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 94. Tasks of the EHDS Board
- 1.The EHDS Board shall have the following tasks relating to primary use in accordance with Chapters II and III:
- (a)assisting Member States in coordinating practices of digital health authorities;
- (b)issuing written contributions and exchanging best practices on matters related to the coordination of the implementation at Member State level, taking into account the regional and local level, of this Regulation and of the delegated and implementing acts adopted pursuant to it, in particular as regards:
(i)
the provisions set out in Chapters II and III;(ii)
the development of online services facilitating secure access, including secure electronic identification, to electronic health data for health professionals and natural persons;(iii)
other aspects relating to primary use;
- (c)facilitating cooperation between digital health authorities through capacity building, establishing the framework for activity-reporting referred to in Article 20 and the exchange of information;
- (d)sharing among its members information concerning risks posed by EHR systems and serious incidents as well as the handling of such risks and incidents;
- (e)facilitating the exchange of views on primary use with the stakeholder forum referred to in Article 93, as well as with regulators and policy-makers in the health sector.
- 2.The EHDS Board shall have the following tasks related to secondary use in accordance with Chapter IV:
- (a)assisting Member States in coordinating practices of health data access bodies in the implementation of provisions set out in Chapter IV, to ensure a consistent application of this Regulation;
- (b)issuing written contributions and exchanging best practices on matters related to the coordination of the implementation at Member State level of this Regulation and of the delegated and implementing acts adopted pursuant to it, in particular as regards:
(i)
implementation of rules for access to electronic health data;(ii)
technical specifications or existing standards regarding the requirements set out in Chapter IV;(iii)
incentives for promoting data quality and interoperability improvement;(iv)
policies concerning fees to be charged by the health data access bodies and health data holders;(v)
measures to protect the personal data of health professionals involved in the treatment of natural persons;(vi)
other aspects of secondary use;
- (c)creating, in consultation and cooperation with relevant stakeholders, including representatives of patients, health professionals and researchers, guidelines in order to help health data users to fulfil their duties under Article 61(5), and in particular to determine whether their findings are clinically significant;
- (d)facilitating cooperation between health data access bodies through capacity building, establishing the framework for activity-reporting referred to in Article 59(1), and the exchange of information;
- (e)sharing information concerning risks and incidents related to secondary use, as well as the handling of such risks and incidents;
- (f)facilitating the exchange of views on secondary use with the stakeholder forum referred to in Article 93, as well as with health data holders, health data users, regulators and policy-makers in the health sector.
Relevant Recitals for this Article
In order to promote the consistent application of this Regulation, including as regards cross-border interoperability of electronic health data, a European Health Data Space Board should be set up. The Commission should participate in its activities and co-chair it. The EHDS Board should be able to issue written contributions related to the consistent application of this Regulation throughout the Union, including by helping Member States to coordinate the use of electronic health data for healthcare and certification, but also concerning secondary use, and the funding for those activities. This could also include sharing information on risks and incidents in the secure processing environments. The sharing of that kind of information does not affect obligations under other legal acts, such as data breach notifications under Regulation (EU) 2016/679. More generally, the activities of the EHDS Board are without prejudice to the powers of the supervisory authorities pursuant to Regulation (EU) 2016/679. Given that, at national level, digital health authorities dealing with primary use may be different from the health data access bodies dealing with secondary use, the functions are different and there is a need for distinct cooperation in each of those areas, the EHDS Board should be able to set up subgroups dealing with those two functions, as well as other subgroups, as needed. In order for there to be an efficient working method, the digital health authorities and health data access bodies should create networks and links at national level with other bodies and authorities, but also at Union level. Such bodies could comprise data protection authorities, cybersecurity, eID and standardisation bodies, as well as bodies and expert groups under Regulations (EU) 2022/868, (EU) 2023/2854 and (EU) 2024/1689 and Regulation (EU) 2019/881 of the European Parliament and of the Council . The EHDS Board should operate independently, in the public interest and in line with its code of conduct.