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 58. Obligations of health data access bodies towards natural persons
- 1.Health data access bodies shall make information on the conditions under which electronic health data are made available for secondary use publicly available, easily searchable through electronic means and accessible for natural persons. That information shall cover the following:
- (a)the legal basis under which access to electronic health data is granted to the health data user;
- (b)the technical and organisational measures taken to protect the rights of natural persons;
- (c)the applicable rights of natural persons in relation to secondary use;
- (d)the arrangements for natural persons to exercise their rights in accordance with Chapter III of Regulation (EU) 2016/679;
- (e)the identity and the contact details of the health data access body;
- (f)who has been granted access to datasets of electronic health data and to which datasets they were granted access and details of the data permit regarding the purposes for processing such data as referred to in Article 53(1);
- (g)the results or outcomes of the projects for which the electronic health data were used.
- 2.If a Member State has provided for the right to opt out pursuant to Article 71 to be exercised through the health data access bodies, the relevant health data access bodies shall provide public information about the procedure to opt out and facilitate the exercise of that right.
- 3.Where a health data access body is informed by a health data user of a significant finding related to the health of a natural person, as referred to in Article 61(5), the health data access body shall inform the health data holder about that finding. The health data holder shall, under the conditions laid down by national law, inform the natural person or health professional treating the natural person concerned. Natural persons shall have the right to request not to be informed of such findings.
- 4.Member States shall inform the public at large about the role and benefits of health data access bodies.
Relevant Recitals for this Article
Natural persons should be informed by the health data holders about significant findings related to their health made by health data users. Natural persons should have the right to request not to be informed of such findings. Member States could lay down conditions on the arrangements for the provision by the health data holders of such information to the natural persons concerned and on the exercise of the right not to be informed. Member States should be able, in accordance with Article 23(1), point (i), of Regulation (EU) 2016/679, to restrict the scope of the obligation to inform natural persons whenever necessary for their protection based on patient safety and ethics, by delaying the communication of their information until a health professional can communicate and explain to the natural persons concerned information that potentially can have an impact on their health.