Η συγκρότηση του Ευρωπαϊκού Χώρου Δεδομένων Υγείας (Πρόταση Κανονισμού για τον Ευρωπαϊκό Χώρο Δεδομένων Υγείας) : η ανάπτυξη της ιατρικής ακριβείας & η προστασία των δεδομένων υγείας

Πάντου, Δανάη

The introduction of a European Health Data Space (Proposal for a Regulation of the European Parliament and of the Council on the European Health Data Space – COM/2022/197 final 17) : the development of precision medicine & the protection of health data

Master Thesis

Author

Πάντου, Δανάη

Date

2024-07

Abstract

This Master’s thesis is on the Proposal for a Regulation on the European Health Data Space and in particular the new rules on the secondary use of health data for research purposes. It explores the potential impact of this Regulation on the development of scientific research on the one hand and on the rights of patients on the other hand. The thesis highlights precision medicine as the most prominent example of secondary use of health data. At the same time, the paper mentions the definition of health data and genetic data, highlighting their constitutional dimension while drawing attention to the challenges of establishing a digital health ecosystem. The second chapter delves into privacy issues arising from the secondary use of health data, with an emphasis on the scope of consent. It also highlights the challenges of balancing patient privacy on the one hand and the fostering of medical research on the other. The third chapter reviews the European regulatory framework of eHealth, identifying long-standing loopholes and pathogens, which the EU aims to overcome by establishing a healthcare ecosystem with common rules and governance standards, as outlined in the Proposal for a Regulation on the European Health Data Space. The fourth chapter analyses the new model of health data governance and attempts to answer whether the creation of a European Health Data Space can promote the secondary use of health data without compromising the rights of data subjects. At the same time, a critical review of the new regulatory framework for secondary use of health data is attempted, with a focus on bioethical issues. A persistent question of this paper is if the establishment of the European Health Area will improve access to health data in order to enhance research without undermining the protection of human dignity and privacy.

Postgraduate Studies Programme

Δίκαιο και Τεχνολογίες Πληροφορικής και Επικοινωνιών (MSc in Law and Information and Communication Technologies)

Department

Σχολή Τεχνολογιών Πληροφορικής και Επικοινωνιών. Τμήμα Ψηφιακών Συστημάτων

Number of pages

124

Language

Greek

URI

https://dione.lib.unipi.gr/xmlui/handle/unipi/17275
http://dx.doi.org/10.26267/unipi_dione/4698

Collections

Τμήμα Ψηφιακών Συστημάτων

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Except where otherwise noted, this item's license is described as
Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ελλάδα