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 39
(39) This Regulation imposes a mandatory conformity self-assessment scheme for the harmonised software components of EHR systems to ensure that EHR systems placed on the Union market are able to exchange data in the European electronic health record exchange format and that they have the required logging capabilities. That mandatory conformity self-assessment, which would be in the form of an EU declaration of conformity by the manufacturer, should ensure that those requirements are fulfilled in a proportionate way, while avoiding an undue burden on Member States and manufacturers.