Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (O’Rourke et al. [2020,International Journal of Technology Assessment in Health Care36, 187–90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technology’s value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Union’s program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the project’s websitewww.validatehta.eu.

Introduction: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that will hopefully increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to ad-hoc accelerated MD approval processes elsewhere (e.g., US). Areas covered: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in pre-market clinical evidence generation and lack of oversight for post-approval evidence requirements. Implications for MD approval, HTA and coverage are explored. Expert opinion: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed that can fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers’ evidence generation plans along the MD lifecycle (pre-, post-market), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.

Early health technology assessment (HTA), which includes all methods used to inform industry and other stakeholders about the potential value of new medical products in development, including methods to quantify and manage uncertainty, has seen many applications in recent years. However, it is still unclear how such early value assessments can be integrated into the technology innovation process. This commentary contributes to the discussion on the purposes early HTA can serve. Similarities and differences in the perspectives of five stakeholders (i.e., the hospital, the patient, the assessor, the medical device industry, and the policy maker) on the purpose, value, and potential challenges of early HTA are described. All five stakeholders agreed that integrating early HTA in the innovation process has the possibility to shape and refine an innovation, and inform research and development decisions. The early assessment, using a variety of methodologies, can provide insights that are relevant for all stakeholders but several challenges, for example, feasibility and responsibility, need to be addressed before early HTA can become standard practice. For early evaluations to be successful, all relevant stakeholders including patients need to be involved. Also, nimble, flexible assessment methods are needed that fit the dynamics of medical technology. Best practices should be shared to optimize both the innovation process and the methods to perform an early value assessment.

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.

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.