Regulation on the European Health Data Space (EHDS)
EHR Requirements

Regulation on the European Health Data Space (EHDS) EHDSREG-1: Mandatory Requirements for EHR Systems (Articles 14-29)

Per EHDS Regulation: EHR system requirements. Requirements include (a) Mandatory requirements for EHR systems placed on the market (Article 14) including conformity + (b) Identification and Authentication (Article 12) of healthcare professionals + patients + (c) maintain interoperability per European Electronic Health Record Exchange Format (EEHRxF) + (d) implement Conformity Assessment per Articles 23-29 + (e) maintain CE marking + technical documentation.

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