The European Health Data Space and Data Quality: A Comparison with the IDEFIM Framework for Empirical Health Research

The European Health Data Space (EHDS) regulation sets high requirements on the reporting of datasets' quality. The regulation's wording used for categories and for the definition of elements seems unfamiliar at first glance. This gives rise to the fears of negative side effects for empirical health research. A comparison between the QUANTUM proposal of a datasets' quality and utility label with the IDEFIM framework, ISO/IEC 25012 and the FAIR Guiding Principles should therefore evaluate common and distinguishing features. On the one hand, the comparison revealed relevant discrepancies on how to organize requirements and how to evaluate their fulfilment. On the other hand, the QUANTUM project offers a bridge from the confusing approach of the EHDS regulation to a broad consent about dimensions of datasets found in ISO/IEC 25012 and the IDEFIM framework. It is of utmost importance for empirical health research that the further elaboration of the respective EHDS regulation strives at the best possible convergence with established standards and quasi-standards including the FAIR Guiding Principles.