Desiderata for the governance of health data hubs for research

Abstract

Background Digital transformation in healthcare and the growth of health data generation and collection include an important challenge for the secondary use of healthcare records in the health research field. Likewise, due to the ethical and legal constraints for using sensitive data, understanding how health data is managed by dedicated infrastructures called data hubs is essential to facilitate data sharing and reuse. Methods In order to capture the different data governance behind health data hubs across Europe, a survey focused on analysing the feasibility of linking individual-level data between data collections and the generation of health data governance patterns was carried out. The target audience of this study was National, European, and Worldwide data hubs. In total, the designed survey was sent to a representative list of 99 health data hubs in January 2022. Results In total, 41 survey responses received till June 2022 were analysed in-depth. Stratification methods were performed to cover the different levels of granularity identified in some data hubs’ characteristics. Firstly, a general pattern of data governance for data hubs was defined. Afterward, specific profiles were defined, generating specific patterns of data governance through the stratifications in terms of the kind of organisation (centralised vs. decentralised), and role (data controller or data processor) of the health data hubs interviewees. Conclusions The in-depth analysis of the responses from health data hubs interviewees across Europe provided a list of the most frequent aspects that concluded a set of specific recommendations on data management and governance, taking into account the constraints of sensitive data. In summary, a data hub should work in a centralised way providing a Data Processing Agreement and a formal procedure to identify data providers, as well as data quality control, data integrity and anonymisation methods.