The EHDS regulation of EHR systems – Blind spots and pain points – A review session
The EHDS regulation was published and went into force in March 2025. European Member States, industry, and stakeholders are beginning to align to a new world where the seamless exchange of health data will help advance healthcare delivery, research, and innovation. But healthcare is complex, and it is becoming clear that the legislative process behind the EHDS could have benefitted from more deliberation and perspectives given by healthcare providers, vendors, and innovators.
The EHTEL Task Force has been working on a working paper outlining how the EHDS, and especially the regulation of EHR systems, suffers from having several blind spots and pain points.
EHDS blind spots and pain points: By including almost all connected IT systems and medical technologies used in healthcare, in the scope of “EHR systems”, the EHDS does not consider sufficiently the complexity of healthcare delivery. The EHDS implementation timelines are ambitious, and they risk the stability of a sector that usually proceeds slowly and carefully. The process for developing interoperability specifications by regulatory fiat risks appropriate transparency, collaboration, and sustainability. The resulting pain points include widespread uncertainty not just for European manufacturers and innovators, but also for providers and the health systems in the Member States and regions.
This meeting of the Task Force will consider an internal draft version of a working paper entitled, "The EHDS regulation of EHR systems: Blind spots and pain points, and how to address them" for your review and feedback. As a result, through a structured and interactive discussion, EHTEL members will agree on a number of conclusions and EHTEL recommendations.
All EHTEL members are invited to review the current version of the working paper (provided to you by email) and offer your feedback.
Share your insights by taking the floor during the Task Force meeting: contact Maria Leeman, and schedule your intervention of 3-5 minutes.
Why offer your feedback:
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Influence EHDS implementation: Ensure real-world healthcare and innovation needs are reflected in how the regulation is applied.
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Bring practice to policy: Help correct gaps in how EHR systems and connected technologies are understood. Your input can make the eventual policy more realistic, sustainable, and workable.
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Protect stability and innovation: Flag risks that can arise from over-ambitious timelines and unclear requirements before they create uncertainty for implementers.
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Strengthen EHTEL’s collective voice: Through your coordinated member feedback, guarantee that EHTEL has a stronger influence in shaping guidance, standards, and future revisions of the EHDS. Your contribution will ensure your organisation’s priorities are represented in this important European dialogue.