Member states’ readiness to benefit from the EHDS regulation varies
EU member states support the cross-border use of health data for research and policymaking. But legal barriers and difficulties in data access have led to the underuse of data sources and repositories. Member states vary widely in how they organise and manage health data, as well as in their preparedness to facilitate the secondary use of health data as part of the future EHDS.
A new report of the joint action Towards the European Health Data Space (TEHDAS) summarises the results of 12 country visits carried out under the project. The report finds that EU member states have the political will to join the European health data space (EHDS). However, there are some concerns among countries, for instance on their capacity to join the EHDS. All countries agree that there will be a significant need for more staff with technical and legal expertise and more time to support the activities envisioned by the EHDS.
Member states welcome the benefits of the European health data space (EHDS) in enabling the cross-border use of health data for secondary purposes such as research, innovation and policymaking. They expect the EHDS to lead to increased joint European research for better health across Europe.
The report provides an overview of the health data management system of 12 member states, their political will and technical preparedness to join the European health data space (EHDS). This overview is crucial to building a sustainable and pragmatic EHDS. Health data management includes how health data from different sources is collected, stored, accessed, shared and (re)used and the governance and legal aspects of data management.
Maturity to implement EHDS is multi-dimensional
The report highlights the diversity of the member states’ health data management procedures. In most countries data management is organised among various stakeholders while only a few countries have centralised organisation. Although the EHDS plans to harmonise the secondary use of health data by creating a common legal framework, the visits clearly indicate that all member states have steps to take to meet the EHDS requirements.
Each country will need its own roadmap to achieve the steps. Many countries expressed a need for additional human and financial resources. TEHDAS will deliver recommendations on EHDS sustainability in spring 2023.
Legal barriers hinder the use of data repositories
Many countries also reported legal barriers as the main obstacles to the secondary use of health data. Currently, countries and even organisations in the same country interpret the General Data Protection Regulation (GDPR) differently. Most do not have specific national legislation for the secondary use of health data. TEHDAS has previously identified options to overcome data barriers.
Most of the countries visited have rich data repositories. However, the countries reported that researchers and policymakers experience challenges in accessing data from different repositories due to diverse, lengthy and sometimes nontransparent access procedures.
TEHDAS visited the countries in 2021–2022. The visits included interviews with national health data stakeholders, using a tool developed to map the countries’ health data management systems and preparedness for the EHDS. This TEHDAS mapping tool can be used in the future for similar mapping exercises and is found in the report. A factsheet on each country visited was also created.
The report has been approved by the project steering group. The European Commission gives final approval to all joint action’s deliverables.