EU-wide mapping report on legal and ethical considerations regarding data protection, clinical trials regulation and patient rights for predictive silico models in personalized medicine

This report will describe the outcomes of an in depth analysis regarding (i) international and European data protection and clinical trials regulation as well as legal and ethical regulation relevant for protection of equal access to health, and right to information and self-determination relevant for harmonization and integration of data in in-silico modelling, and (ii) an assessment of the challenges and options this regulation provides for harmonization and integration of data in in-silico modelling. Despiste the existence of European law (GDPR and clinical trials regulation), there are still uncertainties regarding e.g. the impact of the GDPR in regards to this kind of data sharing. E.g. the continuing differences in the interpretation of anonymisation/pseudonymisation is a key example of this uncertainty. We are completely lacking in caselaw on the major changes to the legislation, and thus far there has been relatively little guidance from the European Data Protection Board (EDPB). BBMRI may cover the general ground, as might other suggestions for Charters etc. of international data sharing principles. But these will be a) novel in themselves b) not complete solutions and c) not targeted at in silico models for precision medicine. Concequently, our report will evaluate the impact of European law (data protection, research ethics- and regulation and patients’ rights ) as well as existing general standardization strategies specifically in the context of in silico modelling approaches for personalized medicine. We will explore this thoroughly based on input from the other WP’s and the ongoing H2020 research projects of EU-STANDS4PM.