[Big Data in health: a new paradigm to regulate, a challenge for social justice.]

In addition to the opportunities posed by the use of Big Data in health, it also generates important challenges in the field of research, especially from the point of view of its management and ethical considerations. The European Union has been promoting different initiatives that allow the exploitation of this data in the context of the knowledge economy. The UNESCO Ethics Committee has identified three ethical principles to take into account regarding the application of Big Data in Health: independence, privacy and justice. The protection of privacy and patient safety is questioned in a context where cybersecurity is far to be complete. In addition, an imbalance in the exploitation of these data by the public and private sectors could generate inequalities that would represent a significant problem of social justice. This article follows a qualitative methodology based on the documentary analysis of current legislative texts, especially the recently approved General Data Protection Regulation (GDPR), as well as non-legislative documents of projects and parliamentary communications throughout the last two legislatures, with the aim of analyzing them and evaluating how they conform to the principles outlined by UNESCO, especially with respect to the principle of social justice. The most representative national projects that have started to be adopted are also reviewed.