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 37
(37) EHR systems should be accompanied by an information sheet that includes information for its professional users and by clear and complete instructions for use, including in accessible formats for persons with disabilities. If an EHR system is not accompanied by such information, the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators should be required to add to the EHR system that information sheet and those instructions for use.