Recital 25

Gradual improvement of interoperability and data sharing

The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity as regards standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category.

Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of certain categories of electronic health data is needed. Categories of electronic health data such as patient summaries, electronic prescriptions and dispensations, medical imaging studies and related imaging reports, medical test results such as laboratory results and related reports, and discharge reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission.

Where such priority categories of data represent groups of electronic health data, this Regulation should apply to both the groups as a whole and to the individual data entries included in those groups. For example, given that vaccination status is part of a patient summary, the rights and requirements linked to the patient summary should also apply to such vaccination status even if it is processed separately from the patient summary as a whole.

When further needs for the exchange of additional categories of electronic health data are identified for healthcare purposes, access to and exchange of those additional categories should be possible under this Regulation. The additional categories should be first implemented at Member State level and the exchange on a voluntary basis of such categories of data in cross-border situations between the cooperating Member States should be provided for in this Regulation. Particular attention should be given to data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.

Discussion

Regarding 'Where such priority categories of data represent groups of electronic health data, this Regulation should apply to both the groups as a whole and to the individual data entries included in those groups.'

• One can interpret this to apply to auditing, access control etc., but one could also interpret this to mean that one should provide access at the individual resource level, not just at the group level.
• This causes 'stickiness' of obligations. If you receive a document, and pull a resource from it, there could / will be additional EHDS obligations above and beyond GDPR.

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