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 anonymization, data protection and data from the design and default, the analysis of the impact in the data protection.
In a context of processing of the reform of the Organic Law 15/1999 of 13 December, Protection of Data of and one year before the full enforcement of the General Law of data protection, it is necessary to address the future of health research from the identification of opportunities that this new framework offers.
On the other hand, the application in 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 can offer generic solutions hosted in reality. To find spaces to build shared knowledge is essential.
