23 Implementing Act

Implementing Act related to EHDS Articles 23(4) and 23(8)

Subject of this implementing act are the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of personal electronic health data and the conditions for compliance checks necessary to join and remain connected to MyHealth@EU. Also covered are rules regarding the requirements of cybersecurity, technical interoperability, semantic interoperability, operations and service management in relation to the processing by the processor referred to in paragraph 7 of this Article and its responsibilities towards the controllers, in accordance with Chapter IV of Regulation (EU) 2016/679.

March 2027 is the deadline for the Commission to adopt this implementing act, providing detailed rules for the regulation operationalisation.

Discussion

This article is focused on NCP-NCP communications, and requirements for NCP applications. As such it doesn't impact EHRs as used within member states, and hence it is out of scope for this website.

This implementing act is likely to be based on the current MyHealth@EU specifications and rules, as well as on the EEHRExF specifications defined in Article 15.

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About Ringholm bv

Ringholm bv is a group of European experts in the field of messaging standards and systems integration in healthcare IT. We provide the industry's most advanced training courses and consulting on healthcare information exchange standards.