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) 40: Test the harmonised components in the digital testing environment before placing on the market

Article 40: the Commission develops an open-source European digital testing environment and Member States operate national testing environments complying with its common specifications; manufacturers must use them to assess the harmonised components before placing EHR systems on the market, include the results in the technical documentation and database registration, and elements with positive results are presumed to conform.

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