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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 operates a regionalised National Health Service (Servizio Sanitario Nazionale, SSN), which has provided universal coverage to all citizens and residents by a mixed public-private system. The public part is the Servizio Sanitario Nazionale (SSN), which legal residents since 1978. The SSN is organised under the 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 oversees the system, establishes the national benefits package, and allocates funding for to the regional health systemsregions. The regions are in charge of latter are 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 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

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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). The law established that:

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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).

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• 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 2 decadesdecade, 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 reachedachieved (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.

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• heterogeneity of data

• utilisation of different standards by different Regions

• presence of different laws

(Posteraro, 2021)

Carlo De Masi, the president of the national Italian National Consumers Protection Association, sid stated in 2023 that the lack of interoperability of among regional systems , that doesn’t safeguard the health of the patients, diminish the usefulness and the efficacy of the FSE.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.

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Published outcomes - statistics

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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.

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• 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.

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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. Stato dell’arte sulle iniziative nazionali relative allo sviluppo di sistemi ICT interoperabili per la Salute Digitaleresearchgate.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). http:// 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).