Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS Article 14. 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).
- 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.
Relevant Recitals for this Article
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.