Laura Sampietro-Colom

Objectives: The objective of this study is to evaluate the feasibility of implementing Hospital-Based Health Technology Assessment (HB-HTA) within Ukraine’s healthcare system, focusing on its potential to strengthen evidence-based decision-making regarding clinical effectiveness, safety, cost-efficiency, and organizational and strategic impact of health technologies (HTs) in healthcare facilities (HCFs). Methods: We collected and synthesized key initiatives implemented between 2021 and 2025, outlining the main steps involved in introducing HB-HTA in Ukraine. Results: The article describes the landscape of the Ukrainian healthcare system and shares the experience of the initial steps of HB-HTA introduction amid tight budgets and increasing demands. Drawing on international models and adapting them to the national context, we outline key implementation strategies, the development of scientific and methodological approaches for HB-HTA, and the integration of a pilot HB-HTA project within a leading national HCF known for its high-level diagnostic and operational capabilities. Conclusions: The conducted pilot laid the groundwork for integrating HB-HTA into Ukraine’s healthcare system and demonstrated its role in empowering HCFs to guide smarter budget allocation and procurement decisions, especially in the context of decentralization. With continued investment in expertise, legal integration, and streamlined methodology, HB-HTA can become a cornerstone of transparent, cost-effective decision-making across the HCFs of the National healthcare system. The experience gained in Ukraine provides valuable insights that can support other countries in effectively adopting and utilizing HTs at the hospital level.

Background: Digital health technologies—including mobile applications, telemedicine platforms, artificial intelligence, and eHealth tools—are transforming health care delivery by enhancing access, personalization, and efficiency. However, traditional technology readiness levels (TRLs), while widely used to assess technological maturity, do not explicitly account for patient involvement—an essential factor in usability, acceptability, and real-world effectiveness. Objective: This study aimed to integrate patient perspectives into the TRLs framework, specifically tailoring it for applications in digital health innovations. By developing a patient-centered dimension using a Delphi methodology, this study provides actionable insights to enhance usability, acceptance, and real-world effectiveness of digital health technologies such as mHealth apps, telemedicine platforms, and eHealth solutions. Methods: A Delphi methodology was applied, involving 24 Spanish-speaking experts from diverse disciplines, including patient advocacy, clinical care, public health, ethics, and digital health engineering. Experts evaluated patient involvement statements across 10 TRL stages using a 6-point Likert scale. Consensus was defined a priori as ≥75% agreement and a mean score of ≥4.5. The Delphi process included 2 iterative rounds, allowing for refinement of the content despite initial consensus. Results: The Delphi process finally included 2 rounds, achieving a final 83.3% participation rate (20 of 24 experts). In round 1, all 10 TRL statements reached the predefined consensus threshold, with median scores ranging from 5.0 to 6.0 (83.3% to 100%) and mean scores from 4.70 (TRL2, 78.3%) to 5.25 (TRL5, 87.5%). While consensus was achieved, the presence of variability and qualitative feedback—particularly in early-stage TRLs such as TRL2 (Idea)—motivated a second round for refinement. In round 2, revised statements incorporating expert feedback were re-evaluated. Agreement increased across all TRLs, with mean scores ranging from 5.00 (TRL2, 83.3%) to 5.65 (TRL5, 94.2%). In total, 4 TRLs (TRL3, TRL4, TRL5, and TRL10) received a median of 6.0, indicating a unanimous strong agreement. Key refinements included more precise patient roles in usability testing, co-creation, clinical protocol design, and implementation monitoring. The framework also integrates patient-reported experience measures and patient-reported outcome measures in TRLs 5, 7, and 8. Conclusions: The PULSO-Tech-Clinic (Patient Participation, User/Usability, Literacy, System, and Observatory) Model is the first framework to systematically embed patient perspectives within the TRLs. Although consensus was achieved in the first round, a second round allowed for methodological rigor and optimization of clarity and inclusivity. This validated model enhances alignment with real-world patient needs and supports the design, evaluation, and adoption of patient-centered digital health technologies. Further research should evaluate its adaptability in diverse health care systems.

Background: While the HTA community appears well-equipped to assess preventive and diagnostic technologies, certain limitations persist in evaluating technologies designed for rare diseases, including those based on Artificial Intelligence (AI). In Europe, the EUnetHTA Core Model^® serves as a reference for assessing preventive and diagnostic technologies. This study aims to identify key ethical, legal, and social issues related to AI-based technologies for the prevention and diagnosis of rare diseases, proposing enhancements to the Core Model. Methods: An exploratory sequential mixed methods approach was used, integrating a PICO-guided literature review and a focus group. The review analyzed six peer-reviewed articles and compared the findings with a prior study on childhood melanoma published in this journal (Healthcare), retaining only newly identified issues. A focus group composed of experts in ethical, legal, and social domains provided qualitative insights. Results: Thirteen additional issues and their corresponding questions were identified. Ethical concerns related to rare diseases included insufficient disease history knowledge, lack of robust clinical data, absence of validated efficacy tools, overdiagnosis/underdiagnosis risks, and unknown ICER thresholds. Defensive medicine was identified as a legal issue. For AI-based technologies, concerns included discriminatory outcomes, explicability, and environmental impact (ethical); accountability and reimbursement (legal); and patient involvement and job losses (social). Conclusions: Integrating these findings into the Core Model enables a comprehensive HTA of AI-based rare disease technologies. Beyond the Core Model, these issues may inform broader assessment frameworks, ensuring rigorous and ethically responsible evaluations.

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.

Background: The ultra-rare nature of melanoma in children, adolescents, and young adults poses significant challenges to the development and implementation of effective prevention and diagnostic strategies. This article delves into the ELSIs surrounding these strategies, placing particular emphasis on the transformative potential of AI-driven tools and applications. Methods: Using an exploratory sequential mixed methods approach, this study integrated a PICO-guided literature review and qualitative insights from two focus groups. The review included 26 peer-reviewed articles published in English from January 2019 to January 2024, addressing ELSIs in melanoma, rare diseases, and AI in dermatology. Focus groups included a March 2024 session in Berlin with 15 stakeholders (patients, caregivers, advocates, healthcare professionals) and a November 2024 online session with 5 interdisciplinary experts. Results: Six key priorities for healthcare policies emerged: addressing cultural factors, such as the glorification of tanned skin; enhancing professional training for accurate diagnosis; balancing the risks of overdiagnosis and underdiagnosis; promoting patient autonomy through transparent communication; reducing inequalities to ensure equitable access to care; and making ethical and legal use of AI in healthcare. Conclusion: These priorities provide a comprehensive framework for advancing the prevention and diagnosis of melanoma in children, adolescents, and young adults, leveraging AI technologies while prioritizing equitable and patient-centered healthcare delivery.

IntroductionInterest in early detection of complications in hospitals has increased recently. Complications after elective or urgent surgery are frequent and are associated with higher mortality rates, longer hospital stays, and more resource utilization. The ZERO project implemented an educational nursing program and developed an innovative algorithm that assesses a patient’s complication risk based on clinical parameters to prevent complications and reduce hospital burden. Our aim was to present the results from one year of implementing ZERO at the Clinic Barcelona University Hospital.MethodsA comparative effectiveness and cost study was conducted. Data from patients admitted after elective or urgent surgery were collected for one year retrospectively (n=8,844 from January 2019 to December 2019) and prospectively (ZERO) (n=8,163 from October 2021 to October 2022). Effectiveness was measured in terms of mortality, complications, and life-years gained (LYG). Length of stay (LoS) at conventional, intermediate, and intensive care units and rates of readmissions were collected for resource use. The chi-square test was used to compare categorical variables. The t-test and Wilcoxon test were used for normally and non-normally distributed continuous variables, respectively.ResultsThere was a significant decrease in the rate of complications (7.8%, 95% confidence interval [CI]: -8.46, -7.19; p<0.001) with ZERO. Moreover, there were statistically significant reductions in mean LoS for readmissions to conventional wards (-5.04 days, 95%CI: -9.9, -0.18; p=0.04) and to the intensive care ward within the same episode (-4.68 days, 95%CI: -9.26, -0.14; p=0.02). The mean cost per patient was EUR2,772.92 and EUR2,591.57 before and after ZERO implementation, respectively. After accounting for the cost of implementing ZERO, there was a cost saving of EUR147.76 per patient (p=0.048), which yielded a yearly impact of EUR1,206,165 for the hospital budget.ConclusionsThis one-year analysis of the effect of ZERO on surgical patients shows that it decreases complication rates and all types of LoS, leading to overall cost savings for the hospital.

Introduction: Melanoma is the deadliest of all the skin cancers and its incidence is increasing every year in Europe. Patients with melanoma often present late to the specialist and treatment is delayed for many reasons (delay in patient consultation, misdiagnosis by general practitioners, and/or limited access to dermatologists). Beyond this, there are significant inequalities in skin cancer between population groups within the same country and between countries across Europe. The emergence of the COVID-19 pandemic only aggravated these health deficiencies. Objectives: The aim was to create an expert opinion about the challenges in skin cancer management in Europe during the post COVID-19 acute pandemic and to identify and discuss the implementation of new technologies (including e-health and artificial intelligence defined as "Smart Skin Cancer Care") to overcome them. Methods: For this purpose, an ad-hoc questionnaire with items addressing topics of skin cancer care was developed, answered independently and discussed by a multidisciplinary European panel of experts comprising dermatologists, dermato-oncologists, patient advocacy representatives, digital health technology experts, and health technology assessment experts. Results: After all panel of experts discussions, a multidisciplinary expert opinion was created. Conclusions: As a conclusion, the access to dermatologists is difficult and will be aggravated in the near future. This fact, together with important differences in Skin Cancer Care in Europe, suggest the need of a new approach to skin health, prevention and disease management paradigm (focused on integration of new technologies) to minimize the impact of skin cancer and to ensure optimal quality and equity.