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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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The Italian National Health Service has over 214 thousand regular inpatient beds, of which 20.5% are in accredited private facilities. There are 12,027 spots for day hospital care, nearly all of which are public (88.6%), and 8,132 spots for day surgery, predominantly public (76.7%).
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The national PHR
History
From a normative perspective, the Italian National PHR, called ‘Fascicolo Sanitario Elettronico (FSE)’ has been introduced from Art. 12 of 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 region had to create and implement a PHR by the 20th of June 2015.
the user interfaces, the systems, and the software had to ensure full interoperability on a regional, national, and European basis.
Even before this law, some Regions already started projects to realise local FSEs (e.g. Emilia Romagna region).
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 relevant 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.
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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 pediatrician). This should be a support especially for emergency situations, 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 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 for medical decisions taken by others on the basis of the patient’s summary. Then there are usage statistics, it is possible to see that GPs tend to avoid using the patient summary feature. The reasons for low adoption seems to be: the doctors' belief that redacting this section is very time-consuming; the fact that GPs do not perceive personal benefit in its use, as the patient summary data is primarily meant for other clinicians; GPs feeling uneasy about being held accountable for medical decisions made by others based on the patient's summary.
Apart from the core elements of the FSE, there are some optional elements. Each region can decide which ones to have in its FSE, for example:
a feature to let the patient add notes and clinical documents. This is an important promoter of patient self-management and empowerment . It and it is argued that this should become a core element. ;
in-home assistance programs,;
care plans;
medical certificates;
Vaccinations
others vaccinations.
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 managing data regarding the National Transplants Network). ;
the Italian Vaccine Registry;
“CUPs”: regional centres for appointment management.
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Challenges and areas for improvement
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.)
Single 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 change their access modality and they might find it difficult or impossible to access their record (e.g. in the case of moving to a different Countryregion).
The law d.p.c.m. from 2015 established that each Region has had to implement the FSE through a technological infrastructure that is was 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 that the National Infrastructure for Interoperability (INI), which should have signed the moving move 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 Carlo De Masi, the president of the national Consumers Protection Association, sid in 2023 that the 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 Consumers protection association).”
New architecture:
In
New architecture:
In 2022, on the Gazzetta Ufficiale della Repubblica Italiana*, guidelines for the creation of the FSE were published. (*The "Gazzetta Ufficiale della Repubblica Italiana" -Official Gazette of the Italian Republic- is the official journal of record of the Italian government. It publishes legal notices, laws, decrees, and other official information from the government )
The image below shows in black, what already exists, and 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, as stated in the picture, should be in FHIR format), making the interoperability platform uselessunusable.
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Published outcomes - statistics
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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).
auto testing (covid test)
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Bibliography:
Posteraro, N. (2021). La digitalizzazione della sanità in Italia: uno sguardo al Fascicolo Sanitario Elettronico (anche alla luce del PNRR). FEDERALISMI. IT, 2021, 1-42.
Ciampi, M., Esposito, A., & Sicuranza, M. Stato dell’arte sulle iniziative nazionali relative allo sviluppo di sistemi ICT interoperabili per la Salute Digitale.
Gazzetta Ufficiale della Repubblica Italiana. (2022, July 11). FSE (Allegato A). Gazzetta Ufficiale della Repubblica Italiana, Serie generale - n. 160, 11-07-2022. Accessed at Gazzetta Ufficiale della repubblica Italiana 11-07-2022
Fascicolo Sanitario Elettronico. Monitoring.https://www.fascicolosanitario.gov.it/en/monitoring