Ethical and social reflections on the proposed European Health Data Space

Ethical and social reflections on the proposed European Health Data Space

2024 | Ciara Staunton, Mahsa Shabani, Deborah Mascalconi, Signe Mezinska, Santa Slokenberga
The article discusses the ethical and social implications of the proposed European Health Data Space (EHDS), a regulatory framework aiming to facilitate the secondary use of electronic health data across the European Union. The EHDS seeks to address legal complexities arising from the fragmented application of the General Data Protection Regulation (GDPR) and to enable data sharing for purposes such as research, innovation, and public health. However, the proposed framework raises concerns about ethical principles, including the protection of individual rights, autonomy, and the prevention of discrimination and stigmatization. The article critiques the EHDS for not adequately addressing ethical, legal, and social issues (ELSI) in data sharing, particularly in relation to the right to autonomy, the need for ethical oversight, and the potential for data misuse. It highlights the importance of ensuring that data sharing aligns with societal expectations and that individuals have control over their data. The article also emphasizes the need for a balanced approach that considers both data protection and the broader ethical implications of data use. Recommendations include the implementation of ethical oversight mechanisms, the development of dynamic consent processes, and the inclusion of mechanisms for individuals to opt-out of data sharing. The article calls for a revised EHDS that ensures ethical principles are upheld and that data sharing is conducted in a manner that maintains public trust and social licence.The article discusses the ethical and social implications of the proposed European Health Data Space (EHDS), a regulatory framework aiming to facilitate the secondary use of electronic health data across the European Union. The EHDS seeks to address legal complexities arising from the fragmented application of the General Data Protection Regulation (GDPR) and to enable data sharing for purposes such as research, innovation, and public health. However, the proposed framework raises concerns about ethical principles, including the protection of individual rights, autonomy, and the prevention of discrimination and stigmatization. The article critiques the EHDS for not adequately addressing ethical, legal, and social issues (ELSI) in data sharing, particularly in relation to the right to autonomy, the need for ethical oversight, and the potential for data misuse. It highlights the importance of ensuring that data sharing aligns with societal expectations and that individuals have control over their data. The article also emphasizes the need for a balanced approach that considers both data protection and the broader ethical implications of data use. Recommendations include the implementation of ethical oversight mechanisms, the development of dynamic consent processes, and the inclusion of mechanisms for individuals to opt-out of data sharing. The article calls for a revised EHDS that ensures ethical principles are upheld and that data sharing is conducted in a manner that maintains public trust and social licence.
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