Articles of the European Health Data Space (EHDS), Article 5, Priority categories of personal electronic health data for primary use



Article 5, Priority categories of personal electronic health data for primary use, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

Priority categories of personal electronic health data for primary use.

1. Where data is processed in electronic format, Member States shall implement access to and exchange of personal electronic health data for primary use fully or partially falling under the following categories:

(a) patient summaries;

(b) electronic prescriptions;

(c) electronic dispensations;

(d) medical images and image reports;

(e) laboratory results;

(f) discharge reports.

The main characteristics of the categories of electronic health data in the first subparagraph shall be as set out in Annex I.

Access to and exchange of electronic health data for primary use may be enabled for other categories of personal electronic health data available in the EHR of natural persons.


2. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list of priority categories of electronic health data in paragraph 1. Such delegated acts may also amend Annex I by adding, modifying or removing the main characteristics of the priority categories of electronic health data and indicating, where relevant, deferred application date. The categories of electronic health data added through such delegated acts shall satisfy the following criteria:

(a) the category is relevant for health services provided to natural persons;

(b) according to the most recent information, the category is used in a significant number of EHR systems used in Member States;

(c) international standards exist for the category that have been examined for the possibility of their application in the Union.