European Health Data Space Regulation
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Table of Contents
Chapter I – General provisions
Chapter II – Primary use
Chapter III – Ehr systems and wellness applications
Chapter IV – Secondary use
Chapter V – Additional actions
Chapter VI – European governance and coordination
Chapter VII – Delegation of powers and committee procedure
Chapter VIII – Miscellaneous
Chapter IX – Deferred application, transitional and final provisions
Recitals (115)
Annexes
Recital 51
(51) The distribution of information on certified EHR systems and labelled wellness applications is necessary to enable procurers and users of such products to find interoperable solutions for their specific needs. A database of interoperable EHR systems and wellness applications, which do not fall within the scope of Medical Devices Regulation (MDR) and (EU) 2024/1689, should therefore be established at Union level, similar to the European database on medical devices (Eudamed) established by Medical Devices Regulation (MDR). The objectives of the EU database for registration of EHR systems and wellness applications should be to enhance overall transparency, to avoid multiple reporting requirements and to streamline and facilitate the flow of information. For medical devices and AI systems, the registration should be maintained under the existing databases established, respectively, under Medical Devices Regulation (MDR) and (EU) 2024/1689, but the compliance with interoperability requirements should be indicated by manufacturers when they claim such compliance, in order to provide information to procurers.