Regulation on the European Health Data Space (EHDS)
EHR systems: requirements and economic operators – Regulation on the European Health Data Space (EHDS)

Regulation on the European Health Data Space (EHDS) 26: Place or put into service only EHR systems whose harmonised components comply with Chapter III

Articles 25 and 26: EHR systems (software intended by the manufacturer for providers or patients to store, intermediate, export, import, convert, edit or view priority-category data) must include a European interoperability software component and a European logging software component, and may be placed on the market or put into service only if they comply with Chapter III; systems made and used in-house by health institutions or offered as a service to persons in the Union count as put into service. General-purpose software used in healthcare is excluded; Member States may not restrict compliant systems on harmonised-component grounds.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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