Defining Scientific Research Within the EU’s Politics of Data: The Impact on Personalized Smart Medicine

Personalized smart medicine is currently a major strand of research in the health sector that promises to profoundly innovate clinical practice and patient care through massive amounts of data processing. However, within the current and proposed EU legal frameworks on data governance, there are multiple definitions of “scientific research” or “research purposes”, and none of them are consistent nor harmonized. This is particularly relevant since European lawmakers frequently impose special rules over scientific research activities. Hence, this chapter aims to investigate whether and to what extent the EU legal framework influences health research for personalized smart medicine. Here, focus is placed on the notions of scientific research according to different legal provisions and what consequences this has for studies in the field of personalized smart medicine. A normative analysis reveals three interpretations of what constitutes scientific research: narrow, broad, and undefined. With these three definitions in hand, the study outlines several different criteria for action and governance that must be taken into account in any framework designed to guide research into personalized smart medicine. The action criteria include FAIRness, accountability, and proactivity, while the governance criteria encompass participation rules, data stewardship, and horizontal coordination.