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 could have benefitted from more deliberation and perspectives of healthcare providers, vendors, and innovators.
EHTEL has been working on a working paper outlining how the EHDS, and especially the regulation of EHR systems, suffered from several blind spots. By including in the scope of “EHR systems” almost all connected IT systems and medical technologies used in healthcare, it does not consider sufficiently the complexity of healthcare delivery. The implementation timelines are ambitious and risk stability of a sector that usually proceeds slowly and carefully. And 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 among providers and the health systems in the Member States and regions.
This meeting of the Task Force will consider an internal draft version for review and feedback, and to agree conclusions and EHTEL recommendations. There will be a structured and interactive discussion.