricerca scientifica sui dati sanitari. L’analisi si concentra sulle seguenti fonti: l’art. 110 del Codice in materia di protezione dei dati personali, recentemente riformato; l’art. 8 del disegno di legge sull’IA; l’art. 71 dell’EHDS, che ha introdotto il diritto di esclusione per l’uso secondario. Il lavoro esamina l’impatto delle nuove regole sulla ricerca scientifica, evidenziando i limiti del consenso e il rischio di frammentazione normativa
I trapianti d’organo del futuro: potenzialità e limiti degli xenotrapianti
No full textXenotransplantation from genetically modified animals to humans holds the promise of revolutionise transplantation medicine, addressing the chronic shortage of human organs. Despite the extraordinary results achieved in recent years, many scientific still remain, both scientifically and from an ethical-regulatory point of view. In particular, this paper focuses on the issue of animal testing in the field of xenotransplantation research and, more specifically, on the contradictions between the Italian legislation (Legislative Decree no. 26/2013) and the European Directive 2010/63/EU, which risk hampering scientific and medical progress.Gli xenotrapianti da animali geneticamente modificati all’uomo promettono di rivoluzionare la medicina dei trapianti e di porre rimedio alla cronica carenza di organi umani. Nonostante gli straordinari risultati raggiunti negli ultimi anni, restano numerose sfide da affrontare, sia dal punto di vista scientifico che sotto il profilo etico-normativo. In particolare, il presente contributo si concentra sul delicato tema della sperimentazione animale nell’ambito della ricerca sugli xenotrapianti e, nello specifico, sulle contraddizioni esistenti tra la normativa italiana (D.Lgs. n. 26/2013) e la Direttiva europea 2010/63/UE, che rischiano di frenare il progresso scientifico e medico
Identità di genere e genitorialità: un binomio da (ri)costruire
No full textThe paper aims to investigate, using a comparative methodological approach, the ongoing relationship between the legal recognition of gender identity and the legal recognition of parenthood. The purpose of the paper is twofold: first, to highlight the points of intersection between these two forms of legal recognition, and second, to examine the most relevant legal issues that arise from these points of contact.Il presente contributo mira ad indagare, con metodologia comparata, il rapporto sussistente tra riconoscimento giuridico dell’identità di genere e riconoscimento giuridico della genitorialità. Lo scopo del paper è quello di cogliere i punti di intersezione tra le due dinamiche di riconoscimento considerate e osservare le più rilevanti questioni giuridiche che da tali punti di contatto emergono
Advanced Euthanasia Directives. From the «Koffie» judgment to the need for euthanasia beyond reasonable doubt
No full textWhile the ethical legitimacy of euthanasia and assisted suicide is still being debated in Italy and France, in some Northern European countries euthanasia is legitimately carried out on incompetent patients suffering from mental illness, even against their actual will, on the basis of an advanced euthanasia directive. Based on the well-known Dutch "Koffie" case and the principles affirmed by the United Nations Convention on the Rights of Persons with Disabilities, this paper will attempt to review the ethical legitimacy of the practice of anticipated termination of life performed on patients incapable due to mental illness, even against their will, on the basis of advanced euthanasia directives, arguing that in certain cases the performance of euthanasia should be subject to a precautionary principle, such that it is granted only beyond reasonable doubt and that the need for consent is stressed at least until the last moment of life.While the ethical legitimacy of euthanasia and assisted suicide is still being debated in Italy and France, in some Northern European countries euthanasia is legitimately carried out on incompetent patients suffering from mental illness, even against their actual will, on the basis of an advanced euthanasia directive. Based on the well-known Dutch “Koffie” case and the principles affirmed by the United Nations Convention on the Rights of Persons with Disabilities, this paper will attempt to review the ethical legitimacy of the practice of anticipated termination of life performed on patients incapable due to mental illness, even against their will, on the basis of advanced euthanasia directives, arguing that in certain cases the performance of euthanasia should be subject to a precautionary principle, such that it is granted only beyond reasonable doubt and that the need for consent is stressed at least until the last moment of life
Interdisciplinarità e comparazione: dieci anni con la Rivista di BioDiritto
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La Dichiarazione di Helsinki 2024: gli aggiornamenti dell’etica della ricerca biomedica
No full textThe 2024 update of the Declaration of Helsinki reflects the profound social, technological, and cultural changes that have occurred in recent decades and introduces significant innovations. Among the main updates is the shift from research “on” subjects to research “with” participants, who are now regarded as active agents and co-creators of the scientific process. The dimension of public health and community involvement is emphasized, even in intercultural contexts. Informed consent is redefined as “free” and “communicated,” based on clear and bidirectional interaction. The concept of risks and benefits is broadened to include psychosocial aspects and collective well-being. The notion of vulnerability is redefined, shifting from fixed categories to contextual factors and emphasizing inclusivity. Scientific integrity, data protection, and fair distribution of benefits become central elements. The document reaffirms the importance of ethics committees, equity in access, and transparency, outlining a vision of research that is increasingly inclusive, responsible, and grounded in respect for human dignity.L’aggiornamento del 2024 della Dichiarazione di Helsinki riflette i profondi cambiamenti sociali, tecnologici e culturali avvenuti negli ultimi decenni e introduce importanti novità. Tra i principali aggiornamenti si evidenzia il passaggio da una ricerca “sui” soggetti a una ricerca “con” i partecipanti, considerati attori attivi e co-creatori del percorso scientifico; viene valorizzata la dimensione della salute pubblica e il coinvolgimento delle comunità, anche in contesti interculturali; il consenso informato viene ridefinito come “libero” e “comunicato”, basato su un’interazione chiara e bidirezionale; si amplia la concezione di rischi e benefici, includendo aspetti psico-sociali e di benessere collettivo; si riformula il concetto di vulnerabilità, passando dalle categorie ai contesti ed evidenziando l’inclusività; l’integrità scientifica, la protezione dei dati e la giusta distribuzione dei benefici diventano elementi centrali. Il documento riafferma l’importanza dei comitati etici, dell’equità nell’accesso e della trasparenza, delineando una visione della ricerca sempre più inclusiva, responsabile e orientata al rispetto della dignità umana