Country’s healthcare system in a nutshell

Italy's healthcare system is consistently ranked among the best in the world. Life expectancy is the 4th highest among OECD countries and the world's 8th highest according to the WHO. Healthcare spending accounted for 9.7% of GDP in 2020.

The Italian state has run a universal public healthcare system since 1978. However, healthcare is provided to all citizens and residents by a mixed public-private system. The public part is the Servizio Sanitario Nazionale (SSN), which is organised under the Dr Maria Montessori was appointed co-director of Rome’s new Scuola Ortofrénica, dedicated to training teachers to work with children who had cognitive and developmental challenges. Starting in 1899, her techniques helped the children with difficulties catch up with those without. So she wondered how much normal schooling was holding back normal children. Montessori schools would eventually teach many technology founders including Larry Page and Sergey Brin (Google), Jeff Bezos (Amazon) and Jimmy Wales (Wikipedia).

Country’s healthcare system in a nutshell

Italy’s regionalised National Health Service (Servizio Sanitario Nazionale, SSN) has provided universal coverage to all citizens and legal residents since 1978. The SSN is organised under the national Ministry of Health and administered on a devolved regional basis. The public system is a regionalised National Health Service, that provides universal coverage to all citizens and legal residents. The central government provides overall stewardship, sets Central government establishes the national benefits package , and allocates funding for to the regional health systemsregions. The regions are in charge of responsible for financing, planning, and provision of delivering healthcare services at the local level

Public vs private

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In 2021, hospital care relied on 995 healthcare facilities, of which 51.4% were public and the remaining 48.6% were accredited private facilities.

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%).

The national PHR

History

From a normative perspective, the Italian National PHR, called ‘Fascicolo Sanitario Elettronico (FSE)’ has been .

The 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 that takes into account epidemiological factors such as population age structure. This formula is agreed annually between the national government and the regions at the State-Regions Conference, an intergovernmental forum for decision-making. The national government 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.

Out-of-pocket (OOP) payments in Italy are significantly higher than the EU’s average. In 2019, Italy’s OOP accounted for 23.3% of total health expenditure while the EU average was 15.4%. The majority of OOP spending in Italy goes towards direct payments for services not covered by the SSN particularly outpatient medical care and over-the-counter medications. Remaining OOP are co-payments for covered services such as medications, outpatient specialist visits, and diagnostic tests (World Health Organization, 2022).

Health insurance covers the entire population of Italy. This encompasses both those who are members of health insurance schemes and those who have free access to state-provided healthcare services (Our World in Data, n.p.).

Public vs private

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The national PHR

History

Fascicolo Sanitario Elettronico (FSE), the Italian National PHR, was introduced from Art. 12 of Law Decree 18 Oct 2012 n. 179 ( “decreto crescita”, converted into law 17 Dec 2012, n. 221). The 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 Some regions had started local FSE projects 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, 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.

Italy’s National Plan of Recovery and Resilience (PNRR) allocated 2.5 billion euros for digital health, with 1.3 billion euros dedicated to establishing a national data infrastructure for the FSE. The infrastructure aims to be homogeneous across the country and to include the entire clinical history of patients. The budget is for 2021-2026 (Permanent Conference for Relations between the State, the Regions, and the Autonomous Provinces, 2022).

Features

Regional Fascicolo Sanitario Elettronico (FSE) systems must adhere to the national minimum standards for data sharing and basic features. However, each FSE is still distinct, with variation across regions, and it is therefore difficult to define a uniform set of features.

The core elements of the FSE as stated in the national legislation include: 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. It 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;.

• vaccinationsVaccination records.

RecentlyRecent legislation, the Law Decreet “decreto rilancio” 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 the last 2 decades, some Regions have started initiatives to realise platforms for the collection of Over the past decade, 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 reached.

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 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 technological advancements across these regions have prevented the achievement of true interoperability (Ciampi et al., 2019).

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 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, centralized national one . In the same year, 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:

• heterogeneity of data

• utilisation of different standards by different Regions

• presence of different laws

Carlo De Masi, the president of the national Consumers Protection Association, sid in 2023 . 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, remarked that the lack of interoperability of between regional systems , that doesn’t safeguard the health of the patients, diminish the usefulness and the efficacy of the FSEnot only compromises patient safety but also diminishes the FSE’s overall utility and effectiveness (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 "in the Gazzetta Ufficiale della Repubblica Italiana" -Official Gazette of the Italian Republic- is the (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 black, what already exists, and in grey, 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

https://www.fascicolosanitario.gov.it/en/monitoring

Almost all the Italian citizens activated their FSE (57.663.021 people having activated their FSE in a population of 58.851.000). However, the login activity is quite low.

If we look at the data from the third trimester of 2023, we can see that, for what concerns utilisation by patients:

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only in one Region, more than 50% of the citizens utilised the FSE (Emilia Romagna)

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As of the third trimester of 2023, nearly all Italian citizens have activated their Fascicolo Sanitario Elettronico (FSE), with 57.66 million users out of a total population of 58.85 million. However, login and usage rates remain low.

Patient Utilisation:

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

• 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.

Screenshots

Note: the screenshots refer to the FSE of the Emilia Romagna region, which, at the moment, is the one showing the highest utilisation.

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• Recent;

• Preferred;

• All;

  • Reports:

    • Tests

    • Radiology

    • Specialty Medicine

    • A&E

  • Prescriptions:

    • Appointments and exams

    • Medications

    • Deliverable drugs

    • Care plans

  • Admissions

  • Patient summary

  • Vaccinations

  • Screening

  • Self-certifications

  • Others

  • Contributed by me

  • Archived

  • Personal notes

  • Tag

  • Upload document

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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(AGID Agenzia per l’Italia Digitale, 2023-2024).

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.

Statistics are also available regarding other services offered through the FSEs. In 95% of the regions, the FSEs are configured to display the COVID-19 certificate. More than half of the regions allow patients to request exemption certificates for service fees through their PHRs (81%), make co-payments for services (76%), book appointments with specialists in public healthcare facilities upon referral (76%), choose and change general practitioners (76%). In 48% of the Regions, patients can also invite carers to view their records.

(AGID Agenzia per l’Italia Digitale, 2023-2024)

Screenshots

• Lepida’s platform for Emilia-Romagna in Italy

Bibliography

• AGID Agenzia Per l’Italia Digitale, n.d. Fascicolo Sanitario Elettronico - Monitoring. Available at: https://www.fascicolosanitario.gov.it/en/monitoring (accessed: 29 April 2024).

• Ciampi, M., Esposito, A.

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• and Sicuranza, M., n.d. Stato dell’arte sulle iniziative nazionali relative allo sviluppo di sistemi ICT interoperabili per la Salute Digitale. Available at: https://www.researchgate.net/profile/Mario-Ciampi/publication/334204495_Stato_dell'arte_sulle_iniziative_nazionali_relative_allo_sviluppo_di_sistemi_ICT_interoperabili_per_la_Salute_Digitale/links/5d1cc763299bf1547c94fbd3/Stato-dellarte-sulle-iniziative-nazionali-relative-allo-sviluppo-di-sistemi-ICT-interoperabili-per-la-Salute-Digitale.pdf (accessed: 29 April 2024).

• CISL, 2023. Consumatori. Adiconsum Cisl: “The Current Electronic Health Record Without Interoperability Does Not Protect Citizens' Health and Increases Healthcare Costs, Making the Tool Useless and Ineffective”. (online) 26 January. Available at: https://www.cisl.it/notizie/categorie-ed-enti-cisl/consumatori-adiconsum-cisl-lattuale-fascicolo-sanitario-elettronico-senza-interoperabilita-non-tutela-la-salute-dei-cittadini-consumatori-e-fa-lievitare-i-costi-della-sanita-rende/ (accessed: 29 April 2024).

• Gazzetta Ufficiale della Repubblica Italiana

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• , 2022, 11 July

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• . FSE (Allegato A). Gazzetta Ufficiale della Repubblica Italiana, Serie generale - n. 160, 11-07-2022.

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• Available at: https://www.gazzettaufficiale.it/eli/id/2022/07/11/22A03961/sg .(accessed: 29 April 2024).

• Permanent Conference for Relations between the State, the Regions, and the Autonomous Provinces ,2022. Digital Health. Presentation to the Permanent Conference for Relations between the State, the Regions, and the Autonomous Provinces, Rome, 2 March 2022. REP. ATTI No. 22/CSR of 2 March 2022. Available at: https://www.statoregioni.it/it/conferenza-stato-regioni/sedute-2022/seduta-del-02032022/atti/repertorio-atto-n-22csr/ (accessed: 29 April 2024).

• Posteraro, N., 2021. La digitalizzazione della sanità in Italia: uno sguardo al Fascicolo Sanitario Elettronico (anche alla luce del PNRR). FEDERALISMI. IT, 2021, pp.1-42. Available at: https://air.unimi.it/handle/2434/946488 (accessed: 29 April 2024).

• World Health Organization, 2022. Italy: health system review. Health Systems in Transition, 24(4). Available at: https://eurohealthobservatory.who.int/publications/i/italy-health-system-review-2022 (accessed: 29 April 2024).

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