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
Article 42
National requirements and reporting to the Commission
1. Member States may adopt national requirements for EHR systems and provisions on their conformity assessment in relation to aspects other than the harmonised software components of EHR systems.
2. The national requirements or provisions referred to in paragraph 1 shall not adversely affect the harmonised software components of EHR systems.
3. When Member States adopt requirements or provisions in accordance with paragraph 1, they shall inform the Commission thereof.