European Health Data Space Regulation
Navigation log
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
Article 26
Placing on the market and putting into service
1. EHR systems shall be placed on the market or put into service only if they comply with the provisions laid down in this Chapter.
2. EHR systems that are manufactured and used within health institutions established in the Union, as well as EHR systems offered as a service as defined in Article 1(1), point (b), of Single Market Transparency Directive of the European Parliament and of the Council to a natural or legal person established in the Union, shall be considered as having been put into service.
3. Member States shall not prohibit or restrict the placing on the market of EHR systems which comply with this Regulation, on account of considerations relating to aspects concerning the harmonised software components of EHR systems regulated by this Regulation.