From electronic health records to personal health records: emerging legal issues in the Italian regulation of e-health

In 2012, the Italian Legislator has provided an appropriate legal framework for the realisation of the national Electronic Health Records (EHR) system, in which the patient plays a pivotal role: with the implementation of the Fascicolo sanitario elettronico (FSE), patients will have access to their EHRs through the online platform, and decide which data to share and with whom. In this perspective, one of the most interesting innovations is the so-called ‘taccuino’, a digital space of patients’ FSE in which they can autonomously record data and information relating to their health. Patients’ ability to access their own health data and EHR at any time and to enter information by themselves in a personal area is a unique form of power at a European level, but their legal consequences are still vague. The aim of this contribution is to offer a first review of the Italian e-health reform, showing the most critical aspects.