The Decree Law 18 October 2012, n. 179 (so-called “Growth 2.0”), and subsequent amendments, in article 12 establishes the Electronic Health Record (FSE) as a set of digital health and social-health data and documents concerning the patient, provided by the Regions and the Autonomous Provinces.
The Decree of the President of the Council of Ministers of 29 September 2015, n.178 containing the “Regulations on the Electronic Health Record” contains the technical rules according to which the Regions realize their own regional FSE systems. The Decree provides for the mandatory use of LOINC codes for the unambiguous identification of the tests within the laboratory reports in HL7 CDA2 format.
The document “Technical specifications for interoperability between regional FSE systems“, drawn up and periodically updated by CNR and AgID in agreement with the Department for Digital Transformation (DTD) and Sogei in accordance with the Decree-Law of 19 May 2020 , n. 34 and the subsequent legislation regarding the FSE, specifies the coding systems to be used to promote the interoperability of the regional FSE systems, with particular reference to the clinical coding systems envisaged by the Prime Ministerial Decree on the FSE, as well as further administrative coding systems aimed at defining the values of the metadata transported in the IHE (Integrating the Healthcare Enterprise) transactions and used for the exchange of messages between the regional FSE systems and of the signed SAML v2.0 assertions, which has to be produced by the regional domains and inserted in the Header section of the SOAP messages.
In 2022 the Guidelines for the implementation of the FSE have reiterated the importance of adopting dictionaries and standards to encode data contained in clinical documents and ensure their semantic interoperability, and therefore the assignment of a unique meaning for all the users involved. Among them LOINC is identified to encode clinical and laboratory observations.
The recent Decree of 7 September 2023 Electronic health record 2.0 intervenes to specify the limits of responsibility and the tasks of the subjects who contribute to its implementation, the guarantees and security measures to be adopted in the processing of personal data in compliance with the rights of the patient, the methods and diversified levels of access to the FSE.