# Ensuring the Long-Term Preservation of and Access to the Italian Federated Electronic Health Record
## 1 Introduction  
The Italian federated Electronic Health Record, called the Fascicolo Sanitario Elettenrico (hereafter FSE), is a pillar within the initiatives relevant to the accomplishment of Digital Health [1]. It provides a consistent information base that is useful for the entire healthcare pathway to improve the cooperation among different healthcare professionals. Patients also have the possibility to access, trace, and consult their healthcare history and to share it, anytime and anywhere all over the country, with healthcare professionals, who have constant access to a clear and complete view of the patient's health conditions and can, therefore, ensure an effective and efficient care service, especially in emergency situations. The first Italian regulations for the FSE were the guidelines issued by the Italian Data Protection Authority in 2009 [2], which mainly addressed the management of patient data privacy. Subsequently, in 2012, the Legislative Decree n. 179 urged Italian regions and autonomous provinces to establish and implement regional FSE systems, highlighting the need to ensure interregional interoperability services. In 2015, the Prime Minister Decreen. 178 intervened specifically on the matter by regulating the FSE legislation with an annex focused on the technical requirements, i.e., document formats, clinical coding systems usage, etc. Recently, the Decree Law n. 34/2020 [3] enhanced the FSE functions and scope, in relation to the clinical data and document types and the plethora of healthcare subjects who can feed it, as well as introducing the patient's explicit consensus for FSE activation and indexing of medical records produced before the Decree itself. In this context, the Agency for Digital Italy (AgID) and the Italian National Research Council (CNR), cooperating with expertise from the Ministry of Health and the Ministry of Economics and Finance, defined a series of technical specification documents to address interoperability services [4]. The national federated and interoperable infrastructure applied to FSE [5; 6; 7], as mentioned, aims to facilitate access to healthcare data and documents for both healthcare providers and patients and so to improve diagnostic and therapeutic care pathways. It is built to allow the management and sharing of clinical documents among the different regional FSE systems through the National Infrastructure for the regional FSE Interoperability (INI). Its architecture is based on a network of registries, one per region, and repositories, which can be centralized or distributed within a region (e.g., located in the healthcare facilities or hospitals). FSE registries index metadata of the clinical documents in order to be an assured reference for finding and retrieving them; FSE repositories physically collect documents that are available for access and consultation. All the advantages that FSE offers are feasible if the documents, and the information they contain, are updated, accessible and available over time. Moreover, it is fundamental for the FSE system to ensure access to legally valid, reliable documents, which are also enforceable towards third parties, guaranteed by the application of the reference legislation. Within the Italian normative framework, all these requirements can be achieved if the document is inserted in a long-term preservation system, arranged by document producers in compliance with the principles of the Italian national guidelines for the creation, management and preservation of digital documents, edited by AgID (hereafter Guidelines) [8]. The producers ensure that no modifications have been made to the original document during the custodianship, and for them digital preservation is both a practical necessity and a legal obligation [9]. Long-term preservation represents the final step of the document management process and it is closely influenced by the accuracy of the prior steps regarding document creation and management.