In Italy, FHIR is gaining ground as a key standard for health data exchange. It is already used in several projects, especially at the regional level, though adoption varies across the country. Italy's health system is regional, so different regions move at different speeds.

The most widely used version is FHIR R4, with some use of R4B. Earlier versions like DSTU2 and STU3 are largely phased out, and R5 is just starting to appear.

Looking ahead, respondents expect a strong increase in FHIR adoption over the coming years. FHIR is now a mandatory requirement in new public health tenders, and momentum is building through national and regional projects.

Rules and Support

Italy has regulation that supports the use of standards in electronic health data exchange. Key points include:

  • FHIR is advised (not strictly mandated) in current regulations.
  • No compliance deadline is set, and fines for non-compliance are not clearly defined.
  • FHIR is a mandatory requirement in public health tenders.
  • FHIR is the chosen standard for the national Electronic Health Record project (Fascicolo Sanitario Elettronico, or FSE 2.0).
  • Government funds are available, mainly through the National Recovery and Resilience Plan (PNRR).

Useful links:

Each region (for example, Lombardy) is actively promoting FHIR adoption and including it in new projects.

National Setup

Italy has organizations dedicated to health data standards:

  • HL7 Italy – the main FHIR community body.
  • UNINFO – the national standards organization.

For implementation guides:

  • A national base/core FHIR implementation guide is under development.
  • It is published at HL7 Italy FHIR Core.

For terminology services:

  • There is no national FHIR terminology server yet.
  • Plans exist to build one, but it is not in production.

Active Use Cases

FHIR specifications are being developed in Italy for several use cases:

  • Prescriptions and pharmacy
  • Referrals and continuity of care
  • Diagnostic orders and reports
  • Imaging
  • Laboratory order management
  • Home care management
  • Patient summary
  • Terminology
  • Provider directory
  • Consent
  • Document exchange
  • Allergy intolerance
  • Telehealth

Italian guides also draw on international specifications, including:

  • European Implementation Guides
  • International Patient Summary
  • IHE profiles

Examples of regional FHIR work include:

Who's Using FHIR

The main stakeholders adopting FHIR in Italy include:

  • Care providers
  • EHR (Electronic Health Record) system vendors
  • Government agencies
  • App developers
  • Researchers

The main drivers behind adoption are:

  • Regulation and government funding
  • Innovation
  • Improving patient data access
  • Improving care workflows and health outcomes

In practice, FHIR is mostly used through:

  • FHIR REST API (a web-based way to exchange data) – widely used
  • FHIR Messaging – used in some contexts
  • FHIR Documents – moderate use
  • FHIR Questionnaires and SDC (Structured Data Capture) – limited use
  • SMART on FHIR (a framework for health apps) – limited use
  • FHIR Shorthand (a shorthand language for writing FHIR profiles) – limited use

Open-source and proprietary FHIR software are both in use, with a slight lean toward proprietary tools.

Successes and Challenges

Successful FHIR projects in Italy have delivered clear benefits, including:

  • Better access to health information
  • Improved care workflows

Notable examples include:

  • The regional Clinical Data Repository (CDR) in Lombardy
  • The regional CDR in Marche
  • Several regional FHIR-based infrastructures

The main challenges respondents identified are:

  • Unclear regulations
  • Lack of FHIR knowledge among teams
  • Unclear benefits for some stakeholders
  • Possible changes in political direction

Looking ahead, the European Health Data Space (EHDS) priority domains are a key area to watch.

Future Plans

Over the past year, Italy has made the progress respondents expected. Key achievements include:

  • New regulation that supports standards in electronic health data exchange
  • Launch of pilot projects with healthcare stakeholders

For the coming year, respondents expect:

  • Development of a national FHIR data model
  • Further regulation on standards in electronic health data exchange
  • Expanded adoption of FHIR across the healthcare ecosystem
  • More FHIR standards for specific use cases

On the FHIR Community Process (FCP), Italy already has specifications in development. Within two to three years, respondents expect Italy to have approved FCP specifications and participants.

Overall satisfaction with the current adoption rate is neutral, but respondents are cautiously optimistic about the benefits FHIR will deliver in the next three years.

Contributors

  • Paolo Testa, Reply S.p.a.
  • Ilenia Centonze, Reply S.p.a.
  • Alessandro Palmieri, Reply S.p.a.
  • Giorgio Cangioli, Consultant
  • Vania Manzelli, Nuvyta

The above summary is based on the answers to the State of FHIR Survey 2026, organized by Firely and HL7 International.

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