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 77. Dataset description and dataset catalogue
- 1.Health data access bodies shall, through a publicly available and standardised machine-readable dataset catalogue, provide a description in the form of metadata of the available datasets and their characteristics. The description of each dataset shall include information concerning the source, scope, main characteristics, and nature of the electronic health data in the dataset and the conditions for making those data available.
- 2.The dataset descriptions in the national dataset catalogue shall be available in at least one official language of the Union. The dataset catalogue for Union institutions, bodies, offices and agencies provided by the Union health data access service shall be available in all official languages of the Union.
- 3.The dataset catalogue shall be made available to single information points established or designated under Article 8 of Regulation (EU) 2022/868.
- 4.By 26 March 2027, the Commission shall, by means of implementing acts, set out the minimum elements health data holders are to provide for datasets and the characteristics of those elements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Relevant Recitals for this Article
The health data access bodies should provide information about the available datasets and their characteristics so that health data users can be informed of elementary facts about the dataset and assess the possible relevance of those facts to those users. For this reason, each dataset should include, at least, information concerning the source and nature of the data and the conditions for making the data available. The health data holder should, at least every year, check that its dataset description in the national dataset catalogue is accurate and up to date. Therefore, an EU dataset catalogue should be established to: facilitate the discoverability of datasets available in the EHDS; help health data holders to publish their datasets; provide all stakeholders, including the general public, taking into account the specific needs of people with disabilities, with information about datasets placed on the EHDS, such as quality and utility labels and dataset information sheets; and provide health data users with up-to-date data quality and utility information about datasets.