[version 2; peer review: 2 approved with reservations]
No competing interests were disclosed.
Implementation of Electronic Health Records (EHRs)—termed
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.
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.
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.
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.
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
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%.
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.
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.
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.
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.
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.
| Source category | N. sources | Thematic focus | Time period |
|---|---|---|---|
| Peer-reviewed literature (PubMed, Scopus, CINAHL) | 34 | EHR implementation barriers, digital health competencies, quality management, international comparators | 2018–2025 |
| Institutional monitoring reports (GIMBE, Osservatorio, SVIMEZ, AGENAS, Corte dei Conti) | 12 | FSE adoption metrics, regional disparities, PNRR progress, infrastructure gaps | 2023–2025 |
| Government policy documents (Ministero della Salute, AgID, Dipartimento Trasformazione Digitale) | 8 | PNRR targets, FSE 2.0 regulatory framework, EDS architecture, PSS implementation | 2021–2025 |
| EU regulatory and strategic frameworks (European Commission, EHDS) | 5 | European Health Data Space, Digital Decade Programme 2030, eHealth adoption benchmarks | 2018–2025 |
| International case studies (Estonia, Denmark, NHS England) | 7 | Governance models, opt-out consent, interoperability standards, implementation success factors | 2008–2025 |
| Grey literature and expert reports | 6 | Cybersecurity trends, workforce training programmes, digital literacy assessments | 2022–2025 |
In total, 72 sources were systematically consulted. Barriers were thematically organised into four categories derived from the Consolidated Framework for Advancing Implementation Science (CFIR):
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.
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 (
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.
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 (
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.
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.
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.
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.
The ISO/IEC 27001:2022 information security management standard establishes frameworks for asset classification, access control, incident response, and security awareness.
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.
The extremely low citizen consent rates in Southern regions—as low as 1% in Abruzzo, Calabria, and Campania compared to 92% in Emilia-Romagna
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.
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 documents
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 (
| Policy pillar | Key performance indicator | Target | Timeline |
|---|---|---|---|
| Pillar 1: Governance | Southern regions with established Digital Health Units | ≥6 regions | End 2026 |
| Pillar 1: Governance | Senior CIO-level appointment per unit | 100% | End 2026 |
| Pillar 2: Training | Healthcare professionals completing health informatics ECM | ≥80% | 2028 |
| Pillar 2: Training | Certified health informatics trainers per Southern region | ≥10 | 2027 |
| Pillar 3: Standards | New tenders with mandatory ISO certification | 100% | Immediate |
| Pillar 3: Standards | Contracts with SNOMED CT/HL7 FHIR compliance | ≥90% | End 2027 |
| Pillar 4: Twinning | Formal twinning agreements established | ≥4 pairs | Mid-2026 |
| Pillar 4: Twinning | Personnel exchanges completed per year | ≥20 | 2027 |
| Cross-cutting | Citizen FSE consent rate in Southern regions | ≥30% | End 2027 |
| Cross-cutting | Citizen 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%
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,
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.
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.
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 (
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.
No primary data were generated in this analysis. All data cited are from published peer-reviewed literature, publicly available institutional monitoring dashboards (Dipartimento per la Trasformazione Digitale FSE dashboard, updated 31 March 2025; Osservatorio Sanità Digitale annual reports 2024–2025; Fondazione GIMBE, 9th Forum Mediterraneo in Sanità, July 2025), or published policy reports from the Italian Ministry of Health, AGENAS, SVIMEZ, and the Corte dei Conti. Specific URLs and access information are provided within reference citations.
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 the work in extant literature, and perhaps make the topic seem more urgent, and the recommendations more actionable.
The study outlines why EHR adoption is important (innovation). But the authors could add a sentence of two about WHY is it important with EHR (FSE) adoption, for whose sake? I am particularly thinking of the citizen perspective, as digital EHRs make EHRs potentially at least, more accessible for patients from home etc. (see later suggestions).
Who should adopt - the professionals?
Also, the patients?
Citizen asking for access to digital EHRs could be a potential driver.
The paper could also benefit from engaging with existing work (see references below), which compares patient-accessible electronic health record policies and implementations across countries. Such studies demonstrates that EHR adoption and use are shaped not only by technical infrastructure but also by governance arrangements, access rights, authentication procedures, interoperability choices, and the design of patient-facing services. By documenting substantial international variation in these dimensions, these studies provide a useful framework for interpreting the regional disparities observed in Italy. Incorporating this literature would strengthen the paper’s theoretical grounding and help position the Italian experience within a broader international debate on how governance and institutional design influence EHR uptake, citizen engagement, and the realization of digital health policy objectives.
A four-pillar strategy is nice. Could this proposed action be summarized into a visualization? Maybe this was provided but I did not see that in the pdf I could access. If so I apologize. The more concrete and visually clear, the better. Maybe a sequence of action could be suggested, where the order is logical and increases the chances of an outcome desired.
The discussion of low citizen engagement and consent rates could draw on Essén et al. (2018), which highlights how patient access arrangements, login procedures, and governance models influence the usability and uptake of electronic health records, similar to the above, all of which are central to understanding regional differences in FSE adoption.
The findings on governance fragmentation and uneven implementation capacity could be further strengthened by linking them to Gerrits, and Kuhlmann (2017), who showed that gaps often emerge between policy ambitions, regulatory frameworks, technological solutions, and provider-level practices in the implementation of patient-accessible EHRs. The Italian case provides further empirical support for this argument, suggesting that successful EHR adoption depends not only on technological infrastructure but also on effective coordination between policy and organisational levels.
Please note that these are only suggestions that may or may not inspire you and give you some food for thought!
Best of luck with this important work!
Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader?
Yes
Is the discussion on the implications clearly and accurately presented and does it cite the current literature?
Partly
Are the recommendations made clear, balanced, and justified on the basis of the presented arguments?
Yes
Reviewer Expertise:
Digital health
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
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 devoted to producing such actionable suggestions.
We will not submit a revised version of the present manuscript at this time. Rather, we will incorporate your recommendations comprehensively into a forthcoming scoping review that we are preparing. Specifically, that scoping review will:
• Clarify why adoption of the Fascicolo Sanitario Elettronico (FSE) matters, explicitly addressing citizen/patient benefits (access to personal records, care continuity, remote access to results, patient activation) as well as provider- and system-level gains (coordination, reduced duplication, public-health uses).
• Distinguish the adoption roles of health professionals and citizens, and examine how patient demand and ease of access can act as drivers of uptake.
• Systematically engage with the international comparative literature on patient-accessible EHRs, including governance arrangements, access rights, authentication procedures, interoperability choices, and patient-facing service design, to situate the Italian regional variation in a broader policy and institutional context.
• Integrate the specific works you cited (including Essén et al. (2018) and Gerrits & Kuhlmann (2017)) and related studies to strengthen our theoretical framing and to explain how governance fragmentation and implementation capacity shape observed disparities.
• Translate the four-pillar strategy into a more actionable format: a visual summary and a suggested, evidence-informed sequence of implementation steps (short- and medium-term priorities) to improve policymakers’ ability to operationalize the recommendations.
• Expand the discussion of low citizen engagement and consent rates by examining how access arrangements, login procedures, and governance models influence usability and uptake.
We intend the scoping review to provide the comparative evidence and theoretical grounding necessary to refine and prioritize the policy recommendations set out in the present manuscript. Once completed, the scoping review will also inform a revised manuscript should we choose to submit one in the future.
With your permission, we would like to (a) acknowledge and cite your referee comments in the scoping review, and (b) invite you to review the scoping manuscript when it is ready. Your expertise would be extremely valuable for ensuring we have correctly interpreted and incorporated the international literature and policy implications.
Thank you again for your constructive engagement and helpful suggestions.
Best regards,
Giuseppe Fumai (on behalf of the authors)
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. Drawing on 72 sources across peer-reviewed literature, institutional monitoring reports, government policy documents, EU frameworks, and international case studies, the authors identify four interconnected barrier domains — infrastructure, governance, workforce capability, and quality/security standardisation — and propose a corresponding four-pillar policy strategy supported by measurable Key Performance Indicators.
The manuscript makes a valuable and timely contribution to the Italian and European debate on equitable healthcare digitalisation. The argument is coherent, the policy recommendations are operationally feasible within PNRR timelines, and the integration of international comparative evidence (Estonia, Denmark, Germany) appropriately situates the Italian case within a wider European context. The revised version (v2) substantially strengthens the original submission through three meaningful additions: the explicit summary of evidence sources (Table 1), the consolidated KPI framework (Table 2), and the new subsection on citizen-facing barriers. These additions address the multidimensional nature of EHR adoption more fully than supply-side analyses alone typically achieve.
I particularly commend the authors for three editorial choices.
First, the explicit linkage of each policy pillar to measurable KPIs is a notable strength, as policy briefs in this field too often present aspirational goals without accountability benchmarks.
Second, the integration of ISO 9001 and ISO/IEC 27001 certification requirements into procurement specifications is a concrete, implementable proposal that fills a real gap in current Italian regional practice.
Third, the framing of the digital divide as a manifestation of deeper institutional and governance asymmetries — rather than a purely technological problem — reflects a sophisticated understanding of implementation science.
The manuscript is, in my view, ready for indexing. The suggestions below are offered as constructive input for the authors' future work on this research programme rather than as conditions for approval.
The following points are intended to strengthen the work further and may be of interest for future research or future iterations of the policy brief.
Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader?
Yes
Is the discussion on the implications clearly and accurately presented and does it cite the current literature?
Yes
Are the recommendations made clear, balanced, and justified on the basis of the presented arguments?
Yes
Reviewer Expertise:
nursing practice, clinical management, transplant coordination
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
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 to provide a comprehensive and accessible overview of the policy and its implementation context, and that the discussion on implications was considered clearly and accurately presented, with appropriate citation of current literature. We are equally glad that the recommendations were judged to be clear, balanced, and well-justified.
Your positive assessment is highly encouraging and confirms that the work meets the standards expected for this journal. We remain committed to maintaining this quality and will carefully consider any further suggestions you may have to strengthen the manuscript.
Thank you again for your valuable contribution to the peer review process.
Sincerely,
Giuseppe Fumai and co-authors