The current availability of both qualitative and quantitative health data is unprecedented in the history of mankind (i.e., 2.5 quintillion bytes/day which means 1,7 Mb per person/per second from 200 Billion connected devices by the end of 2020).

Soon technology-computing, connectivity and storage capacity will enable further availability of health data exponentially in two ways: increasing computerization and quantifying self and mobile-health.

Both these advances have potential issues. The increased computerization of medical processes and procedures would need to provide means to link data to information and to knowledge in a virtuous interexchange while quantifying self and mobile-health, (i.e. the possibility for each person, healthy or not, to measure their medical condition through smartphones, wearable sensors and any other digitally reducible phenotypes) by becoming the primary source of health data that would need to be reconciled with data access, usage, portability, privacy and – in Europe – with GDPR compliance.

The present proposal aims at addressing in a solution-based methodology both issues.

The overall goal of this 4-years project is the development of a patient centered process prototype to allow the direct generation and the return of clinical trials data to study participants.

By putting the study participants at the very core of their data portability and secondary use the FACILITATE project will make it easier to integrate both local and pan-European implementations considering best practices and data protection regulations.

This prototype process will be delivered as part of the project alongside a robust business plan to ensure its sustainability to foster the harmonization of the legal framework applicable to medical research in different European Member States.