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The public system is a regionalised National Health Service (Servizio Sanitario Nazionale, SSN), that provides universal coverage to all citizens and legal residents. The central government provides overall stewardship, sets the national benefits package, and allocates funding for the regional health systems. The regions are in charge of financing, planning, and provision of services at the local level
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From a normative perspective, the FSE has been introduced from artArt. 12 of law decret Law Decree 18 Oct 2012 n. 179 ( “decreto crescita”, converted into law 17 Dec 2012, n. 221). Nevertheless, even before this instrument got national significance, some Regions already started projects to realise local FSEs (e.g. Emilia Romagna region).
The law established that:
each regions region had to create and implement a PHR within by the 20th of June 2015.
the user interfaces, the systems, and softwares the software had to ensure full interoperability at on a regional, national, and European basis.
Features
It’s hard to define the features of the Italian FSE because, as discussed in the following paragraph, each regional FSE has different ones.
According to the law (d.p.c.m. n. 178/2015), the FSE has to include a minimum amount of “compulsory/core” elements, which are: patient demographic, clinical reports (reports of specialists visits, test results, radiology), A&E reports, discharge letters, organ donations consent, patient summary, and pharmaceutical dossier.
The pharmaceutical dossier is a section, which is updated by the pharmacies, that can then help tracking track the pharmacological history of the patient, monitoring monitor whether the new medications are appropriate, and whether the patient is adhering to therapies. This section is, at the moment, not completely developed.
The patient summary is a summary of the clinical profile of the patient - e.g. chronic conditions, transplants, adverse reactions to medications, allergies -, redacted by the GP (or paedpediatrician). This should be a support especially for emergency situationsituations, so that a clinician can easily get a summary of the patient’s condition. Looking at the data, we can see that this section has a use which that is close to zero. (from Gazzetta ufficiale ) One of the reasons why this is not used is because redacting it is seen as time-consuming, and requires change in the normal workflow. Moreover, the GPs don’t see any benefit in using it as the data of the patient’s summary are not for them but for other clinicians. This way, the GPs become responsible of for medical decisions taken by others on the basis of the patient’s summary.
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a feature to let the patient add notes and clinical documents. This is an important promoter of patient self-management and empowerment. It is argued that this should become a core element.
in-home assistance programmesprograms,
care plans
medical certificates
Vaccinations
others
Recently, the Law Decreet “decreto rilancio” (2020), has set that the FSE has to integrate also with:
the Transplants Informative System ( Sistema Informativo Trapianti - SIT, a digital infrastructure for the management of data regarding the National Transplants Network).
the Italian Vaccine Registry
“CUPs”: regional centres for appointments appointment management.
Source: “La digitalizzazione della sanità in Italia: uno sguardo al Fascicolo Sanitario Elettronico (anche alla luce del PNRR)” → “Healthcare digitalisation in Italy: looking at the FSE”
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In the last 2 decades, some Regions have started initiatives to realise platforms for the collection of clinical records produced by their healthcare institutions. The adoption of different processes, the development of different architectural and technological models, and the different level of advancement of these projects , is the reason why, until now, interoperability hasn’t been reached. ( Ciampi, M., Esposito, A., & Sicuranza, M. Stato dell’arte sulle iniziative nazionali relative allo sviluppo di sistemi ICT interoperabili per la Salute Digitale.)
FSE is established by single regionsSingle regions establish FSE: this is a model in which the architecture is based on a national net of regional architectures.
At the moment, the patient can access the FSE through the modalities established by the laws of their region, and can only have access to their data through the access point of their region. If the patient moves, they need to chance change their access modality and they might find it difficult or impossible accessing to access their record (e.g. in the case of moving to a different Country). .
The law d.p.c.m. from 2015 establish established that each Region has to implement the FSE through a technological infrastructure that is interoperable with all the other Regional FSE. This is because patients should be able to move from Region to Region without losing their data. In 2018 it was established the National infrastructure Infrastructure for interoperablity Interoperability (INI), that which should have signed the moving from a federal system to a centralised, national one. In the same year, a single point of access was going to be established (which should have been this), but this never happened.
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heterogeneity of data
utilisation of different standards by different Regions
presence of different laws
The lacking lack of interoperability of regional systems, that doesn’t safeguard the health of the patients, diminish the usefulness and the efficacy of the FSE.” 26 Jan, 2023(Carlo De Masi, president of the national’s national Consumers protection association).”
New architecture:
In black, what is already existingexists, in grey, is the hypothesis of intervention. This shows that there are regional registries , and a platform for interoperability. However, there’s no central data repository, no national registry, and no structured data (which ideally should be in FHIR format), making the interoperability platform useless.
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If we look at the data from the third trimester of 2023, we can see that, for what concerns utilisation by patients:
only in one Region, more than 50% of the citizens utilised the FSE (Emilia Romagna)
in 7 regions, less than 20% of patients used it
in 9 regions, 0% of patients used it
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in 5 regions, 0% of the clinicians used it
in 7 regions, less than 50% of the clinicians used it.
only in 2 regions, the clinicians added to the “patient summary”.
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in 10 regions (including one autonomous province), there’s there are no healthcare facilities that adds add data to the FSE of its citizens.
In 6 regions less than 60% of healthcare facilities do that.
In only 4 regions, the percentage is more than 60%
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personal data
my clinicians
consents
delegations: share the management of your FSE with one or more people of your choice (delegates).
autotesting auto testing (covid test)
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