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 59. Reporting by health data access bodies
- 1.Each health data access body shall publish an activity report every two years and make it publicly available on its website. If a Member State designates more than one health data access body, the coordinating body referred to in Article 55(1) shall be responsible for the activity report and request the necessary information from the other health data access bodies. That activity report shall follow a structure agreed by the EHDS Board pursuant to Article 94(2), point (d), and contain at least the following categories of information:
- (a)information relating to the health data access applications and health data requests submitted, such as the types of health data applicants, number of data permits issued or refused, categories of purposes of access and categories of electronic health data accessed, and a summary of the results of the electronic health data uses, where applicable;
- (b)information on the fulfilment of regulatory and contractual commitments by health data users and health data holders, as well as the number and amount of administrative fines imposed by health data access bodies;
- (c)information on audits carried out on health data users to ensure compliance of the processing they carry out in the secure processing environment pursuant to Article 73(1), point (e);
- (d)information on internal and third-party audits on compliance of secure processing environments with the defined standards, specifications and requirements, as referred to in Article 73(3);
- (e)information on the handling of requests from natural persons relating to the exercise of their data protection rights;
- (f)a description of the health data access body’s activities carried out in relation to engagement with and consultation of relevant stakeholders;
- (g)revenues from data permits and health data requests;
- (h)the average number of days between health data access applications or health data requests and access to data;
- (i)the number of data quality labels issued by health data holders, disaggregated per quality category;
- (j)the number of peer-reviewed research publications, policy documents and regulatory procedures using data accessed via the EHDS;
- (k)the number of digital health products and services, including AI applications, developed using data accessed via the EHDS.
- 2.The activity report referred to in paragraph 1 shall be submitted to the Commission and the EHDS Board within six months of the end of the second year of the relevant reporting period. The activity report shall be accessible via the Commission’s website.
Relevant Recitals for this Article
In order to promote transparency, health data access bodies should also publish activity reports, every two years, providing an overview of their activities. Where a Member State has designated more than one health data access body, the coordinating body should prepare and publish a common report every two years. Activity reports should follow a structure agreed by the EHDS Board and provide an overview of activities, including information regarding decisions on applications, audits and engagement with relevant stakeholders. Such stakeholders can include representatives of natural persons, patient organisations, health professionals, researchers and ethical committees.