Ricerca e Spazio Europeo dei Dati Sanitari tra regole proprietarie e apertura

21.12.2025

R. Caso, P. Guarda, Ricerca e Spazio Europeo dei Dati Sanitari tra regole proprietarie e apertura, in Accademia -Rivista dell’Associazione Civilisti Italiani, nr. 9 Settembre/Dicembre 2025, 837-850, https://zenodo.org/records/18253933

Abstract

Il saggio esamina il Regolamento sullo Spazio Europeo dei Dati Sanitari (EHDS) nel contesto della tensione tra l’apertura dei dati per la ricerca scientifica e la pseudo-proprietà intellettuale (segreto commerciale, diritto sui generis delle banche dati, tutela delle misure tecnologiche di protezione) che mira a controllare i dati e le informazioni. L’EHDS cerca di bilanciare esclusiva e apertura a!raverso l’art. 52, ma ha sollevato critiche soprattutto per il rischio di “over-claiming” della protezione da parte dei titolari. Nonostante le sfide e l’effetto “nebbia” creato dalla “European Data Strategy”, l’approccio settoriale specifico dell’EHDS è visto con un cauto o!imismo.

The paper examines the European Health Data Space Regulation in the context of the tension between data openness for scientific research and the pseudo-intellectual property (trade secret, database sui generis right, legal protection of Technological Protection Measures) that aims to control data and information. The EHDS seeks to balance exclusive and access through Art. 52, but it has raised criticisms, especially regarding the risk of “over- claiming” of protection by data holders. Despite the challenges and the “fog” effect created by the “European Data Strategy”, the EHDS’s specific sector-based approach is viewed with cautious optimism.

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