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Last week, the EU Parliament and Council agreed on a draft regulation for the "European Health Data Space" (EHDS). The EHDS enables the storage of health data of the EU's 450 million citizens. The primary goal is to facilitate cross-border transfer of health data, both for primary and secondary use. Primary data refers to patient data used for treatment and patient care purposes. Within the scope of secondary use, data can be used for research purposes. Given that health data constitutes particularly sensitive categories of data, requirements for data protection and security must be exceptionally high. With the EHDS, the EU aims to provide access to health data for research purposes while maintaining a high level of data protection and security. This may include granting patients the right to object to the use of their data (opt-out).
Furthermore, if third parties access patient data, there is an obligation to inform patients. It is prohibited to use sensitive data for advertising purposes or similar commercial uses such as insurance scoring. Exceptions are also provided for the secondary use of patient data, and patients can object to the use of their health data for research purposes.
NFDI4Health welcomes the agreement on the EHDS at the European level, as the current initiative strikes an appropriate balance between protecting sensitive patient data on the one hand and the public interest in using such data for scientific purposes on the other. In particular, the opt-out procedure and information obligations comply with the principles of the EU General Data Protection Regulation.
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For further information, please refer to the official press releases of the European Council and the European Commission.
