Are EU member states ready for the European Health Data Space? Lessons learnt on the secondary use of health data...

The proposal for a regulation on the European Health Data Space (EHDS) contains provisions that would significantly change health data management systems in European member states (MS). This article presents results of a country mapping exercise conducted during the Joint Action 'Towards the European Health Data Space' (TEHDAS) in 2022. It presents the state-of-play of health data management systems in 12 MS and their preparedness to comply with the EHDS provisions. The country mapping exercise consisted of virtual or face-to-face semi-structured interviews to a selection of key stakeholders of the health information systems. A semi-quantitative analysis of the reports was conducted and is presented here, focusing on key aspects related to the user journey through the EHDS. This article reveals a heterogenous picture in countries' readiness to comply with the EHDS provisions. There is a need to improve digitalization and quality of health data at source across most countries. Less than half of the countries visited have or are developing a national datasets catalogue. Although the process to access health data varies, researchers can analyse health data in secure processing environments in all countries visited. Most of the countries use a unique personal identifier for health to facilitate data linkage. The study concluded that the current landscape is heterogeneous, and no member state is fully ready yet to comply with the future regulation. However, there is general political will and ongoing efforts to align health data management systems with the provisions in the EHDS legislative proposal.