Legal Challenges for the regulation of the European Health Data Space

In the present context of the so-called ‘Digital Society’, an important process of legislative reform is taking place inside the European Union. In areas such as the digital transformation of the health sector, these actions have a considerable impact on traditional legal concepts and categories such as privacy or informed consent. This is especially relevant in the realm of health science research in the context of Big Data. The nature of this type of research projects requires a new model of consent, which is called broad consent. The legislator faces the challenge of having to respect, on the one hand, the balance between the possibility of obtaining consent in a simple and feasible way, and on the other, the need to provide data subjects the necessary information and control over their sphere of privacy. Likewise, a formula must be found that protects individuals, but does not unduly hinder progress in biomedical research. This issue requires an assessment from both an ethical and a legal perspective. Here comes into play the role of Research Ethics Committees that is reinforced by these new legislative measures, so that the concept of data ethics is coined. In the drafting of this work, my experience as a member of the Research Ethics Committee of the University of Valencia has been fundamental.