Big Data and Health Care: Challenges and Opportunities for Coordinated Policy Development in the EU.

Abstract-As global policy makers prioritize big data policy, it is important to try to outline expected outcomes vis-à-vis health sector objectives. We identify initiatives aimed at promoting the use of big data in European Union (EU) health care, highlight expected challenges, and use these to evaluate EU big data policy developments to the extent that they are able to advance health sector priorities. A comprehensive approach is used to capture and examine peer-reviewed and gray literature publications on the use of big data in global health systems. This approach involved electronic database and specialist website searching, as well as complementary use of search engines and qualitative inputs from key EU policy stakeholders. Ongoing health data initiatives revolve around data center development, confidentiality and security, e-health and m-health, and genomics and bioinformatics. The literature acknowledges several main challenges to the successful integration of big data in health care, classified as either ethical (confidentiality and data security, access to information) or technical (data reliability, interoperability, data management and governance). EU data policy has started to address these issues, though additional work remains. A larger outstanding challenge is the lack of a comprehensive health and research policy strategy for big data that targets sectoral objectives. It remains unclear how big data integration will affect the quality and performance of health care in the EU. The promises of big data are being eroded by a failure to develop a coherent approach to adequately address conceptual, ethical, and technical challenges pertaining to its use within EU health systems.