Digitising Health Research and Evolving Inequalities: Where Does the EU Stand?

Big data and information technology are at the basis of great transformations in the ways health care is performed and in the way health services and products are delivered. Among these transformations one of the most challenging ones is related to the digitization and datification of health research patterns. The proliferation of health-related apps and other software is extending the range of the tools relevant for the conduction of research. This is in turn also causing the increasing relevance of digital datasets for the design and testing of new health-related products, such as pharmaceuticals. This contribution demonstrates that these technological developments are provoking mutations in the health research environment, raising new risks for the final consumers/patients enjoying the outputs of such research, in terms of new health products and services. As will be shown, these risks primarily relate to the occurrence of new biases affecting health research and the emergence of new stigmatizing patterns. These biases ultimately risk to negatively affect the resulting digital health products’ and services’ accessibility. The traced scenario shows the need of an adequate regulatory governance of the currently developing datafied and digitized research environment, capable of effectively addressing the identified concerns. For these purposes, the suitability of the current European framework regarding health research, provided by the General Data Protection Regulation and the Clinical Trials Data Regulation is questioned. Ultimately, the study identifies the relevant responses currently provided by the existing normative framework, the emerging policy developments and persisting gaps