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 41
(41) Member States should remain competent to define requirements relating to any other software components of EHR systems and the terms and conditions for connection of healthcare providers to their respective national infrastructures, which could be subject to third-party assessment at national level. In order to facilitate the smooth functioning of the internal market for EHR systems, digital health products and associated services, it is necessary to ensure as much as possible transparency as regards national law establishing requirements for EHR systems and provisions on their conformity assessment in relation to aspects other than the harmonised software components of EHR systems. Therefore, Member States should inform the Commission of those national requirements so it has the necessary information to ensure that they do not adversely affect the harmonised software components of EHR systems.