The recent normative development will have a significant impact in the needs of regulatory compliance and security in the development of health research. Particularly, researches with an intensive use of personal data may be involved as well as the results and processes based on them.

Surely, the most significant impact will occur when the Law (EU) 2016/679 is launched. This law of the European Parliament and the Council of 27 April 2016 concerning physical persons’ protection when it comes to the treatment of personal data and the free circulation of these data and repealing the Directive 95/46/CE (Data Protection Regulation).

This law incorporates relevant forecast for health research like for example pseudonymisation, a widely used technic in health research and the issues raised by anonymisation, data protection and data from the design and default, the analysis of the impact in the data protection.

On the other hand, the processing of the reform of the Organic Law 15/1999, of December 13, for Protection of Personal Data predicts a moratorium of two years in the development of an specific legislation, entering a certain amount of uncertainty. 

On the other hand, the application of the normative framework requires the understanding of research necessities. And this understanding is bidirectional. If it is considered as necessary to integrate conditions of normative compliance and to guarantee safety, regulators cannot offer generic solutions hosted in reality. On the other hand, the sanitary and research management start to share the use of data, which makes these relations even more difficult. To find spaces to build shared knowledge is essential.