AIHealth
On-premise clinical platform with local LLMs, RAG on FHIR/DICOM data, diagnostic support, remote follow-up. Architecture designed for the MDR pathway.
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Digital Health
Medical software development compliant with CE and MDR regulatory standards. Clinical decision support systems, AI integration in clinical workflows.
Discover →The PNRR frame
Italy’s National Recovery and Resilience Plan (PNRR) — approved by the Italian Government in April 2021 and positively assessed by the European Commission in June 2021 — allocates to Italy resources of around EUR 191.5 billion in grants and loans under NextGenerationEU, with an implementation horizon of 2021–2026. The Plan is structured into six Missions. Mission 6 — Health has a total envelope of EUR 15.63 billion, articulated into two Components:
- M6C1 — Community-based networks, facilities and telemedicine for territorial healthcare (EUR 7 billion): Community Houses, Community Hospitals, COT (Territorial Operational Centres), development of territorial telemedicine
- M6C2 — Innovation, research and digitalisation of the National Health Service (EUR 8.63 billion): technological modernisation, biomedical research, digitalisation of healthcare information systems
Within Component 2, Investment 1.3 — “Strengthening the technological infrastructure and the tools for data collection, processing, analysis and simulation” — allocates EUR 1.38 billion to the evolution of healthcare information systems. The larger share of this investment is devoted to the Electronic Health Record 2.0 (FSE 2.0) and to the construction of the national Health Data Ecosystem.
FSE 1.0 and FSE 2.0: why a second generation
The first-generation FSE, built between 2012 and 2020, consolidated a document-centric architecture based on Italian HL7 CDA R2, sharing via IHE XDS.b, and the Sogei INI gateway for interoperability across Regions. As of 2022 the FSE is established in all Regions, but with very uneven adoption — heterogeneous content, uneven provider adherence, misaligned portal usability, actual use by patients and professionals below expectations.
The document “Plan for the adoption of the Electronic Health Record (FSE 2.0)” — approved by the State-Regions Conference on 17 March 2022 — captures the outcome of preparatory work by the Ministry of Health, the Minister for Technological Innovation and Digital Transition, the Department for Digital Transformation and AgID, with the contribution of the Regions. The Plan identifies the lines of intervention for the second generation of the FSE:
- Content alignment to the national minimum core, filling regional gaps
- Retroactive population starting with data from 2020
- Broader content covering telemedicine data, outpatient specialist services, pharmaceutical prescriptions, exemptions, vaccines, the patient’s personal notebook
- FHIR adoption as exchange format, alongside CDA R2 for legacy documents
- New architecture: national FSE Gateway run by Sogei + regional Health Data Ecosystem (EDS) in each Region
- Improved accessibility for patients and professionals, with uniform user experience
The target architecture
The redesign introduces a model distinct from the previous one:
- Regional Health Data Ecosystem (EDS) — each Region consolidates in a single regional platform its healthcare data: structured clinical documents, NSIS flows, telemonitoring data, vaccinations. The EDS is the single aggregation and population point for the regional FSE and for flows to the national level
- National FSE Gateway — managed by Sogei, replaces/evolves the existing INI. Takes a broader role: not only inter-regional interoperability, but also national catalogue services, document identification, vaccine metadata, dematerialised prescriptions
- Centralised national services — National Registry of Assisted Persons, Vaccination Registry, Electronic Prescription, Tessera Sanitaria remain MEF/Sogei infrastructures; FSE 2.0 integrates them as consumed services and data sources
- Portals and apps — accessible interfaces for citizens and professionals, with uniform experience and access via SPID, CIE and CNS
The CDA R2 document model remains, but is joined by FHIR R4 — with Italian Implementation Guides under development by HL7 Italia, AgID, the Ministry of Health and Sogei — as the format for new content (patient summary, outpatient reports, telemonitoring data, vaccination and allergy information).
Governance and actors
FSE 2.0 governance is multi-level:
- Inter-ministerial steering committee for strategic coordination among the Ministry of Health, the Minister for Technological Innovation, the Department for Digital Transformation
- Ministry of Health as system owner of the FSE
- AgID for technical coordination and approval of specifications
- Sogei as technical body responsible for the national FSE Gateway, on behalf of the Ministry of Economy and Finance
- Agenas for monitoring and technical support to the Regions
- Regions and Autonomous Provinces as owners of the respective regional FSEs and EDSs
The Decree of the Ministry of Economy and Finance of 20 May 2022 — being published at the time of writing — allocates the PNRR resources for FSE 2.0 across Regions on the basis of demographic and care-related criteria. Further implementing acts will follow: a ministerial decree updating DPCM 178/2015 to the new functionalities, the AgID technical Guidelines for FSE 2.0, and the Italian FHIR Implementation Guides.
Numerical targets
The Plan sets PNRR milestones to be met by 2026:
- 85% of general practitioners populating the FSE by June 2025
- FSE 2.0 implementation in 100% of Regions by 2026
- Retroactive population of data from 2020
- Patient Summary (PSS) available for all consenting patients
- Fully functional consultation of a patient’s data in cross-regional mobility
Meeting the milestones is a condition for disbursement of NextGenerationEU funds by the European Commission, under the PNRR mechanism: funds tied to measurable results, not to spend.
The complexity of the undertaking
The scale of intervention is remarkable: twenty-one regional FSEs with different histories, architectures and vendors; hundreds of health and social-health agencies with heterogeneous clinical records; tens of thousands of general practitioners and paediatricians with independent management systems; an ecosystem of over thirty regional and national information flows (NSIS, pharmaceuticals, SDO, ED, specialist, territorial assistance) to be realigned.
The technical challenge intertwines with the organisational and contractual one: each Region has to redefine its tenders towards clinical record vendors, update agreements with contracted physicians, reorganise the internal skills of its ICT services. The fixed timeline — just over four years — is tight, particularly given structural constraints of the Italian vendor market for clinical records and of ICT staffing in health agencies.
Secondary use
An aspect explicitly foreseen in the FSE 2.0 Plan is enabling research purposes and healthcare planning on structured data. The regional EDS must be able to produce pseudonymised extracts for observational studies, pharmacovigilance, assessment of care effectiveness. The theme links to the ongoing European discussion on the European Health Data Space, a regulation proposed by the European Commission in May 2022 in the same weeks in which the Italian FSE 2.0 Plan is being approved.
The EHDS proposal introduces a regime of primary use (care) and secondary use (research, statistics, policy), with obligations and infrastructures that will require national systems to be compatible — FSE 2.0 is, in effect, Italy’s vehicle for this compatibility.
Trajectory
The coming months and years will see the sequence of implementing decrees, the Italian FHIR Implementation Guides, the contracts with regional vendors. The path will be iterative — some results will arrive earlier (retroactive population, PSS), others will take more time (full FHIR convergence, secondary-use services). The theme running through the work is a paradigm shift: from the Record as a document collector to the Record as a repository of structured data, usable for the patient, the clinician, the researcher, and the planner. The technical transition from CDA R2 to FHIR is the most visible signature of this shift, but it is the data architecture — with EDSs at the centre — that will determine whether FSE 2.0 becomes a genuinely new-generation tool or a cosmetic upgrade.
References: National Recovery and Resilience Plan, Mission 6 — Health, Component 2, Investment 1.3. Plan for the adoption of the Electronic Health Record (FSE 2.0), approved by the State-Regions Conference on 17 March 2022. MEF Decree of 20 May 2022. Regulation (EU) 2016/679 (GDPR). Proposal for EHDS Regulation, COM(2022) 197 final, 3 May 2022.