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Unpacking B2G data sharing mechanism under the EU data act
No full textThe paper proposes an analysis of the business-to-government (B2G) data sharing mechanism envisaged by the Regulation EU 2023/2854, the so-called Data Act. The Regulation, in force since 11 January 2024, will be applicable from 12 September 2025, requiring the actors involved to put in place a compliance process. The focus of the paper is to present an assessment of the mechanism foreseen by the EU legislators, with the intention of highlighting two bottlenecks, represented by: (i) the flexibility of the definition of “exceptional need”, “public emergency” and “public interest”; (ii) the cumbersome procedure for data holders. The paper discusses the role that could be played by in-house data stewardship structures as a particularly beneficial contact point for complying with B2G data sharing requirements.The paper proposes an analysis of the business-to-government (B2G) data sharing mechanism envisaged by the Regulation EU 2023/2854, the so-called Data Act. The Regulation, in force since 11 January 2024, will be applicable from 12 September 2025, requiring the actors involved to put in place a compliance process. The focus of the paper is to present an assessment of the mechanism foreseen by the EU legislators, with the intention of highlighting two bottlenecks, represented by: (i) the flexibility of the definition of “exceptional need”, “public emergency” and “public interest”; (ii) the cumbersome procedure for data holders. The paper discusses the role that could be played by in-house data stewardship structures as a particularly beneficial contact point for complying with B2G data sharing requirements
Linee guida, intelligenza artificiale e medicina. Riflessioni sintetiche
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L’uso di sistemi di IA in ambito medico: qualche strategia per un’amministrazione sanitaria compliant con le regole europee e capace di affrontare la sfida
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I CPR come “nonluoghi” della marginalità e della crisi costituzionale
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La tutela della salute mentale nei Centri di permanenza per i rimpatri
No full textAfter an overview of the right to mental health within the Italian legal system, the focus shifts to the protection of the right to health for irregular immigrants. It highlights how, although specific regulations are in place to safeguard this right even for those without Italian citizenship, its actual implementation remains largely inadequate. This appears to stem both from legal uncertainties and from the practical management of this right by the competent authorities. The analysis then turns to the guarantees of the right to health within the Repatriation Detention Centers, emphasizing not only the frequent denial of this right, but also the use of sedation and other restrictive practices.Dopo una panoramica sul diritto alla salute mentale nell’ordinamento italiano, l’analisi si concentra sulla tutela del diritto alla salute degli immigrati irregolari, evidenziando come, sebbene siano in vigore normative specifiche per tutelare questo diritto anche per chi non ha cittadinanza italiana, la sua effettiva attuazione risulta ancora in larga parte insufficiente. Questo sembra derivare sia dalle incertezze normative, sia dalla garanzia in concreto del diritto alla salute da parte degli enti preposti. La riflessione si concentra quindi sulle garanzie del diritto alla salute all’interno dei Centri di permanenza per i rimpatri, sottolineando non solo la sua frequente negazione, ma anche il ricorso alla sedazione, ovvero a pratiche di tipo contenitivo
Limiti e opportunità dell’AI Act: due spunti di riflessione in tema di definizioni e approccio by design
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Ripensare l’evidenza: approccio multidisciplinare all’uso dei dati sintetici in ambito sanitario – Parte II
No full textThe essay examines the role of synthetic data in clinical trials and health technology assessment, highlighting its epistemological, legal, and ethical implications. Moving beyond the dichotomy between real and virtual data, it seeks to affirm the full scientific and regulatory legitimacy of synthesization as a generative operation of evidence. Rethinking evidence: a multidisciplinary approach to the use of synthetic data in healthcare – Part IIThrough a multidisciplinary approach and the analysis of a clinical case study, the essay underscores the need for new legal grammar capable of governing the ongoing transformation, combining technological innovation with the protection of fundamental rights and the systemic coherence of the legal order.Il saggio analizza il ruolo dei dati sintetici nella sperimentazione clinica e nella valutazione delle tecnologie sanitarie, mettendone in luce le implicazioni epistemologiche, giuridiche ed etiche. Superando la dicotomia tra dato reale e virtuale, si vuole sostenere la piena legittimità scientifica e regolatoria della sintetizzazione come operazione generativa di evidenza. Attraverso un approccio multidisciplinare e l’analisi di un caso studio clinico, si evidenzia la necessità di una nuova grammatica giuridica capace di governare la trasformazione in atto, coniugando l’innovazione tecnologica con la tutela dei diritti fondamentali e la coerenza sistemica dell’ordinamento
GPAI e AI Act: tra innovazione regolatoria e fragilità applicative
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Introduction
Get PDFIntroduction to the issue “Italianicity is not Italy”. Questioning Contemporary Italian Art History.Introduzione al fascicolo “Italianicity is not Italy”. Questioning Contemporary Italian Art History
Linee di scritture e di orizzonti
No full textNell’editoriale si introduce al tema del nuovo numero di Digiti e si presentano i contributi