A reflection from the theory of fundamental rights on the secondary use of health data in the framework of Big Data

Abstract

Big Data offers great opportunities in the field of health research. The interrelation and exploitation of health data, even, correlating them with non-traditional ones, will allow progress in the fight against diseases and in favor of prevention and prediction in terms that are surely not going to find a match in the History of the Medicine and humanity. However, the traditionally settled model, so-called Helsinki paradigm by reference to the Declaration of the same name, signed by the 18th World Medical Assembly in 1964, and the legal regulation of the protection of health data do not appear to be adequate to take advantage of such opportunities that Big Data offers. The balance between risks for individual rights and benefits for common interest seems to have been transformed. This requires us to reflect on whether a new paradigm can be developed that allows us to combine the health benefits of massive data research with the required protection of individual rights. In other words, to choose, within the margins offered by the regulation of data protection, for the most appropriate legal framework, taking into account the developments that, in this regard, offer the EU Regulation and the Spanish specific new regulation of data protection. As we are maintaining in our work, we consider that the new concept of pseudonymization has to play a leading role within this new model.

Summary:
I. Introduction. II. Solving some myths: will the human being retain an essential role in the fight against disease in the days of Big Data? III. The impact of Big Data opportunities in the conflict between individual rights and common good. IV. The necessary overcoming of the Helsinki
paradigm in the secondary use of health data safeguarding people’s rights. V. Have the new Spanish Regulation of data protection opted for the new paradigm? VI. Conclusions