Pingitore Marco (Dirigente Psicologo ASP Cosenza), De Lorenzo Antonino (Professore Emerito Università “Tor Vergata” e Consigliere del Ministro della Salute), Iachino Achille (Direttore dell’Unità di missione per l’attuazione degli interventi del PNRR presso il Ministero della Salute), Mattei Marco (Capo di Gabinetto del Ministro della Salute), Milito Sisto (Direttore Sanitario Distretto Cosenza-Savuto ASP Cosenza), Fantozzi Iole (Dirigente Generale del “Dipartimento per l’inclusione sociale, la sussidiarietà e il welfare di comunità” della Regione Calabria)

I see this transformation every day at the ground level, where national strategies meet regional reality.

Today I want to share with you the story of a structural transformation underway in Italy. The Italian National Health Service — the Servizio Sanitario Nazionale — is universal and publicly funded, but historically fragmented across 20 autonomous regional systems.

Thanks to the PNRR — Italy’s National Recovery and Resilience Plan, funded by NextGenerationEU — we are not simply upgrading software. We are building a national Health Data Ecosystem, the Ecosistema Dati Sanitari. I will show you how HL7 FHIR has been chosen as the strategic interoperability standard for this transition — where it is already being implemented, where it is still a target, and what lessons we are learning along the way.

Until recently, regional autonomy translated into inaccessible data silos. This technical fragmentation quickly became a clinical problem: inequality in access to care across different areas of the country.

A recent editorial in The Lancet Regional Health – Europe described Italy’s health data system as — frankly — ‘broken’, mainly because of the absence of unified governance. Twenty regions operating with their own, often incompatible policies, infrastructures, and information systems.

It is confirmed that the current decentralized model has led not only to syntactic inconsistencies, but also to deep semantic differences — different terminologies, proprietary encodings, and data models that are not aligned with national or international standards. To give you a sense of the scale: a single region like Veneto may still have up to 26 different local coding systems inherited from its former Local Health Units.

The priority objective of the Ministry of Health is to reduce these inequalities in the delivery of Essential Levels of Care — what we call LEA — and to integrate hospital and community care.

For Italy, data interoperability has become a fundamental political mission before it is a technological one. HL7 FHIR is the standard chosen to get there.

To achieve this vision, we need to shift paradigms. And I want to be transparent with this audience about exactly where we are on this journey.

First, we must understand our core infrastructure: the Fascicolo Sanitario Elettronico, or FSE. In Italy, the FSE is our national Health Information Infrastructure. It is the digital collection of an individual’s health and social-health data and documents, designed to be available nationwide to ensure continuity of care and improve healthcare delivery.

However, because Italy’s healthcare system is highly decentralized, each of our 20 regions actually operates its own independent FSE IT system to store this data. To connect these 20 regional silos, we rely on the Infrastruttura Nazionale per l’Interoperabilità (INI). INI does not store clinical content; rather, it serves as a central interoperability hub for federated queries and document routing.

Today, this INI infrastructure is strictly document-centric. It routes clinical documents in HL7 CDA R2 format embedded in digitally signed PDFs, transported via IHE XDS profiles and SOAP web services. The January 2026 technical specifications—version 2.6.3—confirm this: the only permitted MIME type for current FSE feeding is application/pdf+text/x-cda-r2+xml. This is the system currently in production, serving 60 million citizens.

But we are evolving. Driven by our National Recovery and Resilience Plan, we are transitioning to FSE 2.0. With FSE 2.0, we added a new architectural component: the Gateway. The Gateway validates documents, constructs SAML security assertions, extracts metadata from CDA2, and routes to the correct regional registry. It is a critical step forward in quality control. But the document format currently flowing through it remains CDA R2 plus PDF.

So where is FHIR? FHIR is the target standard for the Ecosistema Dati Sanitari (EDS)—the Health Data Ecosystem. The EDS represents our strategic shift from a document-centric repository to a fully data-centric ecosystem. While the Gateway currently bridges our legacy systems, FHIR is the native standard being mandated for new national platforms, such as Telemedicine.

We know a ‘Big Bang’ is not possible in healthcare. We are managing a pragmatic, phased transition—maintaining the production system while building the next one. The Gateway is that bridge.

The heart of this ecosystem is the Fascicolo Sanitario Elettronico 2.0 — the Italian Electronic Health Record.

It is evolving from a simple document archive into an active data platform. To make this work at a national scale without disrupting existing services, our official guidelines define a dual-track architecture.

On one track, we manage clinical documents in CDA R2 format, which are validated by the Gateway and stored in regional repositories. In parallel, on the second track, we are collecting structured data in HL7 FHIR format, acquired directly from the producing systems and stored in the central Data Repository of the EDS.

This dual-track approach is our key architectural decision. It allows regions to continue feeding the FSE with CDA2 documents — which is exactly what their legacy systems produce today — while the EDS simultaneously builds a FHIR-native data layer for analytics, national governance, and future primary use.

Furthermore, the Ministerial Decree of December 2024 introduced a game-changing requirement: all services delivered by private providers — including out-of-pocket care — must now contribute clinical data to the FSE within 5 days.

We are bringing 100% of Italian healthcare, both public and private, into a single national health record infrastructure. And the Implementation Guides developed by HL7 Italia are the exact technical specifications making this massive convergence possible.

HL7 Italia has published 18 normative CDA R2 Implementation Guides — the production backbone — and is now building the parallel FHIR layer starting with telemedicine and laboratory.

What is the practical value of a connected health data ecosystem? Governance. And in Italy, the most pressing governance issue—and the biggest concern for our citizens—is waiting lists.

To understand how we are tackling this, you first need to understand how patients access our National Health Service. The journey typically begins with the General Practitioner (GP), who acts as the primary gatekeeper. When a patient needs a specialist visit or a diagnostic exam, the GP issues a ‘ricetta dematerializzata’—a fully electronic prescription. This digital prescription is the key that allows the patient to book their appointment through the regional Central Booking System, known as the CUP. 

Historically, these regional CUPs operated as completely isolated silos. To tackle this fragmentation, we launched the Piattaforma Nazionale Liste di Attesa — the National Waiting List Platform.

This platform connects with those regional booking systems — the CUP regionali — across the country to provide national visibility on demand and supply. For the first time, the Ministry can see where bottlenecks form and intervene in a timely manner.

Today, the PNLA operates primarily through administrative data flows — appointments, prescriptions, availability slots. The semantic standardization of this layer is still evolving. But the lesson is clear: without a shared semantic framework for defining services, availability, and performance metrics, this kind of national governance visibility would be impossible. HL7 FHIR resource definitions — like Appointment, Schedule, Slot, and HealthcareService — are designed precisely for this, and represent the exact direction for our next phase of integration.

If you want to see where HL7 FHIR is already a reality in the Italian NHS — not a plan, not a roadmap, but a deployed standard — the answer is Telemedicine.

The National Telemedicine Platform was designed with FHIR as the native interoperability standard from the outset. Unlike the FSE document layer, which is transitioning gradually from CDA2, the telemedicine infrastructure was built on FHIR.

HL7 Italia achieved a major milestone in 2025: a complete set of FHIR Implementation Guides was published for all core telemedicine services — Televisita, Teleconsulto, and Teleassistenza — all based on FHIR R4. The Implementation Guide for Telemonitoraggio was published in early 2026, completing the full set of FHIR specifications for all four telemedicine services.” This work was managed in ‘Fast Track’ mode given its strategic importance for the national telemedicine program.

The architecture works like this: clinical data generated during telemedicine encounters — vital parameters, televisit reports, telemonitoring alerts — flow through the Gateway. A key function of the Gateway in this flow is that it translates documents from CDA2 to FHIR standard before forwarding them to the EDS. The EDS then notifies the National Telemedicine Platform, ensuring centralized governance of telemedicine data.

Telemedicine is the beachhead of FHIR in Italy — the proof point that the standard works in production, at scale, in the Italian NHS.

Importantly, HL7 Italia has published Implementation Guides for both tracks — CDA2 for the document layer and FHIR for the data layer — ensuring that both paths are fully standardized.

We are not stopping at clinical care. The European Health Data Space Regulation — which entered into force in March 2025 — distinguishes between primary use and secondary use of health data. Italy needs to build infrastructure for both.

A concrete example is the DHEAL-COM project — Digital Health Solutions in Community Medicine — a research initiative funded by the National Complementary Plan to the PNRR. DHEAL-COM is documented in a peer-reviewed paper published in Frontiers in Medicine in December 2025.

The project adopts a two-level harmonization strategy that I believe is a replicable pattern. At the local nodes — partner healthcare organizations — health data is converted into FHIR-compliant resources using national Implementation Guides. At the central repository, a dedicated ETL component transforms de-identified FHIR data into the OMOP Common Data Model, maintained by the OHDSI community, for population analytics and research.

This is a federated architecture by design. Personal health data never leaves the local nodes. Only de-identified aggregates or OMOP-transformed data reach the central hub. This aligns directly with the EHDS principle of minimizing data movement while enabling cross-site analytics.

The pipeline is clear: FHIR for primary use, OMOP for secondary use. Two complementary standards, two complementary purposes — and Italy is building both.

Hospitals-on-FHIR expresses Healthcare providers intent to explore and support the adoption of HL7 FHIR, and accelerate their progress towards safe, secure and effective participation in the EHDS and EU-level healthcare.

HoF allows hospitals to assess their status, their maturity level, overall and in regard to specific domains, linked to the European EHRxF.

HoF also is valuable for patients and for national and Europe level efforts to benefit from better digital health.

Key principles of HoF are:

• Interoperability: not just technical, but also organisational, is necessary for patient safety and better care.
• Cooperation: It is high time that a landscape map of FHIR interoperability capabilities is established. While pointing to supported technical FHIR resources, the HoF map can serve as a proxy for organisations where it is easier to connect and solve problems

Building all of this requires continuous engagement with the Italian Data Protection Authority — the Garante per la protezione dei dati personali.

The Garante adopts a conservative approach, particularly regarding secondary data use, cross-border sharing, and anonymization practices. This is essential for protecting fundamental rights, but it can also introduce delays and additional compliance costs. For organizations engaged in pan-European projects like the EHDS, navigating these evolving national interpretations is a real operational challenge.

We have adopted a pragmatic approach. An excellent example is emergency data access — the ‘break-the-glass’ procedure. The regulatory framework establishes that unrestricted emergency access without prior consent will be enabled only when we can guarantee a high level of data security and completeness: specifically, when a critical mass of the population has an active, validated Patient Summary.

The philosophy is clear: privacy is defended by guaranteeing data quality, not by restricting data flow.

I should also mention a semantic gap that matters for international interoperability: Italy, to date, has not purchased a national license for SNOMED CT. This limits the use of one of the primary tools for ensuring semantic interoperability across borders. However, the International Patient Summary — standardized through HL7 International and ISO — leverages the SNOMED CT Global Patient Set (GPS), a freely available subset specifically designed for cross-border use cases. This provides a practical workaround that enables meaningful semantic interoperability even without a national license, while the broader terminology question is resolved.

To translate this vision into action within the European timelines, a phased roadmap has been published.

Phase 1, by March 2025, focused on consolidating logging and security systems. Phase 2, by September 2025, targeted the massive implementation of the Patient Summary through General Practitioners. And Phase 3, by March 2026 — essentially now — establishes the universal rule: every healthcare service, public or private, must feed the FSE within 5 days.

I want to be candid with this audience: implementation across 20 regions with very different levels of digital maturity is uneven. Some regions are advanced — Lombardia is already deploying a regional FHIR interoperability platform connecting its entire healthcare network, covering over 200 hospitals and serving more than 68,000 telemedicine patients in 2024 alone. Others are still building basic infrastructure. This is where the ‘subsidiarity’ model becomes essential: if a Region does not have the capacity to implement its own FSE 2.0 regional node, the central government provides the National Infrastructure — INI — as a turnkey cloud service. We set the bar high for everyone, but we provide the ladder to those who need it.

Let me close with the honest picture.

Italy has chosen HL7 FHIR as its strategic interoperability standard. In Telemedicine, FHIR is already native — with published Implementation Guides and regional deployments in production. In the FSE document layer, CDA R2 remains the current format, with the Gateway and the EDS building the bridge to FHIR. In waiting list governance, standardized data is enabling national visibility for the first time. And in research, the FHIR-to-OMOP pipeline is being proven in funded projects.

The EHDS Regulation gives us until 2034 for full implementation. The journey is long, the challenges are real — governance fragmentation, semantic gaps, privacy constraints, uneven digital maturity. But the direction is clear, the investment is unprecedented, and the standard is chosen.

This is not a finished success story. It’s a transformation underway — and I hope the lessons from Italy’s complexity are useful to anyone building interoperable health systems at scale.

The Italian National Health Service (SSN) serves a diverse population across 20 autonomous regions, historically resulting in fragmented, regionally-siloed patient data. This session details Italy’s ambitious national strategy to transition to a truly unified digital health ecosystem through the development and nationwide rollout of the Fascicolo Sanitario Elettronico (FSE) as the core interoperability hub.

We will demonstrate how Italy is leveraging the HL7 FHIR standard to unify and standardize not only the FSE but also critical national services, including:

The National Waiting List Platform (PNLA), integrated with fragmented regional Central Booking Systems (CUP regionali) to provide unified scheduling visibility and management.
The National Telemedicine Platform, ensuring standardized service delivery and data exchange for remote patient care.

We will explore the complex technical and political roadmap required to mandate the use of FHIR-based APIs across these diverse regional and national components. The presentation will address the unique governance model needed to align autonomous regional health authorities with central governmental directives and the comprehensive privacy framework necessary for cross-regional data sharing. Key lessons will be shared regarding scaling this integrated FHIR-based infrastructure and discussing the measurable impact of this standardization on access, waiting list efficiency, and clinical decision support. Attendees will gain actionable insights into governing large-scale, decentralized digital health transformation projects leveraging modern standards.

Learning Objectives

Upon completing this session, attendees will be able to:

Analyze the governance model and key challenges inherent in implementing a mandated national EHR (FSE) system across a decentralized healthcare landscape (like Italy’s 20 regions).
Identify the technical architecture and standardization mechanisms, including the mandatory use of HL7 FHIR data models and national APIs, leveraged to enforce clinical data interoperability across the FSE, regional booking systems (CUPs), and Telemedicine platforms.
Evaluate the political and change management strategies necessary to achieve alignment between central governmental health agencies and autonomous regional health authorities.

Understand the measurable impact of enforced data sharing on public health reporting, waiting list management, and patient access to comprehensive, longitudinal health information.

Il Servizio Sanitario Nazionale (SSN) italiano serve una popolazione eterogenea attraverso 20 regioni autonome, il che ha storicamente portato a dati dei pazienti frammentati e isolati a livello regionale. Questa sessione illustra in dettaglio l’ambiziosa strategia nazionale dell’Italia per la transizione verso un ecosistema sanitario digitale realmente unificato attraverso lo sviluppo e la diffusione su scala nazionale del Fascicolo Sanitario Elettronico (FSE) come fulcro centrale di interoperabilità.

Dimostreremo come l’Italia stia sfruttando lo standard HL7 FHIR per unificare e standardizzare non solo il FSE, ma anche servizi nazionali critici, tra cui:

Piattaforma Nazionale Liste d’Attesa (PNLA): integrata con i vari sistemi di prenotazione regionali (CUP regionali) per fornire visibilità e gestione unificata delle agende.
Piattaforma Nazionale di Telemedicina: per garantire l’erogazione di servizi standardizzati e lo scambio di dati per l’assistenza remota ai pazienti.

Esploreremo la complessa tabella di marcia tecnica e politica necessaria per rendere obbligatorio l’uso di API basate su FHIR attraverso queste diverse componenti regionali e nazionali. La presentazione affronterà il modello di governance unico necessario per allineare le autorità sanitarie regionali autonome con le direttive governative centrali, oltre al quadro normativo sulla privacy indispensabile per la condivisione dei dati tra regioni.

Verranno condivise le lezioni chiave riguardanti la scalabilità di questa infrastruttura integrata basata su FHIR e l’impatto misurabile di questa standardizzazione sull’accesso alle cure, sull’efficienza delle liste d’attesa e sul supporto alle decisioni cliniche. I partecipanti otterranno spunti pratici sulla gestione di progetti di trasformazione digitale sanitaria decentralizzati su larga scala utilizzando standard moderni.

Obiettivi Formativi

Al termine di questa sessione, i partecipanti saranno in grado di:

Analizzare il modello di governance e le sfide principali inerenti all’implementazione di un sistema EHR nazionale (FSE) obbligatorio in un panorama sanitario decentralizzato (come quello delle 20 regioni italiane).
Identificare l’architettura tecnica e i meccanismi di standardizzazione, incluso l’uso obbligatorio dei modelli dati HL7 FHIR e delle API nazionali, utilizzati per imporre l’interoperabilità dei dati clinici tra il FSE, i sistemi di prenotazione regionali (CUP) e le piattaforme di telemedicina.
Valutare le strategie politiche e di gestione del cambiamento necessarie per raggiungere l’allineamento tra le agenzie sanitarie governative centrali e le autorità sanitarie regionali autonome.

Comprendere l’impatto misurabile della condivisione forzata dei dati sulla reportistica di salute pubblica, sulla gestione delle liste d’attesa e sull’accesso dei pazienti a informazioni sanitarie complete e longitudinali.