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 38
(38) While EHR systems specifically intended by the manufacturer to be used for processing one or more specific categories of electronic health data should be subject to mandatory self-certification, software for general purposes should not be considered to be an EHR system, even when used in a healthcare setting, and should therefore not be required to comply with this Regulation. That covers cases such as text-processing software used for writing reports that would then become part of written electronic health records, general-purpose middleware, or database management software that is used as part of data storage solutions.