In recent years, the European Union has been heavily impacted by the increasing costs of the healthcare systems: data-driven health research could play a major role in such a framework. This chapter aims at presenting the legal framework and the initiatives currently implemented for the secondary use of health data. The European Commission has defined a strategy that aims at supporting the exploitation of data while ensuring the fundamental rights of citizens, and it is working on the definition of a legislative framework allowing the secondary use of data. The reference point related to the processing of personal data is the General Data Protection Regulation (GDPR) that defines the main fundamental principles to be complied with and the Data Governance Act proposal, which aims at enabling the safe reuse of certain categories of public-sector data subject to the rights of others, such as data concerning health. However, the proposal compliance with the GDPR has been questioned by the European Data Protection Board and Secretariat. Within the healthcare sector, initiatives were developed to boost the secondary use of data. Some of these are led by the policymakers, such as the European Health Data Space, while others have emerged from the civil society and leverage on the concepts of data donation and data altruism. Still, the application of both these concepts raises legal uncertainty: therefore, it is crucial to guarantee a legislative framework that supports the positive exploitation of data.

An Overview of the Secondary Use of Health Data Within the European Union: EU-Driven Possibilities and Civil Society Initiatives

Sara Testa
2022

Abstract

In recent years, the European Union has been heavily impacted by the increasing costs of the healthcare systems: data-driven health research could play a major role in such a framework. This chapter aims at presenting the legal framework and the initiatives currently implemented for the secondary use of health data. The European Commission has defined a strategy that aims at supporting the exploitation of data while ensuring the fundamental rights of citizens, and it is working on the definition of a legislative framework allowing the secondary use of data. The reference point related to the processing of personal data is the General Data Protection Regulation (GDPR) that defines the main fundamental principles to be complied with and the Data Governance Act proposal, which aims at enabling the safe reuse of certain categories of public-sector data subject to the rights of others, such as data concerning health. However, the proposal compliance with the GDPR has been questioned by the European Data Protection Board and Secretariat. Within the healthcare sector, initiatives were developed to boost the secondary use of data. Some of these are led by the policymakers, such as the European Health Data Space, while others have emerged from the civil society and leverage on the concepts of data donation and data altruism. Still, the application of both these concepts raises legal uncertainty: therefore, it is crucial to guarantee a legislative framework that supports the positive exploitation of data.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11582/334367
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