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 80. Minimum specifications for datasets of high impact
- The Commission may, by means of implementing acts, determine the minimum specifications for datasets of high impact for secondary use, taking into account existing Union infrastructures, standards, guidelines and recommendations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Relevant Recitals for this Article
Cooperation and work are ongoing between different professional organisations, the Commission and other institutions to set up minimum data fields and other characteristics of different datasets, for instance registries. That work is more advanced in areas such as cancer, rare diseases, cardiovascular and metabolic diseases, risk factor assessment and statistics, and should be taken into account when defining new standards and disease-specific harmonised templates for structured data elements. However, many datasets are not harmonised, raising comparability issues and making cross-border research difficult. Therefore, more detailed rules should be set out in implementing acts to ensure a harmonised coding and registration of electronic health data to enable the supply of such data for secondary use in a consistent way. Such datasets could include data from registries of rare diseases, orphan drugs databases, cancer registries and registries of highly relevant infectious diseases. Member States should work towards ensuring that European electronic health systems and services and interoperable applications deliver sustainable economic and social benefits, with a view to achieving a high level of trust and security, enhancing continuity of healthcare and ensuring access to safe and high-quality healthcare. Existing health data infrastructures and registries can provide models that are useful for defining and implementing data standards and interoperability and should be leveraged to enable continuity and to build on existing expertise.