Short answer: Italy's Fascicolo Sanitario Elettronico (FSE) is the national electronic health record, implemented by each of the 21 regions and autonomous provinces and connected through a national interoperability infrastructure (INI), so that a citizen's documents can be found and read anywhere in the country. FSE 2.0, launched in 2022 with funding from the national recovery plan (PNRR), adds a national gateway that validates and routes every document, a central Ecosistema Dati Sanitari (EDS) for structured data, a uniform set of document types for all regions, and FHIR alongside the CDA documents the system was built on. Citizens access it through regional portals and the national entry point with SPID or CIE identity; vendors connect through regional onboarding against the national specifications.
What the FSE contains
Italy's Fascicolo Sanitario Elettronico (FSE) contains the documents every region must feed: laboratory, radiology and pathology reports, discharge letters, emergency department reports, dematerialised prescriptions, the GP's Profilo Sanitario Sintetico patient summary, vaccinations, specialist reports and the citizen's own taccuino notebook, with FSE 2.0 adding home care, telemedicine and pharmacy documents, all as HL7 CDA R2 templates.
The core documents every region must feed: referti (lab, radiology, pathology reports), lettere di dimissione (discharge letters), verbali di pronto soccorso (emergency department reports), prescrizioni (the dematerialised prescription, which also drives pharmacy dispensing), the Profilo Sanitario Sintetico (patient summary written by the GP), vaccinations, specialist reports, and the taccuino, a notebook where the citizen adds their own documents and notes. FSE 2.0 extends the list to include home care, telemedicine reports and pharmacy services, with every document in a standard HL7 CDA R2 template defined nationally.
How it is built
Italy's FSE is built as a federation: each region stores or indexes its residents' documents, the national INI infrastructure lets one region query another's FSE, the FSE 2.0 gateway validates every document against national schematrons and extracts structured data, and the EDS holds that structured data in FHIR. Citizens log in with SPID or CIE.
- Regional FSE systems store the documents (or index documents kept in the hospitals' repositories) for their residents.
- INI (Infrastruttura Nazionale per l'Interoperabilità) lets a region query another region's FSE for a citizen treated away from home, using IHE XDS-style queries.
- The FSE 2.0 gateway: every document a provider produces passes through a national gateway that validates the CDA against the national schematrons, extracts structured data and forwards it to the regional repository and to the EDS. Validation errors are returned to the provider's system.
- EDS: the national repository of structured data extracted from documents, in FHIR, for the citizen's own view, for care and, with safeguards, for research and planning.
- Identity: citizens use SPID (the national digital identity) or the electronic identity card (CIE); professionals use regional credentials and the national health card infrastructure.
Standards and codes
Italy's FSE uses HL7 CDA R2 level 3 documents with national Italian templates, and FSE 2.0 adds FHIR R4 for the EDS and new APIs with Italian profiles. Diagnoses and procedures in hospital discharge data are coded in ICD-9-CM, laboratory results in LOINC with UCUM units, medicines in ATC and national AIC codes, with SNOMED CT entering gradually.
The documents are HL7 CDA R2 level 3 with Italian templates (for example the lab report with LOINC-coded observations and UCUM units, the discharge letter with ICD-9-CM diagnoses). FSE 2.0 introduces FHIR R4 for the EDS and for new APIs, with Italian profiles published with the specifications. Coding systems: ICD-9-CM for hospital discharge diagnoses and procedures (Italy did not switch its discharge data to ICD-10), LOINC for laboratory, ATC and the national AIC codes for medicines, SNOMED CT entering through the national terminology work. See ICD-10 variants for why ICD-9-CM persists.
For vendors
A software vendor connects to Italy's FSE through regional onboarding, since each region runs its own integration, while following the national CDA document specifications from the Ministry of Health and AgID and passing the FSE 2.0 gateway's validation. There is no national citizen-facing API yet; patients read and download their documents through regional or national portals.
Software used in Italian care feeds the FSE through the regional integration (each region publishes its onboarding) following the national document specifications from the Ministry of Health and AgID, now with the FSE 2.0 gateway as the single validation point. A vendor serving several regions implements the national CDA templates once and the regional transport per region. Patient-facing apps have no national API for citizens' data yet; the citizen reads the FSE through the regional portal or the national portal and can download documents.
Research and secondary use
FSE 2.0's EDS is also the basis for the national secondary-use infrastructure foreseen by the EHDS, with pseudonymised data for public health, planning and research under national rules and the citizen's choices. Italy exchanges the patient summary and ePrescription through MyHealth@EU via its national contact point.
For a person with an FSE
A person with an Italian FSE can read their documents in the regional portal or the national access point, add documents to the taccuino, set two separate consents, one for feeding the record and one for consultation, and download documents. Downloaded documents can be kept in a personal record such as Anpheros Daily for use abroad.
You can see your documents region by region in your portal, add your own documents to the taccuino, set consent for feeding and for consultation (two separate consents in the Italian model), and download documents. A record such as Anpheros Daily can store what you download, with the original CDA kept and the coded content mapped to FHIR, so a clinician abroad can read it; see Health data portability.
National systems change often. This page describes the situation as published by the operators linked under Sources, last reviewed in October 2026; the operator's documentation is the authority for connection requirements.
Related pages
- National electronic health records in Europe and the US
- MyHealth@EU and the cross-border patient summary
- Your medical data in the EU: GDPR, EHDS and your rights
- Health records online: how to access yours in the EU, UK and US
- CDA and C-CDA explained
- ICD-10 vs ICD-10-CM vs ICD-10-GM
Sources
- Fascicolo Sanitario Elettronico (national portal)
- Ministero della Salute: FSE
- AgID: FSE 2.0 specifications and gateway
- HL7 Italia: CDA and FHIR implementation guides
- Italia Domani (PNRR): Mission 6 Health
Frequently asked questions
Is the FSE the same in every region?
The document standards and the citizen's rights are national; the systems, portals and onboarding are regional. FSE 2.0 reduces the differences by routing every document through one national gateway and one set of templates.
Why does Italy still use ICD-9-CM?
Hospital discharge records (SDO) were standardised on ICD-9-CM and the switch to ICD-10 or ICD-11 has been repeatedly planned and postponed. Clinical documents may carry other codes, but official discharge coding remains ICD-9-CM.
Can a foreign app read an Italian FSE?
Not directly; there is no citizen-facing API for third-party apps. The citizen can download documents and share them. The patient summary and ePrescription cross borders through MyHealth@EU.
What is the taccuino?
The citizen's own section of the FSE, where they can upload documents and notes that are visible to professionals the citizen allows, separate from the documents produced by the health service.
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