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Discover →The FSE 2.0 implementing decree
After the FSE 2.0 adoption Plan approved by the State-Regions Conference on 17 March 2022 and the PNRR resource allocation with the MEF decree of 20 May 2022, the next regulatory step arrived with the Decree of the Ministry of Health of 7 September 2023 — “Implementing arrangements for Article 12, paragraph 15-quater, of Decree-Law 18 October 2012, no. 179, converted, with amendments, by Law 17 December 2012, no. 221” — published in the Italian Official Gazette no. 225 of 26 September 2023.
The decree updates the operational framework of the FSE relative to DPCM 178/2015 — which remains in force in compatible parts — and reflects the changes introduced by paragraph 15-quater of Article 12 of DL 179/2012, inserted by legislative provisions following the FSE 2.0 Plan (DL 4/2022 “Decreto Sostegni ter” converted into Law 25/2022, and subsequent measures).
Pillars of the 7 September 2023 Decree
The decree articulates in detail:
- FSE 2.0 contents — national minimum core plus additional contents
- Architecture — national FSE Gateway run by Sogei, regional Health Data Ecosystem (EDS) in each Region and Autonomous Province
- Processing purposes — care, prevention, scientific research, healthcare planning, care assessment
- Consents — the model is simplified: FSE population takes place ex lege for care purposes (no longer subject to consent), while consultation remains conditional on patient consent
- Access — channels for the patient (portal, mobile app, SPID/CIE/CNS access), healthcare professional (strong credentials, integration with regional systems) and institutional parties (Ministry of Health, ISS, Agenas) for planning, research and statistics purposes
- Population — obligations for NHS and social-health bodies to populate the FSE with all clinical documents produced, with retroactive population from 1 January 2020
- Interoperability — reference to HL7 FHIR R4 standards with Italian Implementation Guides + CDA R2 compatibility for legacy documents
The technical annexes to the decree define document contents, formats, publication modalities, document LOINC codes, Value Sets and applicable Italian FHIR profiles.
The FSE Gateway
The FSE Gateway is the new single point of national interoperability, built and operated by Sogei on behalf of the Ministry of Economy and Finance, based on technical specifications produced by the Ministry of Health and AgID. It replaces and absorbs the functions of INI (National Interoperability Infrastructure) introduced by DPCM 178/2015 and integrates them with new capabilities.
FSE Gateway functions:
- Cross-regional interoperability — facilitates exchange of documents and healthcare data between regional FSEs/EDSs, inheriting INI’s original role
- National document catalogue — registry of document metadata held by regional FSEs, with federated search
- Demographic services — integration with the National Registry of Assisted Persons (ANA) and with the Tessera Sanitaria systems for identification and demographic data
- Pharmaceutical services — integration with the electronic prescription system (dematerialised) and the pharmaceutical dossier
- Vaccination services — integration with the National Vaccination Registry
- Notification service — events of publication, access, masking of documents
- Centralised consent service — unified national management of patient consent
- FHIR R4 exposure — APIs conformant to the Italian FHIR profiles for access to structured data, alongside the CDA R2 document interoperability
The technical infrastructure is based on:
- FHIR REST APIs conformant to the Italian Implementation Guide, in JSON
- Legacy SOAP/WSDL for inherited IHE XDS.b and XCA transactions from FSE 1.0
- OAuth 2.0 for authorisation of consumer applications, with SPID/CIE integration for the patient context
- mTLS and qualified certificates for authentication between national/regional nodes
- Audit trail conformant with the IHE ATNA profile, with statutory preservation of logs
The regional Health Data Ecosystem
Mirroring the national FSE Gateway, each Region must build (or update) its Health Data Ecosystem. The EDS is the regional layer that:
- Collects healthcare data produced by SSR providers in the Region — hospitals, IRCCS, community houses, general practitioners, paediatricians, pharmacies, affiliated labs
- Harmonises data according to the Italian profiles (FHIR IT for structured contents, CDA R2 for legacy documents)
- Feeds the regional FSE and, through it, the national FSE Gateway
- Enables data use for care purposes (with regional professionals’ access), planning (for the Regional Health Department) and — after anonymisation or pseudonymisation with reinforced safeguards — research
The EDS is the most innovative node of FSE 2.0: it separates the regional data infrastructure from the publication/sharing one. Historically regional FSEs were view/sharing systems over documents living in hospital HIS; with the EDS the data flow into a regional repository, which then publishes them into the FSE and makes them available for secondary purposes.
Italian FHIR Implementation Guides
The decree explicitly references the Italian FHIR Implementation Guides as the reference for the new structured contents of FSE 2.0. IGs are published by HL7 Italia in coordination with AgID, the Ministry of Health and Sogei, on Simplifier.net and in the GitHub HL7Italy repository.
The first generation of IGs covers:
- IT Core — base profiles (Patient, Practitioner, Organization, Location, Identifier)
- Document profiles — Patient Summary (PSS), Laboratory Report, Emergency Department Record, Hospital Discharge Letter, Specialist Report, Vaccination Record
- Structured data profiles — Allergy, Active Problem, Drug in Use, Laboratory Observation, Vital Sign, Device, Performed Vaccination
- Patient’s personal notebook — patient-entered contents
IGs continue to evolve across successive iterations, with clinical record vendors and Regions involved.
Consent: the pivotal change
The change to the consent model is one of the most structural aspects of FSE 2.0. DPCM 178/2015 conditioned both population and consultation on patient consent, producing widely under-populated FSEs due to unmet consent collection across care pathways.
The new regime — in line with Article 9(2)(h) of the GDPR and with the updated national legal basis — decouples the two dimensions:
- Population is due ex lege for care purposes; the FSE receives the patient’s clinical documents regardless of consent
- Consultation remains subject to patient consent, who also retains the right to mask individual documents and to view the complete access log
- Use for purposes other than care (research, statistics, planning) is regulated separately
The normative change is accompanied by renewed information notices to all patients and by centralised consent management mechanisms on the FSE Gateway.
Implementation status as of September 2024
One year after the decree, implementation is uneven:
- The FSE Gateway is operational; Regions have connected progressively
- Regional EDSs are being built at different paces; some Regions are further along (Emilia-Romagna, Lombardy, Tuscany, Trentino, Veneto), others still in progress
- Retroactive population of data from 2020 is partially complete, with heterogeneous situations across Regions
- General practitioners are halfway through their population path; the PNRR target is 85% by June 2025
- Italian FHIR profiles are published in first version and in use on the more advanced Regions’ production platforms
- Integration with FSE 2.0 of commercial vendors’ clinical records is under way; regional public procurement has incorporated FHIR requirements in more recent tenders
The vendor and clinical-record bottleneck
The most visible bottleneck is adapting enterprise clinical record systems (HIS and departmental records) to native Italian FHIR production. The Italian hospital clinical-record vendor market — about a dozen main players — must upgrade products to produce and consume FHIR IT profiles, in place of (or in addition to) current CDA R2 documents.
The upgrade is not only technical: it requires revising internal data schemas, document-production clinical flows, integrations with departmental systems. Regional tenders progressively incorporate the requirements, with contract renewal timings distributing over 2024-2026.
Outlook
The next significant deadline is end of 2025, when many PNRR targets must be reached:
- 100% of Regions with operational FSE 2.0
- 85% of general practitioners populating the FSE
- Complete regional EDSs
- Retroactive population from 2020 completed
In parallel, the formal adoption of the European Health Data Space (EHDS) Regulation — being published in the coming months — will bring European obligations on primary use (interoperability, cross-border patient access to their data) and secondary use (structured access for research and policy) that will have to be absorbed by the Italian system. FSE 2.0 as designed is structurally compatible with these obligations but will require regulatory and operational adjustments — which will constitute the next chapter of the path.
References: Ministry of Health Decree of 7 September 2023, published in Official Gazette no. 225 of 26 September 2023. DPCM 178/2015. DL 179/2012 Article 12 (converted into Law 221/2012), as amended by DL 4/2022 (converted into Law 25/2022). PNRR Mission 6 Component 2 Investment 1.3. Italian FHIR Implementation Guides HL7 Italia (repository github.com/HL7Italy, publications simplifier.net/HL7italy).