EHDS: The Real Challenge Has Just Begun

Following the European Parliament's vote in favor of the European Health Data Space (EHDS), EU member states are now considering how to implement this ambitious initiative. At the HIMSS Europe 2024 conference (Rome, 29-31 May), representatives from health ministries, businesses, academic institutions, and patient organizations outlined several critical steps for moving forward.

European Health Data Space

The EHDS introduces new rules for the primary and secondary use of health data. First, patient data will be more accessible across the EU, allowing doctors abroad to access a summarized electronic patient record (Patient Summary). Second, anonymized data will be readily available for scientific research, the development of new drugs and innovations, and health policymaking.

Advocates of the EHDS emphasize that it will benefit everyone. Isabelle Zablit-Schmitz (Director of Europe and International at the Ministerial Delegation for Digital Health, Ministry of Prevention and Health, France) calls EHDS a""win-win-wi"" situation. Patients will receive evidence-based diagnosis and treatment regardless of where they are in the EU. Doctors will gain access to critical data, enabling better decision-making (thereby increasing patient safety). The health systems, as well as innovators, will acquire data for developing new data-based and AI-driven solutions or speed up the development of new medicines.

The newly passed law provides a solid foundation for a new infrastructure to share and process medical data. Regulators alse that the EHDS will ensure EuropEurope'stal sovereignty, reducing dependence on data from other regions. The EHDS regulations will take effect in two years,completeh full implementation expected tfour toour and ten years.

Implementation Challenges

At HIMSS Europe 2024, representatives from the health ministries of the Netherlands, France, and Italy expressed concerns about the implementation challenges. They noted that the EHDS is not only a technical challenge but also a structural and organizational one. Key issues include:

• Healthcare data is fragmented due to heterogeneous health systems. For instance, central e-health platforms often do not receive data from the private sector, and some countries have highly regionalized health systems;
• Low data quality due to a lack of standards and guidelines (interoperability);
• Siloed data and skepticism about sharing data within the medical community (a long-term side effect of the GDPR);
• High regional gaps in the development of data-sharing infrastructure.
• Changing patients' patients'ef that their data should only be shared with explicit consent after years of such practices (EHDS introduces an "opt-out" ap"roach);
• Lack of guidelines for EHDS implementation;
• Complex healthcare legislation;
• Significant shortcomings in data security in healthcare.

Implementation Priorities

During the HIMSS Europe conference, experts highlighted several priorities for EHDS implementation, including capacity building, investing in data exchange infrastructure, strengthening public trust in data design and processing, and changing the healthcare work culture. The most immediate priority is to begin working on the EHDS at the national level, as full implementation will be a long and bumpy journey.

The eHealth Network, a European cooperation network for healthcare digitizatirently developing guidelines for the EHDS. Hela Ghariani (co-head of the Digital Health Delegation, Ministry of Social Affairs and Health, France, and co-chair of the EU eHealth Network) emphasized that implementing the EHDS requires five key elements:

1. Examine the impact of the EHDS at legal, financial, and organizational levels.
2. Prepare a national investment plan.
3. Build trust among citizens.
4. Convince healthcare organizations of the benefits of data sharing.
5. Engage in European initiat are already part of the EHDS, such as MyHealth@EU and TEHDAS.

Things that can go wrong

However, the ambitious and necessary project of EHDS can falter over nuances. For example, some countries may impose stricter regulations on processing sensitive data, such as genetic information. Although anonymized patient data can be used by default for secondary purposes on an "opt-out" basis, patients - the no trust w"

ll be b"ilt - can start to restrict their data. Anti-data sharing campaigns may arise, leading to significant numbers of people opting out, potentially jeopardizing the project.

Besides, the member countries have a substantial degree of control over EHDS data processing. If each country introduces its own rules, the success of the EHDS could be at risk.

As the EHDS progresses from concept to reality, the collaboration and commitment of all stakeholders within EU healthcare ecosystem will be crucial to navigate these challenges and achieve the vision of a cohesive European health data space.

Rome wasn't built in a day, but the Great Fire destroyed the city in a day. This time, the biggest danger could be a lack of trust.