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Policy Brief
Revised

Bridging the Digital Divide: Evidence-Informed Health Policy Recommendations to Accelerate Electronic Health Record Implementation in Southern Italian Regions

[version 2; peer review: 2 approved with reservations]
PUBLISHED 13 Apr 2026
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This article is included in the Health Services gateway.

Abstract

Background

Implementation of Electronic Health Records (EHRs)—termed Fascicolo Sanitario Elettronico (FSE) in Italy—is a strategic priority within the National Recovery and Resilience Plan (PNRR), which allocates investments under Mission 6 (Health) to healthcare digitalisation. Despite national commitment, adoption of the FSE shows significant regional disparities. Data from the Fondazione GIMBE (July 2025), based on the Dipartimento per la Trasformazione Digitale monitoring dashboard updated to 31 March 2025, show that only 21% of citizens nationally consulted their FSE within a 90-day window, with citizen consent for data sharing ranging from 1% in several Southern regions (Abruzzo, Calabria, Campania) to 92% in Emilia-Romagna. Among medical specialists, FSE enablement rates in Calabria (26%) and Liguria (16%) remain far below the national average of 72%. The Osservatorio Sanità Digitale (2025) reports that digital health spending in Italy reached €2.47 billion in 2024, yet 55% of healthcare facilities identify resource constraints as the most significant barrier to digital innovation, with workforce competency gaps (40%) and insufficient digital culture (34%) as additional critical obstacles. This digital divide reflects interconnected barriers spanning infrastructure, governance, workforce capacity, and quality standardisation. Understanding these barriers and their policy implications is essential to achieve equitable healthcare digitalisation and to meet PNRR targets by mid-2026.

Policy and Implications

Four primary barriers were identified: (1) infrastructural deficits—documented digital divides between Northern and Southern Italy, with the SVIMEZ 2023 Report and the Osservatorio Sanità Digitale confirming persistent resource and connectivity gaps disproportionately concentrated in Southern and insular regions; (2) governance fragmentation—characterised by the absence of dedicated digital health units and senior information technology leadership in most Southern regions; (3) workforce capability gaps—with only 36% of medical specialists and 52% of general practitioners having used telemedicine services by 2025, and substantial training gaps in health informatics; and (4) insufficient integration of quality management and information security standards within procurement specifications.

Recommendations

A four-pillar policy strategy is proposed: (1) establish dedicated Regional Digital Health Units with autonomous governance, protected multiyear budgets, and measurable performance indicators; (2) integrate mandatory health informatics education into Continuing Medical Education (ECM) programmes, targeting ≥80% workforce digital competency by 2028; (3) require SNOMED CT/HL7 FHIR interoperability and ISO 9001/ISO IEC 27001 certification as mandatory procurement criteria; and (4) establish formal twinning arrangements between digitally mature Northern regions and developing Southern regions.

Conclusions

Bridging the North–South digital divide requires coordinated policy reform addressing governance, professional development, technical standardisation, and inter-regional collaboration. International evidence from Estonia and Denmark demonstrates that centralised governance, mandatory interoperability standards, and opt-out consent models accelerate nationwide EHR adoption. This evidence-informed strategy is operationally feasible within PNRR timelines and will strengthen the quality governance of health information systems across Southern Italian healthcare.

Keywords

Electronic Health Records; Digital health; Health policy; Italy; Healthcare digitalisation; Interoperability; ISO 9001; Implementation science

Revised Amendments from Version 1

This revised version integrates material from the broader research programme that could not be included in the initial submission due to the timing of data releases and editorial constraints.
Most notably, the quantitative evidence base has been updated to incorporate the Fondazione GIMBE analysis presented at the 9th Forum Mediterraneo in Sanità (July 2025), drawing on the Dipartimento per la Trasformazione Digitale FSE monitoring dashboard updated to 31 March 2025, as well as the Osservatorio Sanità Digitale annual report released in May 2025. These datasets, which were not yet publicly available at the time of the original submission, provide a more current and granular picture of regional disparities in FSE adoption, citizen consent, specialist enablement, and digital health expenditure.
The Methods section now includes a summary table (Table 1) categorising the full scope of the 72 sources consulted across six evidence domains, offering greater transparency on the breadth and structure of the analysis. Similarly, each policy pillar has been complemented with explicit Key Performance Indicators, consolidated in a new table (Table 2), to facilitate prospective evaluation and accountability — an element originally planned but deferred to ensure alignment with the most recent institutional targets.
The Discussion has been expanded to include the international comparative dimension that informed the policy design from the outset, specifically the experiences of Estonia, Denmark, and Germany in nationwide EHR implementation, with particular attention to governance models and consent architecture.
Finally, a dedicated subsection on citizen-facing barriers — examining digital literacy, institutional trust, and the structural implications of the opt-in consent model — has been added to complement the supply-side analysis already presented in Version 1 and to more fully reflect the multidimensional nature of the adoption challenge.
The reference list has been updated accordingly.

See the authors' detailed response to the review by Anna Essén
See the authors' detailed response to the review by Federico Ruta

Introduction

The digital transformation of healthcare systems constitutes one of the defining challenges of contemporary health policy. Within the European Union, the digitalisation of health services is framed as a fundamental enabler of healthcare quality, efficiency, and patient safety. In Italy, the implementation of Electronic Health Records (EHRs), termed Fascicolo Sanitario Elettronico (FSE), has been designated as a strategic priority within the National Recovery and Resilience Plan (PNRR). Mission 6 (Health) of the PNRR sets binding targets: 85% of general practitioners were required to actively feed the FSE by 2025, and all Regions and Autonomous Provinces must adopt and utilise the FSE by mid-2026.1,2 Total investment for the FSE 2.0 and the broader Ecosistema Dati Sanitari (EDS) amounts to €1.38 billion, representing one of the most significant healthcare digitalisation efforts in Europe.3

Despite this substantial policy commitment, implementation outcomes reveal a striking geographical pattern. Data from the Fondazione GIMBE, based on the Dipartimento per la Trasformazione Digitale FSE monitoring dashboard updated to 31 March 2025, show that only 21% of citizens accessed their FSE within a 90-day reference period. Crucially, the consent rate for FSE data sharing by citizens ranges from as low as 1% in Abruzzo, Calabria, and Campania to 92% in Emilia-Romagna. Among the regions of the Mezzogiorno, only Puglia (73%) exceeds the national average of 42%. Among medical specialists in public health authorities, enablement rates range from 16% in Liguria to 100% in twelve regions and autonomous provinces, with Southern regions such as Calabria (26%) and Sicily (36%) significantly below the national average of 72%.4 Only four document types out of sixteen monitored are available in all regions, and in the Mezzogiorno FSE utilisation remains below 11%.4

This digital divide is not merely a technological gap; it reflects and potentially reinforces existing health inequities. International evidence indicates that effective EHR implementation delivers clinical benefits, including improved guideline adherence, enhanced medication safety, and better continuity of care.5,6 In Italy, where an ageing population and the rising prevalence of chronic diseases create substantial healthcare demands, the underutilisation of FSE infrastructure in Southern regions raises significant concerns regarding equitable access to healthcare innovation.

The persistence of this geographical disparity, despite EU-wide commitments to digital health integration, suggests that technological diffusion is mediated by complex institutional, infrastructural, and human factors that extend beyond simple resource constraints.7,8 Furthermore, the binding deadline imposed by PNRR targets (mid-2026) creates temporal pressure for evidence-informed policy interventions. The Corte dei Conti has already noted delays in the FSE implementation chronogram, with the milestone on full national interoperability postponed from June 2024 to December 2024.3

This policy brief presents a narrative, evidence-informed analysis aimed at: (1) systematically identifying the primary barriers to FSE implementation in Southern Italian regions; (2) analysing the interconnections among infrastructural, organisational, educational, and standardisation-related obstacles; (3) proposing actionable, evidence-based policy recommendations with measurable performance indicators that address these multidimensional challenges at regional and national levels; and (4) contextualising these recommendations within international evidence from successful EHR implementation experiences.

Methods

This analysis employed a narrative policy research approach, combining a literature review with institutional document analysis. This methodology was selected because the research question—identifying barriers to complex policy implementation and generating feasible recommendations—calls for the synthesis of existing evidence and institutional knowledge to inform policy dialogue, rather than experimental design.9,10

Literature searches were conducted across three biomedical databases (PubMed/MEDLINE, Scopus, CINAHL) for peer-reviewed publications (2018–2025) examining EHR/digital health implementation, barriers, or policy frameworks in European or OECD health systems. Key search terms included “electronic health record,” “fascicolo sanitario elettronico,” “digital health implementation,” “barriers,” and “health policy Italy.” Additional targeted searches were conducted for international comparator cases using terms “Estonia e-health system,” “Denmark EHR governance,” and “NHS digital health.”

Institutional monitoring data were retrieved from the following authoritative sources: the Dipartimento per la Trasformazione Digitale (FSE monitoring dashboard, updated 31 March 2025); the Osservatorio Sanità Digitale of Politecnico di Milano (annual reports 2024 and 2025); the Fondazione GIMBE (FSE adoption analyses, November 2024 and July 2025); the SVIMEZ annual reports on the economy and society of the Mezzogiorno; AGENAS monitoring datasets; the Corte dei Conti; and European Commission digital health frameworks. Grey literature from the Ministry of Health (Ministero della Salute), the Garante per la protezione dei dati personali, and EU regulatory guidance was also reviewed.

Table 1 provides a summary of the evidence sources consulted, categorised by type and thematic focus.

Table 1. Summary of evidence sources consulted.

Source categoryN. sourcesThematic focus Time period
Peer-reviewed literature (PubMed, Scopus, CINAHL)34EHR implementation barriers, digital health competencies, quality management, international comparators2018–2025
Institutional monitoring reports (GIMBE, Osservatorio, SVIMEZ, AGENAS, Corte dei Conti)12FSE adoption metrics, regional disparities, PNRR progress, infrastructure gaps2023–2025
Government policy documents (Ministero della Salute, AgID, Dipartimento Trasformazione Digitale)8PNRR targets, FSE 2.0 regulatory framework, EDS architecture, PSS implementation2021–2025
EU regulatory and strategic frameworks (European Commission, EHDS)5European Health Data Space, Digital Decade Programme 2030, eHealth adoption benchmarks2018–2025
International case studies (Estonia, Denmark, NHS England)7Governance models, opt-out consent, interoperability standards, implementation success factors2008–2025
Grey literature and expert reports6Cybersecurity trends, workforce training programmes, digital literacy assessments2022–2025

In total, 72 sources were systematically consulted. Barriers were thematically organised into four categories derived from the Consolidated Framework for Advancing Implementation Science (CFIR):11 infrastructural, organisational/governance, educational/workforce, and standardisation-related factors. Where specific quantitative data for Southern Italian regions were unavailable, this is explicitly noted in the text rather than extrapolated from other contexts.

Policy outcomes and implications

Infrastructural barriers and policy implications

The most immediately evident barrier to FSE implementation in Southern regions is inadequate digital infrastructure. The SVIMEZ 2023 Report documents a persistent digital gap between Northern and Southern Italy across multiple dimensions, including broadband connectivity and ICT infrastructure in public services.12 Data from the Osservatorio Sanità Digitale (2025) confirm that 55% of healthcare facilities nationally identify insufficient economic resources as the most significant barrier to digital innovation, with workforce competency gaps (40%) and digital culture deficits (34%) as further critical obstacles.13 These barriers are disproportionately concentrated in Southern and insular regions.

Technological obsolescence compounds this barrier. Many Southern healthcare facilities rely on legacy computing systems incompatible with contemporary FSE platform requirements. Capital expenditure for hardware modernisation has historically been constrained by the limited fiscal capacity of regions under health system recovery programmes (piani di rientro), creating a mechanism by which historical financial disadvantage translates into persistent technological disadvantage. The Corte dei Conti has documented that PNRR spending on anti-seismic interventions for healthcare facilities in the Mezzogiorno reaches barely 6% of allocated funding, illustrating the broader pattern of delayed infrastructure investment in the South.3

Policy Implication: Infrastructure deficits require sustained, protected investment rather than one-off capital infusions. Regional health authorities should establish multiyear investment commitments aligned with PNRR accountability mechanisms, ensuring that capital expenditure for connectivity, hardware modernisation, and system maintenance is decoupled from short-term budgetary fluctuations.

Governance fragmentation and policy implications

Fragmentation of regional health governance represents a second critical barrier. Northern regions such as Emilia-Romagna and Veneto—which achieve near-universal FSE utilisation among general practitioners—maintain dedicated, well-resourced digital health units with clear mandates and autonomous decision-making authority. In contrast, many Southern regions address digital transformation through ad hoc, uncoordinated mechanisms dispersed across multiple administrative units.7,14

This governance fragmentation is compounded by the absence of senior leadership positions dedicated to digital health strategy. The role of Chief Information Officer (CIO) in healthcare—a standard institutional function in Northern European and North American health systems—remains rare in Southern Italian regions. Where such positions exist, they frequently lack adequate authority over procurement, technology selection, and implementation timelines. This structural deficit is exacerbated by high turnover among health system administrators and discontinuity in regional health policy following electoral cycles.

The 8th GIMBE Report on the SSN (2025) confirms a persistent “structural fracture” between North and South in cumulative LEA (Livelli Essenziali di Assistenza) compliance: in the period 2010–2019, no region of the Mezzogiorno ranked among the top ten; in 2022, only thirteen regions were compliant, with a widening gap.15 This systemic governance imbalance directly undermines the capacity for coherent digital health planning.

Policy Implication: Institutional reform must establish durable, depoliticised structures for digital health governance. Each Southern Italian region should establish a formally constituted Regional Digital Health Unit reporting directly to the regional health commissioner, with protected multiyear budgets and autonomous authority over FSE strategy, procurement processes, and implementation timelines.

Educational and workforce capacity gaps and policy implications

Deficits in health professionals’ digital competencies represent a third barrier. Data from the Osservatorio Sanità Digitale (2025) show that 36% of medical specialists and 52% of general practitioners report having used telemedicine services (televisit); telemonitoring has been used by 30% of specialists and 46% of GPs.13 A recent systematic review of digital health competencies among healthcare professionals confirmed that insufficient training is a major barrier to EHR adoption across European health systems.16 The Fondazione GIMBE further notes that 95% of GPs have accessed the FSE at least once, but the depth and quality of engagement varies dramatically by region, with nine regions reaching 100% utilisation while Southern regions show lower consistency.4

This skills deficit generates multiple downstream consequences: resistance to system adoption; reduced efficiency gains in clinical workflows; increased risk of user errors; and failure to realise the clinical and organisational benefits that justify capital investment. The Osservatorio Sanità Digitale (2025) specifically identifies the informal use of generalist AI tools (such as ChatGPT) by 46% of GPs and 26% of specialists for clinical information—rather than dedicated clinical platforms—as evidence of a critical gap between technological awareness and structured digital competency.13

In regions such as Emilia-Romagna, targeted training programmes (“Competenze digitali per la salute”) have demonstrated the effectiveness of structured digital literacy initiatives for healthcare workers.17

Policy Implication: Education must be institutionalised as a mandatory component of professional practice. Regional health authorities should integrate mandatory health informatics modules into ECM programmes, drawing on successful Northern models such as the Emilia-Romagna digital competency programme.

Quality management and information security standardisation—Policy implications

Deficits in quality management and cybersecurity frameworks constitute a fourth barrier. The ISO 9001:2015 quality management standard provides organisations with systematic methodologies for process documentation, risk identification, continuous improvement, and stakeholder satisfaction measurement.18 In the FSE context, ISO 9001 implementation ensures that clinical workflows are systematically mapped, user requirements are formally captured, and system failures are documented and remediated.

The ISO/IEC 27001:2022 information security management standard establishes frameworks for asset classification, access control, incident response, and security awareness.19 The Osservatorio Sanità Digitale confirms that cybersecurity remains a top strategic priority for Italian healthcare facilities, with investments continuing to increase in response to the growing frequency and sophistication of cyberattacks against the health sector.13

At present, the majority of Southern Italian regional health authorities do not mandate ISO 9001 or ISO/IEC 27001 certification within procurement specifications for FSE systems. This omission exposes organisations to risks including: acquisition of systems lacking documented quality assurance; inadequate security controls against cyber threats; vulnerability to GDPR sanctions; and compromised interoperability due to non-standard implementations.

Policy Implication: Quality and security standards must be elevated from optional attributes to mandatory procurement criteria. Award criteria in competitive tenders should allocate significant weighting (minimum 25-30%) to quality and security compliance.

The Citizen Perspective: Digital Literacy, Trust, and Demand-Side Barriers

The extremely low citizen consent rates in Southern regions—as low as 1% in Abruzzo, Calabria, and Campania compared to 92% in Emilia-Romagna4—cannot be fully explained by supply-side factors alone. Analysis of the demand-side barriers reveals three interconnected dimensions that contribute to citizen disengagement from the FSE.

First, digital literacy deficits are particularly acute in Southern Italy. The SVIMEZ Report documents lower rates of internet access and digital skills in the Mezzogiorno compared to Northern regions.12 The Osservatorio Sanità Digitale (2025) notes that 41% of Italian citizens have used the FSE, but this national average masks profound territorial inequalities: in the Mezzogiorno, utilisation remains below 11%.4,13 As the GIMBE President Nino Cartabellotta has emphasised, uploading data is insufficient without putting citizens in a position to actually use them, which requires serious investment in digital literacy.4

Second, trust in data security and institutional handling of personal health information varies substantially across the national territory. Citizens in Southern regions exhibit greater diffidence toward digital systems, reflecting broader patterns of lower institutional trust documented in socio-political research. The FSE 2.0 decree of 30 December 2024 introduced important privacy safeguards—including data obscuring capabilities and the right to control which health professionals access specific documents20—but these provisions require effective communication to citizens who may be unaware of them.

Third, the design of the consent model itself plays a critical role. International evidence from Germany, where an opt-in model similarly resulted in low EHR adoption, and from Estonia and Denmark, where opt-out models achieved near-universal coverage, demonstrates that the choice of consent architecture is a structurally determinative factor in citizen engagement.21 Italy’s current consent model, while respecting individual autonomy, may require supplementary measures—such as assisted digital onboarding at the point of care and proactive outreach campaigns in community settings—to overcome passive non-participation.

Policy Implication: Citizen engagement must be treated as a distinct policy priority. Southern regions should implement structured digital health literacy programmes at community level, deploy assisted FSE activation services within primary care facilities, and launch transparent communication campaigns addressing data security concerns. Additionally, the impact of the current opt-in consent model on adoption should be systematically evaluated, with consideration of alternative consent architectures that balance individual rights with public health benefits.

Actionable recommendations

The recommendations presented here constitute a four-pillar policy strategy designed to address the multidimensional barriers identified above. These pillars are conceptually distinct yet operationally interdependent; implementation of any single pillar in isolation will be insufficient to resolve the underlying systemic constraints. Each pillar includes measurable Key Performance Indicators (KPIs) to enable systematic evaluation.

Pillar 1: Institutional Reform—Dedicated Digital Health Governance

Action: Each Southern Italian region should establish a formally constituted Regional Digital Health Unit with the following attributes:

  • Autonomous governance structure: reporting directly to the regional health commissioner, minimising bureaucratic obstruction and ensuring decision-making agility.

  • Multiyear protected budget: allocation of dedicated resources for 5–10-year horizons, shielded from short-term budgetary fluctuations.

  • Qualified personnel: recruitment of senior digital health professionals (CIO or equivalent), health informaticists, change management specialists, and project managers.

  • Clear mandate: formal authority over regional FSE strategy, procurement, implementation timelines, and performance evaluation.

  • Accountability mechanisms: regular reporting to regional health authorities and the national PNRR monitoring framework.

KPIs: (a) Number of Southern regions with formally established Digital Health Units by end of 2026; (b) presence of a senior CIO-level appointment in each unit; (c) percentage of annual digital health budget executed against plan; (d) quarterly reporting compliance rate to the PNRR monitoring framework.

Expected Outcome: Institutional capacity for strategic digital health planning, vendor selection based on technical merit, and coherent implementation timelines.

Implementation Timeline: Establishment by end of 2026, aligned with PNRR deadlines.

Pillar 2: Professional Development—Mandatory Health Informatics Training

Action: Integrate mandatory health informatics education into regional ECM programmes:

  • Credit allocation: minimum 10 ECM credits per three-year cycle dedicated to digital health competencies for all healthcare professionals.

  • Curriculum content: (a) fundamentals of health information systems; (b) FSE functionality and clinical workflow integration; (c) health data security and privacy; (d) interoperability standards (SNOMED CT, HL7 FHIR); (e) quality improvement using health IT; (f) responsible use of AI-based tools in clinical practice.

  • Delivery modality: mixed approach combining in-person training, e-learning, and hands-on system simulations.

  • Evaluation: pre- and post-training assessments of knowledge and confidence.

  • Trainer qualification: establishment of a cadre of certified health informatics educators, building on the model of Emilia-Romagna’s “Competenze digitali per la salute” programme.

KPIs: (a) Percentage of healthcare professionals completing mandatory health informatics ECM credits (≥80% by 2028); (b) pre−/post-training knowledge improvement scores; (c) FSE active utilisation rate among trained professionals; (d) number of certified health informatics trainers per region.

Expected Outcome: Systematic improvement in workforce digital literacy; reduced resistance to implementation; improved system utilisation and clinical workflow efficiency.

Implementation Timeline: Integration into ECM curricula beginning 2026, with full incorporation by early 2027.

Pillar 3: Quality and Security Standardisation—Procurement Reform

Action: Mandate compliance with international quality and security standards in all regional FSE procurement processes:

  • Interoperability: conformity to SNOMED CT, HL7 FHIR API standards, validated through independent certification with contractual penalties for non-compliance.

  • Quality management: ISO 9001:2015 certification required at procurement and throughout the system lifecycle (annual audits).

  • Information security: ISO/IEC 27001:2022 certification with biennial audit reports and mandatory security requirements in procurement specifications.

  • Procurement weighting: quality and security compliance to receive minimum 25–30% of total award criteria weighting.

KPIs: (a) Percentage of new FSE-related procurement tenders including mandatory ISO 9001 and ISO/IEC 27001 certification requirements; (b) number of awarded contracts with full SNOMED CT/HL7 FHIR compliance; (c) cybersecurity incident rate in FSE systems per region (year-on-year reduction target); (d) audit compliance rate for existing contracts.

Expected Outcome: Elevated technical and organisational quality; reduced cybersecurity risk; improved interoperability; reduced vendor lock-in.

Implementation Timeline: Immediate implementation for new tenders; existing contracts amended by end of 2026.

Pillar 4: Inter-Regional Knowledge Networks—Twinning and Capacity Transfer

Action: Establish formal twinning arrangements between digitally mature and developing regions:

  • Partnership structure: formal agreements between pairs of regions (e.g., Emilia-Romagna with Campania; Veneto with Calabria) specifying objectives for technical assistance and knowledge sharing.

  • Personnel exchange: structured rotations of 3–6 months enabling Southern health IT professionals to work within Northern digital health units.

  • Mentorship model: senior Northern health IT leaders as formal mentors with regular interactions.

  • Peer learning networks: working groups focused on specific challenges (vendor selection, cybersecurity, clinical user engagement, citizen outreach).

  • Funding mechanism: PNRR resources to support personnel exchanges and peer-learning activities.

KPIs: (a) Number of formally established twinning agreements; (b) number of personnel exchanges completed per year; (c) documented knowledge transfer outcomes (e.g., procurement specifications adopted, training programmes replicated); (d) FSE adoption rate improvement in twinned Southern regions versus non-twinned regions.

Expected Outcome: Accelerated transfer of implementation knowledge; reduced costly implementation errors; identification of scalable best practices.

Implementation Timeline: Twinning partnerships formally established by mid-2026, with exchanges commencing thereafter.

Discussion

The digital health divide between Northern and Southern Italy represents not merely a technological gap but a manifestation of deeper institutional, governance, and human-capacity asymmetries. Addressing this divide requires coordinated intervention across four interdependent policy domains: institutional governance, professional development, technical standardisation, and inter-regional collaboration.

International Comparative Evidence

The policy recommendations proposed here are informed by international evidence from countries that have achieved successful nationwide EHR implementation. Three cases are particularly instructive.

Estonia launched its national e-Health Information System (EHIS) in 2008, achieving near-universal coverage within a decade. By 2017, approximately 99% of medical prescriptions were issued electronically, and over 10,000 healthcare professionals used the system daily.22 The key success factors identified in the Estonian experience—clear governance through a dedicated e-Health Foundation, legal clarity through mandatory participation for all healthcare institutions, standardisation of medical data using HL7 CDA, and agreement on access rights22—directly correspond to the governance and standardisation pillars proposed in this policy brief. Estonia’s experience demonstrates that even a small country with limited resources can achieve comprehensive EHR implementation when institutional structures are coherent and standards are enforced.

Denmark represents a second instructive case. The Danish health data network achieved near-complete primary care physician participation by 2010, supported by strong coordination between national and regional health authorities, a unique patient identifier system (CPR-number), and the establishment of MedCom as a national e-Health competence centre responsible for interoperability standards.23,24 Denmark’s consolidation of hospital EHR systems to just two national platforms illustrates how reducing system fragmentation—the inverse of Italy’s current situation—facilitates data sharing and quality governance.

Critically, both Estonia and Denmark adopted opt-out consent models for their EHR systems, in contrast to the opt-in approach used in Italy and Germany. A recent comparative analysis of the German EHR implementation demonstrates that the choice of an opt-in procedure was a structurally determinative factor in the low adoption rates observed, while Estonia and Denmark’s opt-out approach resulted in near-universal population coverage.21 This international evidence is directly relevant to the extremely low citizen consent rates observed in Southern Italian regions (1% in Abruzzo, Calabria, and Campania) and supports the recommendation for a systematic evaluation of Italy’s consent architecture.

The European Commission’s eHealth adoption study confirms that countries with the highest adoption levels—Denmark, Estonia, Finland, Spain, Sweden, and the United Kingdom—share common characteristics: national health service-type systems, strong central coordination, and mandated interoperability standards.25 Italy’s NHS-type structure (SSN) provides a favourable institutional foundation, but the devolved governance model creates implementation challenges that the proposed Regional Digital Health Units are specifically designed to address.

Synthesis and strategic implications

The four-pillar strategy proposed here offers a comprehensive yet operationally feasible policy framework. The inclusion of ISO 9001 and ISO/IEC 27001 certification requirements within procurement specifications represents a particularly important innovation, enabling regions to address quality and cybersecurity imperatives while promoting technical standardisation and vendor market discipline.

The introduction of measurable KPIs for each pillar (Table 2) addresses a gap frequently observed in digital health policy frameworks, where aspirational goals lack concrete benchmarks for accountability. These indicators are designed to enable both internal management monitoring and external accountability through the PNRR reporting framework.

Table 2. Key performance indicators for the four-pillar policy strategy.

Policy pillarKey performance indicatorTargetTimeline
Pillar 1: GovernanceSouthern regions with established Digital Health Units≥6 regionsEnd 2026
Pillar 1: GovernanceSenior CIO-level appointment per unit100%End 2026
Pillar 2: TrainingHealthcare professionals completing health informatics ECM≥80%2028
Pillar 2: TrainingCertified health informatics trainers per Southern region≥102027
Pillar 3: StandardsNew tenders with mandatory ISO certification100%Immediate
Pillar 3: StandardsContracts with SNOMED CT/HL7 FHIR compliance≥90%End 2027
Pillar 4: TwinningFormal twinning agreements established≥4 pairsMid-2026
Pillar 4: TwinningPersonnel exchanges completed per year≥202027
Cross-cuttingCitizen FSE consent rate in Southern regions≥30%End 2027
Cross-cuttingCitizen FSE utilisation rate in Southern regions≥20%End 2027

The addition of a citizen-centred perspective—addressing digital literacy, trust, and consent architecture—recognises that sustainable FSE adoption cannot be achieved through supply-side interventions alone. The GIMBE finding that Mezzogiorno FSE utilisation remains below 11%4 despite 95% GP access rates nationally underscores the critical importance of demand-side engagement strategies.

Implementation of this strategy, combined with rigorous PNRR accountability mechanisms and the recent legislative developments including the Decreto 30 December 2024 and the Decreto 27 June 2025 on the Profilo Sanitario Sintetico,20 is necessary—although not by itself sufficient—to achieve health equity in digital healthcare access. The proposed timelines are aligned with PNRR deadlines and demonstrate operational feasibility.

Conclusions/Discussion

The digital health divide between Northern and Southern Italy represents not merely a technological or resource gap, but a manifestation of deeper institutional, governance, and human‑capacity asymmetries. Addressing this divide requires coordinated intervention across four interdependent policy domains: institutional governance, professional development, technical standardisation, and inter‑regional collaboration.The four‑pillar strategy proposed here offers a comprehensive yet operationally feasible policy framework for Southern Italian regions to accelerate EHR implementation while simultaneously strengthening the quality and security governance of their health information systems. The inclusion of ISO 9001 and ISO/IEC 27001 certification requirements within procurement specifications represents a particularly important innovation, enabling regions to address quality and cybersecurity imperatives while simultaneously promoting technical standardisation and vendor market discipline.Implementation of this strategy, combined with rigorous PNRR accountability mechanisms and sustained political commitment, is necessary—although not by itself sufficient—to achieve health equity in digital healthcare access and to meet European Union digital health integration targets by 2026. The proposed implementation timeline for the four pillars (establishment of Regional Digital Health Units by Q2 2026; commencement of ECM curriculum integration by Q3 2026; immediate implementation of procurement reform) is aligned with binding PNRR deadlines and demonstrates operational feasibility.

Key stakeholders and implementation roles

Regional Health Authorities must establish Regional Digital Health Units, mandate ISO standardisation in procurement, integrate health informatics into ECM curricula, and deploy citizen-facing digital literacy programmes.

National Ministry of Health must provide regulatory guidance, allocate PNRR resources for inter-regional twinning, establish national accountability mechanisms, and evaluate the impact of the current consent model on FSE adoption.

Northern Italian Regions must commit to formal mentorship and knowledge-transfer arrangements with Southern regions.

Healthcare Facilities must comply with mandatory workforce training, adopt ISO-certified FSE systems, and participate in evaluation mechanisms.

Citizens and Patient Organisations should be actively engaged in the design and evaluation of digital health services, contributing to the development of user-centred interfaces and the identification of barriers to adoption.

Anticipated barriers to implementation and mitigation strategies

Political resistance stemming from administrative transitions may impede the establishment of depoliticised Regional Digital Health Units. Mitigation: PNRR regulations should specify that Regional Units are protected entities with dedicated funding streams insulated from electoral cycles.

Fiscal constraints in economically disadvantaged Southern regions may limit multiyear budgeting. Mitigation: the national government should allocate PNRR resources specifically to support Southern infrastructure investments and provide additional support for regions unable to meet matching-fund requirements.

Workforce resistance to mandatory health informatics training may arise if training is perceived as burdensome. Mitigation: curriculum development must be practitioner-centred and context-specific, with training delivery emphasising workflow integration and demonstrable clinical benefits.

Citizen resistance to FSE adoption, particularly in communities with low digital literacy and low institutional trust, may persist despite infrastructure improvements. Mitigation: citizen engagement strategies must be culturally sensitive, community-based, and co-designed with local patient organisations and primary care providers.

Limitations

This analysis has several limitations that should be acknowledged. First, as a narrative policy analysis rather than a systematic review, the evidence synthesis does not follow formal systematic review protocols (e.g., PRISMA) and may not capture all relevant literature, although 72 sources across six categories were systematically consulted (Table 1). Second, granular quantitative data on FSE adoption at the level of individual healthcare facilities in Southern regions remain limited; available monitoring data are primarily aggregated at regional level, as also noted by the Fondazione GIMBE. Third, the policy recommendations are informed by evidence from comparable European health systems (Estonia, Denmark, Germany) but have not been empirically tested in the specific Southern Italian context. Fourth, the analysis incorporates the citizen perspective through institutional monitoring data and international comparative evidence, but does not include primary qualitative data from Southern Italian citizens. Future research should address this gap through structured qualitative investigations including focus groups and interviews with citizens, patients, and community health workers in underserved Southern communities.

Future research should prospectively evaluate the implementation effectiveness of these recommendations and assess their impact on clinical outcomes, healthcare efficiency, and patient experience. Longitudinal assessment of FSE adoption rates, quality metrics, cybersecurity incident rates, and workforce satisfaction should inform iterative refinement of the policy strategy. Particular attention should be devoted to evaluating the impact of alternative consent architectures on citizen engagement, drawing on the natural experiments provided by international comparators.

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Fumai G, Menolascina F and Morelli C. Bridging the Digital Divide: Evidence-Informed Health Policy Recommendations to Accelerate Electronic Health Record Implementation in Southern Italian Regions [version 2; peer review: 2 approved with reservations]. F1000Research 2026, 15:434 (https://doi.org/10.12688/f1000research.176771.2)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 2
VERSION 2
PUBLISHED 13 Apr 2026
Revised
Views
6
Cite
Reviewer Report 08 Jun 2026
Anna Essén, Stockholm School of Economics, Stockholm, Sweden 
Approved with Reservations
VIEWS 6
Review 

Thank you for providing me with the opportunity to review this interesting and meaningful study! I largely approve of the content and structure, and the policy recommendations. Below, I provide some ideas that could further anchor ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Essén A. Reviewer Report For: Bridging the Digital Divide: Evidence-Informed Health Policy Recommendations to Accelerate Electronic Health Record Implementation in Southern Italian Regions [version 2; peer review: 2 approved with reservations]. F1000Research 2026, 15:434 (https://doi.org/10.5256/f1000research.198115.r486200)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 10 Jun 2026
    Giuseppe Fumai, Scienze Biomediche, Universita degli Studi di Foggia Dipartimenti di Area Medica, Foggia, 71100, Italy
    10 Jun 2026
    Author Response
    Dear Reviewer,
    Thank you for your careful, thoughtful, and constructive review and for your positive appraisal of our manuscript’s structure, findings, and policy recommendations. We greatly appreciate the time you ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 10 Jun 2026
    Giuseppe Fumai, Scienze Biomediche, Universita degli Studi di Foggia Dipartimenti di Area Medica, Foggia, 71100, Italy
    10 Jun 2026
    Author Response
    Dear Reviewer,
    Thank you for your careful, thoughtful, and constructive review and for your positive appraisal of our manuscript’s structure, findings, and policy recommendations. We greatly appreciate the time you ... Continue reading
Views
4
Cite
Reviewer Report 26 May 2026
Federico Ruta, Azienda Sanitaria Locale Barletta Andria Trani, Barletta, Italy 
Approved with Reservations
VIEWS 4
This policy brief addresses a timely and policy-relevant question: the persistent North–South divide in the adoption of the Fascicolo Sanitario Elettronico (FSE) in Italy, and the structural barriers that prevent Southern regions from meeting PNRR Mission 6 targets by mid-2026. ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Ruta F. Reviewer Report For: Bridging the Digital Divide: Evidence-Informed Health Policy Recommendations to Accelerate Electronic Health Record Implementation in Southern Italian Regions [version 2; peer review: 2 approved with reservations]. F1000Research 2026, 15:434 (https://doi.org/10.5256/f1000research.198115.r481041)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 01 Jun 2026
    Giuseppe Fumai, Scienze Biomediche, Universita degli Studi di Foggia Dipartimenti di Area Medica, Foggia, 71100, Italy
    01 Jun 2026
    Author Response
    Dear Reviewer,
    Thank you sincerely for taking the time to evaluate our manuscript and for your thoughtful and constructive feedback.
    We are pleased to learn that the paper was found ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 01 Jun 2026
    Giuseppe Fumai, Scienze Biomediche, Universita degli Studi di Foggia Dipartimenti di Area Medica, Foggia, 71100, Italy
    01 Jun 2026
    Author Response
    Dear Reviewer,
    Thank you sincerely for taking the time to evaluate our manuscript and for your thoughtful and constructive feedback.
    We are pleased to learn that the paper was found ... Continue reading

Comments on this article Comments (0)

Version 2
VERSION 2 PUBLISHED 25 Mar 2026
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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