The overcome of public health research data management chaos: exploratory study on research infrastructure implementation

Background and objective: Digital healthcare research infrastructures integrate data, global health, people, processes, and technology. Public health decisionmakers face problems of access to data and the current debate focuses on ethical and data protection issues, looking for systems’ interoperability constraints. The aim of this study is to understand the process of digital healthcare research infrastructures. Methods: The study is a literature review on digital healthcare infrastructures integrating data supplemented with two use cases of public health research implementation focusing on data management and protection processes at different scales (centralized-national and distributed-federated). Results: The use cases presented are different in scales and nature, having multiple levels of constraints in the research infrastructure pipeline. 1. National, Portugal: literature identifies the bottleneck at the implementation and interoperability levels, for research systems. Review on national data protection emphasizes official deliberations, since the European general data protection regulation (GDPR) launch, focusing on health databases protection, the need of improving communication among institutions and professionals, and less bureaucratic processes for local implementation of health information systems. 2. Europe (EU) member states: review on EU official decisions on the adequate protection of personal data in the context of international research data flows, points to the need of FAIR processes and share of data. The bottleneck seems to be at national health security level, where policy dialogue is of major importance and national affairs need to be protected. Sharing data can vulnerable, therefore is controlled, sometimes not reflecting the process. Conclusion: Jurisprudence, official and unofficial institutional documents, and peer review research publications give an important documental subtract for this research. First-hand experience will contribute to the reveal and validation of main constraints and possible solutions for the research problem. A roadmap for health research data protection implementation, in Portugal following the EU context is being set-up.