Italian FHIR Implementation Guides: base profiles and FSE 2.0 profiles

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From international to Italian profile

FHIR is a deliberately generic standard: the base specification of a resource — Patient, Observation, Encounter — allows many optional attributes, wide cardinalities, example terminologies to be replaced based on context. Real-world exchange between systems requires a further level of constraint, oriented to country, clinical domain or specific programme. This level is the Implementation Guide (IG).

An IG is a technical document made of:

• Profiles (StructureDefinition) that constrain base resources, making otherwise optional fields mandatory, fixing cardinalities, restricting data types
• Extensions (Extension) for adding attributes not in the standard but needed in context
• Specific Value Sets and Code Systems (ValueSet, CodeSystem)
• Examples of conformant instances
• Capability Statement (CapabilityStatement) describing the APIs expected from conformant servers
• Explanatory narrative with use cases, interaction patterns, regulatory references

IGs are published as HTML generated by the FHIR IG Publisher — HL7’s official tool — from source files in FHIR Shorthand (FSH) or directly XML/JSON.

HL7 Italia’s work

HL7 Italia — Italian affiliate of HL7 International — has coordinated since 2019 the work on Italian FHIR profiles, with a dedicated working group and regular meetings. The stated goal: produce a set of Italian IGs that reflect the normative and technical choices of the national context, with the rigour needed to serve as reference in public procurement, certifications and production integrations.

Work unfolds on three progressive levels:

• Italian base IG — general profiles adapted to the national context: Italian Patient (with fiscal code as primary identifier, NHS registry alignment, link to the National Registry of Assisted Persons), Practitioner, Organization, Location, supporting demographic resources
• Domain IGs — profiles for specific clinical or administrative domains (laboratory, pharmacy, radiology, emergency)
• Programme IGs — profiles for specific national programmes: FSE 2.0 first and foremost, but also the National Vaccination Registry, pharmaceutical dossier, disease registries

Institutional coordination

The change in scenario is that since 2022 — with the launch of PNRR Mission 6 and the FSE 2.0 Plan — work on Italian FHIR profiles is no longer a community initiative but ties tightly into regulatory production. HL7 Italia works in close coordination with:

• Ministry of Health — system owner of the FSE and responsible for producing implementing decrees
• AgID — for approval and publication of national technical standards
• Sogei — for implementation of the national FSE Gateway and national services
• Ministry for Public Administration, Department for Digital Transformation — for alignment with the broader Italian digital framework
• Regions and Autonomous Provinces — for implementation in the regional EDSs

The FSE 2.0 implementing decree — expected in the course of 2023, with Official Gazette publication in the following months — will integrate references to the Italian FHIR Implementation Guides as technical annexes. This is the mechanism that gives normative force to technical specifications produced in typically collaborative mode.

Infrastructure: GitHub and Simplifier

The technical infrastructure adopted is the one typical of FHIR communities internationally:

• GitHub — public repository of the HL7Italy organisation (github.com/HL7Italy), hosting IG projects, FSH sources, issue trackers and discussions
• Simplifier.net — FHIR registry platform used for IG publication and navigation (simplifier.net/HL7italy)
• FHIR IG Publisher — HL7 official tool (Java) that produces the HTML IG site from sources; -docker version for CI/CD
• FHIR Shorthand (FSH) + SUSHI — DSL and compiler to write profiles more compactly and readably than raw JSON/XML
• HL7 International Zulip — operational community chat, with dedicated #italy channel

The typical workflow of an IG:

1. GitHub issue with description of the needed profile and regulatory references
2. Discussion in the HL7 Italia working group
3. Proposal of FSH sources via pull request
4. Review, changes, iterations
5. Build with FHIR IG Publisher and publish on Simplifier as draft
6. Test events / Connectathons to validate conformance on real scenarios
7. Eventual approval of release candidate, then stable

Base profiles: what IT Core IG contains

The Italian base Implementation Guide defines the constraints common to every domain profile. Central elements:

• Identifier — IdentifierIT with coded types (fiscal code, health insurance card code, regional identifier), Italian OIDs under root 2.16.840.1.113883.2.9
• Patient — extensions for fiscal code, care regime (exempted, co-payment), assisted/non-assisted, assigned general practitioner; constraints on identifier, name, birthDate
• Practitioner — healthcare professional with regional code, coded specialisation
• Organization — healthcare organisation with ministerial code (HSP.11, STS.11), owning ASL/AO
• Location — wards, clinics, pharmacies; integration with ministerial flow codes
• Address — Italian address with ZIP, province, municipality (ISTAT codes)
• HumanName — Italian rules (surname, given names)

Base profiles are not formally original compared with work done in other European countries (Germany with gematik, UK with NHS Digital Care Connect, Switzerland with CH Core) but reflect the Italian demographic and administrative context.

FSE 2.0 profiles

The current priority is producing profiles for the FSE 2.0 contents. The 2022 Plan annexes and the implementing decree in preparation identify FSE document/data types, each to be modelled in FHIR:

• Patient Summary (PSS) — Italian patient summary, built as a Composition with sections conforming to IPS (International Patient Summary) with Italian adaptations
• Laboratory Report — DiagnosticReport with LOINC-coded Observation
• Outpatient Specialist Report — Composition + outpatient Encounter
• Emergency Department Record — new FHIR profile with emergency-class Encounter
• Hospital Discharge Letter — Composition with history, diagnoses, procedures, therapy sections
• Vaccinations — Immunization conformant with Italian vaccination schedules, recorded with the National Vaccination Registry
• Specialist and Pharmaceutical Prescription — ServiceRequest and MedicationRequest
• Patient’s Personal Notebook — new information entered by the patient (measurements, symptoms, notes)

Work proceeds in parallel for profiles (what documents must contain) and interaction scenarios (how they are published and consumed, with which endpoints, with which authentication mechanisms — typically OAuth 2.0 with SPID/CIE integration for patients and regional identities for professionals).

CDA R2 / FHIR coexistence

The transition is not a clean cut: for years — plausibly through the end of the decade — the Italian FSE will continue to host legacy CDA R2 documents and FHIR documents. The Sogei FSE Gateway must support both formats, and the regional Health Data Ecosystem (EDS) must expose unified read interfaces.

Technical coexistence tools:

• CDA-on-FHIR — FHIR profiles (Composition + Bundle) structurally equivalent to a CDA document, usable as an alternative format
• CDA → FHIR converters — transformation tools (available as open source and commercial components), used in integration engines like Mirth Connect
• Dual exposure of documents: the system producing a report can populate both the legacy XDS.b repository and the FHIR endpoint, letting consumers choose the preferred format

Test events and Connectathons

Profile conformance verification proceeds through test events and Italian Connectathons. HL7 Italia organises themed days with predefined exchange scenarios: a vendor/organisation implements a role (Italian FHIR server, consultation client, report producer), works with other implementers, and inconsistencies and interpretive questions emerge that feed back into profile refinement. It is the same model HL7 International has used for years with global Connectathons — scaled to Italy with Sogei, regional vendors and universities involved.

Next steps

Expected in the coming months:

• Publication of the FSE 2.0 Ministry of Health implementing decree, with technical annexes referencing the Italian IGs
• First stable release of the IT Core IG
• Release of the first FSE 2.0 profiles (Italian PSS, laboratory report)
• Test events with vendors of clinical records and departmental systems for conformance verification
• Update of AgID guidelines on adoption modalities

The overarching theme is the cultural transformation of system actors: after twenty years of working with HL7 v2 and CDA R2, the move to FHIR requires new skills in teams not natively web-first. This — more than the time to finalise profiles — is the factor that will determine the actual pace of FSE 2.0 adoption.

References: HL7 Italia — GitHub repository HL7Italy, publications on Simplifier.net. FHIR Implementation Guide Publisher (HL7 International). FHIR Shorthand + SUSHI. FSE 2.0 Plan of 17 March 2022. PNRR Mission 6 Component 2 Investment 1.3.