Future of Data Analytics in the Era of the General Data Protection Regulation in Europe.

ABSTRACT

The development of evidence to demonstrate 'value for money' is regarded as an important step in facilitating the search for the optimal allocation of limited resources and has become an essential component in healthcare decision making. Real-world evidence collected from de-identified individuals throughout the continuum of healthcare represents the most valuable source in technology evaluation. However, in the European Union, the value assessment based on real-world data has become challenging as individuals have recently been given the right to have their personal data erased in the case of consent withdrawal or when the data are regarded as being no longer necessary. This act may limit the usefulness of data in the future as it may introduce information bias. Among healthcare stakeholders, this has become an important topic of discussion because it relates to the importance of data on one side and to the need for personal data protection on the other side, especially when it comes to "personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveals information about his or her health status". At the forefront of these discussions are data protection issues as well as the population's trust in digital services. It seems that the new era has begun, where citizens and patients will have the ability to manage their personal or self-generated data. The European Commission has laid the groundwork for this paradigm shift that will steadily emerge in the coming years. To prepare for this change, we believe attention should be given to data security and other rules of data privacy. It has become increasingly important to ensure that individuals are properly introduced into complex environments with multiple sources of Big Data for clinical and behavioral purposes to provide an optimal balance between societal and individual benefits. In this article, a number of issues are considered and discussed, based upon the authors' experience, with the aim of helping the reader better understand the implications of the use of Big Data and the importance of data protection in the coming years.