Lack of persistence and adherence to growth hormone therapy negatively impacts growth outcomes. Real-world international studies report that a significant proportion of children discontinue somatropin treatment. However, this information is not available for Argentina. The aim of this study was to describe the persistence and reasons for discontinuation of somatropin treatment in pediatric patients in the real-world setting of Argentina.

This retrospective cohort study analyzed data from the Anhelos program (Argentina) to evaluate somatropin treatment in children under 16 years of age. Persistence and treatment discontinuation were measured, with causes classified as medical or non-medical. Statistical methods were used to analyze predictive factors such as sex, age, diagnosis, region, and healthcare coverage. Persistence was analyzed using Kaplan-Meier, while discontinuation was studied through logistic regression and Cox proportional hazards models. SPSS v26.0 was used, with significance defined as p-value≤0.05.

We analyzed 1,159 patients, 42.8 percent of whom were female; 58.7 percent were aged eight years or younger. A total of 56.7 percent discontinued somatropin treatment at least once. No significant differences were observed in sex, age, or region between those who interrupted treatment and those who did not. However, differences were found based on diagnosis and healthcare coverage. Non-medical causes accounted for 64.6 percent of treatment discontinuations, primarily due to delivery issues. Public healthcare coverage was associated with a higher likelihood of discontinuation and lower treatment persistence than social security or private health insurance coverage.

Our data suggested a high rate of at least one treatment discontinuation among pediatric patients in Argentina receiving somatropin, primarily driven by non-medical causes.

Decision-making in the context of health technology assessment (HTA) of gene therapies for hemophilia needs to be tailored toward patients’ preferences. To promote equitable and patient-centered decision-making, it is crucial to provide patients with culturally attuned educational materials to ensure comprehension of key aspects of gene therapy so they can make legitimate and informed treatment decisions based on their preferences.

In this mixed methods study, we used a contextualization approach to translate the educational tool from the PAVING study (Patient Preferences to Assess Value IN Gene Therapies in Hemophilia) into Brazilian Portuguese. Translated versions were reviewed by a hematologist, a patient association representative, and two industry professionals. The tool was subsequently piloted with two people with hemophilia (PWH). After revisions, the tool was virtually presented to 12 PWH to transfer knowledge in preparation for the interview about their willingness to receive gene therapy. They were also required to perform the attribute-ranking exercise from the PAVING study.

The translation process led to minor adaptations required for local context. The original version designed for computer use was adapted for use on a mobile phone. Pilot testing with PWH resulted in minor changes to optimize clickstreams. Ten participants indicated some baseline awareness of gene therapy for hemophilia (good n=2; reasonable n=3; bad or very bad n=5). Participants indicated a general willingness to receive gene therapy (very willing n=7; willing n=2; neutral n=3). The six top-ranked treatment attributes were “effect on factor level,” “dose frequency,” “impact on daily life,” “probability that prophylaxis can be stopped after treatment,” and “effect on annual bleeding rate.”

These findings may contribute to further developments of the design and contextualization of hemophilia educational resources of gene therapy. The preliminary results on patient preferences will also inform future quantitative preference studies to be considered in the decision-making related to individual care and to reimbursement and coverage decisions in health systems, thus incorporating the patient perspective in HTA processes.

Clinical assessment is a continuous process during the life cycle of a medical device for obtaining evidence about performance, safety, demand, and effectiveness in patient care. The objective of this work was to carry out the clinical evaluation of a sample of 66 mechanical ventilators from the National Institute of Respiratory Diseases in Mexico.

The multi-criteria decision analysis method was used. Eleven variables were defined: three related to the patient (number of patients treated, illness, and average length of stay), and eight related to the medical device (amount, location, type, function, use hours, out of service hours, brand, and model). Three partial indicators were developed to evaluate availability, demand, and operation aspects of the medical device. These partial indicators were integrated into a global indicator called clinical use. The numerical result was interpreted with a qualitative scale defined with four levels of clinical use (low, regular, medium, and high). Data from the year 2023 were used.

The sample evaluated contained seven brands and 12 different models of mechanical ventilators. Forty-two percent were classified as low clinical use (they are underutilized) and 39 percent were regular clinical use. These two results indicated that these 54 devices have a low impact on patient care. On the other hand, only 11 percent had medium use and 8 percent had high use. In this last case, we must note the overuse of these five ventilators; that is, they were used almost 24 hours a day in patient care.

Sixty-two devices in the sample had a clinical use that allowed them to be available for mechanical ventilation of patients with respiratory conditions that require it. In the case of ventilators with high clinical use, technological improvements due to the brand had an influence on their constant use, allowing effective care for the patients in critical condition.

People frequently use litigation to access technologies in Brazil. From 2020 to 2023 there was a 38 percent increase in the lawsuits requesting drugs (55,600 to 76,700). The Ministry of Health’s expenditure on litigation reached USD428 million in 2023. This study analyzed the decision issued on September 2024 by the Brazilian Supreme Court (STF) to address litigation.

The study reviewed the STF decision, identifying the requirements for judicial provision of medicines not incorporated into the public health system that are directly related to the health technology assessment process.

By a 10-to-one majority, the STF decided that medicines not incorporated into the public health system should not be judicially granted. Exceptions apply to medicines registered by the National Health Surveillance Agency and are based on several criteria: evidence of illegality in a decision by the National Committee for Health Technology Incorporation (CONITEC) or excessive delays in its analysis; lack of substitutes in the public health system; or scientific evidence of efficacy and safety. It was also concluded that CONITEC’s recommendation not to incorporate a drug should be considered, and that when a drug is judicially granted it could be submitted to CONITEC for assessment.

The STF decision seeks to guarantee both the right to health and the financial sustainability of the public health system. By requiring robust scientific evidence for judicially granted medicines, it underscores CONITEC’s crucial role and the need for evidence-based decision-making at an individual level. Its determination also pushes for greater coordination between the Judiciary and Executive Branches of the government.

Artificial intelligence (AI) in health technology assessment (HTA) report development addresses three needs: accelerating processes via automation, standardizing tools for quality and consistency, and training to responsibly integrate generative AI. Conducted at the Agency for Health Quality and Assessment of Catalonia (AQuAS), this study identified tasks that generative AI can enhance and evaluated the team’s perceptions, knowledge, attitudes, and experience with these tools.

A review of technical literature and an exploration of leading tools, including ChatGPT and Copilot, were conducted to identify relevant functionalities and their potential applications in HTA. Additionally, an online survey was designed to assess the team’s knowledge and use of AI with four sections: (i) team characteristics; (ii) knowledge and use of generative AI; (iii) practical applications and perceived utility in specific tasks; and (iv) perspectives on potential and adoption barriers. Created using Microsoft Forms, the survey was distributed in October 2024.

An initial best practices guide was developed, detailing how to interact with generative AI tools, key elements for integration, and practical application examples, including training materials to mitigate risks. The survey achieved a 100 percent response rate, with participation from the entire evaluation team (n=14) and administrative support (n=1). Of respondents, 53 percent reported intermediate knowledge, 80 percent use these tools in daily tasks, and 41 percent have used them for over a year. Among users (n=12), key tasks included text drafting (92%), information retrieval (83%), and PDF reading (67%). Participants reported high satisfaction, and non-users expressed willingness to adopt these tools.

Generative AI showed great potential to enhance efficiency and quality in report development at AQuAS. High satisfaction among current users and a willingness to adopt it by non-users supported its implementation. The initial best practices guide and ongoing training will be essential to standardize the use of AI and maximize its impact.

To identify challenges in adopting new methodologies for assessing medical devices we aimed to explore underlying views of health technology assessment (HTA) practitioners about appropriate methodology at HTA agencies. Inspired by the “values in doing assessments of health technologies” (VALIDATE) approach, we focused on the role of normative commitments of HTA practitioners in the adoption of new methods.

Based on desk research, an online survey (including questions on procedures, scoping, and assessments of high risk medical devices) was developed and sent to members of the International Network of Agencies for Health Technology Assessment. Semi-structured interviews were conducted with survey respondents involved in assessments of transcatheter aortic valve implantation to gain an in-depth understanding of choices made and views about assessing medical devices. Data collection occurred between January and May 2023. Descriptive statistics were used to summarize survey findings, thematic analysis for the interviews, and the Consolidated Criteria for Reporting Qualitative Research checklist was used for reporting.

Twenty-two out of 50 survey invitees responded, and 15 indicated they assessed medical devices. Among these, eight were willing to be interviewed, of which four accepted the interview invitation. The consolidated results showed that the current practice of assessing medical devices at HTA agencies is predominantly based on procedures, methods, and epistemological principles developed for assessments of drugs. Both practical factors (available time, demands of decision-makers, existing legal frameworks, and HTA guidelines), as well as the commitment of HTA practitioners to principles of evidence-based medicine, made the adoption of new HTA methodology difficult.

There is broad recognition that assessments of medical devices may require changes in HTA methodology. To realize this, the HTA community may need to discuss the role, responsibility, and goals of HTA, and to inform decisions on how to implement new HTA processes and methods for assessing devices.

In recent years, there has been an increase in judicial claims in Uruguay seeking pembrolizumab-axitinib for the treatment of advanced kidney cancer. Understanding the characteristics and clinical evolution of patients accessing this medication through judicial rulings is essential to support health policies based on real-world evidence (RWE).

This study aimed to describe the sociodemographic and clinical characteristics, as well as global survival, of patients diagnosed with advanced clear cell renal carcinoma who received pembrolizumab-axitinib through judicial claims against the National Resources Fund (Fondo Nacional de Recursos) in Uruguay between 2020 and 2022. Patients with a favorable judicial ruling during the study period who received at least one dose of the combination therapy were included. Descriptive analyses of sociodemographic and clinical characteristics were conducted, and survival was estimated using the Kaplan-Meier method.

Between 2020 and 2022, 46 patients received pembrolizumab-axitinib treatment through judicial claims for advanced clear cell renal carcinoma. The average age of the patients, who were predominantly male, was 55.6 years. Most patients were from the private healthcare sector, with a similar distribution between the capital and the interior of the country. The survival analysis showed a global survival rate of 84.8 percent at 12 months (95% confidence interval [CI]: 70.7, 92.4), 78.3 percent at 24 months (95% CI: 61.8, 88.3), and 67.1 percent at 36 months (95% CI: 38.8, 84.5).

This real-world study provided promising results regarding the effectiveness of pembrolizumab-axitinib treatment in the Uruguayan healthcare context. The findings favored the opportunity to incorporate this therapy for advanced kidney cancer into the Comprehensive Health Care Plan. Additionally, it highlighted the importance of RWE in supporting healthcare policy decisions.

Health technology assessments (HTAs) are essential for evidence-informed decision-making. In urgent clinical scenarios, ultra-rapid HTAs provide concise evaluations to guide patient-specific decisions in 72 hours. The Institute for Clinical Effectiveness and Health Policy (IECS), with over 20 years of experience in HTA, has played a key role in delivering these rapid assessments to support efficient healthcare decisions in Argentina.

A descriptive analysis was conducted using the registry of ultra-rapid HTA reports produced by the IECS from April 2012 to August 2024. Two independent researchers extracted data from the historical database where the data on requests are stored. The database contains information about the requesters, type of technology, pathology, request dates, and delivery dates. The researchers categorized the information by type of technology (drugs, devices, procedures, diagnostics), therapeutic area (surgery, cardiovascular, infections, neurology, endocrinology, metabolic disorders, etc.), disease type (rare or not), and the requester of the report. The data were analyzed quantitatively.

Over 12 years, IECS produced 544 ultra-rapid HTA reports. The most requested therapeutic areas were oncology (n=124; 23%), neurology (n=94; 17%), musculoskeletal (n=45; 8%), other (n=39; 7%), and ophthalmology (n=31; 6%). Evaluated technologies primarily included drugs (n=255; 47%), followed by procedures (n=152; 28%), devices (n=70; 13%), and diagnostic tests (n=67; 12%). Reports on orphan diseases represented 19 percent of the total. Most requests were submitted by social health insurance providers (n=413; 76%), private insurers (n=123; 23%), hospitals (n=7; 1%), and the Ministry of Health (n=1).

The IECS analyzed 544 ultra-rapid HTA reports, showing a growing demand for timely evaluations, especially in oncology and neurology. Only 19 percent focused on orphan diseases, with most addressing prevalent conditions. These findings underscore the need for rapid assessment to support decision-making by social health insurers, improve access to critical technologies, and achieve a more equitable, transparent, and fair health system.

In South Korea, health technology assessment (HTA) evaluates the safety, efficacy, and cost effectiveness of technologies reimbursed by national health insurance. The National Evidence-Based Healthcare Collaborating Agency (NECA) engages the public and patients in HTA to enhance transparency and relevance. This study examined intra-articular corticosteroid injections (IACS) for knee osteoarthritis and radiofrequency ablation (RFA) for thyroid nodules to illustrate the role of diverse stakeholder input in decision-making.

Public Participation for IACS: IACS is a familiar treatment for knee osteoarthritis in Korea and has been used extensively for decades. To capture public perceptions, a structured survey was conducted to identify concerns about treatment frequency, safety, and efficacy. Findings were synthesized with systematic reviews to create public-friendly materials such as infographics, videos, and social media content.

Patient Participation for RFA: RFA, a non-reimbursed procedure for thyroid nodules, required direct input from patients to assess its value. Semi-structured interviews with RFA recipients explored their decision-making priorities, such as symptom relief, cosmetic concerns, and post-procedure recovery. These insights informed the evaluation framework for RFA in HTA.

Public surveys on IACS emphasized the need for clearer guidelines about dosing and safety, particularly for repeat injections. Systematic reviews showed limited evidence on long-term adverse effects, prompting further research. Educational materials enhanced public awareness of risks and benefits, supporting informed choices.

Interviews with patients who had received RFA revealed unique challenges and shared concerns specific to thyroid conditions, such as post-procedure discomfort and symptom management priorities. These insights, including preferences for nodule size reduction and recurrence rates, aligned with expert-defined outcome priorities, validating patient-reported outcomes in HTA. These findings led to a conditional recommendation balancing clinical value and misuse prevention.

Integrating public and patient voices into HTA strengthens evidence generation and fosters trust in health policy decisions. By addressing diverse stakeholder concerns, NECA aims to expand engagement mechanisms throughout the HTA life cycle. This dual-participation model demonstrated a scalable framework for global HTA practices, promoting inclusivity and transparency in healthcare decision-making.

There is a lack of family-based psychosocial support interventions in palliative care when a parent of children or youths has a life-threatening illness. One intervention that has shown positive effects is the family talk intervention (FTI). This study aimed to describe the influence of contextual factors on FTI sustainability, as perceived by healthcare professionals (HCPs), after a median of 18 months of implementation in clinical practice in cancer and palliative care when a parent of children or youths has a life-threatening illness.

Focus groups and individual interviews were conducted with 15 HCPs working with FTI. Data were analyzed using conventional qualitative content analysis.

HCPs identified contextual factors that facilitated or hindered the use of FTI. The analysis resulted in 3 categories, Trying to prioritize FTI and coordinate families in a complex context is challenging, Working alone without FTI-educated colleagues hampers sustainability, the satisfaction of seeing families become stronger contributes to a receptiveness for change.

This study shows that organizational support and resources, alongside the individual’s facilitating factors, such as receptiveness for change, are crucial for sustainability after the initial implementation. Witnessing a positive impact is motivational and also supports the sustainability of an intervention despite contextual constraints.

The establishment of health technology assessment (HTA) in health systems is essential for their sustainability. In Brazil, CONITEC was legally established in 2011, and its first reports were published in 2012. CONITEC has consistently contributed to maintaining evidence-based access to technologies in Brazil’s Unified Health System (SUS).

This study aimed to summarize and understand the characteristics of submitted requests such as type of technology, tendencies, and deliberation outcomes. All reports for technologies submitted to CONITEC that were available on the official website, published from 2012 to November 2024, were included. Data of interest included: year of assessment, nature of the request (inclusion, disinvestment, or expansion of use to subgroups not already indicated for the technology), type of technology (medication, procedure, or health product), and medical field (e.g., oncology, rheumatology). Absolute and relative frequencies as well as temporal analyses were performed on the extracted data.

From a total of 1,084 (average of 90.3 per year) identified reports, 836 were related to medications, 173 to products, and 75 to procedures. Inclusion, disinvestment, and expansion accounted for 928 (85.6%), 89 (8.2%), and 63 (5.8%) of the reports, respectively. A growth trend in the number of reports per year was not observed, despite a peak in 2021 (115 assessments). This peak was due to a concentration of reports on disinvestment, which represented 31.3 percent of the reports conducted that year. The three most represented medical fields were infectiology (14.2%), oncology (11.5%), and hematology (7.2%).

The large number of HTA reports assessed by CONITEC showed the potential of the Brazilian SUS to promptly respond to health needs. Further studies may reveal why incorporation and disinvestment are the most frequently submitted requests. Monitoring requests can help understand the dynamics of HTA, which is crucial for system management and sustainability.

One of the main objectives of health systems should be to try to reduce inequality gaps. America is the most unequal region in the world. Until recent years, equity continued not to be part of standard health technology assessment (HTA) reports of the main world agencies. We conducted a survey of member institutions of the Health Technology Assessment Network of the Americas (RedETSA) and the Pan American Health Organization (PAHO) to explore the approaches used to measure equity across American countries.

A survey was conducted addressing equity in HTA in the institutions that make up RedETSA. It was sent to members of the technical teams of the institutions that are part of this network. Through a semi-open questionnaire sent in electronic format, we searched to identify which organizations are addressing equity in HTA, as well as perceptions and personal opinions about its importance and the level of training in this regard. Positive case examples were requested. A scoping review of worldwide methods related to equity-HTA was conducted.

Responses were obtained from 39 individuals working in 34 institutions in 14 countries. All those who responded belong to the technical teams of the institutions that are members of RedETSA. Of these respondents, 97.4 percent consider that the potential impact on equity of new health technologies should always be evaluated in HTA reports, but only 10.8 percent respond that they always do it in their agencies. The approaches used by these institutions were heterogeneous. In order to organize the various proposals that were identified to address equity in HTA, a graph was prepared where the different tools and approaches were classified.

The results of our survey of HTA organizations in the region coincided with global publications, such as the 2015 review of 121 HTA world agencies, which identified that the approach to equity is not systematic; it is performed in few cases and with different methodological approaches. The scoping review identified a wide range of proposed methodological approaches to measure equity.

Quantum technologies, driven by principles of quantum mechanics like superposition and entanglement, have shown transformative potential in health and medicine. However, the understanding of these technologies in early to late stages of development is limited. This study aimed to investigate the emerging applications of quantum technologies in health care, with a focus on quantum computing, diagnostics, and therapeutics.

Horizon scanning researchers, in collaboration with information specialists and with steering from subject matter experts at National Health Service England, developed search strategies for identifying relevant emerging and established quantum applications in healthcare domains such as drug design, personalized medicine, diagnosis assistance, and treatment or interventions. We conducted a comprehensive review of this landscape by analyzing data from clinical trials, published literature, and soft intelligence sources. Primary and secondary sources were reviewed systematically using a combination of traditional methods and the Innovation Observatory’s in-house semi-automated Search Companion for Advanced News Article Retrieval (SCANAR) tool to capture non-traditional soft intelligence sources.

The scan identified 116 quantum technologies in health care, with magnetoencephalography (MEG), quantum dots, and superconducting quantum interference devices (SQUIDs) being the most frequently used for brain mapping, imaging, and cardiac diagnostics. Over half (54%) of these technologies assist in diagnosis, while others are used in drug design (15%), treatment (15%), and precision medicine (13%). Quantum computing applications (28%) and quantum dots (24%) were the most common applications identified. Non-commercial trials dominated (88%), reflecting a focus on advancing care. Additionally, 27 percent of the technologies incorporate artificial intelligence, mainly for personalized medicine and imaging diagnosis.

Quantum technologies in health care are advancing areas of diagnostics, personalized medicine, and therapeutics. Diagnostics are the most popular area, most frequently using technologies such as MEG, SQUIDs, and quantum dots. Quantum computing algorithms accelerate drug discovery and precision medicine. Although promising, integrating quantum technologies into health care faces challenges in infrastructure demands and regulatory frameworks, and requires professional training in quantum literacy.

The Shared Learning model redefines patient engagement in health technology assessment (HTA) by combining immersion, knowledge sharing, and network expansion. Through flexible programs like Patient Voice Initiative (PVI) Patient Partners, it empowers advocates to deepen their understanding of HTA processes and disseminate insights broadly. This innovative, scalable approach ensures patient voices are central to decision-making, fostering informed contributions and addressing the challenges of rapidly evolving health technologies.

The Shared Learning model piloted by the PVI supported three patient advocates through a structured immersion in HTA processes. Advocates engaged directly in HTA discussions, meetings, and consultations, attending the HTAi Annual Meeting 2024 for deeper insights and networking. The model emphasized peer knowledge dissemination through webinars, workshops, and community forums, creating a ripple effect of shared learning. Advocates reflected on their experiences, identifying insights to benefit broader patient networks. This approach combined immersive learning, knowledge-building, and capacity expansion, fostering both vertical engagement with HTA stakeholders and horizontal knowledge-sharing within patient communities.

The Shared Learning pilot demonstrated success in enhancing patient engagement within HTA. Advocates deepened their understanding of HTA processes through direct participation and shared insights with wider patient networks, fostering a multiplier effect. Peer-to-peer knowledge dissemination expanded patient capacity, strengthening advocacy communities. Advocates utilized their experiences to host webinars, workshops, and community forums, broadening the reach of HTA knowledge. The initiative also improved the ability of patient networks to contribute meaningfully to decision-making processes. These outcomes highlight the model’s potential for creating sustainable, informed, and resilient advocacy communities equipped to address the challenges of rapidly evolving health technologies.

The Shared Learning model revolutionized patient engagement in HTA by emphasizing immersion, knowledge sharing, and network expansion. Through flexible programs like PVI Patient Partners, the model deepened engagement while enabling broader dissemination of insights. As health technologies rapidly evolve, this scalable approach ensures patient voices remain central to HTA decision-making, fostering informed, sustainable contributions within patient communities.

The Health Technology Assessment (HTA) Network of the Americas (RedETSA) is composed of health ministries, HTA agencies, regulatory authorities, and collaborating centers that exchange valuable cooperation and information to promote the HTA processes in the Americas region. Since its creation, the network has grown significantly, and several milestones have been reached.

A retrospective review of HTA milestones in the region and RedETSA network achievements was conducted, covering its inception at the HTAi annual meeting in Rio de Janeiro, Brazil, in 2011 to the present. The review included: the number of member countries and institutions; milestones in HTA development, implementation, and institutionalization; key Pan American Health Organization (PAHO) resolutions supporting HTA; advances in the Regional Database of Health Technology Assessment Reports of the Americas (BRISA); the number of annual meetings; regional and international cooperation; and capacity building support in the region.

Following the approval of the CSP28.R9 resolution on HTAs and Health Decision-Making by the PAHO in 2012 and the WHA67.23 resolution (World Health Organization) in 2014, HTA was implemented or institutionalized in several countries. Since its inception, RedETSA has grown to include 21 member countries in the Americas, represented by 40 institutions. HTA capacity building was supported by 482 scholarships and courses since 2015, as well as 43 webinars by RedETSA. The BRISA database now includes over 3,800 HTA reports. Moreover, RedETSA collaborates with various HTA institutions and initiatives, including HTAi, the International Network of Agencies for HTA (INAHTA), the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), RedCritieria (a network initiative of the Inter-American Development Bank), HTAsiaLink, and EuroScan.

Significant progress in HTA has been made in the Americas, with RedETSA playing a key role in these achievements. Challenges remain, including establishing explicit links between HTA and decision-making, consolidating institutional frameworks, increasing local data availability, continuing capacity building efforts, and standardizing HTA reports. Continued cooperation between countries and institutions through network collaboration is essential to address these needs.

Health technology assessment (HTA) evaluates the cost effectiveness and clinical efficacy of health technologies to inform policy decisions. Established in 2017 by the Department of Health Research, the Office of Health Technology Assessment in India is housed within the Ministry of Health and Family Welfare; however, challenges remain. This study analyzed gaps in India’s HTA framework to aid policymakers in making improvements.

The study conducted a systematic review of HTA literature and a focus group discussion with Ministry of Health representatives. A search on PubMed using “HTA” AND “India” yielded 74 papers from the last seven years, with 12 additional papers found through Google. Using the PRISMA methodology, titles, abstracts, and full texts were evaluated, and duplicates were managed with Zotero. Data were collected in an excel sheet, and the HTA scorecard from Türkiye helped identify context-specific gaps in India, which were discussed with six focus-group members from the HTA department at the Ministry of Health and Family Welfare and the National Health Systems Resource Centre.

The desk review identified gaps in India’s data usage, including a fragmented data ecosystem, limited electronic health records, and challenges with real-world evidence that affect HTA effectiveness. A major issue was the scarcity of trained professionals for high quality HTA and insufficient public funding for HTA research. The potential of HTA remains underutilized. Barriers to effective HTA legislation include the complexity of central policies, incoherence with state administration, and fragmented insurance schemes. Focus group participants recommended capacity building and orientation programs for the HTA department and state procurement, highlighting the need for funding to support implementation research for benchmark development.

India faces challenges in data infrastructure, stakeholder involvement, funding, and policy integration for HTA. Investments in data collection and training are essential. With initiatives such as Digital India and Make in India, the country aims to establish itself as a global digital economy. Strengthening HTA institutionalization and implementing an artificial intelligence-based HTA framework can position India as a leader in HTA.

To support decision-making regarding the introduction of digital health technologies (DHTs) with added value for patients and society, health technology assessment (HTA) frameworks for DHTs are needed. However, the absence of standardized definitions and taxonomies creates a barrier to the development of such a framework. This research addressed these challenges by developing a consensus-based unified definition and taxonomy for DHTs.

The study comprised a scoping review of existing definitions of DHTs, a targeted review of taxonomies used across European countries, and a two-round Delphi process. For the scoping review, data on the source identifier, type of DHT, the definition itself, and the purpose of the definition were extracted. For identified taxonomies, data on criteria of classification (e.g., functionality, risk, user), types of DHTs, and background of the classification (development process, purpose, and policy context) were extracted. Thematic analysis of both reviews informed the development of an online Delphi survey, distributed via several HTA stakeholder groups and societies, including HTAi.

We identified 8,651 unique records from four databases (PubMed, the Cochrane Library, Embase, EconLit) and extracted 328 definitions. Analysis revealed three key components of a definition for DHT: intended purpose, users, and underlying technology. The targeted review identified nine taxonomies classifying DHTs by maturity stages, intended purpose, digital health architecture, illness severity, personalization capacity, and levels of human intervention. The first round of the Delphi survey, with 118 complete responses, achieved consensus on the three key components, using intended purpose as a classification criterion. The results of the second round will be available in January 2025.

This study provided a unified definition for DHTs, incorporating three key components: intended purpose, users, and underlying technology. The Delphi process validated intended purpose as a primary classification criterion. This standardized definition and taxonomy streamlines assessment, enhances cross-border HTA collaboration, and enables stakeholders to compare and evaluate the impact of DHTs appropriately, thus fostering informed decision-making.