Country’s healthcare system in a nutshell

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 are responsible for financing, planning, and delivering healthcare services at the local level.

The primary funding for the Italian SSN comes from a mix 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 age structure and other epidemiological factors. This formula is annually agreed upon between the national government and the regions at the State-Regions Conference, an intergovernmental 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 from national value-added tax.

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

(World Health Organization, 2022)

Public vs private

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). 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) (Posteraro, 2021).

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 2.5 billion euros on digital health, of which 1.3 billion euros to create a data infrastructure for the Italian FSE, which has to be homogeneous across the nation and include the whole 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 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 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 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 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 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 and it is argued that this should become a core element;

• in-home assistance programs;

• care plans;

• medical certificates;

• 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 managing data regarding the National Transplants Network);

• the Italian Vaccine Registry;

• “CUPs”: regional centres for appointment management.

(Posteraro, 2021)

Challenges and areas for improvement

In the last decade, 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 achieved (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 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 the National Infrastructure for Interoperability (INI), should have signed the move from a federal system to a centralised, national one. In the same year, 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

(Posteraro, 2021)

Carlo De Masi, president of the Italian National Consumers Protection Association, stated in 2023 that the lack of interoperability among regional systems not only fails to safeguard patients' health but also diminishes the usefulness and effectiveness of the FSE (CISL, 2023)

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 unusable.

Published outcomes - statistics

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:

• 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

Regarding the use by clinicians:

• 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”.

For what concerns the use by healthcare facilities:

• in 10 regions (including one autonomous province), there are no healthcare facilities that 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%

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

Screenshots

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

• 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

• 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)

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