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Italy operates a regionalised National Health Service (Servizio Sanitario Nazionale, SSN), which has provided universal coverage to all citizens and legal residents since 1978. The SSN is organised under the Ministry of Health and administered on a regional basis. The central government oversees the system, establishes the national benefits package, and allocates funding to the regions. The latter , which are responsible for financing, planning, and delivering healthcare services at the local level.

The primary funding for the Italian SSN comes from a mix SSN is primarily funded through a combination of regional and national taxes, with pooled funds managed at the national level. Each region’s share of funding is determined by a formula which considers the population's that takes into account factors such as population age structure and other epidemiological factorsconsiderations. This formula is agreed annually agreed upon between the national government and the regions at the State-Regions Conference, an intergovernmental forum for decision-making forum. The national government covers the financial gap between each region's estimated financial needs and the revenue they raise through an equalisation fund, sourced provides additional financial support through an equalisation fund, sourced from national value-added tax, to cover the gap between each region's estimated financial needs and their own revenue.

Italian household outOut-of-pocket payments (OOP) in Italy are significantly higher than the EU average (e.g. . For instance, in 2019, OOP in Italy were accounted for 23.3% , while of total health expenditure, compared to the EU average was of 15.4%). While some services, such as medicinesmedications, outpatient specialist visits, and diagnostic and laboratory tests, require co-payments, the vast majority of OOP spending in Italy is on goes towards direct payments for services, in particular particularly outpatient medical care , and over-the-counter medicines medications not covered by the SSN.

(World Health Organization, 2022)

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From a normative perspective, the Italian National PHR, called known as the ‘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). The This law established that:

• each Each region had to create and implement a PHR by the 20th of June 20, 2015.

• the The user interfaces, the systems, and the software had to must ensure full interoperability on a at regional, national, and European basislevels.

Even before this law, some Regions regions had already started initiated projects to realise develop local FSEs (e.g. , such as the Emilia Romagna region ) (Posteraro, 2021).

In more recent years, Italy wrote, as requested by the EU recovery package Next Generation EU (NGEU), the National Plan of Recovery and Resilience (PNRR), in which each country has to define a plan of reforms and investments for the period 2021-2026. The Italian PNRR was officially approved by the Italian Government on the 13th of July 2021.

The PNRR invests around allocates approximately 2.5 billion euros on for digital health, of which with 1.3 billion euros dedicated to create establishing a national data infrastructure for the Italian FSE, which has FSE. This infrastructure aims to be homogeneous across the nation country and to include the whole entire clinical history of the patients (Permanent Conference for Relations between the State, the Regions, and the Autonomous Provinces, 2022).

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 visitsEven though all regional Fascicolo Sanitario Elettronico (FSE) systems must adhere to the minimum standards set by law for data sharing and basic features, each region’s FSE is still distinct. As a result, the functionalities of the Italian FSE vary across regions, making it challenging to define a uniform set of features.

According to the legislation, the FSE must include a set of "core" elements, such as patient demographics, clinical reports (e.g., specialist visit reports, test results, radiology), A&E reports, discharge letters, organ donations donation consent, a patient summary, and a pharmaceutical dossier.

The pharmaceutical dossier is a section, which is updated by the pharmacies, that can then help track the pharmacological history of the patient, monitor whether the new medications are appropriate, and whether the patient is adhering to therapies. This section is, at the moment, not completely developedpharmacies and helps track a patient's medication history, assess the appropriateness of new prescriptions, and monitor adherence to therapies. However, this feature is still underdeveloped in many regions.

The patient summary is provides a summary concise overview of the patient's clinical profile of the patient - e.g. , including chronic conditions, transplants, adverse drug reactions to medications, allergies -, redacted and allergies. It is created 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 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 or paediatrician and is particularly useful in emergencies, offering clinicians a quick snapshot of the patient’s health. Despite its importance, GPs have been slow to adopt this feature, citing the time-consuming nature of creating the summary, the lack of direct benefit to their own practice, and concerns about being held accountable for medical decisions made by others other clinicians 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:

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this information.

In addition to these core features, regions may choose to include optional elements in their FSE. These can include:

• Patient ability to add notes and clinical documents, which promotes self-management and empowerment. Some argue that this should become a core element;feature.

• inIn-home assistance programs;

• care Care plans;

• medical Medical certificates;

• vaccinations.

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• Vaccination records

Recent legislation, the Decreto Rilancio (2020), has set that mandates the integration of the FSE has to integrate also withwith other national systems, including:

• the The Transplants Informative Information System (Sistema Informativo Trapianti - SIT), a digital infrastructure platform for managing data regarding related to the National Transplants Network);

• the The Italian Vaccine Registry;

• “CUPs”: regional centres for Regional appointment management . systems (CUPs)

(Posteraro, 2021)

Challenges and areas for improvement

In Over the last past decade, some Regions have started initiatives to realise platforms for the collection of several regions in Italy have initiated projects to develop platforms for collecting clinical records produced by their healthcare institutions. The adoption of different However, differences in 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 achieved models, and technological advancements across these regions have prevented the achievement of true interoperability (Ciampi et al., 2019).

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 Each region establishes its own Fascicolo Sanitario Elettronico (FSE), following a model based on a network of regional systems rather than a unified national system. Therefore, currently, patients can only access their FSE through the platform provided by their region. This creates challenges when they move to a different region, as they may need to adopt a new access method, potentially finding it difficult or impossible to access their record (e.g. in the case of moving to a different region). The law d.p.c.m. from 2015 established that each Region had to implement the FSE through a technological infrastructure that 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 retrieve their previous records.

A law from 2015 mandated that each region implement the FSE using a technological infrastructure interoperable with other regional FSEs, ensuring that patients could move between regions without losing access to their data. To achieve this, in 2018, the National Infrastructure for Interoperability (INI) , should have signed the move was introduced, aiming to transition from a federal federated system to a centralised, national one. In the same year, centralized national one with a single point of access was going to be established, but this never happened.

At the moment, interoperability is not real in practice, because of:

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heterogeneity of data

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utilisation of different standards by different Regions

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. However, this centralization has not yet been realized.

Currently, interoperability remains ineffective due to several factors:

• Data heterogeneity across regions

• The use of different technological standards

• The existence of varying regional laws

(Posteraro, 2021)

In 2023, Carlo De Masi, president of the Italian National Consumers Protection Association, stated in 2023 remarked that the lack of interoperability among between regional systems not only fails to safeguard patients' health compromises patient safety but also diminishes the usefulness FSE’s overall utility and effectiveness of the FSE (CISL, 2023).

New architecture:

In 2022, on the Gazzetta Ufficiale della Repubblica Italiana*, guidelines for the creation of the a more integrated FSE were published . (*The "Gazzetta Ufficiale della Repubblica Italiana" -Official Gazette of the Italian Republic- is in the Gazzetta Ufficiale della Repubblica Italiana (the official journal of record of for the Italian government. It publishes legal notices, laws, decrees, and other official information from the government )The image below shows in dark purple, what already exists, and in purple, is the hypothesis of intervention. This shows that there are ). The diagram below illustrates the existing regional registries and an interoperability platform (shown in dark purple) alongside the proposed future interventions (in purple). Despite having regional registries and a platform for interoperability. However, there’s no , the absence of a central data repository, no a national registry, and no structured data (which ideally , as stated in the picture, should be in FHIR format) , making renders the current interoperability platform largely unusable.

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Published outcomes - statistics

As of the third trimester of 2023, almost nearly all the Italian citizens activated their FSE (57.663.021 people having had activated their FSE in a Fascicolo Sanitario Elettronico (FSE), with 57.66 million users out of a total population of 58.851.000)85 million. However, the login activity is quite login and usage rates remain low.

For what concerns utilisation by patientsPatient Utilisation:

• only Only in one Region, region (Emilia Romagna) did more than 50% of the citizens utilised use the FSE (Emilia Romagna)in 7 .

• In seven regions, less than 20% of patients used itin 9 accessed their FSE.

• In nine regions, 0% of patients used it

Regarding the use by clinicians:

• in 5 utilized the FSE.

Clinician Utilisation:

• In five regions, 0% of the clinicians used itin 7 the FSE.

• In seven regions, less than 50% of clinicians accessed the clinicians used itplatform.

• only Only in 2 two regions , the did clinicians added add information to the “patient summary”"patient summary.

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Healthcare Facility Participation:

• in In 10 regions (including one autonomous province), there are no healthcare facilities that add contributed data to the FSE of its citizenstheir citizens' FSE.

• In 6 six regions, less than 60% of healthcare facilities do thatparticipated.In only 4 regions, the percentage is

• Only in four regions did more than 60% of facilities add data to the FSE.

As of May 2024, the Government has released new statistics on the percentage of Regions and Autonomous Provinces where the FSE is configured to store specific types of documents. However, while the system is capable of storing these documents, their actual presence in a patient’s record depends on the particular healthcare facility involved. All of them are configured to store: discharge letters, prescriptions, referrals, lab results, imaging results, outpatient appointment reports, and emergency admission reports. More than half also have: pathology reports, patient summaries, vaccination certificates, documents attesting specialist care service have been provided, documents attesting the prescribed medication has been bought, and personal health diary.

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