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Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance)

article  14

CELEX:  32025R0327

Priority categories of personal electronic health data for primary use
1. For the purposes of this Chapter, where data are processed in electronic format the priority categories of personal electronic health data shall be the following:
(a) patient summaries;
(b) electronic prescriptions;
(c) electronic dispensations;
(d) medical imaging studies and related imaging reports;
(e) medical test results, including laboratory and other diagnostic results and related reports; and (f) discharge reports. The main characteristics of the priority categories of personal electronic health data for primary use shall be as set out in Annex I. Member States may provide in their national law for additional categories of personal electronic health data to be accessed and exchanged for primary use pursuant to this Chapter. The Commission may, by means of implementing acts, lay down cross-border specifications for the categories of personal electronic health data referred to in the third subparagraph of this paragraph pursuant to Article 15(3) and Article 23(8). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance)

article  14

CELEX:  32025R0327

2. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend this Regulation by amending Annex I through the addition, modification or removal of the main characteristics of the priority categories of personal electronic health data as referred to in paragraph 1, provided that the amendments are aimed at adapting the priority categories of personal electronic health data to technical developments and international standards. Moreover, additions and modifications of those characteristics shall satisfy both of the following criteria:
(a) the characteristic is relevant for healthcare provided to natural persons;
(b) the characteristic is used in the majority of Member States according to the most recent information.