ТРАНСГРАНИЧНИЯТ ДОСТЪП ДО ЗДРАВНИ ДАННИ – РЕГУЛАТОРНА РАМКА И НОРМАТИВНИ РЕФЛЕКСИИ
CROSS-BORDER ACCESS TO HEALTH DATA – REGULATORY FRAMEWORK AND REGULATORY REFLEDTIONS

Author(s): Galina Yolova-Paskaleva
Subject(s): Economy, Sociology, Health and medicine and law, ICT Information and Communications Technologies
Published by: Икономически университет - Варна
Keywords: e-health; European Health Data Space; the reuse of health data
Summary/Abstract: The report analyzes the regulatory mechanism for secondary processing and cross-border access to health data in the context of Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847. By clarifying the main trends and directions of establishment and development, the framework for the secondary use of health data is outlined in the specifics of the introduced basic instrumental concepts and institutions, and the regulatory mechanisms for data exchange are summarized in a systematic order the regulatory mechanisms for data exchange in terms of their admissibility, scope of application and processing, competent entities, objectives and policies for use and exchange. At the research level, some more characteristic conclusions are summarized regarding the specifics and trends in establishing the mechanisms for the secondary use of health data and their related reflection on certain commitments of national legislation.

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