The EHDS regulation inevitably contained some blind spots in the face of the complexity of Europe’s healthcare delivery. These blind spots are now emerging and causing pain points for implementers. This EHTEL Symposium session featured perspectives from healthcare providers, industry and Member States, and discussed policy recommendations to ensure a successful EHDS implementation.

An EHTEL working paper entitled "The EHDS regulation of EHR systems: Blind spots and pain points, and how to address them" lay at the heart of this session. If you haven't yet read it, download it now.

Panellists

Moderator: Lars Hulbaek, MedCom, Denmark

Building a bridge with the morning’s plenary session, Lars asked how to realise the dream of the EHDS. He then welcomed the panel and speakers. After introducing Denmark’s MedCom, he announced the country’s plans for the establishment of Digital Health Denmark. This new organisation will strengthen digital development in healthcare.

Mariam Shokralla, HIMSS, The Netherlands

Mariam outlined the gap between the EHDS regulation and reality in terms of electronic health record systems (EHR systems), and the challenges that many healthcare providers – especially hospitals – are facing today. She differentiated between electronic medical records, personal health records, and EHRs. She emphasised the trend towards merging/sharing different types of healthcare data. In her opinion, implementation of the EHDS could be “a long journey”. Hence, her major concluding messages were around “align now, deliver better, decide now, and execute faster”. She finally highlighted the importance of two of the EHTEL working paper’s recommendations for the future implementation of the EHDS regulation.

Dr. Jörg Köpke, CompuGroup Medical (CGM), Germany

Jörg introduced CGM as a leading European eHealth company, still family-owned. He highlighted a number of Europe’s strengths e.g., spotting potential turning points, and developing inventions. But, “Europe must not just own the data – Europe must use it.” He therefore described health data as a strategic resource. He outlined at least four different pain points for industry in the EHDS regulation, and offered examples of what other countries (e.g., Singapore) do, and what needs to be done in relation to patients with rare conditions. For industry it is vitally important to clarify the scope of the definition of EHR systems in the EHDS regulation.

Dr. Juha Mykkänen, Finnish Institute for Health and Welfare (THL), Finland

Juha offered a national viewpoint, and discussed Finland’s experience with health data and its history of EHR systems regulation. Among his messages: in 2026 the national EHR infrastructure, Kanta’s services, will expand to include social welfare data. Useful viewpoints have been published by the Nordic Council of Ministers on support for healthcare professionals’ work and data quality. On practicalities: “EHR systems are not stand-alone.” “There is no single EHR system that does all [everything].”“It’s impossible to upgrade all at once!” “The devil is in the detail.” And, lastly, must-haves include international collaboration; refinement of national initiatives; and the use/re-use of systems and infrastructures already in existence.

Discussions

Throughout the session, discussions returned to the EHTEL EHDS implementers’ task force working paper on "The EHDS regulation of EHR systems: Blind spots and pain points, and how to address them". Attendees had been encouraged to read this Working Paper and its details ahead of the Symposium.

Specific questions posed by audience members related to:

• The breadth of other types of data (besides health data) that are likely to be used in conjunction with EHR systems.
• Solutions regarding the use of pseudonymised data.
• Precisely how standards and specifications related to different types of data (e.g., logical models; technical standards) should be governed and updated.

Short polls shared with attendees showed overall support for these four recommendations:

✅ Clarify the scope of EHR systems.

✅ Relax European Electronic Health Record exchange Format (EEHRxF – “the format”) compliance timelines for some types of EHR systems.

✅ Organise appropriate governance and processes for updating of the EEHRxF.

✅ Integrate EHDS governance and EEHRxF governance.

There was a variety of views expressed, however, on compliance timelines, including a concern about any further complacency or relaxation (especially on the part of vendors). Suggestions were made to work both on EHRs at a European level as well as in hospitals specifically; and to focus compliance on already-existing (country) roadmaps.

In conclusion

The session covered several key issues. They included: coverage of both large and small-scale information technology systems; standards and their governance; which organisations/entities have expertise in EHR systems (e.g., HL7, Integrating the Healthcare Enterprise); the use of “logic models” (theories of change); and the use of appropriate use cases.

Look out for more news in the short-term future on the work of EHTEL’s EHDS Implementers’ Task Force.