The DPCM n. 178/2015 establishes that each Italian region and autonomous province must establish the Electronic Health Record (EHR) through a technological infrastructure capable of interoperating with the other regional EHR solutions, exposing appropriate services that allow the realization of a series of interregional processes. The interoperability services allow to carry out the search, recovery, registration, cancellation of documents and index transfer of the EHR. The regulatory changes that took place in the context of the 2017 Budget Law (Law 11 December 2016, no.232 published in the Official Gazette no.297 of 21 December 2016) introduced the Infrastructure National for Interoperability (INI), whose design is by the Agency for Digital Italy, in agreement with the Ministry of Health and the Ministry of Economy and Finance and with the regions and autonomous provinces, and whose implementation is provided by the Ministry of Economy and Finance.
The INI has the task of ensuring the interoperability of regional EHRs, the identification of the assisted person through alignment with the National Registry of Patients, the interconnection of the subjects envisaged for the telematic transmission of data for regions that will request it by 31 March 2017, the management of the national and regional codes established and made available by the Public Administrations and Authorities that hold them.
The interoperability processes, functionalities, access methods and technical rules of interaction between the regional systems and the INI are described in the AgID circular no. 4/2017 of 1 August 2017, in the Ministerial Decree of 4 August 2017 of the Ministry of Economy and Finance in agreement with the Ministry of Health and in the related technical specifications. These documents were produced as part of a working group in which have actively participated the Agency for Digital Italy, the Ministry of Health, the Ministry of Economy and Finance, the Italian Data Protection Authority, the italian regions and autonomous provinces, Sogei and the National Research Council of Italy.