OBJECTIVES:The objectives of this study are to map definitions of digital health, eHealth, mHealth, telehealth, telemedicine, and artificial intelligence to further expand an existing conceptual map to distinguish between these terms and propose a harmonized definition for "digital health technologies." METHODS:A scoping review was conducted to identify definitions of digital health, eHealth, mHealth, telehealth, telemedicine, and artificial intelligence. PubMed/MEDLINE, Embase, Cochrane Library, and EconLit were searched between January 2015 and May 2024. A 2-round modified Delphi, informed by the scoping review, was undertaken to develop a harmonized definition of digital health technologies (DHTs). Numerical summary analyses were performed for identified definitions and Delphi responses, and thematic and content analyses were applied to the definitions and free-text responses. RESULTS:The search yielded 11,041 records, of which 482 articles were included after screening and snowballing. A total of 328 definitions were identified for digital health, eHealth, mHealth, telehealth, telemedicine, and artificial intelligence. Higher number of definitions were identified for the term telehealth/telemedicine. Across the definitions, 3 key components consistently emerged: purpose, users, and underlying technology. Round 1 of the Delphi received 118 complete responses, and round 2 received 54. Consensus was achieved on the key components, their subcomponents, and the final definition of DHTs. CONCLUSION:This study proposes a unified definition of DHTs, grounded in the components of purpose, users, and technology. Recognition of AI within the definition reflects its growing role in digital health. This definition provides a foundation for developing classification criteria that support consistent health technology assessment of DHTs.

Digital health technologies (DHTs) are transforming healthcare by enabling for example new care models, improving patient access and engagement, and streamlining healthcare workflows. They have the potential to increase efficiency, reduce administrative burdens, and enhance the overall quality of care. However, across Europe, DHTs evaluation frameworks remain fragmented, and while new approaches continue to emerge, they often focus on specific types of DHTs or particular stages of the product lifecycle. Moreover, traditional Health Technology Assessment (HTA) frameworks have been developed mostly to evaluate medicinal products, which may limit their applicability to DHTs, ultimately constraining health systems’ ability to capture DHTs’ added value. The European Digital Health Technology Assessment (EDiHTA) is a EU-funded project, which started in January 2024 to co-create an HTA framework for DHTs in order to face these challenges. It is aimed at co-developing together with different key stakeholders a comprehensive and flexible assessment framework tailored to different DHTs, applicable across DHTs lifecycle and across EU member states. In this perspective article, we present our concept design that is being used as foundation of the development of the EDiHTA framework, and we address current challenges in the assessment of DHTs, and the opportunities that lie ahead.

BACKGROUND:Organizations worldwide have faced many challenges due to the COVID-19 pandemic. In the health care sector, including breast cancer, multidisciplinary teams have suffered disruptions due to changes in the organization of work and in membership composition. Moreover, the entire health care workforce has been impacted by significant stress. PURPOSE:This study aimed to understand how these challenges affected the probability of observing changes in breast unit (BU) patients' perceptions of the quality of care received. METHODOLOGY/APPROACH:We tested three research hypotheses using a sample of 366 patients nested in 68 BUs, performing logistic regression using STATA 14. RESULTS:The stress experienced by BU team leaders had a positive impact on the perceived stability of quality of care, whereas changes in team composition and social distancing among members had a negative impact on it. PRACTICE IMPLICATIONS:Health care managers should develop new training paths to help professionals adapt to new ways of working using appropriate technologies. Organizations should make teams able to share knowledge and practices through specific instruments, such as repository tools that can support teams even in cases of membership changes. Policymakers should pay greater attention to the mental health of health care workers, especially in emergencies. CONCLUSIONS:This paper highlights the key factors that enable multidisciplinary teams to succeed, even under emergency conditions.

Background Advanced therapies (ADTs) have transformed the management of chronic immune-mediated inflammatory diseases (IMIDs) across gastroenterology, dermatology, and rheumatology. Their growing use pressures universal, regionalized systems such as the Italian National Health System, challenging sustainability, equitable access, and integration of innovation. To address these challenges, an interdisciplinary Italian consortium (Latium Net) developed consensus-based recommendations on sustainability and innovation in IMIDs care. Methods Three-phases: (1) targeted literature review; (2) round-table discussions involving clinicians, pharmacists, administrators, and patient-representatives, then a modified Delphi survey with iterative voting and refinement; (3) final discussion and approval (consensus: ≥80% agreement on a 5-point Likert-scale). Results After three Delphi-rounds, 31 of 37 preliminary statements achieved consensus. Recommendations addressed: cross-stakeholder responsibilities within a regional system; sustainability indicators (biosimilar uptake, persistence, hospitalization rates, PROs/PREMs, direct and indirect costs); criteria for innovation and timely drug availability; and multidisciplinary management for complex IMID patients. Emphasis was placed on biosimilar adoption in biologic-naïve patients, harmonized data collection, and mitigating regional inequalities in access to therapies, key issues in the decentralized Italian SSN. Conclusions This consensus provides a pragmatic multidisciplinary framework to guide sustainable, innovative ADT use in IMIDs, supporting equitable access, optimized resource allocation, and long-term healthcare sustainability within regionalized health systems.

IntroductionGenomics holds significant promise for prevention and clinical care yet integrating it into the national healthcare system (NHS) requires considerable system-wide changes. This study assessed the current stage of Italy in the use of genomics, to map critical areas for improvement and contribute to a strategic plan.MethodsA total of 18 experts rated individually the level of maturity of the Italian NHS on a scale from 1 (lowest) to 5 (highest) using the B1MG Maturity Level Model tool. This instrument is an European matrix of 49 indicators grouped into eight domains: governance, economic aspects, ethics and legislation, public awareness, workforce skills, clinical organization, clinical guidelines, and data infrastructure. Consensus procedures were performed within each domain to finally agree on one maturity level per indicator.ResultsDespite a few national initiatives, Italy shows a local level of implementation in most indicators. Genomic medicine is considered a priority, but still lacks an updated strategy and investment plans. A higher maturity is reached for ethical and legal aspects, but there is a strong need to invest in workforce training, citizen engagement and literacy, and large-scale adoption of tools and novel technologies. Infrastructures and guidelines to improve data storage, management, analysis, interpretation, and sharing are not yet widespread available.DiscussionItaly is at the beginning of its journey towards a sustainable implementation of genomics. An updated national strategy with coordinated actions and investment plans is needed to make progress in key areas, including personnel education, public engagement, technical infrastructure, and clinical organization.

This article presents the outcomes of a national initiative aimed at developing a technical document to support the future Italian National Genomic Strategy, carried out from 2021 to 2024 through the collaboration of 14 research institutions. The project was designed to align with major European genomic initiatives, particularly the “1 + Million Genomes” (1 + MG) Declaration and its supporting programs, including Beyond 1 Million Genomes (B1 + MG), the Genomic Data Infrastructure (GDI), and Genome of Europe (GoE). The initiative was structured around 12 National Mirror Groups (NMGs), each addressing a specific domain such as clinical implementation, ethical and legal issues, data governance, health economics, and public engagement. Through expert consensus and coordinated activities, the project produced a comprehensive technical document outlining seven strategic lines and related intervention areas. These include the integration of genomic testing into clinical practice, development of specialized genomic centers, creation of a national genomic data infrastructure, professional training, and public education. The proposed strategy emphasizes equitable access to genomic medicine, the use of health technology assessment to evaluate new technologies, and the importance of citizen engagement and literacy. By fostering collaboration among institutions, healthcare professionals, and the public, the final goal is to position Italy as a leader in genomic medicine and ensure the responsible, effective, and ethical use of genomics in public health and clinical care.

OBJECTIVES:Hospital-Based Health Technology Assessment (HB-HTA) is a heterogeneous phenomenon constantly evolving to respond to the needs of decision-makers at the hospital level. In 2023, The HB-HTA Interest Group of Health Technology Assessment International (HTAi) surveyed HB-HTA activities with the aim to provide an updated description of the actual scenario. METHODS:An online survey was conducted to gather data on the main characteristics of hospitals, HB-HTA activities, outputs, role in the decision-making processes, dissemination and training activities, and their interaction and collaboration with other stakeholders and HTA-related regulations. Finally, the survey collected feedback on the perception of and current barriers to HB-HTA. Three categories of responders were identified: Both hospitals performing and not performing HTA and policymakers. RESULTS:Eighty-seven responses were collected from twenty-eight countries. Nearly half of the responders (n = 41) conducted HB-HTA, whereas eighteen consisted of hospitals not performing HTA, and twenty-eight were policy makers. HB-HTA was performed mainly in hospitals with >500 beds. HB-HTA units were organized in 40 percent of cases as an "independent group." The survey showed that HTA units could contribute to all the steps of the decision-making processes, whereas the impact of the assessments on the decisions was mainly perceived as a medium. Furthermore, HB-HTA was not seen as a duplication of effort, even without specific regulations. CONCLUSIONS:The survey highlighted the role of HB-HTA in hospital decision-making supporting the vision of HB-HTA as one of the actors in the HTA ecosystem, the success of which depends on collaboration with other stakeholders.

The practice of healthcare management is essential for the efficient operation of health services, encompassing leadership, management, and direction within healthcare organisations. 'Health management' extends beyond healthcare management by integrating principles of public health and health policy. As health management is commonly practised but not cohesively recognised, the European Health Management Association (EHMA) conducted this study to develop a cohesive definition of health management. Developed through a qualitative methodology comprising focus group discussions and validation through quantitative expert interviews, this study proposed a holistic definition of health management, incorporating social, environmental and economic determinants of health, cross-sector collaboration, and the 'One Health' approach. The publication of this unified definition has important implications for professional training, policy development, and health outcomes. It provides a foundational framework for curricula, informs precise policy formulation, and promotes excellence through health service delivery that reflects efficiency, sustainability, and equity.

Introduction: Market access, pricing, and reimbursement of digital health technologies (DHTs) in Europe are significantly challenged by regulatory fragmentation and various assessment methodologies. Understanding the challenges and priorities of technology developers is essential for developing effective and relevant policy responses. This study explores perceived barriers and developer-driven priorities to inform the development of a harmonized health technology assessment (HTA) framework under the EDiHTA project. Methods: A mixed-methods approach was adopted, including a scoping review to identify key challenges, a survey of 20 DHT developers, and interviews and focus groups with 29 industry representatives from startups to multinational companies across 10 European countries during 2024. Results: Key challenges included a lack of transparency in reimbursement processes, fragmented HTA requirements, and misalignment between traditional evidence models and the agile development of DHTs. Developers highlighted the need to integrate real-world evidence, consider usability and implementation factors, and provide structured, lifecycle-based guidance. Financial barriers and procedural burdens were particularly significant for small and medium-sized enterprises. Conclusions: These findings highlight the need for an HTA framework that reflects the iterative nature of digital development, integrates real-world evidence, and reduces uncertainty for developers. The EDiHTA project aims to respond to these challenges by building a harmonized and flexible approach that aligns with the goals of the European HTA Regulation.

The EDiHTA project aims to deliver an innovative health technology assessment (HTA) framework for digital health technologies (DHT) that integrates existing methods with new ones to inform decision-making across Europe at different levels. In the development phase of the EDiHTA framework, it has been essential to identify all relevant stakeholders and their roles in the innovation process, while also capturing their needs and requirements. The Innovation of Health Technology Assessment Methods framework was applied to identify relevant stakeholders and their needs and requirements regarding the design of the EDiHTA framework. Once stakeholders and their roles (practitioners or beneficiaries) were identified, their needs were assessed by reviewing existing and new HTA methodologies for DHT as used in 17 countries across Europe. Future scenarios were examined and gaps to be addressed were determined. Various methods were used to elicit the views of different stakeholders (policymakers, HTA agencies and bodies, industry, healthcare professionals, patients). including literature reviews, two online surveys, semi-structured online interviews, and focus groups. We engaged policymakers from 15 European countries; 15 HTA agencies from nine European countries; 29 developers (startups and big companies) from 10 different European markets; 14 healthcare professionals from nine European countries plus eight from Brazil, Canada, and the USA; and 15 patient representatives from 10 European countries. The analysis highlighted the heterogeneity among European health systems in assessing, implementing, and reimbursing DHT. All stakeholder groups emphasized the need for a harmonized HTA framework to assess DHT efficiently and accurately, including elements specific to DHT, such as cybersecurity, economic and organizational impact, and patient-centered outcomes. There is a clear need among European stakeholders for an agile, flexible, and multidimensional HTA framework that facilitates stepwise assessments across the technology life cycle and involves all relevant stakeholders in the assessment to inform decision-making. The stakeholder interaction also identified new HTA topics and domains essential for effectively addressing the unique challenges of DHT within the EDiHTA framework.

OBJECTIVES:The increasing use of digital health technologies (DHTs) in Europe presents opportunities and challenges. Although DHTs could enhance care delivery and health outcomes, existing health technology assessment (HTA) methods often lack flexibility to address their diverse, fast-evolving nature. This article explores the perspectives of 5 stakeholder groups-policy makers, HTA agencies, technology developers, healthcare providers, and patients-regarding the development of a harmonized HTA framework for DHTs within the Horizon Europe funded European Digital Health Technology Assessment (EDiHTA) project. METHODS:Findings are drawn from mixed-method research, including stakeholder surveys, interviews and focus groups with 97 stakeholders across European countries. The analysis of the data was performed per each stakeholder group through thematic analysis to identify points of consensus before identifying needs and requirements across stakeholders, relevant to the development of EDiHTA, using the Innovation Health Technology Assessment Methods framework. RESULTS:Results from 8 focus groups and more than 45 interviews are presented concentrating on 5 main themes. The emerging themes focus on the need for harmonization of HTA methods related to DHTs, the current characteristics of DHTs that are most highly valued, the importance of multistakeholder collaboration, the principles of a concept design for EDiHTA framework, and the discussion on the most relevant domains and criteria to be considered. CONCLUSIONS:Stakeholders agreed that a harmonized HTA framework is needed; however, differences persist regarding timing and flexibility of evaluation, evidence types, and stakeholder involvement. The EDiHTA project will address differences through framework piloting, supported by multistakeholder workshops and expert advisory groups.

IntroductionSeveral organizations specializing in health technology assessment (HTA), at various levels, are exploring avenues to integrate the dimension of environmental sustainability (ES) within their assessments. However, evidence remains scant on how best to do this. Across the different levels, hospital-based HTA (HB-HTA) also needs to comply with the leadership and strategies of the hospital and adapt to the existing resources and established partnerships.MethodsThe purpose of this study is threefold: to provide an overview of the progress achieved by hospitals with respect to the integration of ES into HB-HTA; to detect consistencies between HB-HTA activities and hospital ES strategies; and to explore possible approaches and methods for integrating ES into HB-HTA. The methodology is structured in two steps: (i) a literature review on HB-HTA and environmental impact/sustainability to identify emerging approaches and methods for integrating environmental sustainability into HB-HTA; (ii) data collection by means of a questionnaire submitted to hospitals/organizations based on their membership of Health Technology Assessment International.ResultsPreliminary results highlight a widespread awareness of the importance of integrating ES issues into HTA at the different levels at which it is performed. The incorporation of ES issues into HB-HTA is still in its infancy. There are some factors hindering the development of methods, such as the absence of scientific evidence on emerging approaches and the scarce availability of data or difficulty in tracing data back to a specific technology.ConclusionsThe integration of the dimension of ES into HB-HTA still appears to be very immature. Coordination between the different actors in the system seems necessary to overcome the obstacles identified.

Objectives: Artificial intelligence (AI)-based health technologies (AIHTs) have already been applied in clinical practice. However, there is currently no standardized framework for evaluating them based on the principles of health technology assessment (HTA). Methods: A two-round Delphi survey was distributed to a panel of experts to determine the significance of incorporating topics outlined in the EUnetHTA Core Model and twenty additional ones identified through literature reviews. Each panelist assigned scores to each topic. Topics were categorized as critical to include (scores 7-9), important but not critical (scores 4-6), and not important (scores 1-3). A 70 percent cutoff was used to determine high agreement. Results: Our panel of 46 experts indicated that 48 out of the 65 proposed topics are critical and should be included in an HTA framework for AIHTs. Among the ten most crucial topics, the following emerged: accuracy of the AI model (97.78 percent), patient safety (95.65 percent), benefit-harm balance evaluated from an ethical standpoint (95.56 percent), and bias in data (91.30 percent). Importantly, our findings highlight that the Core Model is insufficient in capturing all relevant topics for AI-based technologies, as 14 out of the additional 20 topics were identified as crucial. Conclusion: It is imperative to determine the level of agreement on AI-relevant HTA topics to establish a robust assessment framework. This framework will play a foundational role in evaluating AI tools for the early diagnosis of dementia, which is the focus of the European project AI-Mind currently being developed.

Abstract Background Seasonal influenza has a significant impact on public health, generating substantial direct healthcare costs, production losses and fiscal effects. Understanding these consequences is crucial to effective decision-making and the development of preventive strategies. This study aimed to evaluate the economic and the fiscal impact of implementing an incremental strategy for seasonal influenza prevention using the cell-based quadrivalent influenza vaccine (QIVc) among healthcare workers (HCWs) in Italy. Methods To estimate the economic impact of implementing this strategy, we performed a cost analysis that considered direct healthcare costs, productivity losses and fiscal impact. The analysis considered a 3-year time horizon. A deterministic sensitivity analysis was also conducted. Results Assuming a vaccination coverage rate of 30% among HCWs, the analysis considered a total of 203 018 vaccinated subjects. On analysing the overall differential impact (including direct costs, indirect costs and fiscal impact), implementing QIVc vaccination as a preventative measure against influenza among HCWs in Italy would yield societal resource savings of €23 638.78 in the first year, €47 277.56 in the second year, and €70 916.35 in the third year, resulting in total resource savings of €141 832.69. Conclusions The study demonstrated that implementing the incremental use of QIVc as part of a preventive strategy for seasonal influenza among HCWs in Italy could yield positive economic outcomes, especially in terms of indirect costs and fiscal impact. The resources saved could be utilized to fund further public health interventions. Policy-makers should consider these findings when making decisions regarding influenza prevention strategies targeting HCWs.

IntroductionThe European parliament is working on a proposal for an Artificial Intelligence (AI) Act. The goal is to guarantee that AI systems used in the European Union are “safe, transparent, traceable, non-discriminatory and environmentally friendly.” The Act is not directly linked to health technology assessment (HTA), but implications for HTA are expected.MethodsThe final aim of the AI Act is the adoption of harmonized rules for AI foundation models. Foundation models are designed to produce a wide variety of outputs that are being adopted across various sectors. Therefore, their adaptation to specific (clinical) needs plays a key role and has implications on the required training data. The goal of our analysis was to critically investigate the potential implications of the Act’s requirements for HTA. The analysis moves from the technology (foundation models in health care) to the requirements and adopted terminology.ResultsThe definition of methods to assess the adaptation of foundation models has become a priority for HTA. The Act focuses on data quality, transparency, human oversight, and accountability. Available frameworks, such as the one developed by the AI MIND project, include them, but experience is required. HTA must define how to adapt its methods and frameworks as well as the risk levels addressed by the Act. In addition, the reference to energy efficiency standards confirms the need for HTA to clarify the role of and methods for environmental impact assessment. Finally, the patient perspective has great relevance in relation to the risk of discrimination.ConclusionsThe AI Act confirms the importance of topics already debated in HTA that still need resolution and testing. Harmonization of rules for AI and approaches for HTA is the main challenge. The AI Act, the HTA regulation, and ongoing European Union projects (i.e., AI-MIND and European Digital Health Technology Assessment) are showing the route to follow in the coming years.