Committee vote on EHDS expected in September

The European Health Data Space (EHDS) took centre stage on Thursday, June 29, as experts and stakeholders gathered to discuss one of the most ambitious and debated files currently under Parliament and Council’s scrutiny. Organised by EY in cooperation with CEPS and UTOPIA, the event, titled “European Health Data Space – Balanced Interoperability for Innovative Healthcare,” delved into the strategies, challenges, and potential benefits associated with EHDS.

EHDS co-rapporteur Mr Tomislav Sokol said that the vote in both committees will probably take place in September, due to a large number of amendments and the technical nature of this legislative act: «The EHDS will create a new legal framework to access and share health data in Europe, allowing free movement and sharing of data between different Member States. Harmonised electronic health records will help deliver efficient healthcare across the EU and its citizens. At the same time, it will be highly beneficial for healthcare professionals to make their job more efficient».

MEP Sokol outlined the points of contention concerning the scope of EHDS. While there is a broad political consensus regarding the primary use of patient data, the secondary use of this data for research and industry purposes has sparked considerable debate, which will likely force Parliament Co-Rapporteurs to postpone the vote later than expected.

All participants were in agreement on the need for ambition with EHDS. Mr Martin Dorazil, Deputy Head of Unit Digital, EU4Health and Health Systems Modernization at European Commission DG SANTE, outlined the three main objectives of the proposal, which are empowering citizens to exercise control over their health data, unleashing the market potential of this data while ensuring a level playing field, and establishing a framework for the reuse of health data for purposes beyond specific health services, such as research. Dorazil however acknowledged the current challenges in accessing and utilizing health data for research and expressed the plan to provide support to Member States in establishing the necessary infrastructure.

«We truly believe that the legislative process can be concluded by the end of the mandate to make EHDS become a reality. It will put in place rules, common standards, and practices, as well as infrastructures and a governance framework for the use of electronic health data. Among other provisions, this proposal strengthens patients’ control over their data, promotes the reliability, security and interoperability of electronic health records and establishes rules as well as infrastructures for both primary and secondary use of health data», said Dorazil.

Participants discussed the introduction of new requirements regarding security and interoperability aimed to facilitate more efficient access to data while implementing safeguards to protect privacy. A proposed permit scheme would assess each application for data access, with data being provided in an anonymized format to prevent any compromise of personal information.

The issue of interoperability and compliance with other regulations, such as the data act and the pharma strategy, was also raised. EHDS aims to be interoperable with these regulations, ensuring harmonization while recognizing the diverse requirements of different countries. However, challenges remain, particularly in addressing the fragmentation of healthcare systems and the need for significant investments to modernize existing systems.

During the discussion, various speakers explored potential future situations involving new models and risks stemming from technological advancements and the implementation of the EHDS. Mr Florian Benthin, EU Institutions’ EY Digital Health Leader, highlighted the potential benefits of utilizing the infrastructure outlined in the recent EY study titled ‘How innovative infostructure can power the purpose of integrated care systems.’ He emphasized that adopting this infrastructure could help healthcare systems better prepare for future demands and integrate innovative solutions.

Ms Clara Leonard, Public Strategy Director at Doctolib, added her perspective on the EHDS initiative, where she sees a big challenge in the definition of new standards for Electronic Health Record (HER) systems, explaining that healthcare is a legacy market with big companies already having their own ideas. Citing the example of France, Ms Leonard explained that the proposal will reap little of the anticipated benefits unless obligations on healthcare workers to share such data are enforced.

«EHDS sets an ambitious framework for the use of electronic health data in the European Union. The main challenge remains how we will manage to generate usage from healthcare professionals and patients, by putting them at the centre of implementation modalities», concluded Leonard.

The debate comes at a time when the European Parliament and the Council are hosting lively debates on the scope and key provisions of EHDS, including the degree of decentralisation of the health data infrastructure, the level of mandatory interoperability of future health data, to be achieved i.e. through reliance on a single European or international health data standard (e.g. the Fast Healthcare Interoperability Resources), and amendments aimed at stronger privacy safeguards for data subjects. Following the dynamics of the ongoing discussion, many are eager to see when will the final agreement be reached.