Recital 85

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.