European Parliament and Council reach deal on European Health Data Space

European Health Data Space

(19 March 2024) Negotiators from the European Parliament and Council of the European Union reached a provisional deal on the European Health Data Space in the early hours of Friday, 15 March 2024.

The agreed text says that citizens have a right to opt out of sharing their data for secondary use. However, this right can be overridden if a public health body, Union institution or office requests data for “scientific research for important public interest.” While any form of consent mechanism is an improvement on the initial proposal from the European Commission – which lacked any kind of consent mechanism for the sharing of data for secondary uses – the Member State override of the opt-out is very broad. It runs the risk of uneven implementation of the agreement across Europe.

Beyond the broad Member State override provision, which could lead to uneven implementation, the text does not address the significant differences in digitalisation capabilities among European countries and regions. Moreover, it fails to acknowledge the challenges posed by inadequate funding and staffing shortages, which could seriously impede the initiative's implementation. Neither does the agreement rule out the risk of major tech companies controlling the necessary infrastructure.

As the file moves towards a final vote in the European Parliament in late April, EPSU urges policymakers to keep in mind the best interests of both the patients and healthcare workers who are essential to the success of any European Health Data Space.

Read EPSU’s position on the European Health Data Space here.

Read EPSU’s reaction to the European Parliament’s position on the European Health Data Space here.

Read EPSU’s reaction to the Council of the EU position here