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.
The COVID-19 pandemic has significantly accelerated the digital transformation of the health care sector, providing an opportunity to leverage software to prevent, manage, or treat disease [- ]. Digital health solutions encompass a broad range of technologies that promote, improve, or support health system functioning and the delivery of health care, including electronic health records, telemedicine, mobile health apps, health data analytics, and digital therapeutics [ , ]. These solutions can be used for a range of functions, including web-based consultations with medical professionals, tools and software for remote patient monitoring, real-time updates of algorithms based on patient data, and the delivery of health care interventions. Recent studies have indicated that combining medication with digital health solutions can lead to improved outcomes for a variety of chronic conditions such as type 2 diabetes, cardiovascular diseases, and psychiatric and mental health conditions [ , ].
The adoption of digital health solutions within health systems is subject to various factors, including pricing and reimbursement [, , - ]. Pricing models in health comprise mechanisms such as cost-based pricing (ie, the price of a product is based on the cost of care provided to patients and allowable covered costs), the use of cost-effectiveness thresholds (ie, the price or quality-adjusted life-year is compared with a preset threshold), external price referencing (ie, the price of a product is based on the prices set in other countries), and value-based pricing (ie, the price is based on the value that an intervention adds to the health care process, such as improved health outcomes or reduced costs) [ , ]. The latter approach is recognized as a promising solution to optimize resource allocation and address numerous challenges faced by health systems [ ]. National price regulations that incorporate value-based elements, such as the price regulations in Germany, have also been shown to more closely align the prices paid for medical products with their benefit to patients [ ]. Value-based pricing also supports evidence-based decision-making in health care procurement by providing a benchmark for what constitutes a high-quality intervention [ ]. However, applying a value-based framework to digital health care requires the use of comprehensive frameworks to determine the value of digital interventions and can be challenging because of the continuous improvement of digital health apps through performance data and patient feedback [ , ]. Finally, there is a dearth of data and assessment frameworks in use to evaluate the cost-effectiveness of digital health care [ , ] as well as a scarcity of established pricing models that can be used to streamline the introduction of digital health apps to the health care market [ ].
Robust reimbursement mechanisms are vital in facilitating the access and affordability of new health technologies , although the reimbursement landscape for digital health in Europe remains underresearched and poorly characterized. Although various emergency reimbursement decisions were made during the COVID-19 pandemic to enable health care delivery through videoconferencing and asynchronous care [ , ], such tools represent only a small set of digital health approaches. Additonally, research so far has primarily focused on the policy innovations that facilitated this outside of Europe. As an example, studies have focused on the Australian government’s recent expansion of Medicare-subsidized telehealth services to facilitate the remote delivery of care and mitigate the risk of virus transmission. Consequently, telehealth services became eligible for reimbursement through the Australian Medicare system and eventually became subject to copayments [ , ]. In the United States, research has highlighted the rapid modification of coverage and payment parity policies by states in response to the COVID-19 pandemic to promote the adoption of telehealth and minimize physical contact, thereby overcoming a significant use barrier [ , ]. In comparison, developments in Europe, particularly in terms of the eligibility of digital health apps (ie, software designed to provide a specific form of therapy with or without the involvement of a health care professional) for reimbursement, remain largely unexplored (a notable exception being Germany, which created the first combined regulation and reimbursement pathway for digital health apps in 2019, which has been described in the literature) [ ].
This study presents information on the reimbursement practices for digital health in 9 countries within the World Health Organization European Region (WHO/Europe): Belgium, France, Germany, Israel, Italy, the Netherlands, Poland, Sweden, and the United Kingdom. These countries were chosen based on the availability of information on the reimbursement of digital health and feedback received from the Data and Digital Health Unit at WHO/Europe [, - ]. We aim to map and compare four distinct reimbursement characteristics across the studied countries: (1) whether digital health solutions are recognized as a reimbursable form of health care, (2) what mechanisms are used to reimburse digital health solutions, (3) how digital health solutions are priced and whether value-based health care frameworks are embedded in that process, and (4) whether any funding is available to reimburse digital health solutions outside of public or private insurance policies.
Policy Mapping Framework
This study uses a policy mapping framework, which has been used and validated by previous research in the fields of autism, disability, and substance abuse policy [- ]. The policy mapping framework is based on the foundation of a scoping review, which allows for the rapid mapping of the key concepts underpinning a broad research area that is particularly valuable for complex issues that have not been reviewed comprehensively to date [ , ]. The established framework is suited to analyzing the development of health and social policy over time and across multiple layers of governance. In the context of this study, we only sought to collect information on current digital health reimbursement practices; as such, the longitudinal aspect of the policy mapping framework was not applied. We further developed this policy mapping framework from a cross-country analysis lens by presenting both individual country information in tabulated form and cross-country differences narratively. This approach is also supported by previous policy mapping exercises [ - ].
Data Collection and Analysis
In line with the Joanna Briggs Institute Manual for Evidence Synthesis for Scoping Reviews , we searched MEDLINE (Ovid), Embase (Ovid), Global Health (Ovid), and Web of Science on January 20, 2023, and conducted a follow-up search on August 18, 2023, for articles addressing the reimbursement and financing of digital health apps in Belgium, France, Germany, Israel, Italy, the Netherlands, Poland, Sweden, and the United Kingdom. These databases were chosen to cover both the health-specific and interdisciplinary academic fields. To identify gray literature, Google Scholar (first 300 hits [ ]) was used. To be eligible for inclusion, a record had to capture a part of the reimbursement or financing pathway of digital health apps in the studied countries. Only records from 2018 onward were eligible for inclusion as this timeframe captures the developments before and during the COVID-19 pandemic in terms of digital health reimbursement and financing as well as the launch of the first country-level reimbursement policy for digital health apps in Germany in late 2019 [ ]. The policy mapping framework, in contrast to a traditional scoping review, takes a broader approach to the types of evidence that are eligible for inclusion. Specifically, after searching exclusively for original research and literature reviews, we identified only 14 articles eligible for inclusion, which was too scarce to provide information on existing digital health reimbursement pathways in the studied countries. As such, we expanded the eligibility criteria to include editorials, commentaries, viewpoints, and gray literature as these documents may provide important details of policy developments before these are more rigorously captured in empirical research. We did not directly search for policy repositories as is common practice in the policy mapping framework seeing as we aim to map reimbursement processes rather than the legal basis for reimbursement. Given our specific interest in policy developments in the WHO/Europe region, articles without a focus on the abovementioned countries were excluded.
shows the build-up of the search strings for the academic database searches as well as the number of hits per query. The search string was reviewed and validated by an information specialist at the London School of Economics and Political Science Library. The search terms for the supplementary searches in Google Scholar consisted of the phrases “reimbursement of digital health,” “reimbursement of digital therapeutics,” “financing of digital health,” “financing of digital therapeutics,” “digital health tariff,” “digital health pricing,” “telehealth pricing,” “telehealth tariff,” and “financing of telehealth” combined with the respective country. This combination of keywords ensured that less complex forms of digital health solutions (eg, telehealth and telemedicine) and more complex forms (eg, digital health apps or digital therapeutics) were covered in the search string. If the dominant language was a language other than English, we used Google Translate to translate the search phrases into the desired language [ ]. To minimize the potential bias introduced through machine translations, experts from the studied countries were asked to assist in searching and interpreting the digital health reimbursement landscape for their respective countries. Additional articles were identified through a review of the references of the studies included through database search. Policy contents and mechanisms were identified from the selected references and reviewed using thematic content analysis. After finalizing the data collection and analysis, country experts reviewed the collected information to validate the findings and, where necessary, add additional expertise and insights. Finally, individual country information was tabulated per studied reimbursement characteristic and the disparities between countries were narratively synthesized.
aSearches were originally performed using straight quotations.
This study has no inherent ethical implications or considerations.
Our search strategy yielded a total of 1536 records (1235 documents through academic database searching and 301 through supplementary searches). A further 23 records were identified through the country experts. After deduplication, 1266 documents were screened for eligibility, and 2.57% (40/1559) were ultimately included in the analysis. Most documents were excluded because they did not discuss the current reimbursement or financing pathways in place in the studied countries. We included 9 original research articles [, , - ], 5 reviews [ , , , , ], 4 conference abstracts [ - ], 18 gray literature sources [ , - ], 3 reports [ - ], and 1 commentary [ ]. In terms of country focus, 3 documents focused on Belgium [ - ], 8 on France [ , , , - , , ], 6 on Germany [ , , , , , ], 3 on Israel [ , , ], 4 on Italy [ - , ], 5 on the Netherlands [ , , , , ], 5 on Poland [ , - , ], 3 on Sweden [ - ], and 6 on the United Kingdom [ , , , , , ]. shows a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flowchart of the data collection process. The PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist is shown in . shows the details of country-specific digital health reimbursement.
|Eligible for reimbursement||Mechanism of reimbursement||Pricing of digital health||Noninsurance reimbursement|
|Belgium||Yes||The TBMb program aims at contributing to the implementation of new therapies, diagnostic techniques, and preventive methods, which, without government funding, would not make it to the patient due to a lack of industrial interest .|
|France||Yes||Until December 2022 inclusive, a second reimbursement pathway existed in the form of the experimental program for telemonitoring in France (ETAPES), which focused on the development of telemonitoring approaches in 5 health specialties: heart failure, kidney failure, respiratory failure, diabetes, and implantable cardiac devices [, ].|
|Germany||Yes||Financial support for the development of digital health apps can be obtained from the German Innovation Fund, funded by the German Health Insurance (Gestzlicher Krankenversicherung) .|
amHealth: mobile health.
bTBM: Toegepast Biomedisch onderzoek met een primair Maatschappelijke finaliteit.
cETAPES: Expérimentations de Télémédecine pour l’Amélioration des Parcours en Santé.
dPECAN: Prise en Charge Anticipée Numerique des Dispositifs Médicaux.
eCEPS: Comité Economique des Produits de Santé.
fNZa: Nederlandse Zorgautoriteit.
gNICE: National Institute for Health and Care Excellence.
hNHS: National Health Service.
Eligibility and Mechanism of Reimbursement Through Insurance
All studied countries except Poland allowed for some reimbursement of digital health solutions. However, the reimbursement mechanisms differed substantially across countries, which can be attributed in part to the differences in how the health systems are financed. Two reimbursement archetypes could be derived from the studied countries: countries either reimbursed the digital health solution itself (France, Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom) or reimbursed the clinical pathway that the digital health solution is part of (Belgium and Israel). Further variation was observed across the studied countries in terms of how the digital health apps were classified. Belgium, France, and Israel classify digital health solutions under the traditional paradigm of medical devices, whereas Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom recognize digital health solutions as their own classification. Italy was the only country to implement an explicit system of parity for the reimbursement of digital health solutions. This means that health providers are paid a fixed fee regardless of whether health care is delivered face-to-face or through digital health.
Pricing of Digital Health Solutions or Apps
Pricing mechanisms were found to be at different stages of development across countries. France, Germany, Israel, and Poland each have a dedicated committee that decides on the price of digital health solutions or apps within their respective national insurance systems, although only Germany reports a concrete framework upon which the prices of digital health apps are based. In contrast, Sweden and the United Kingdom delegate pricing negotiations to the regional level, with each region being responsible for reaching an agreement with the digital health manufacturer. The Netherlands exhibited a combination of both approaches, depending on whether a specific digital health solution was included in their mandatory health insurance package or the optional insurer-determined insurance package. In contrast, Belgium and Italy determine the price of digital health solutions in the context of the health care process in which they are deployed. Italy reported having no concrete pricing framework in place for digital health apps even though they are deployed on a fee-for-service basis. Despite using differentiated approaches, all countries adopted a variation of cost-based pricing for digital health except for Belgium, where it is integrated in a value-based pricing system and Germany, where price negotiations need to be based on the demonstrated value of the digital health solution.
Financing Digital Health Solutions or Apps Outside Insurance
The studied countries reported an array of options for financing digital health solutions that were not reliant on their inclusion in health insurance packages. France offered an experimental program for digital health solutions in the fields of heart failure, kidney failure, respiratory failure, diabetes, and implantable cardiac devices until January 2023. Belgium, Germany, Israel, Italy, the Netherlands, Sweden, and the United Kingdom offer innovation grants that finance treatment options currently under development and are not yet covered by their respective national health insurance frameworks, which can cover digital health solutions. However, in Germany, digital health apps that are approved via Germany’s fast-track process, which combines regulation and reimbursement, have to be directly reimbursed in the statutory health insurance system. Furthermore, certain nongovernmental organizations in the Netherlands offer access to disease-specific digital health solutions outside of insurance packages. In this scenario, they are purchased by the nongovernmental organization and distributed to its members free of charge. Poland was the only country that did not report any concrete funding mechanism for digital health solutions.
Although there is nascent literature on national reimbursement practices vis-à-vis digital health solutions, this study is, to the best of the authors’ knowledge, the first to compare reimbursement pathways across countries in the WHO/Europe region with and without specified digital health pathways and to do so for a broader set of digital health tools and approaches. Our findings reveal that the reimbursement pathways for digital health are varied and that value-based pricing frameworks are rare. Although this can be partly attributed to the distinct systems for financing health care in the examined countries, it also emphasizes how the absence of a consistent definition and classification of digital health can contribute to disparate policy and implementation approaches. The present conceptualization of digital health solutions can encompass a range of meanings, including technology, user experience, individual service, product, or process, and can be viewed as part of the broader ecosystem of health services . Although this expansive definition allows for significant flexibility in integrating digital health into existing health care delivery and reimbursement frameworks, it can also lead to uncertainty regarding where and how digital health is meant to fit within a health system. For instance, digital health solutions are regarded as stand-alone health care products in France, Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom, whereas they are framed as tools to deliver traditional health care in Belgium and Israel. Furthermore, Belgium, France, Germany, Italy, and the United Kingdom have specific policy frameworks in place that outline the concept of digital health apps, whereas the other countries categorize digital health apps under either the broader digitalization of health care or medical devices [ , , , , ].
Overall, the observed differences may be explained by the novelty and unprecedented nature of digital health tools and approaches, especially in light of how change resistant the health care sector can be . Another contributing factor may be the lack of digital health literacy among both clinicians and patient users and the necessity (but not sufficient) for adoption training of the health workforce and policy makers to understand the scope, potential benefits, and limitations of these digital transformations [ , , ]. Furthermore, the acute need to act during the COVID-19 pandemic resulted in divergent policies being implemented across Europe [ , ]. When combined, these factors may help explain why disparate digital health reimbursement policies are currently in place across the studied countries.
In the specific context of digital health apps, we found 2 broad categories of approaches toward reimbursement in the studied countries. On the one hand, digital health apps may be reimbursed per use cycle (ie, the period in which the digital health app must be used to produce positive health benefits). This fee-for-service approach has historically been easy to develop and implement, reflects the actual number of services rendered, and can create an incentive for health care providers to increase access to and use of health care services . However, this reimbursement approach has a significant and oft-cited disadvantage, namely providing health care professionals with the incentive to induce demand [ , ]. In the context of digital health care, which can function autonomously and asynchronously, this risk may be exacerbated as health professionals no longer have to consider their own time constraints in prescribing this form of health care (although it could be tempered when a digital health solution is expected to be a substitute for billable services by a clinician). Consequently, a digital health economic paradox can arise, namely that digital health care has the potential to reduce health care costs relative to in-person services, but can equally inflate health care spending if poorly implemented, although this is dependent on the reimbursement methods applied and whether digital health tools serve as a complement or substitute for in-person care—or a combination of the 2. On the other hand, reimbursement for digital health apps may be included as part of the remuneration of a larger health care process, which is more compatible with diagnosis-related groups or global budget approaches to paying for health care. Both these approaches may be more suited than fee-for-service for realizing the potential for digital health care to reduce costs, as they characteristically introduce incentives to improve efficiency in processes and in the allocation of resources.
Furthermore, reimbursement parity for digital health solutions was explicitly introduced in Italy, although the Belgian and Israeli reimbursement approaches could produce a degree of parity as well. Parity systems are considered enablers for the uptake of digital health [, ], although concerns exist that parity systems could impede the development of innovative care delivery models, which could limit the potential of telehealth to address high health care costs and complicate the introduction of value-based models [ ].
Among the countries examined, the pricing of digital health solutions and apps was mostly determined through discussions between committees at the national or regional level and the digital health app developers and manufacturers. However, it is presently unclear what criteria must be met to participate in these committees and whether the designated institutions have the necessary capabilities to assess the worth of digital health solutions or apps [, ]. Only France, Germany and the United Kingdom have reported the use of value-based frameworks with clear information requirements to help stakeholders navigate the price negotiations for digital health apps. These 3 countries are at a more advanced stage of digital health implementation and both patients and professionals have more experience with digital health apps and their effects, which is an important foundation for the introduction of value-based reimbursement models [ ].
We found that, except for Poland, there were many opportunities for financing digital health solutions and apps outside of insurance-based frameworks in the studied countries. However, there were discrepancies in the specificity of these funding opportunities, as it was unclear whether they targeted digital health specifically or health innovations more generally. Nonetheless, such funding initiatives can alleviate the financial risk for health insurers and allow patients, professionals, and insurers to become accustomed to the use and effects of digital health solutions and apps, which is a key factor in their uptake .
Some limitations of this study need to be considered. As is common with scoping reviews, the quality of the included studies was not assessed, which should be considered when interpreting the results. However, as the aim of this study was not to validate methodological rigor to ascertain confidence in the data synthesis but rather to collect information about reimbursement processes in different countries, the absence of a quality assessment does not inhibit the validity of this study. In fact, the information collected did not solely rely on scientific articles as country experts also ensured that the collected information was complete and correct. We also recognized the possibility of selection bias and failed to capture all relevant studies as only 3 academic databases and Google Scholar were used, and the search strategy was not exhaustive. This study focused on 9 countries in the WHO/Europe region, which may not reflect the realities of other regions or countries. Furthermore, the lack of a uniform definition and classification of digital health across countries may have influenced the interpretation and comparison of the reimbursement pathways. Therefore, caution should be exercised when interpreting and generalizing the findings of this study. Moreover, the rapidly evolving nature of digital health and its reimbursement pathways means that the information presented in this study may become outdated relatively quickly. Finally, this study did not explore the potential impact of reimbursement policies on patient outcomes, which could be an area of future research.
We have identified several avenues for future research. First, the composition of committees that determine the price of the digital health solutions in the studied countries could be better characterized and assessed. Second, the expertise requirements to adequately assess the value and price of digital health solutions could be further investigated and potentially pooled into a comprehensive framework. Third, a comprehensive, value-based, and value-sensitive framework for the assessment of digital health apps should be developed. Although some research in this area has already been conducted [, - ], no comprehensive assessment of how digital health apps generate value across different levels of health systems has been conducted so far. Fourth, a comparative assessment of health expenditure (eg, in the management of a particular disease) after the introduction of digital health care in the studied countries can offer a more sophisticated insight into how digital health interacts with different reimbursement systems to affect overall health expenditure. Fifth, it is unclear whether these findings apply to the broader spectrum of novel health technologies. Digital health is a particular type of innovation in health care and future work can explore how these findings translate to, for instance, the growing role of artificial intelligence in health care, where artificial intelligence–based digital health solutions represent a unique subset of digital health products. Sixth, future research should investigate how digital health solutions or apps would be reimbursed in case of cross-country health service delivery and how these reimbursement practices interact with current international and European Union legislation. Finally, future research should investigate how digital health policy has evolved over time across multiple layers of governance (eg, international, national, and regional where applicable) and even before the COVID-19 pandemic to better understand the extent to which the pandemic accelerated the development of digital health policy holistically and how that affected the formation of reimbursement-specific policy for digital health.
The studied countries have been pursuing heterogeneous approaches to the reimbursement of digital health care. Although no approach is inherently superior, a fee-for-service approach might encourage more prescribing of certain digital health solutions or apps, which may be desirable to increase digital health use for purposes such as screening, yet it equally opens the possibility of supplier-induced demand and thus inflating health care expenditure. Ultimately, reimbursement policies should aim to stimulate the value-based integration of digital health into the health care ecosystem to promote equitable access to innovative health care technologies and improve health outcomes for patients. A clearer understanding of reimbursement and its accompanying incentives at present will help to shape more thoughtful, value-based reimbursement policies going forward. This study can therein serve as a basis for further, more detailed research as the field of digital health reimbursement evolves.
No primary data were collected for this study.
RvK was involved in study conceptualization and methodology, software analysis, validation, formal analysis, investigation, data curation, writing the original draft including reviewing and editing, visualization, and project administration. DS and IK were involved in study conceptualization and methodology, software analysis, validation, formal analysis, investigation, writing the original draft including reviewing and editing, and visualization. GM was involved in validation, writing the original draft including reviewing and editing. DNO, WWZ-C, GN, ADS, and GW performed the data curation, validation, writing the original draft including reviewing and editing. EM was involved in study conceptualization and methodology, validation, formal analysis, writing the original draft including reviewing and editing, and supervising the study.
Conflicts of Interest
DNO is a staff member of the World Health Organization and is solely responsible for the views expressed in this publication, which do not necessarily represent the decisions or policies of the organization. ADS reports consulting income from the US Department of Health and Human Services outside of the context of this project and sits on the Scientific Advisory Board of the German Society for Digital Medicine and on the Strategic Advisory Board of HumanFirst.
PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist.PDF File (Adobe PDF File), 99 KB
- Wong BL, Maaß L, Vodden A, van Kessel R, Sorbello S, Buttigieg S, European Public Health Association (EUPHA) Digital Health Section. The dawn of digital public health in Europe: implications for public health policy and practice. Lancet Reg Health Eur 2022 Mar;14:100316 [https://linkinghub.elsevier.com/retrieve/pii/S2666-7762(22)00009-6] [CrossRef] [Medline]
- van Kessel R, Hrzic R, O'Nuallain E, Weir E, Wong BL, Anderson M, et al. Digital health paradox: international policy perspectives to address increased health inequalities for people living with disabilities. J Med Internet Res 2022 Feb 22;24(2):e33819 [https://www.jmir.org/2022/2/e33819/] [CrossRef] [Medline]
- Lazarus JV, Romero D, Kopka CJ, Karim SA, Abu-Raddad LJ, Almeida G, COVID-19 Consensus Statement Panel. A multinational Delphi consensus to end the COVID-19 public health threat. Nature 2022 Nov 03;611(7935):332-345 [https://europepmc.org/abstract/MED/36329272] [CrossRef] [Medline]
- van Kessel R, Kyriopoulos I, Wong BL, Mossialos E. The effect of the COVID-19 pandemic on digital health-seeking behavior: big data interrupted time-series analysis of Google trends. J Med Internet Res 2023 Jan 16;25:e42401 [https://www.jmir.org/2023//e42401/] [CrossRef] [Medline]
- Holly L, Wong BL, van Kessel R, Awah I, Agrawal A, Ndili N. Optimising adolescent wellbeing in a digital age. BMJ 2023 Mar 20;380:e068279 [http://www.bmj.com/lookup/pmidlookup?view=long&pmid=36940933] [CrossRef] [Medline]
- van Kessel R, Kyriopoulos I, Mastylak A, Mossialos E. Changes in digital healthcare search behavior during the early months of the COVID-19 pandemic: a study of six English-speaking countries. PLOS Digit Health 2023 May 1;2(5):e0000241 [https://europepmc.org/abstract/MED/37126489] [CrossRef] [Medline]
- European Observatory on Health Systems and Policies, Fahy N, Williams GA. Use of digital health tools in Europe: before, during and after COVID-19. World Health Organization. 2021. URL: https://apps.who.int/iris/handle/10665/345091 [accessed 2023-08-20]
- van Kessel R, Roman-Urrestarazu A, Anderson M, Kyriopoulos I, Field S, Monti G, et al. Mapping factors that affect the uptake of digital therapeutics within health systems: scoping review. J Med Internet Res 2023 Jul 25;25:e48000 [https://www.jmir.org/2023//e48000/] [CrossRef] [Medline]
- Patel NA, Butte AJ. Characteristics and challenges of the clinical pipeline of digital therapeutics. NPJ Digit Med 2020 Dec 11;3(1):159 [https://doi.org/10.1038/s41746-020-00370-8] [CrossRef] [Medline]
- Fast N, van Kessel R, Humphreys K, Ward NF, Roman-Urrestarazu A. The evolution of telepsychiatry for substance use disorders during COVID-19: a narrative review. Curr Addict Rep 2023 Apr 25;10(2):187-197 [https://europepmc.org/abstract/MED/37266192] [CrossRef] [Medline]
- Prodan A, Deimel L, Ahlqvist J, Birov S, Thiel R, Toivanen M, et al. Success factors for scaling up the adoption of digital therapeutics towards the realization of P5 medicine. Front Med (Lausanne) 2022 Apr 12;9:854665 [https://europepmc.org/abstract/MED/35492346] [CrossRef] [Medline]
- Kählke F, Buntrock C, Smit F, Ebert DD. Systematic review of economic evaluations for internet- and mobile-based interventions for mental health problems. NPJ Digit Med 2022 Nov 23;5(1):175 [https://doi.org/10.1038/s41746-022-00702-w] [CrossRef] [Medline]
- van Kessel R, Haig M, Mossialos E. Strengthening cybersecurity for patient data protection in Europe. J Med Internet Res 2023 Aug 24;25:e48824 [https://www.jmir.org/2023//e48824/] [CrossRef] [Medline]
- WHO Centre for Health Development (Kobe, Japan), Organisation for Economic Co-operation and Development, Barber SL, Lorenzoni L, Ong P. Price setting and price regulation in health care: lessons for advancing universal health coverage. World Health Organization. 2019. URL: https://apps.who.int/iris/handle/10665/325547 [accessed 2023-08-20]
- Vogler S, Paris V, Ferrario A, Wirtz VJ, de Joncheere K, Schneider P, et al. How can pricing and reimbursement policies improve affordable access to medicines? Lessons learned from European countries. Appl Health Econ Health Policy 2017 Jun 6;15(3):307-321 [CrossRef] [Medline]
- Lauenroth VD, Kesselheim AS, Sarpatwari A, Stern AD. Lessons from the impact of price regulation on the pricing of anticancer drugs in Germany. Health Aff (Millwood) 2020 Jul 01;39(7):1185-1193 [CrossRef] [Medline]
- European C. Defining value in “valuebased healthcare” report of the expert panel on effective ways of investing in health (EXPH). Publications Office of the European Union. Luxembourg: Publications Office of the European Union; 2019. URL: https://health.ec.europa.eu/system/files/2019-11/024_defining-value-vbhc_en_0.pdf [accessed 2023-08-20]
- Gensorowsky D, Witte J, Batram M, Greiner W. Market access and value-based pricing of digital health applications in Germany. Cost Eff Resour Alloc 2022 Jun 13;20(1):25 [https://resource-allocation.biomedcentral.com/articles/10.1186/s12962-022-00359-y] [CrossRef] [Medline]
- Haig M, Main C, Chávez D, Kanavos P. A value framework to assess patient-facing digital health technologies that aim to improve chronic disease management: a Delphi approach. Value Health 2023 Jun 28:S1098-3015(23)03025-5 (forthcoming) [https://linkinghub.elsevier.com/retrieve/pii/S1098-3015(23)03025-5] [CrossRef] [Medline]
- Christie HL, Boots LM, Hermans I, Govers M, Tange HJ, Verhey FR, et al. Business models of eHealth interventions to support informal caregivers of people with dementia in the Netherlands: analysis of case studies. JMIR Aging 2021 Jun 03;4(2):e24724 [https://aging.jmir.org/2021/2/e24724/] [CrossRef] [Medline]
- Medicare billing codes for digital therapeutics: a path forward. HealthLeaders. 2022 Aug 11. URL: https://www.healthleadersmedia.com/innovation/medicare-billing-codes-digital-therapeutics-path-forward [accessed 2022-10-20]
- COVID-19 advice for health professionals. Australian Government Department of Health and Aged Care. URL: https://www.health.gov.au/topics/covid-19/health-sector/health-professionals [accessed 2022-10-21]
- Savira F, Orellana L, Hensher M, Gao L, Sanigorski A, Mc Namara K, et al. Use of general practitioner telehealth services during the COVID-19 pandemic in regional Victoria, Australia: retrospective analysis. J Med Internet Res 2023 Feb 07;25:e39384 [https://www.jmir.org/2023//e39384/] [CrossRef] [Medline]
- Erikson C, Herring J, Park YH, Luo Q, Burke G. Association between state payment parity policies and telehealth usage at community health centers during COVID-19. J Am Med Inform Assoc 2022 Sep 12;29(10):1715-1721 [https://europepmc.org/abstract/MED/35864736] [CrossRef] [Medline]
- Gerke S, Stern AD, Minssen T. Germany's digital health reforms in the COVID-19 era: lessons and opportunities for other countries. NPJ Digit Med 2020 Jul 10;3(1):94 [https://doi.org/10.1038/s41746-020-0306-7] [CrossRef] [Medline]
- Marshall MN. Sampling for qualitative research. Fam Pract 1996 Dec;13(6):522-525 [CrossRef] [Medline]
- Ju JH, Sim B, Lee J, Lee JY. Reimbursement of digital therapeutics: future perspectives in Korea. Korean Circ J 2022 Apr;52(4):265-279 [https://europepmc.org/abstract/MED/35388995] [CrossRef] [Medline]
- Recognising the value of digital health apps: an assessment of five European healthcare systems. MedTech Europe. 2021 Nov 15. URL: https://www.medtecheurope.org/resource-library/recognising-the-value-of-digital-health-apps-an-assessment-of-five-european-healthcare-systems/ [accessed 2023-01-15]
- Chawla V. How to get your digital health app reimbursed in Europe? Start with Germany, Belgium and France. Research 2 Guidance. URL: https://research2guidance.com/how-to-get-your-digital-health-app-reimbursed-in-europe-start-with-germany-belgium-and-france/ [accessed 2022-11-11]
- Neicun J, Steenhuizen M, van Kessel R, Yang JC, Negri A, Czabanowska K, et al. Mapping novel psychoactive substances policy in the EU: the case of Portugal, the Netherlands, Czech Republic, Poland, the United Kingdom and Sweden. PLoS One 2019 Jun 26;14(6):e0218011 [https://dx.plos.org/10.1371/journal.pone.0218011] [CrossRef] [Medline]
- Bunt D, van Kessel R, Hoekstra RA, Czabanowska K, Brayne C, Baron-Cohen S, et al. Quotas, and anti-discrimination policies relating to autism in the EU: scoping review and policy mapping in Germany, France, Netherlands, United Kingdom, Slovakia, Poland, and Romania. Autism Res 2020 Aug 22;13(8):1397-1417 [https://europepmc.org/abstract/MED/32441457] [CrossRef] [Medline]
- van Kessel R, Hrzic R, Czabanowska K, Baranger A, Azzopardi-Muscat N, Charambalous-Darden N, et al. Autism and education-international policy in small EU states: policy mapping in Malta, Cyprus, Luxembourg and Slovenia. Eur J Public Health 2020 Dec 11;30(6):1078-1083 [https://europepmc.org/abstract/MED/32879964] [CrossRef] [Medline]
- van Kessel R, Dijkstra W, Prasauskiene A, Villeruša A, Brayne C, Baron-Cohen S, et al. Education, special needs, and autism in the Baltic states: policy mapping in Estonia, Latvia, and Lithuania. Front Educ 2020 Sep 4;5 [CrossRef]
- van Kessel R, Steinhoff P, Varga O, Breznoščáková D, Czabanowska K, Brayne C, et al. Autism and education-teacher policy in Europe: policy mapping of Austria, Hungary, Slovakia and Czech Republic. Res Dev Disabil 2020 Oct;105:103734 [https://linkinghub.elsevier.com/retrieve/pii/S0891-4222(20)30164-5] [CrossRef] [Medline]
- van Kessel R, Hrzic R, Cassidy S, Brayne C, Baron-Cohen S, Czabanowska K, et al. Inclusive education in the European Union: a fuzzy-set qualitative comparative analysis of education policy for autism. Soc Work Public Health 2021 Feb 17;36(2):286-299 [CrossRef] [Medline]
- Levac D, Colquhoun H, O'Brien KK. Scoping studies: advancing the methodology. Implement Sci 2010 Sep 20;5:69 [https://implementationscience.biomedcentral.com/articles/10.1186/1748-5908-5-69] [CrossRef] [Medline]
- Arksey H, O'Malley L. Scoping studies: towards a methodological framework. Int J Soc Res Methodol 2005 Feb;8(1):19-32 [CrossRef]
- van Kessel R, Forman R, Milstein R, Mastylak A, Czabanowska K, Czypionka T, et al. Divergent COVID-19 vaccine policies: policy mapping of ten European countries. Vaccine 2023 Apr 24;41(17):2804-2810 [https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(23)00320-1] [CrossRef] [Medline]
- Hargreaves S, Nellums L, Ravensbergen S, Friedland J, Stienstra Y, ESGITM Working Group on Vaccination in Migrants. Divergent approaches in the vaccination of recently arrived migrants to Europe: a survey of national experts from 32 countries, 2017. Euro Surveill 2018 Oct;23(41):1700772 [http://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2018.23.41.1700772] [CrossRef] [Medline]
- Dal-Ré R, Banzi R, Becker SL, Launay O, Pavli A. High heterogeneity on the accepted vaccines for COVID-19 certificates in European countries. Travel Med Infect Dis 2022;48:102321 [https://europepmc.org/abstract/MED/35390530] [CrossRef] [Medline]
- Peters MD, Godfrey C, McInerney P, Munn Z, Tricco AC, Khalil H. Chapter 11: scoping reviews (2020 version). In: Aromataris E, Munn Z, editors. JBI Manual for Evidence Synthesis. Adelaide, South Australia: Joanna Briggs Institute; 2020.
- Haddaway NR, Collins AM, Coughlin D, Kirk S. The role of Google scholar in evidence reviews and its applicability to grey literature searching. PLoS One 2015 Sep 17;10(9):e0138237 [https://dx.plos.org/10.1371/journal.pone.0138237] [CrossRef] [Medline]
- Groves M, Mundt K. Friend or foe? Google Translate in language for academic purposes. English Specif Purp 2015 Jan;37:112-121 [CrossRef]
- Gregor-Haack J. [Reimbursement of health apps by the German statutory health insurance]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2018 Mar 26;61(3):328-333 [CrossRef] [Medline]
- Assor Y, Greenberg D. Public legitimacy of healthcare resource allocation committees: lessons learned from assessing an Israeli case study. BMC Health Serv Res 2022 Jun 02;22(1):737 [https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-07992-6] [CrossRef] [Medline]
- Brunetti ND, Molinari G, Acquistapace F, Zimotti T, Parati G, Indolfi C, et al. 2019 Italian Society of Cardiology Census on telemedicine in cardiovascular disease: a report from the working group on telecardiology and informatics. Open Heart 2020 Mar 17;7(1):e001157 [https://air.unimi.it/handle/2434/720536] [CrossRef] [Medline]
- Tarricone R, Petracca F, Ciani O, Cucciniello M. Distinguishing features in the assessment of mHealth apps. Expert Rev Pharmacoecon Outcomes Res 2021 Aug 04;21(4):521-526 [CrossRef] [Medline]
- Pardolesi A, Gherzi L, Pastorino U. Telemedicine for management of patients with lung cancer during COVID-19 in an Italian cancer institute: SmartDoc project. Tumori 2022 Aug 10;108(4):357-363 [CrossRef] [Medline]
- Bally EL, Cesuroglu T. Toward integration of mHealth in primary care in the Netherlands: a qualitative analysis of stakeholder perspectives. Front Public Health 2019 Jan 15;7:407 [https://europepmc.org/abstract/MED/32010660] [CrossRef] [Medline]
- Furlepa K, Śliwczyński A, Kamecka K, Kozłowski R, Gołębiak I, Cichońska-Rzeźnicka D, et al. The COVID-19 pandemic as an impulse for the development of telemedicine in primary care in Poland. J Pers Med 2022 Jul 18;12(7):1165 [https://www.mdpi.com/resolver?pii=jpm12071165] [CrossRef] [Medline]
- Mantovani A, Leopaldi C, Nighswander CM, Di Bidino R. Access and reimbursement pathways for digital health solutions and diagnostic devices: current scenario and challenges. Front Med Technol 2023 Feb 20;5:1101476 [https://europepmc.org/abstract/MED/36891483] [CrossRef] [Medline]
- Stern AD, Brönneke J, Debatin JF, Hagen J, Matthies H, Patel S, et al. Advancing digital health applications: priorities for innovation in real-world evidence generation. Lancet Digit Health 2022 Mar;4(3):e200-e206 [https://linkinghub.elsevier.com/retrieve/pii/S2589-7500(21)00292-2] [CrossRef] [Medline]
- Braileanu G, Tavella F, Rousseau B. PHP227 - the current reimbursement landscape for digital health in the UK: how far are we from a centralised, national system? Value Health 2018 Oct;21(Supplement 3):S188 [CrossRef]
- Vollmer L, Foxon G, Danev V, Berard I, Benazet F, Walzer S. PMD17 comparison of market access routes of digital health applications in France, Germany and the UK. Value Health 2020 Dec;23(Supplement 2):S579 [CrossRef]
- Berard I, Benazet F, Halimi M, Amory D, Bouchara G. PMD148 - the budget impact of global telemedicine solution in France. Value Health 2018 Oct;21(Supplement 3):S268 [CrossRef]
- Barzey V, Brennan J, Tutt S, Cope N. Innovative access pathways for digital healthcare solutions: learnings from a European analogue analysis for Asian HTA bodies. Value Health 2018 Sep;21(Supplement 2):S73 [CrossRef]
- Financing. mHealthBelgium. URL: https://mhealthbelgium.be/financing [accessed 2022-11-11]
- Validation Pyramid. mHealthBelgium. URL: https://mhealthbelgium.be/validation-pyramid [accessed 2022-11-11]
- TBM projects (applied biomedical research with a primary social finality). Flanders. URL: https://www.fwo.be/en/fellowships-funding/research-projects/tbm-projects/ [accessed 2023-04-05]
- LOI n° 2021-1754 du 23 décembre 2021 de financement de la sécurité sociale pour 2022 (1). Legifrance. URL: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000044553428 [accessed 2023-08-23]
- Early access to reimbursement for digital devices (PECAN). French Ministry of Health and Prevention. URL: http://gnius.esante.gouv.fr/en/financing/reimbursement-profiles/early-access-reimbursement-digital-devices-pecan [accessed 2023-05-18]
- The Fast-Track process for digital health applications (DiGA) according to Section 139e SGB V. Federal Institute for Drugs and Medical Devices. URL: https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf?__blob=publicationFile&v=2 [accessed 2022-10-15]
- International profiles of health care systems. The Commonwealth Fund. 2020 Dec. URL: https://www.commonwealthfund.org/sites/default/files/2020-12/International_Profiles_of_Health_Care_Systems_Dec2020.pdf [accessed 2023-08-21]
- Approval of guidelines for telemedicine services - Functional requirements and service levels. (22A06184) (GU General Series n.256 of 02-11-2022). Gazzetta Ufficiale. 2022 Sep 21. URL: https://www.gazzettaufficiale.it/eli/id/2022/11/02/22A06184/sg [accessed 2023-03-23]
- Wegwijzer bekostiging digitale zorg 2023. Nederlandse Zorgautoriteit. URL: https://puc.overheid.nl/nza/doc/PUC_655318_22/1/ [accessed 2022-11-12]
- Rozporządzenie Ministra Zdrowia z dnia 24 września 2013 r. w sprawie świadczeń gwarantowanych z zakresu podstawowej opieki zdrowotnej. ISAP – Internetowy System Aktów Prawnych. URL: https://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20130001248 [accessed 2023-08-24]
- Wycena świadczeń opieki zdrowotnej finansowanych ze środków publicznych. Najwyzsza Izba Kontroli. 2021 Aug 24. URL: https://www.nik.gov.pl/kontrole/P/20/055/ [accessed 2023-08-24]
- Program Rozwoju e-Zdrowia na lata 2022-2027. Ministerstwo Zdrowia. 2022 Oct 20. URL: https://www.gov.pl/web/zdrowie/program-rozwoju-e-zdrowia-na-lata-2022-2027 [accessed 2023-08-24]
- Ersättningar, digitala vårdtjänster i primärvården. Sveriger Kommuner och Regioner. 2022 Mar 22. URL: https://skr.se/skr/halsasjukvard/utvecklingavverksamhet/ehalsa/dethargorskrinomehalsa/digitalavardtjanster/ersattningardigitalavardtjansteriprimarvarden.28836.html [accessed 2022-11-13]
- Blix M. Regeringen lägger krokben för digitala psykologer. Timbro. 2022 Feb 22. URL: https://timbro.se/smedjan/regeringen-lagger-krokben-for-digitala-psykologer/ [accessed 2022-11-13]
- Funding. Vinnova. URL: https://www.vinnova.se/en/apply-for-funding/ [accessed 2023-03-23]
- NHS Scotland pioneers digital insomnia app. The Scotsman. 2022 Sep 15. URL: https://www.scotsman.com/health/nhs-scotland-pioneers-digital-insomnia-app-3844593 [accessed 2022-11-12]
- MedTech funding mandate and MedTech support. National Health Service England. URL: https://www.england.nhs.uk/aac/what-we-do/how-can-the-aac-help-me/the-medtech-funding-mandate/ [accessed 2022-11-13]
- Topór-Mądry R, Balwicki Ł, Kowalska-Bobko I, Włodarczyk CW. Poland. In: Rechel B, Maresso A, Sagan A, Hernández-Quevedo C, Williams G, Richardson E, et al, editors. Organization and Financing of Public Health Services in Europe: Country Reports. Copenhagen, Denmark: World Health Organization Regional Office for Europe; 2018.
- Kroneman M, Boerma W, van den Berg M, Groenewegen P, de Jong J, van Ginneken E. Health system review: Netherlands. The European Observatory on Health Systems and Policies. 2006. URL: https://apps.who.int/iris/bitstream/handle/10665/330244/HiT-18-2-2016-eng.pdf?sequence=5&isAllowed=y [accessed 2023-08-26]
- Rosen B, Samuel H. Health care systems in transition: Israel. The European Observatory on Health Care Systems. 2003. URL: https://apps.who.int/iris/bitstream/handle/10665/107537/HiT-5-1-2003-eng.pdf?sequence=11&isAllowed=y [accessed 2023-08-26]
- Glaser J, Shaw S. Digital transformation success: what can health care providers learn from other industries? NEJM Catal 2022 Mar 22 [https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0434] [CrossRef]
- van Kessel R, Wong BL, Clemens T, Brand H. Digital health literacy as a super determinant of health: more than simply the sum of its parts. Internet Interv 2022 Mar;27:100500 [https://linkinghub.elsevier.com/retrieve/pii/S2214-7829(22)00007-0] [CrossRef] [Medline]
- Kickbusch I, Piselli D, Agrawal A, Balicer R, Banner O, Adelhardt M, Secretariat of the LancetFinancial Times Commission. The Lancet and Financial Times Commission on governing health futures 2030: growing up in a digital world. Lancet 2021 Nov 06;398(10312):1727-1776 [CrossRef] [Medline]
- Langenbrunner J, Cashin C, O’Dougherty S. Designing and implementing health care provider payment systems how-to manuals. The World Bank. URL: https://documents1.worldbank.org/curated/en/577441468169753880/pdf/543180BRI0Box31ymentMethodsoverview.pdf [accessed 2023-08-21]
- Dorn SD. Backslide or forward progress? Virtual care at U.S. healthcare systems beyond the COVID-19 pandemic. NPJ Digit Med 2021 Jan 08;4(1):6 [https://doi.org/10.1038/s41746-020-00379-z] [CrossRef] [Medline]
- Wharton GA, Sood HS, Sissons A, Mossialos E. Virtual primary care: fragmentation or integration? Lancet Digit Health 2019 Nov;1(7):e330-e331 [https://linkinghub.elsevier.com/retrieve/pii/S2589-7500(19)30152-9] [CrossRef] [Medline]
- Whitelaw S, Pellegrini DM, Mamas MA, Cowie M, Van Spall HG. Barriers and facilitators of the uptake of digital health technology in cardiovascular care: a systematic scoping review. Eur Heart J Digit Health 2021 Mar;2(1):62-74 [https://europepmc.org/abstract/MED/34048508] [CrossRef] [Medline]
- Busso M, Gonzalez MP, Scartascini C. On the demand for telemedicine: evidence from the COVID-19 pandemic. Health Econ 2022 Jul 08;31(7):1491-1505 [https://europepmc.org/abstract/MED/35527351] [CrossRef] [Medline]
- D'Anza B, Pronovost PJ. Digital health: unlocking value in a post-pandemic world. Popul Health Manag 2022 Feb 01;25(1):11-22 [CrossRef] [Medline]
- Lantzsch H, Panteli D, Martino F, Stephani V, Seißler D, Püschel C, et al. Benefit assessment and reimbursement of digital health applications: concepts for setting up a new system for public coverage. Front Public Health 2022 Apr 21;10:832870 [https://europepmc.org/abstract/MED/35530738] [CrossRef] [Medline]
- Richardson S, Lawrence K, Schoenthaler AM, Mann D. A framework for digital health equity. NPJ Digit Med 2022 Aug 18;5(1):119 [https://doi.org/10.1038/s41746-022-00663-0] [CrossRef] [Medline]
|PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses|
|PRISMA-ScR: Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews|
|WHO/Europe: World Health Organization European Region|
Edited by L Buis; submitted 14.05.23; peer-reviewed by J Drott, P Mechael; comments to author 17.08.23; revised version received 03.09.23; accepted 08.09.23; published 29.09.23Copyright
©Robin van Kessel, Divya Srivastava, Ilias Kyriopoulos, Giovanni Monti, David Novillo-Ortiz, Ran Milman, Wojciech Wilhelm Zhang-Czabanowski, Greta Nasi, Ariel Dora Stern, George Wharton, Elias Mossialos. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 29.09.2023.
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