Essential requirements for the harmonised components of EHR systems and products claiming interoperability with EHR systems are laid out in in Annex II of the agreed EHDS regulation (version 18 March 2024). Annex II makes the distinction between: General Requirements, Requirements for interoperability (direct reference to the European Electronic Health Record Exchange Format) and Requirements for security and for logging. CEN/TC 251 has provided a first attempt at identifying relevant standards to each of these categories of requirements.
The European Commission conducted a public consultation to gather the views of the public on an EU initiative for a European Health Data Space (EHDS). The purpose of the consultation is to inform the Commission’s work to support the impact assessment accompanying the EHDS proposal on the problems to be tackled, the policy options to be considered and their likely impacts. It was conducted to ensure that all possible views are considered in the design of a legal framework for an EHDS and to ensure transparency and accountability. TC 251 contributed to this consultation.
All the published standards under this TC can be found here.
They can be found and purchased through the NEN website.
They can also be purchased through the National Standardization Body of the CEN National Members.
