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 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 the national benefits package, and allocates funding for the regional health systems. The regions are in charge of financing, planning, and provision of services at the local level

Public vs private

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 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).

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.

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.

Challenges and areas for improvement

In the last 2 decades, 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 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 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

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

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

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:

• 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%

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

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.

Ciampi, M., Esposito, A., & Sicuranza, M. Stato dell’arte sulle iniziative nazionali relative allo sviluppo di sistemi ICT interoperabili per la Salute Digitale.

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

AGID Agenzia Per l’Italia Digitale. Fascicolo Sanitario Elettronico - Monitoring. Available at: https://www.fascicolosanitario.gov.it/en/monitoring