TEHDAS convenes European ministries to discuss implementation of the European health data space
EU member states are preparing to realise the European health data space and are considering what measures will be needed and how to finance them.
TEHDAS hosted its fourth and final policy forum on 30 November, bringing together over 40 representatives of the ministries of health, research and finance from 19 European countries. They discussed the countries’ needs to create the European health data space (EHDS) for the secondary use of health data and how they plan to use EU funding to support the development of data management.
Countries willing to join the EHDS, more investment needed for implementation
In the discussion on national needs, Irene Kesisoglou from Sciensano presented the findings of 11 country visits that TEHDAS has carried out to collect an overview of the countries’ health data management systems. In general, countries are prepared to join the EHDS and welcome its potential and added value for research, policymaking and innovation. However, legal and technical challenges are noted across all countries.
Under the Commission’s proposal, each member state will create one or more health data access bodies to facilitate access to electronic health-related data. All the countries visited are exploring how they will do this, for instance by making use of existing organisations or establishing new ones. The countries also reported a need to invest in human resources and training to increase capacity for the EHDS.
“It is of utmost importance to have high quality structured data at the source and hence there is a need to improve health data literacy for healthcare providers,” said Kesisoglou.
The participants echoed the findings of the country visits. Whilst some countries already have well-developed systems for the secondary use of health data, there may be issues in adapting existing arrangements to match the requirements of the EHDS. The idea of virtual health data access bodies with functionalities split between different organisations was suggested.
Several participants expressed concerns that current funding will be insufficient, especially in terms of long-term sustainability and potential costs for data users, such as researchers and healthcare providers. TEHDAS will issue recommendations on the financial sustainability of the EHDS in spring 2023.
The importance of listening to the wider stakeholder community
All countries recognise the importance of engaging with stakeholders to facilitate the secondary use of health data through the EHDS. Some countries have already started such discussions across different ministries and with the wider stakeholder community. Ministry representatives noted that some key topics that have come up in these national-level stakeholder discussions included the importance of ensuring transparency to citizens. The research community also highlighted the importance of harmonising data and of improving its findability.
It was reported that, in contrast, some countries feel that it is too early to start such discussions, given that EHDS legislation has yet to be finalised.
Member states in support of the EHDS
Negotiations on the EHDS proposal are ongoing in the Council and European Parliament. Petr Čermák, of the Czech presidency to the EU Council, said that there is general support from the member states for the EHDS proposal. Thus far, the discussion has focused on the primary use of health data (chapters 2 and 3).
Some of the challenges identified in the negotiations include financial resources, countries’ administrative capacities to implement the EHDS and the feasibility of the timeline for doing so.
The EHDS proposal was one of the Czech presidency’s priority legislative files on health.
“This is a complex file that will significantly change the landscape of digital health because it introduces a mandatory framework for both primary and secondary use,” said Cermak.
The European Commission outlined several parallel activities to establish the EHDS. It has launched direct grants for member states to create health data access bodies. Other activities on the secondary use of health data include a follow-up joint action and a project on capacity building, both in 2024. A coordination and support action on the data quality and utility label for the EHDS will start in 2023.
Testing secondary use infrastructure
Mario Jendrossek (French Health Data Hub) presented the HealthData@EU pilot project, which started in October 2022. The project is testing the technical infrastructure for the secondary use of health data as presented in the EHDS proposal. It will take place in parallel to the legislative work to contribute to the negotiation process.
This was fourth and final policy forum organised by the TEHDAS Joint Action. “We established this forum to provide an arena for cross-sectoral and informal discussion between ministries to engage the member states and associated countries in shaping the European health data space. I want to thank all ministries for their active participation”, said Petronille Bogaert of Sciensano. Sciensano is the TEHDAS partner responsible for the event.
The policy forums are likely to be continued by the joint action starting in 2024. In the meantime, discussions are ongoing between European health projects to continue the forum in 2023.