This article examines the role of trade secrets within the European Health Data Space Regulation (EHDS), focusing on the tension between the secondary use of electronic health data and the protection of commercially valuable information. The EHDS is the first major sector-specific test of the European Data Strategy in the health sector. It promises to make health data available for research, innovation, policy-making, regulatory activities and the development and evaluation of AI systems. Yet this promise depends on the capacity of the legal framework to manage interests that do not naturally point in the same direction. The article argues that Article 52 EHDS is the key provision for governing this conflict. It does not treat intellectual property rights, trade secrets or regulatory data protection as automatic vetoes against access. Rather, it requires protected electronic health data to be made available for secondary use while entrusting Health Data Access Bodies with the task of adopting specific, appropriate and proportionate preservation measures. In this sense, Article 52 proceduralises the conflict between openness and secrecy. The article identifies three implementation risks: overclaiming by data holders, uneven institutional expertise and fragmentation across Member States. It then situates the EHDS within the broader EU data law framework and uses legal interoperability, comparative approach and interdisciplinarity as tools for moving from regulatory narratives to operational governance. The article concludes that the success of the EHDS will depend on making secrecy governable without allowing secrecy to govern the data space.
The strange case of health data sharing: trade secrets and the European Health Data Space / Guarda, P.. - In: OPINIO JURIS IN COMPARATIONE. - ISSN 2281-5147. - ELETTRONICO. - 2026:1(2026), pp. 1-22.
The strange case of health data sharing: trade secrets and the European Health Data Space
Guarda, Paolo
2026-01-01
Abstract
This article examines the role of trade secrets within the European Health Data Space Regulation (EHDS), focusing on the tension between the secondary use of electronic health data and the protection of commercially valuable information. The EHDS is the first major sector-specific test of the European Data Strategy in the health sector. It promises to make health data available for research, innovation, policy-making, regulatory activities and the development and evaluation of AI systems. Yet this promise depends on the capacity of the legal framework to manage interests that do not naturally point in the same direction. The article argues that Article 52 EHDS is the key provision for governing this conflict. It does not treat intellectual property rights, trade secrets or regulatory data protection as automatic vetoes against access. Rather, it requires protected electronic health data to be made available for secondary use while entrusting Health Data Access Bodies with the task of adopting specific, appropriate and proportionate preservation measures. In this sense, Article 52 proceduralises the conflict between openness and secrecy. The article identifies three implementation risks: overclaiming by data holders, uneven institutional expertise and fragmentation across Member States. It then situates the EHDS within the broader EU data law framework and uses legal interoperability, comparative approach and interdisciplinarity as tools for moving from regulatory narratives to operational governance. The article concludes that the success of the EHDS will depend on making secrecy governable without allowing secrecy to govern the data space.| File | Dimensione | Formato | |
|---|---|---|---|
|
Opinio_Guarda_Online-first_1-2026.pdf
accesso aperto
Descrizione: PDF online-first
Tipologia:
Versione editoriale (Publisher’s layout)
Licenza:
Creative commons
Dimensione
427.29 kB
Formato
Adobe PDF
|
427.29 kB | Adobe PDF | Visualizza/Apri |
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione



