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

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 factors such as population age structure and other epidemiological considerations. 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 payments (OOP) in Italy are significantly higher than the EU average. For instance, in 2019, OOP in Italy accounted for 23.3% of total health expenditure, compared to the EU average of 15.4%. While some services, such as medications, outpatient specialist visits, and diagnostic tests, require co-payments, the majority of OOP spending in Italy goes towards direct payments for services, particularly outpatient medical care and over-the-counter medications not covered by the SSN.

(World Health Organization, 2022)

According to the most recent data from 2010, health insurance covered the entire population of Italy. This coverage 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

The national PHR

History

From a normative perspective, the Italian National PHR, 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). This law established that:

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

• The user interfaces, systems, and software must ensure full interoperability at regional, national, and European levels.

Even before this law, some regions had already initiated projects to develop local FSEs, 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 allocates approximately 2.5 billion euros for digital health, with 1.3 billion euros dedicated to establishing a national data infrastructure for the FSE. This infrastructure aims to be homogeneous across the country and to include the entire clinical history of patients (Permanent Conference for Relations between the State, the Regions, and the Autonomous Provinces, 2022).

Features

Even 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 donation consent, a patient summary, and a pharmaceutical dossier.

The pharmaceutical dossier is updated by pharmacies 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 provides a concise overview of the patient's clinical profile, including chronic conditions, transplants, adverse drug reactions, and allergies. It is created by the GP 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 other clinicians based on 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 feature.

• In-home assistance programs

• Care plans

• Medical certificates

• Vaccination records

Recent legislation, the Decreto Rilancio (2020), mandates the integration of the FSE with other national systems, including:

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

• The Italian Vaccine Registry

• Regional appointment management systems (CUPs)

(Posteraro, 2021)

Challenges and areas for improvement

Over the past decade, several regions in Italy have initiated projects to develop platforms for collecting clinical records produced by their healthcare institutions. However, differences in processes, architectural models, and 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) was introduced, aiming to transition from a federated system to a centralized national one with a single point of access. 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 between regional systems not only compromises patient safety but also diminishes the FSE’s overall utility and effectiveness (CISL, 2023).

New architecture:

In 2022, guidelines for the creation of a more integrated FSE were published in the Gazzetta Ufficiale della Repubblica Italiana (the official journal of record for the Italian government). 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, the absence of a central data repository, a national registry, and structured data (ideally in FHIR format) renders the current interoperability platform largely unusable.

Published outcomes - statistics

As of the third trimester of 2023, nearly all Italian citizens had 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 accessed their FSE.

• In nine regions, 0% of patients utilized the FSE.

Clinician Utilisation:

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

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

• Only in two regions did clinicians add information to the "patient summary."

Healthcare Facility Participation:

• In 10 regions (including one autonomous province), no healthcare facilities contributed data to their citizens' FSE.

• In six regions, less than 60% of healthcare facilities participated.

• 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.

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

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

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).