# Ensuring the Long-Term Preservation of and Access to the Italian Federated Electronic Health Record
## 2 Background
### State of the Art about Clinical Document Long-Term Preservation  
Data and information long-term preservation is a critical issue in the healthcare and clinical research domains. Even though long-term preservation is not usually perceived as associated with interoperability ([PERSON] et al., 2013), its accomplishment also requires the application of suitable solutions able to achieve both technical and semantic interoperability over time. To improve information sharing and communication, several advanced standards such as XML-based data encoding rules, Health level 7 (HL7) and Digital Imaging and Communications in Medicine (DICOM) have been developed. In this section, we are going to refer to some initiatives that deal with how clinical data and information should be preserved, considering that in FSE, the objects to be preserved are mainly documents rather than data, although recently this trend is gradually inverting. The European project ENSURE (Enabling kNowledge Sustainability, Usability and Recovery for Economic Value) ([[https://cordis.europa.eu/project/id/270000](https://cordis.europa.eu/project/id/270000)]([https://cordis.europa.eu/project/id/270000](https://cordis.europa.eu/project/id/270000)), accessed on 9 March 2022) presents a semantic approach to data long-term accessibility and integrity of health care, clinical trial and financial data ([PERSON] et al., 2013), by exploiting the advantages deriving from the combination of the conceptual framework of the Open Archival Information System (OAIS) ([[http://www.oais.info/](http://www.oais.info/)]([http://www.oais.info/](http://www.oais.info/)), accessed on 9 March 2022) model and of the ontology modeling. Indeed, guaranteeing long-term access and preservation is one of the strands of this project. The aim is to enhance workflow management and, therefore, long-term preservation, by considering regulatory compliance and obsolescence factors. The methodology proposed by ENSURE represents a valid reference for our work because, as in FSE, it leverages metadata description to ensure authenticity and integrity over time. In ref. ([PERSON] et al., 2013) is also underlined the role of OAIS, since it allows us to define responsibilities and functions typical of a system aimed at the data preservation, retrieval and access. In this study, the focus is on the lifecycle of biomedical data generated from research, potentially useful for further and future needs. Therefore, a relevant implicit constraint is on which data need to be preserved and for how long. The importance of following a data-driven approach by focusing on data type, on the responsibility and on the fragmented technical systems adopted, is recalled by ([PERSON] et al., 2013). This perspective is partially feasible for FSE, because it mainly collects documents about a patient's clinical history; so far, it has been treated as a document collection (except for the registry) with limited opportunities for data processing and information extraction presently. Similarly to FSE, other initiatives favored the use of standardized EHRs to achieve semantic interoperability, but differently from our approach, adopted the openEHR standard for experimentation purposes. This standard gives consistent indications regarding data storage and archetype-based patient information retrieval, but its application to the FSE setting and thus for its long-term preservation has not been considered since, as stated above, FSE mainly contains clinical documents and their aggregation, which, in addition to being retrieved, need to maintain their authenticity in the long-term. See [PERSON] et al. (2018) and [PERSON] et al. (2019) for storage implementation of standard-based EHR data and a survey of openEHR storage implementation, respectively.