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Regulatory frameworks for artificial intelligence (AI) are needed to mitigate risks while ensuring the ethical, secure, and effective implementation of AI technology in healthcare and population health. In this article, we present a synthesis of 141 binding policies applicable to AI in healthcare and population health in the EU and 10 European countries. The EU AI Act sets the overall regulatory framework for AI, while other legislations set social, health, and human rights standards, address the safety of technologies and the implementation of innovation, and ensure the protection and safe use of data. Regulation specifically pertaining to AI is still nascent and scarce, though a combination of data, technology, innovation, and health and human rights policy has already formed a baseline regulatory framework for AI in health. Future work should explore specific regulatory challenges, especially with respect to AI medical devices, data protection, and data enablement.
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PURPOSE: Patient-report outcome measures (PROMs) have gained widespread support as a mechanism to improve healthcare quality. We aimed to map out key enablers and barriers influencing PROMs implementation strategies in routine clinical practice. METHODS: An umbrella review was conducted to identify reviews exploring enablers and barriers related to the integration of PROMs in routine clinical practice from January 2000 to June 2023. Information on key enablers and barriers was extracted and summarised thematically according to the Theoretical Domains Framework. RESULTS: 34 reviews met our criteria for inclusion. Identified reviews highlighted barriers such as limited PROMs awareness among clinicians and patients, perceived low value by clinicians and patients, PROMs that were too complex or difficult for patients to complete, poor usability of PROMs systems, delayed feedback of PROMs data, clinician concerns related to use of PROMs as a performance management tool, patient concerns regarding privacy and security, and resource constraints. Enablers encompassed phased implementation, professional training, stakeholder engagement prior to implementation, clear strategies and goals, 'change champions' to support PROMs implementation, systems to respond to issues raised by PROMs, and integration into patient pathways. No consensus favoured paper or electronic PROMs, yet offering both options to mitigate digital literacy bias and integrating PROMs into electronic health records emerged as important facilitators. CONCLUSIONS: The sustainable implementation of PROMs is a complex process that requires multicomponent organisational strategies covering training and guidance, necessary time and resources, roles and responsibilities, and consultation with patients and clinicians.
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Background: The aim of this study was to examine some psychometric characteristics of the Chilean-adapted version of the Quantitative Checklist for Autism in Toddlers (Q-CHAT-24) (24) in a group of unselected children (community sample). This version was administered remotely through an online version during the pandemic period to caregivers of children, aged 18-24 months, registered in four primary care polyclinics of the Health Service Araucanía Sur, Chile. Methods: An intentional non-probabilistic sampling was used. Three hundred and thirteen toddlers were examined. Participants completed an online version of the Q-CHAT-24 which was disseminated through the REDCap platform. Evidence of reliability through internal consistency and evidence of predictive validity through ROC curve analysis were realized. Results: The mean age of the children evaluated was 21.16 months. The Shapiro-Wilk test revealed that Q-CHAT-24 scores was normally distributed. 71 cases (23.12%) scored 38 points or more on the Q-CHAT-24, qualifying as Autistic Risk. 48 cases (15.63%) were confirmed as autistic through the ADOS-2 Module T. All items were positively correlated with Q-CHAT-24 total score. All items were positively correlated with Q-CHAT-24 total score. Internal consistency was acceptable for the Q-CHAT-24 (Cronbach ´s α=0.78). The internal consistencies were analyzed for the Q-CHAT-24 Factors, and they were good for factor 1 "Communication and Social Interaction" (Cronbach ´s α=0.85) and acceptable for factor 2 "Restrictive and Repetitive Patterns" (Cronbach ´s α=0.74). Receiver operating characteristic (ROC) curve analyses were performed. The AUC values were 0.93 with statistical significance (p<0.01). For the cut-off point of 38, the Sensitivity, Specificity and Youden index values were 0.89, 0.8 and 0.7, respectively. The Positive Predictive Value (PPV) was 86% and the Negative Predictive Value (NPV) was 85%. Conclusions: In accordance with the objectives of this study, evidence of reliability and predictive validity was demonstrated for the Q-CHAT-24 in this Chilean population. More importantly, this study provides Sensitivity and Specificity data for a remote application version of an autism screening tool already validated in Chile. The implications of this have to do with the possibility of establishing a remote assessment system for children at risk of autism on a population scale.
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BACKGROUND: Patient engagement when providing patient access to health data results from an interaction between the available tools and individual capabilities. The recent digital advancements of the healthcare field have altered the manifestation and importance of patient engagement. However, a comprehensive assessment of what factors contribute to patient engagement remain absent. In this review article, we synthesised the most frequently discussed factors that can foster patient engagement with their health data. METHODS: A scoping review was conducted in MEDLINE, Embase, and Google Scholar. Relevant data were synthesized within 7 layers using a thematic analysis: (1) social and demographic factors, (2) patient ability factors, (3) patient motivation factors, (4) factors related to healthcare professionals' attitudes and skills, (5) health system factors, (6) technological factors, and (7) policy factors. RESULTS: We identified 5801 academic and 200 Gy literature records, and included 292 (4.83%) in this review. Overall, 44 factors that can affect patient engagement with their health data were extracted. We extracted 6 social and demographic factors, 6 patient ability factors, 12 patient motivation factors, 7 factors related to healthcare professionals' attitudes and skills, 4 health system factors, 6 technological factors, and 3 policy factors. CONCLUSIONS: Improving patient engagement with their health data enables the development of patient-centered healthcare, though it can also exacerbate existing inequities. While expanding patient access to health data is an important step towards fostering shared decision-making in healthcare and subsequently empowering patients, it is important to ensure that these developments reach all sectors of the community.
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Motivación , Participación del Paciente , Humanos , Actitud del Personal de Salud , Registros Electrónicos de SaludRESUMEN
This Viewpoint discusses concerns about the data quality of the Global Burden of Disease study with respect to incidence estimates of child and adolescent mental health disorders, such as autism and attention-deficit/hyperactivity disorder, in low- and middle-income countries.
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Trastorno por Déficit de Atención con Hiperactividad , Trastorno del Espectro Autista , Humanos , Carga Global de Enfermedades , Macrodatos , Costo de Enfermedad , Salud Global , PrevalenciaRESUMEN
Digital health technologies used in primary care, referred to as, virtual primary care, allow patients to interact with primary healthcare professionals remotely though the current iteration of virtual primary care may also come with several unintended consequences, such as accessibility barriers and cream skimming. The World Health Organization (WHO) has a well-established framework to understand the functional components of health systems. However, the existing building blocks framework does not sufficiently account for the disruptive and multi-modal impact of digital transformations. In this review, we aimed to develop the first iteration of this updated framework by reviewing the deployment of virtual primary care systems in five leading countries: Canada, Finland, Germany and Sweden and the United Kingdom (England). We found that all five countries have taken different approaches with the deployment of virtual primary care, yet seven common themes were highlighted across countries: (1) stated policy objectives, (2) regulation and governance, (3) financing and reimbursement, (4) delivery and integration, (5) workforce training and support, (6) IT systems and data sharing, and (7) the extent of patient involvement in the virtual primary care system. The conceptual framework that was derived from these findings offers a set of guiding principles that can facilitate the assessment of virtual primary care in health system settings.
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BACKGROUND: The adoption of digital health care within health systems is determined by various factors, including pricing and reimbursement. The reimbursement landscape for digital health in Europe remains underresearched. Although various emergency reimbursement decisions were made during the COVID-19 pandemic to enable health care delivery through videoconferencing and asynchronous care (eg, digital apps), research so far has primarily focused on the policy innovations that facilitated this outside of Europe. OBJECTIVE: This study examines the digital health reimbursement strategies in 8 European countries (Belgium, France, Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom) and Israel. METHODS: We mapped available digital health reimbursement strategies using a scoping review and policy mapping framework. We reviewed the literature on the MEDLINE, Embase, Global Health, and Web of Science databases. Supplementary records were identified through Google Scholar and country experts. RESULTS: Our search strategy yielded a total of 1559 records, of which 40 (2.57%) were ultimately included in this study. As of August 2023, digital health solutions are reimbursable to some extent in all studied countries except Poland, although the mechanism of reimbursement differs significantly across countries. At the time of writing, the pricing of digital health solutions was mostly determined through discussions between national or regional committees and the manufacturers of digital health solutions in the absence of value-based assessment mechanisms. Financing digital health solutions outside traditional reimbursement schemes was possible in all studied countries except Poland and typically occurs via health innovation or digital health-specific funding schemes. European countries have value-based pricing frameworks that range from nonexistent to embryonic. CONCLUSIONS: Studied countries show divergent approaches to the reimbursement of digital health solutions. These differences may complicate the ability of patients to seek cross-country health care in another country, even if a digital health app is available in both countries. Furthermore, the fragmented environment will present challenges for developers of such solutions, as they look to expand their impact across countries and health systems. An increased emphasis on developing a clear conceptualization of digital health, as well as value-based pricing and reimbursement mechanisms, is needed for the sustainable integration of digital health. This study can therein serve as a basis for further, more detailed research as the field of digital health reimbursement evolves.
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COVID-19 , Pandemias , Humanos , Israel , COVID-19/epidemiología , Europa (Continente) , PolíticasRESUMEN
Antimicrobial, and particularly antibiotic resistance are one of the world's biggest challenges today, and urgent action is needed to reinvigorate the antibiotic development pipeline. To inform policy discussions during and after the 2023 Swedish Presidency of the Council of the European Union, we critically appraise incentive options recently proposed by the European Commission, and member states, and consider what has been achieved over the last two decades in relation to antibiotic research and development. While several new antibiotics have achieved regulatory approval in recent years, almost none have innovative characteristics such as new chemical classes or novel mechanisms of action. We consider four incentive options to incentivise research and development of new antibiotics, including subscription payments, market entry rewards, transferable exclusivity extensions, and milestone payments. While each option has advantages and drawbacks, a combination of incentives may be required and continued investment is needed by the EU in push incentives, such as direct funding and grants, to incentivise drug discovery and preclinical stages of development. The EU must also coordinate with international initiatives and support access to new and pre-existing antibiotics in LMICs through platforms such as the WHO, and G7 and G20 group of countries.
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Background: Understanding discrepancies in mental health and substance use treatment utilization can help identify inequities in access to health services. We investigate mental health and substance use treatment utilization as function of demographic and social determinants, as well as pre-existing mental health and substance use disorders. Methods: In this repeated cross-sectional study, we used the 2017-2019 National Survey on Drug Use and Health data on US adults above age 18. Two logistic regression models were conducted, using predictors of age, gender, race/Hispanicity, sexual identity, education, insurance, family income, and past year mental health and substance use disorders, with outcomes of mental health or substance use treatment utilization. Weighted estimates of substance use disorders and insurance types and Pearson's correlation tests of vulnerability among age, gender, and treatment type were reported. Findings: Racial minorities, uninsured populations, sexual minorities, and females had lower odds of receiving mental health treatment, while older populations, lower income groups, and dual eligible enrollees had higher odds. Individuals with substance use disorders but no mental illness had higher odds of receiving mental health treatment. Those utilizing mental health treatment were mostly of high income, privately insured, and using cannabis, cocaine, and opioids. Older populations, men, and Medicaid only enrollees had higher odds of receiving substance use disorder treatment, whereas racial minorities had lower odds. Distribution of income, insurance type, and substance use were more widespread than mental health treatment. Interpretation: Mental health treatment can be used as an avenue for substance use treatment, particularly opioid use disorders. It is important to target vulnerable populations, like racial minorities and uninsured populations to improve access to mental health and substance use treatment.
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The health care sector experiences 76% of cybersecurity breaches due to basic web application attacks, miscellaneous errors, and system intrusions, resulting in compromised health data or disrupted health services. The European Commission proposed the European Health Data Space (EHDS) in 2022 to enhance care delivery and improve patients' lives by offering all European Union (EU) citizens control over their personal health data in a private and secure environment. The EU has taken an important step in homogenizing the health data environment of the European health ecosystem, although more attention needs to be paid to keeping the health data of EU citizens safe and secure within the EHDS. The pooling of health data across countries can have tremendous benefits, but it may also become a target for cybercriminals or state-sponsored hackers. State-of-the-art security measures are essential, and the current EHDS proposal lacks sufficient measures to warrant a cybersecure and resilient environment.
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Seguridad Computacional , Ecosistema , Humanos , Europa (Continente) , Unión Europea , Sector de Atención de SaludRESUMEN
BACKGROUND: Digital therapeutics are patient-facing digital health interventions that can significantly alter the health care landscape. Despite digital therapeutics being used to successfully treat a range of conditions, their uptake in health systems remains limited. Understanding the full spectrum of uptake factors is essential to identify ways in which policy makers and providers can facilitate the adoption of effective digital therapeutics within a health system, as well as the steps developers can take to assist in the deployment of products. OBJECTIVE: In this review, we aimed to map the most frequently discussed factors that determine the integration of digital therapeutics into health systems and practical use of digital therapeutics by patients and professionals. METHODS: A scoping review was conducted in MEDLINE, Web of Science, Cochrane Database of Systematic Reviews, and Google Scholar. Relevant data were extracted and synthesized using a thematic analysis. RESULTS: We identified 35,541 academic and 221 gray literature reports, with 244 (0.69%) included in the review, covering 35 countries. Overall, 85 factors that can impact the uptake of digital therapeutics were extracted and pooled into 5 categories: policy and system, patient characteristics, properties of digital therapeutics, characteristics of health professionals, and outcomes. The need for a regulatory framework for digital therapeutics was the most stated factor at the policy level. Demographic characteristics formed the most iterated patient-related factor, whereas digital literacy was considered the most important factor for health professionals. Among the properties of digital therapeutics, their interoperability across the broader health system was most emphasized. Finally, the ability to expand access to health care was the most frequently stated outcome measure. CONCLUSIONS: The map of factors developed in this review offers a multistakeholder approach to recognizing the uptake factors of digital therapeutics in the health care pathway and provides an analytical tool for policy makers to assess their health system's readiness for digital therapeutics.
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Atención a la Salud , Telemedicina , Humanos , Bases de Datos Factuales , Personal de Salud , Terapéutica , Atención a la Salud/tendenciasRESUMEN
In May 2022, the European Commission issued the Proposal for a Regulation on the European Health Data Space (EHDS), with the aims of granting citizens increased access to and control of their (electronic) health data across the EU, and facilitating health data re-use for research, innovation, and policymaking. As the first in a series of European domain-specific "data spaces", the EHDS is a high-stakes development that will transform health data governance in the EU region. As an international consortium of experts from health policy, law, ethics and the social sciences, we are concerned that the EHDS Proposal will detract from, rather than lead to the achievement of, its stated aims. We are in no doubt on the benefits of using health data for secondary purposes, and we appreciate attempts to facilitate such uses across borders in a carefully curated manner. Based on the current draft Regulation, however, the EHDS risks undermining rather than enhancing patient control over data; hindering rather than facilitating the work of health professionals and researchers; and eroding rather than increasing the public value generated through health data sharing. Therefore, significant adjustments are needed if the EHDS is to realize its promised benefits. Besides analyzing the implications for key groups and European societies at large who will be affected by the implementation of the EHDS, this contribution advances targeted policy recommendations to address the identified shortcomings of the EHDS Proposal.
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Política de Salud , Formulación de Políticas , Humanos , Difusión de la InformaciónRESUMEN
Purpose of Review: This article aims to review and synthesize the current research evidence regarding the efficacy of telepsychiatry-delivered substance use disorder treatment using a narrative review with a focus on the effects of remote healthcare delivery within the substance abuse treatment space. Recent Findings: The COVID-19 pandemic exerted substantial pressures on all levels of society. Social isolation, loss of employment, stress, physical illness, overburdened health services, unmet medical needs, and rapidly changing pandemic restrictions had particularly severe consequences for people with mental health issues and substance use disorders. Since the start of the pandemic, addiction treatment (and medical treatment overall) using remote health platforms has significantly expanded to different platforms and delivery systems. The USA, in particular, reported transformational policy developments to enable the delivery of telehealth during the COVID-19 pandemic. However, systemic barriers such as a widespread lack of internet access and insufficient patient and provider digital skills remain. Summary: Overall, telepsychiatry is a promising approach for the treatment of substance use disorders, but more randomized controlled trials are needed in the future to assess the evidence base of available interventions.
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Public interest is an important component influencing the likelihood of successfully implementing digital healthcare. The onset of the COVID-19 pandemic allowed us to assess how public interest in digital health changed in response to disruptions in traditional health services. In this study, we used a difference-in-differences approach to determine how digital healthcare search behavior shifted during the early months of the COVID-19 pandemic compared to the same period in 2019 across six English-speaking countries: the United States, Canada, the United Kingdom, New Zealand, Australia, and Ireland. In most cases, we observed that the official declaration of the COVID-19 pandemic on 11 March 2020 was associated with a significant overall increase in the volume of digital healthcare searches. We also found notable heterogeneity between countries in terms of the keywords that were used to search for digital healthcare, which could be explained by linguistic differences across countries or the different national digital health landscapes. Since online searches could be an initial step in the pathway to accessing health services, future studies should investigate under what circumstances increased public interest translates into demand for and utilization of digital healthcare.
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Background: The progression into the Digital Age has brought an array of novel skill requirements. Unlike traditional literacy, there are currently few measures that can reliably measure eHealth literacy. The Transactional Model of eHealth Literacy and subsequent Transactional eHealth Literacy Instrument may provide a feasible option for measuring eHealth literacy. Objective: This instrument has yet to be validated, which is the aim of this study. In particular, this article was conducted to validate the TeHLI to see which components of the tool (how many and which components included) would be the best fit statistically and whether the tool applies to groups of different characteristics. Methods: We conducted an online cross-sectional study among 236 Vietnamese young people. A exploratory factor analysis was used to identify the best fit model of the Transactional eHealth Literacy Instrument. A confirmatory factor analysis tested measurement invariance at four levels: configural, metric, scalar, and strict invariance. Only metric invariance was partially invariant, while the rest tested fully invariant. Even with partial metric invariance, there is reason to assume that functional, communicative, critical, and translational eHealth literacy (the four levels according to the transactional model) are consistently measured when deploying the Transactional eHealth Literacy Instrument across groups. Results: The study findings substantiate that the most optimal composition of the TeHLI consists of four factors: functional, communicative, critical, and translational eHealth literacy, with RMSEA = 0.116; CFI = 0.907, and the highest internal consistency (Cronbach's α = 0.91, 0.92, 0.88, and 0.92 for each factor respectively). After using measurement invariance, that gender, education, marital status, age, location, and household economy do not influence the way participants to respond to the TeHLI to the point that would introduce measurement bias. In other word, using TeHLI across population groups should not produce error margins that substantially differ from each other. Conclusions: This study suggests the instrument can be used for comparisons across groups and has the potential to generate high-quality data usable for informing change agents as to whether a particular population is proficient enough to adopt novel eHealth innovations.
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Alfabetización en Salud , Telemedicina , Adolescente , Humanos , Comunicación , Estudios Transversales , Pueblos del Sudeste AsiáticoRESUMEN
Background: In a time of unprecedented global change, the COVID-19 pandemic has led to a surge in demand of COVID-19 vaccines and related certifications. Mainly due to supply shortages, counterfeit vaccines, fake documentation, and alleged cures to illegal portfolios, have been offered on darkweb marketplaces (DWMs) with important public health consequences. We aimed to profile key DWMs and vendors by presenting some in-depth case studies. Methods: A non-systematic search for COVID-19 products was performed across 118 DWMs. Levels of activity, credibility, content, COVID-19 product listings, privacy protocols were among the features retrieved. Open web fora and other open web sources were also considered for further analysis of both functional and non functional DWMs. Collected data refers to the period between January 2020 and October 2021. Results: A total of 42 relevant listings sold by 24 vendors across eight DWMs were identified. Four of these markets were active and well-established at the time of the study with good levels of credibility. COVID-19 products were listed alongside other marketplace content. Vendors had a trusted profile, communicated in English language and accepted payments in cryptocurrencies (Monero or Bitcoin). Their geographical location included the USA, Asia and Europe. While COVID-19 related goods were mostly available for regional supply, other listings were also shipped worldwide. Interpretation: Findings emerging from this study rise important questions about the health safety of certain DWMs activities and encourage the development of targeted interventions to overcome such new and rapidly expanding public health threats. Funding: CovSaf, National Research centre on Privacy, Harm Reduction and Adversarial Influence Online (REPHRAIN), Commonwealth Fund.
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BACKGROUND: The COVID-19 pandemic highlighted the fragmented nature of governmental policy decisions in Europe. However, the extent to which COVID-19 vaccination policies differed between European countries remains unclear. Here, we mapped the COVID-19 vaccination policies that were in effect in January 2022 as well as booster regulations in April 2022 in Austria, Denmark, England, France, Germany, Ireland, Italy, the Netherlands, Poland, and Spain. METHODS: National public health and health policy experts from these ten European nations developed and completed an electronic questionnaire. The questionnaire included a series of questions that addressed six critical components of vaccine implementation, including (1) authorization, (2) prioritization, (3) procurement and distribution, (4) data collection, (5) administration, and (6) mandate requirements. RESULTS: Our findings revealed significant variations in COVID-19 vaccination policies across Europe. We observed critical differences in COVID-19 vaccine formulations authorized for use, as well as the specific groups that were provided with priority access. We also identified discrepancies in how vaccination-related data were recorded in each country and what vaccination requirements were implemented. CONCLUSION: Each of the ten European nations surveyed in this study reported different COVID-19 vaccination policies. These differences complicated efforts to provide a coordinated pandemic response. These findings might alert policymakers in Europe of the need to coordinate their efforts to avoid fostering divergent and socially disruptive policies.
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Vacunas contra la COVID-19 , COVID-19 , Humanos , Pandemias/prevención & control , COVID-19/epidemiología , COVID-19/prevención & control , Europa (Continente)/epidemiología , Política de SaludRESUMEN
BACKGROUND: Due to the emergency responses early in the COVID-19 pandemic, the use of digital health in health care increased abruptly. However, it remains unclear whether this introduction was sustained in the long term, especially with patients being able to decide between digital and traditional health services once the latter regained their functionality throughout the COVID-19 pandemic. OBJECTIVE: We aim to understand how the public interest in digital health changed as proxy for digital health-seeking behavior and to what extent this change was sustainable over time. METHODS: We used an interrupted time-series analysis of Google Trends data with break points on March 11, 2020 (declaration of COVID-19 as a pandemic by the World Health Organization), and December 20, 2020 (the announcement of the first COVID-19 vaccines). Nationally representative time-series data from February 2019 to August 2021 were extracted from Google Trends for 6 countries with English as their dominant language: Canada, the United States, the United Kingdom, New Zealand, Australia, and Ireland. We measured the changes in relative search volumes of the keywords online doctor, telehealth, online health, telemedicine, and health app. In doing so, we capture the prepandemic trend, the immediate change due to the announcement of COVID-19 being a pandemic, and the gradual change after the announcement. RESULTS: Digital health search volumes immediately increased in all countries under study after the announcement of COVID-19 being a pandemic. There was some variation in what keywords were used per country. However, searches declined after this immediate spike, sometimes reverting to prepandemic levels. The announcement of COVID-19 vaccines did not consistently impact digital health search volumes in the countries under study. The exception is the search volume of health app, which was observed as either being stable or gradually increasing during the pandemic. CONCLUSIONS: Our findings suggest that the increased public interest in digital health associated with the pandemic did not sustain, alluding to remaining structural barriers. Further building of digital health capacity and developing robust digital health governance frameworks remain crucial to facilitating sustainable digital health transformation.