Data & Privacy
AI & Trust
Cybersecurity
Digital Services & Media
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
Health data users who benefit from access to datasets provided for under this Regulation could enrich the data in those datasets with various corrections, annotations and other improvements, for instance by supplementing missing or incomplete data, thus improving the accuracy, completeness or quality of the data in the datasets. Health data users should be encouraged to report critical errors in datasets to health data access bodies. To support the improvement of the initial database and further use of the enriched dataset, Member States should be able to establish rules for the processing and the use of electronic health data containing improvements related to the processing of those data. The improved dataset should be made available free of charge to the original health data holder together with a description of the improvements. The health data holder should make the new dataset available, unless it provides a justified notification to the health data access body for not doing so, for instance in cases in which the enrichment by the health data user is of low quality. It should be ensured that non-personal electronic health data are available for secondary use. In particular, pathogen genomic data hold significant value for human health, as shown during the COVID-19 pandemic during which timely access to and sharing of such data proved to be essential for the rapid development of detection tools, medical countermeasures and responses to public health threats. The greatest benefit from pathogen genomics efforts will be achieved when public health and research processes share datasets and cooperate to inform and improve each other.
Information on the quality and utility of datasets increases the value of outcomes from data-intensive research and innovation significantly while, at the same time, promoting evidence-based regulatory and policy decision-making. Improving the quality and utility of datasets through informed customer choice and harmonising related requirements at Union level, taking into account existing Union and international standards, guidelines and recommendations for data collection and data exchange, such as FAIR principles, also benefits health data holders, health professionals, natural persons and the Union economy overall. A data quality and utility label for datasets would inform health data users about the quality and utility characteristics of a dataset and enable them to choose the datasets that best fit their needs. The data quality and utility label should not prevent datasets from being made available through the EHDS, but provide a transparency mechanism between health data holders and health data users. For example, a dataset that does not fulfil any requirement of data quality and utility should be labelled with the class representing the poorest quality and utility, but should still be made available. Expectations set by frameworks created pursuant to Article 10 of Regulation (EU) 2024/1689 and the relevant technical documentation specified in Annex IV to that Regulation should be taken into account when developing the data quality and utility framework. Member States should raise awareness about the data quality and utility label through communication activities. The Commission could support those activities. The use of datasets could be prioritised by their users according to their usefulness and quality.