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This Project is a pilot study focused on the creation of best-practices, from a technical and a legal point of view, to enable automatic clinical data transfers from public and private institutions to one or more repository selected by a citizen. The basic idea is that people are the owners of their data and must have the possibility of managing them, deciding directly all the aspects connected to data storing and sharing. In this model, a person can decide to automatically transfer the data to the desired destinations (dropbox-like repositories, clinical trials, apps, ...), selecting the kind of data to transfer and the time constraints and giving a specific consent, which can be revoked in any time. This implies the definition of a model for a structured and dynamic consent, allowing a person to directly control targets, treatment and purposes for each single data, coming from different sources. This paradigm implies a deep analysis about security, privacy and about ethical, legal and social implications connected to data consent and management, from acquisition to destination.
This Project is a pilot, focused on exploring security aspects and legal implications. From the technical point of view, it will be designed a generic architecture with a central core (Health Gateway) devoted to ensuring consent management and secure transfer from a generic source to a generic destination. Mechanisms about secure authentication, consent confirmation and secure data transfer will be analyzed. From the legal point of view, the whole process will be analyzed considering the present legislation perspective (Italian and international), to develop a valid legal protocol to enable data transfer according to the citizens will. The Project results include the development of a reference implementation, compliant with the legal protocol developed and connected to the Sardinian Region General Practitioner Information system.