EHDS
Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
- GDPR Procedural Regulation
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 IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS
EHDS Article 55. Health data access bodies
- 1.Member States shall designate one or more health data access bodies responsible for carrying out the tasks and obligations set out in Articles 57, 58 and 59. Member States may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this Article. The tasks set out in Article 57 may be distributed between different health data access bodies. Where a Member State designates several health data access bodies, it shall designate one health data access body to act as coordinator, with responsibility for coordinating tasks with the other health data access bodies both within the territory of that Member State and in other Member States. Each health data access body shall contribute to the consistent application of this Regulation throughout the Union. For that purpose, health data access bodies shall cooperate with each other, with the Commission and, for concerns regarding data protection, with the relevant supervisory authorities.
- 2.In order to support the effective performance of the tasks and the exercise of the powers of the health data access bodies, Member States shall ensure that each health data access body is provided with the following elements:
- (a)the necessary human, financial and technical resources;
- (b)the necessary expertise; and
- (c)the necessary premises and infrastructure.
Where an assessment by ethics bodies is required under national law, those bodies shall make expertise available to the health data access body. As an alternative, Member States may provide for ethics bodies to form part of the health data access body.
- 3.Member States shall ensure that any conflicts of interest between the organisational parts of health data access bodies performing the different tasks of such bodies is avoided by, for example, providing for organisational safeguards such as segregation between health data access bodies’ different functions, including assessing applications, the reception and preparation of datasets, for example pseudonymisation and anonymisation of datasets, and the provision of data in secure processing environments.
- 4.In the performance of their tasks, health data access bodies shall actively cooperate with relevant stakeholders’ representatives, especially with representatives of patients, health data holders and health data users and shall avoid any conflicts of interest.
- 5.In the performance of their tasks and exercise of their powers, health data access bodies shall avoid any conflicts of interest. Health data access bodies’ staff shall act in the public interest and in an independent manner.
- 6.Member States shall inform the Commission of the identity of the health data access bodies designated pursuant to paragraph 1 by 26 March 2027. They shall also inform the Commission of any subsequent modification of the identity of those bodies. The Commission and the Member States shall make that information publicly available.