Introduction – The emergence of ICT in medical research brought forth an immense advancement in understanding the human body. Ball and Lillis foresaw in 2001, “[m]anaging disease [would become] a continuous process, not an episodic one”, and “a new level of knowledge and connectivity [would] make us think and operate differently”. Thomas Kienle described three evolutions that, together, create a dynamic technological framework in healthcare: high tech medicine, machine-aided diagnosis producing digital results and intra-and inter-networks. The Internet has enabled the acquisition and dissemination of large global data sets. So-called ‘high-throughput platforms’ use automation equipment for experiments enabling large scale repeated analyses of much larger data sets at a much faster pace. Big data, machine learning and AI thrive on the use of primary data and meta-data to foster discovery-driven approaches to gain knowledge on, for example, the onset and further development of diseases or drug effects.

There is no chicken and egg explanation for this evolution. ICT solutions can be specifically designed to solve issues detected by healthcare professionals. Developments in sectors other than the healthcare sector also inspire healthcare professionals. Although ICT has most certainly been an enabler and innovator, it is, in the end, developed to address societal issues and to accommodate citizens’ demands. Together, the societal and technical evolutions have, over time, also influenced the European appreciation of the fundamental rights to privacy and data protection.

Outlook – To better understand the connection between the societal and technological changes in healthcare and their impact on European data protection law, the next sections provide a high-level overview of a number of transformations that significantly impact patient empowerment and personalised healthcare. The first section illustrates how society moved away from a paternalistic approach to patient-centred healthcare in which, ultimately, patients seem to be considered the owner of not only their body but also their data. The second section illustrates how demographic changes require us to think about new approaches to healthcare. Caring with fewer people for more people prompts us to make changes.