EOSC-Life Public database inventorying the national health databases and registries and describing their access procedures for reuse for research purposes

The digitisation of healthcare has brought new opportunities to complement and enhance the data traditionally utilized in regulatory decision-making. According to the EMA, real world evidence (RWE) has been defined as the information derived from analysis of routinely collected real world data (RWD) relating to a patient’s health status or the delivery of healthcare from a variety of sources other than traditional clinical trials. Before fostering the enormous potential presented by the use of routinely collected RWD (e.g. electronic health records, medical claims, insurance data etc.) several challenges need to be addressed: operational, technical, methodological and ELSI. Reusing RWD for research purposes in Europe and especially in a crossborder manner is hampered by the fact that health databases and registries are not easily discoverable and, even when they are, understanding what data they contain and their suitability for addressing a specific research question remains not trivial due to the lack of detailed data catalogues with adequate metadata (especially in English).

The present report is entitled “D4.5 Public database inventorying the national health databases and registries and describing their access procedures for reuse for research purposes”. As the title indicates, the report delivers an inventory of national health databases and registries covering 15 European countries: Austria, Czech Republic, France, Germany, Hungary, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland. For each country the reader can find information on the national healthcare system, a list of health databases and registries, their description (or links to websites where this description can be found) and information on data access for research purposes. Although this deliverable was initially conceived as a “public database” in the form of a website, the EOSC-Life WP4 partners agreed that this would be unnecessary as the European Health Information Portal1 is already playing this role. Instead, this report will become publicly available through Zenodo and disseminated to relevant stakeholders working on similar issues (including the actors behind the Health Information Portal) as a way to “join forces” and complement each other’s work instead of duplicating efforts.

In summary, we conclude that the picture across Europe is diverse and at times patchy as the health databases and registries are subject to different governance and sustainability models but also to different local laws and access rules. Interestingly, there is still, on a European level, great debate around the terms “anonymisation”, “pseudonymisation” and “de-identification” and when data can be considered anonymised and as such exempted from the GDPR. Additionally, even when the current barriers of discoverability and accessibility (that are the main focus of this report) are lifted, there remains the major question of whether such data sources are suitable for research, as concerns around their quality, completeness and structure (or lack of) are still to be addressed.