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Big data is revolutionising the health care sector by making it easier to analyse large volumes of data. This enables health care providers to monitor individuals or systems in real time. However, the main concern with regard to big data in biomedicine is how to overcome the barriers to using such data for health-related research. The landscape of big data is still evolving and the law has not developed suitable principles for governing access to big data. This paper sketches the fuzzy contours of data ownership and related intellectual property rights to demonstrate that ownership is a concept that is ill-suited for governing rights in big data. The dawn of big data calls for an alternative normative framework. This framework must be capable of reconciling competing societal, individual and industries’ interests in the data with a view to ensuring fair access while minimising legal and ethical risks. Ultimately, the paper proposes a paradigm shift from ownership to custodianship in the governance of access and use of big data, particularly in international health-related research.

Towards a Paradigm Shift in Governing Data Access and Related Intellectual Property Rights in Big Data and Health-Related Research