D2.5 Assessment of the CoBraD PUCs against ethical and legal standards

MES-CoBraD will develop 4 pilot use cases (“PUCs”) each one devoted to a different layer of the project and of the to-be platform. The first two pilot use cases will respectively be about the gathering and storage of real-world data (“RWD”) from the patients of the hospitals participating in the research (PUC1) and about the analysis of those datasets with the aid of advanced analytics tools, between which we include also machine learning (“ML”) and artificial intelligence (“AI”) algorithms (PUC2). The 3rd and 4th pilots (PUC3 and PUC4) will instead be devoted to testing (with the help of the knowledge gathered in the first two PUCs) drugs and therapies on patients and to the development of the final version of the MES-CoBraD platform, which includes an expert system for the diagnosis and care of complex brain diseases.

The objective of this deliverable is the ethical and legal assessment of the MES-CoBraD PUCs to support the project’s pilot partners during execution of their PUCs. Since at M18 only the first two pilots are in a sufficient advanced phase of development, here the focus is on PUC1 and PUC2, keeping in mind that some issues, like the ethical treatment of the patients or the use of AI in healthcare, will continue to be present in all the project and in particular in PUC3 and PUC4, so even though here we will not specifically evaluate PUC3 and PUC4, we lay the basis for their evaluation, which will be done in deliverable D2.8 in M24.