Conceptualization of the Understanding of Participation and Co-Creation in Interdisciplinary Research Groups developing Digital Health Technology: An Exploratory Study
The healthcare sector's digital transformation necessitates the involvement of stakeholders through participation and co-creation processes. This study aims to investigate the understanding and implementation of participation and co-creation in the development of hybrid interaction technologies in healthcare. Eight interdisciplinary research projects were examined through semi-structured group interviews with 49 participants from academia, industry, and the application field. The interviews focused on participants' perspectives on project goals, user groups, access to the field, methods of participation and co-creation, and user motivation. The results highlight the diverse understandings of participation and co-creation, with some perceiving them as research-driven and others as already embedded in user-centered design. The projects emphasized user needs but often excluded stakeholders from collaborative decision-making. Challenges in achieving continuous involvement and co-decision were acknowledged. The findings underscore the need for reflexive practice and evaluation of participation and co-creation throughout the development process, as well as further research on participation across projects. By addressing these challenges and embracing participatory approaches, digital health applications can better address ethical concerns, build trust, and increase acceptance and adoption in the healthcare sector.
- Supplementary Content
1
- 10.1177/20552076251315297
- Aug 18, 2025
- Digital Health
ObjectivesDespite rapid technological advances, the adoption and deployment of digital health and virtual reality (VR) applications in healthcare appears to be progressing slowly. This scoping review is part of the Scale-Up4Rehab (SU4R) project, which aims to create a virtual rehabilitation clinic hosting high-quality digital health interventions. The aim of this review was to identify existing high-quality digital health evaluation frameworks, and from these, extract criteria to inform a new set of guidelines for assessing the applications that will be hosted on the SU4R platform.MethodsThe review followed Arksey and O’Malley's scoping review framework and was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A search strategy that included relevant keywords encompassing the domains of interest; digital health, evaluation frameworks and digital health applications was created between January 2007 and December 2023, across seven medical and computer science databases. Data from each study were extracted by a team of four reviewers using a customized data extraction tool.ResultsThe review included 18 frameworks from 11 countries, incorporating 775 criteria. Nine evaluation frameworks were identified from the included papers (n = 12) and a further nine frameworks from grey literature. The criteria were grouped into 19 categories, with the largest proportion of identified criteria grouped into the categories ‘Data Security and Privacy’ and ‘Validation’.ConclusionThe criteria extracted from the reviewed frameworks will contribute to the creation of a comprehensive evaluation framework. This new evaluation framework will form part of the approval process for the SU4R Virtual Rehabilitation Clinic. This will facilitate a rigorous selection process for the digital health and VR applications to be hosted on the virtual clinic.
- Supplementary Content
10
- 10.2196/40504
- Feb 9, 2023
- Journal of Medical Internet Research
BackgroundKnee pain is highly prevalent worldwide, and this number is expected to rise in the future. The COVID-19 outbreak, in combination with the aging population, rising health care costs, and the need to make health care more accessible worldwide, has led to an increasing demand for digital health care applications to deliver care for patients with musculoskeletal conditions. Digital health and other forms of telemedicine can add value in optimizing health care for patients and health care providers. This might reduce health care costs and make health care more accessible while maintaining a high level of quality. Although expectations are high, there is currently no overview comparing digital health applications with face-to-face contact in clinical trials to establish a primary knee diagnosis in orthopedic surgery.ObjectiveThis study aimed to investigate the currently available digital health and telemedicine applications to establish a primary knee diagnosis in orthopedic surgery in the general population in comparison with imaging or face-to-face contact between patients and physicians.MethodsA scoping review was conducted using the PubMed and Embase databases according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) statement. The inclusion criteria were studies reporting methods to determine a primary knee diagnosis in orthopedic surgery using digital health or telemedicine. On April 28 and 29, 2021, searches were conducted in PubMed (MEDLINE) and Embase. Data charting was conducted using a predefined form and included details on general study information, study population, type of application, comparator, analyses, and key findings. A risk-of-bias analysis was not deemed relevant considering the scoping review design of the study.ResultsAfter screening 5639 articles, 7 (0.12%) were included. In total, 2 categories to determine a primary diagnosis were identified: screening studies (4/7, 57%) and decision support studies (3/7, 43%). There was great heterogeneity in the included studies in algorithms used, disorders, input parameters, and outcome measurements. No more than 25 knee disorders were included in the studies. The included studies showed a relatively high sensitivity (67%-91%). The accuracy of the different studies was generally lower, with a specificity of 27% to 48% for decision support studies and 73% to 96% for screening studies.ConclusionsThis scoping review shows that there are a limited number of available applications to establish a remote diagnosis of knee disorders in orthopedic surgery. To date, there is limited evidence that digital health applications can assist patients or orthopedic surgeons in establishing the primary diagnosis of knee disorders. Future research should aim to integrate multiple sources of information and a standardized study design with close collaboration among clinicians, data scientists, data managers, lawyers, and service users to create reliable and secure databases.
- Research Article
37
- 10.2196/59013
- Aug 29, 2024
- Journal of Medical Internet Research
BackgroundThis study aimed to analyze the rapidly evolving ecosystem of digital health applications (Digitale Gesundheitsanwendung; DiGAs) in Germany, spurred by the 2019 Digital Healthcare Act. With over 73 million people in Germany now having access to DiGAs, these prescribable digital health apps and web-based applications represent a substantial stride in health care modernization, supporting both patients and health care providers with digital solutions for disease management and care improvement.ObjectiveThrough a data-driven approach, this research aimed to unpack the complexities of DiGA market dynamics, economic factors, and clinical evidence, offering insights into their impact over the past years.MethodsThe analysis draws from a range of public data sources, including the DiGA directory, statutory health insurance reports, app store feedback, and clinical study results.ResultsAs of July 1, 2024, there are 56 DiGAs listed by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), divided into 35 permanently and 21 preliminarily listed applications. Our findings reveal that a majority of DiGAs extend beyond the intended 1-year period to achieve permanent listing, reflecting the extensive effort required to demonstrate clinical efficacy. Economic analysis uncovered a dynamic pricing landscape, with initial prices ranging from approximately €200 to €700 (€1=US $1.07), averaging at a median of €514 for a 3-month DiGA prescription. Following negotiations or arbitration board decisions, prices typically see a 50% reduction, settling at a median of €221. Prescription data offer valuable insights into DiGA acceptance, with total prescriptions jumping from around 41,000 in the first period to 209,000 in the latest reporting period. The analysis of the top 15 DiGAs, representing 82% of the total prescriptions, shows that these best-performing apps receive from a minimum of 8 to a maximum of 77 daily prescriptions, with native apps and early market entrants achieving higher rates. Clinical evidence from all 35 permanently listed DiGAs indicates a uniform preference for randomized controlled trials to validate primary end points, with no noteworthy use of alternative study designs encouraged in the Digital Healthcare Act and related regulations. Moreover, all evaluated DiGAs focused on medical benefits, with health status improvement as a key end point, suggesting an underuse of patient-relevant structural and procedural improvement in demonstrating health care impact.ConclusionsThis study highlights the growth and challenges within the DiGA sector, suggesting areas for future research, such as the exploration of new study designs and the potential impact of patient-relevant structural and procedural improvements. For DiGA manufacturers, the strategic advantage of early market entry is emphasized. Overall, this paper underscores the evolving landscape of digital health, advocating for a nuanced understanding of digital health technology integration in Germany and beyond.
- Research Article
280
- 10.1111/acem.12692
- May 21, 2015
- Academic Emergency Medicine
Digital health is an area of growing interest for physicians, patients, and technology companies alike. It promises the ability to engage patients in their care, before, during, and after an emergency department visit. Current efforts to create, study, and disseminate digital health have been limited by lack of user engagement. In this commentary, we outline the imperative for engaging end-users in each phase of digital health design, as well as a few techniques to facilitate better digital health design and implementation.
- Research Article
- 10.1007/s10916-025-02172-5
- Apr 7, 2025
- Journal of Medical Systems
The rapidly advancing digital health requires a standardized approach to classifying Digital Health Interventions (DHIs) for better planning, monitoring, and resource distribution. The World Health Organisation (WHO) developed a Classification for Digital Health Interventions, Services, and Applications in Health (CDISAH) in response to this need. The purpose of this study was to develop an interactive toolkit based on WHO's CDISAH to enhance categorization, making it more interactive, user-friendly, and effective in classifying DHI services and applications, and demonstrate its practical implementation in the field of cardiac rehabilitation. We used a descriptive approach with a seven-step iterative process to create the toolkit. The process began with a review of best practices for converting framework into toolkit, followed by drafting an initial toolkit structure, which was refined through team discussions. The content was based on WHO CDISAH. Expert feedback was incorporated, and quality assurance was conducted through internal and external reviews. The toolkit’s functionality and usability were evaluated through a use case including DHIs, services, and applications for cardiac rehabilitation. The toolkit for WHO CDISAH has a structured interface with clear definitions, practical examples, and intuitive navigation across three main axes: health system challenges, digital health interventions, and digital health applications and services. Pilot testing improved its usability and functionality for accurate classification, highlighting areas for refinement and identifying challenges and solutions for practical implementation. The developed toolkit provides a standardised, portable platform for classifying the multimodal DHIs that align with the framework presented by WHO.
- Front Matter
1
- 10.3389/frhs.2024.1501903
- Oct 30, 2024
- Frontiers in health services
Digital health services have witnessed a growing prevalence in healthcare systems around the world, with diverse levels of implementation and hurdles to surmount. Germany took the lead in creating the possibility for prescribing digital health applications (DHAs) as CE-certified digital medical devices with costs covered by the national health system, a trend that has been emulated by other countries, such as France and Belgium (1). Nonetheless, digital healthcare services continue to be perceived as innovations in most healthcare systems, encountering challenges due to the absence of well-established reimbursement channels. In healthcare systems where statutory health insurance covers the costs of healthcare services, patients are often reluctant to pay for digital health services privately. Additionally, both patients and service providers lack initial experience with these innovations (2-4), giving rise to skepticism and requiring time for the innovation to integrate into healthcare. To secure health insurance coverage for these services, clear evidence of patient benefits is generally required, involving substantial costs and time investment, which smaller innovative companies may find prohibitive. To expedite the integration of DHAs into healthcare systems, several countries have instituted measures to address these barriers. For instance, Germany has adopted a two-phase market entry process, in which an initial pilot study grants market access and reimbursement by the national health system, followed by a confirmatory study to definitively demonstrate the benefits (5). What started as an innovative tool to give patients quick access to DHAs, especially for psychological indications where therapist waiting times are often long, has unfortunately become a very complex system. The requirements for studies to prove a benefit for patients are now much higher, making the studies time consuming and very expensive, so that hardly any new DHA is made available (6).In recent years, digital health services have gained substantial momentum, revolutionizing healthcare delivery and presenting new opportunities for patient care. In this research topic the contributing authors present a variety of perspectives on the digitalisation of the health care sector. For example, Giebel et al. developed the DiGA-Care Path, a step-by-step analysis of DHA supply in Germany (7). This approach comprises a "main path," concentrating on the supply environment, and a "sub-path," illustrating the supply delivered by the DHA. This methodology assists in identifying problems and potential quality improvements in the current DHA supply and can serve as a guidance for international policymakers and stakeholders.Stapelfeldt et al. performed a systematic assessment of DHA intended to treat obesity (8). The study concluded that most apps partially meet guideline recommendations and exhibit adequate to good quality based on the MARS score. However, evaluating the quality of mobile health applications remains challenging for patients, despite their low-threshold accessibility.Naemi et al. designed and evaluated an Electronic Health Record (EHR) for amblyopia patients in Iran, aiming to enhance information management and reduce treatment costs (9). A usability evaluation showed that over 90% of users rated the web-based EHR system as very good or good, demonstrating high patient acceptance. Implementing an EHR for amblyopia has the potential to improve care quality and facilitate complication control.Tischendorf et al. examined the sustainable integration of digitalization in nursing education, pinpointing trends in digitalization-related training and emphasizing the importance of involving nursing professionals in digital technology development (10). The literature review suggests that discussions on this topic in German-language literature lag behind those in the international context, highlighting the need for collaboration between nursing professionals and nursing sciences.Arabian et al. investigated patients' understanding of electronic prescriptions in Iran, underscoring the necessity for improved patient comprehension of the potential consequences of such technology on their relationships with healthcare providers (11). Active patient engagement and positive attitudes toward electronic prescription systems can enhance healthcare service quality, increase acceptance, and simplify system usage.In conclusion, the aforementioned studies of this research topic, accompanied by numerous other investigations, provide valuable insights into the acceptance, benefit evaluation, and cost implications associated with digital health services. As the ongoing proliferation of innovations persistently reconfigures global healthcare infrastructures, it is indispensable to eradicate prospective obstacles and facilitate egalitarian accessibility to superior care, thereby engendering unprecedented possibilities through the utilization of, and access to, data derived from digital health applications among other resources. Collaborative efforts among stakeholders, including policymakers, healthcare professionals, and developers, will be vital in overcoming these barriers (12).
- Book Chapter
7
- 10.1007/978-3-030-82269-9_27
- Jan 1, 2021
In recent times, considerable attention has been given to digital services, mainly digital healthcare, i.e., health and well-being applications and services by health organizations, practitioners, and researchers. One of the significant challenges for today’s digital health and well-being applications and services is that they are not sustainable and focusing less on relevant stakeholders. However, to the best of our knowledge, little is known about relevant stakeholders in the digital health and well-being applications and services, precisely identifying them using an appropriate method. This paper seeks to define and identify the relevant stakeholders in the digital health and well-being applications and services. A literature review is conducted based on relevant articles on stakeholders within the health domain. Hence, the narrative synthesis literature review approach has been used with a combination of the Bryant model of stakeholder-issue interrelationship. We identified relevant stakeholders who may build a better future to enhance the efficacy of the digital health and well-being applications and services in the long run and suggested a future study on value propositions.KeywordsRelevant stakeholdersDigital healthcareNarrative synthesis literature reviewBryant modelSustainability
- Research Article
3
- 10.1186/s13063-025-08809-7
- Apr 10, 2025
- Trials
BackgroundIn the face of extensive waiting times for outpatient psychotherapy, prescriptible digital health applications (DiGA) are a useful and effective addition to the range of available therapy options for patients with mild to moderate depression. However, older adults face a particular challenge in implementing DiGA since higher age is a decisive predictor of lower digital health literacy. The necessity of an independent use of the prescribed DiGA is therefore associated with challenges for older patients and providers. In practice, it is crucial not to leave patients, especially older adults, alone after prescribing, but to maintain close contact to overcome technical and motivational barriers and to ensure that the novel application is used. However, this is difficult for physicians and psychotherapists due to the critical healthcare system situation in Germany described above. Another support system is needed. Hence, the main hypothesis of this study is that the additional implementation of digital nurses leads to a higher percentage of older patients with depressive symptoms starting DiGA use compared to a prescription and information alone.MethodsTwo DiGA for mild to moderate depression in older patients were available and permanently approved at the time of the funding application. Using the most suitable one of them, as shown in a pilot study, the feasibility of implementation will be examined within a randomized proof of concept study. In our study, a digital nurse is trained to support patients with depression in using a DiGA. The main outcome is DiGA use (first session started: yes/no) after 8 weeks. Major secondary outcomes are patient-relevant outcomes, feasibility of recruitment and intervention, and factors moderating the effect or predicting DiGA use in the target group. Best practice guidelines will be elaborated on how to support and improve DiGA prescription and successful use in this population.DiscussionIn Germany, the approved DiGA are currently little used, especially by people with a low digital affinity. This proof of concept study will use the example of older people with depressive disorders to show whether it is possible to increase the usage rate of a DiGA with the support of a digital nurse so that a DiGA can become a serious therapy option.Trial registrationDRKS: DRKS00033535. Registered on February 2, 2024.
- Research Article
8
- 10.1007/s00399-022-00888-2
- Aug 12, 2022
- Herzschrittmachertherapie & Elektrophysiologie
The advances in health care technologies over the last decade have led to improved capabilities in the use of digital health applications (DiHA) for the detection of atrial fibrillation (AFib). Thus, home-based remote heart rhythm monitoring is facilitated by smartphones or smartwatches alone or combined with external sensors. The available products differ in terms of type of application (wearable vs. handheld) and the technique used for rhythm detection (electrocardiography [ECG] vs. photoplethysmography [PPG]). While ECG-based algorithms often require additional sensors, PPG utilizes techniques integrated in smartphones or smartwatches. Algorithms based on artificial intelligence allow for the automated diagnosis of AFib, enabling high diagnostic accuracy for both ECG-based and PPG-based DiHA. Advantages for clinical use result from the widespread accessibility of rhythm monitoring, thereby permitting earlier diagnosis and higher AFib detection rates. DiHA are also useful for the follow-up of patients with known AFib by monitoring the success of therapeutic interventions to restore sinus rhythm, e.g. catheter ablation. Although some studies strongly suggest apotential benefit for the use of DiHA in the setting of AFib, the overall evidence for an improvement in hard, clinical endpoints and positive effects on clinical care is scarce. To enhance the acceptance of DiHA use in daily practice, more studies evaluating their clinical benefits for the detection of AFib are required. Moreover, most of the applications are still not reimbursable, although the German Digital Health Care Act (Digitale-Versorgung-Gesetz, DVG) made reimbursement possible in principle in 2019.
- Research Article
49
- 10.1186/s12913-023-09287-w
- Apr 17, 2023
- BMC Health Services Research
BackgroundWith its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking.ObjectiveThe study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory.MethodsA multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them.ResultsAll DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial.DiscussionIt is striking that— although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes — all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence.ConclusionThe results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.
- Research Article
- 10.55041/ijsrem58616
- Mar 31, 2026
- INTERNATIONAL JOURNAL OF SCIENTIFIC RESEARCH IN ENGINEERING AND MANAGEMENT
Abstract: The increasing integration of digital technologies in healthcare has significantly influenced consumer behavior, particularly in the context of financial decision-making. This study examines the impact of digital health applications on consumer insurance buying decisions in India. The research focuses on key factors such as digital health app usage, health awareness, and perceived usefulness to understand their influence on insurance purchase intention. The study is based on primary data collected from a sample of 320 respondents using a structured questionnaire measured on a five-point Likert scale. Descriptive statistics, correlation analysis, and simple linear regression were employed using IBM SPSS Statistics to analyze the data. The findings reveal that digital health applications play a significant role in shaping consumer insurance decisions. Health awareness emerges as the most influential factor, indicating that individuals who are more conscious of their health risks are more likely to purchase insurance. Digital health app usage also has a positive impact, suggesting that increased engagement with health platforms encourages proactive financial planning. Additionally, perceived usefulness of digital health applications positively influences purchase intention, highlighting the importance of user experience and perceived benefits. The study contributes to the existing literature in Consumer Behavior and Behavioral Finance by providing an integrated analysis of digital health engagement and insurance buying behavior. It offers practical implications for insurers, policymakers, and consumers by emphasizing the need to leverage digital health platforms to enhance awareness, improve customer engagement, and promote informed decision-making. The findings underscore the growing interconnection between healthcare technology and financial services in shaping consumer behavior. Keywords: Digital Health Apps, Insurance Buying Decision, Health Awareness, Perceived Usefulness, Consumer Behavior, Behavioral Finance, Digital Healthcare, India
- Research Article
10
- 10.1007/s40744-025-00744-y
- Jan 21, 2025
- Rheumatology and Therapy
IntroductionPrescribable digital health applications (DiGAs) present scalable solutions to improve patient self-management in rheumatology, however real-world evidence is scarce. Therefore, we aimed to assess the effectiveness, usage, and usability of DiGAs prescribed by rheumatologists, as well as patient satisfaction.MethodsThe DiGAReal registry includes adult patients with rheumatic conditions who received a DiGA prescription. Data at baseline (T0) and the 3-month follow-up (T1) were collected through electronic questionnaires. Study outcomes included DiGA-specific outcome assessments as well as generic outcome assessments, including the Patient Global Impression of Change (PGIC), Patient Activation Measure (PAM®), and the German Telehealth Usability and Utility Short Questionnaire (TUUSQ). Changes between T0 and T1 were analyzed using descriptive statistics and paired tests.ResultsA total of 191 patients were included between June 2022 and April 2023. Of these, 127 completed the 3-month follow-up, and 114 reported using the prescribed DiGA, with 66% reporting weekly use and 15% completing the full DiGA program. The most commonly prescribed DiGAs targeted pain management (53%). Symptom improvement was reported by 51% of patients using a DiGA, with significant reductions in exhaustion levels (p = 0.03). Significant DiGA-specific improvements were observed for DiGAs addressing back pain (p = 0.05) and insomnia (p = 0.006). However, no overall significant changes were detected in patient activation, health literacy, pain, overall health, or disease activity. Back pain and weight management DiGAs were the most effective, frequently used, and best-rated DiGAs, with symptom improvements reported by 50% to 82% of patients.ConclusionThe findings suggest that DiGAs can improve symptom management in rheumatic patients, especially for conditions like back pain and weight control. Further real-world evidence is needed and may support value-based digital health efforts and reimbursement frameworks.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-025-00744-y.
- Research Article
33
- 10.1186/s12962-022-00359-y
- Jun 13, 2022
- Cost Effectiveness and Resource Allocation : C/E
In December 2019, the Digital Health Care Act (“Digitale-Versorgung-Gesetz”) introduced a general entitlement to the provision and reimbursement of digital health applications (DiGA) for insured persons in the German statutory health insurance. As establishing a new digital service area within the solidarity-based insurance system implies several administrative and regulatory challenges, this paper aims to describe the legal framework for DiGA market access and pricing as well as the status quo of the DiGA market. Furthermore, we provide a basic approach to deriving value-based DiGA prices.To become eligible for reimbursement, the Federal Institute for Drugs and Medical Devices evaluates the compliance of a DiGA with general requirements (e.g., safety and data protection) and its positive healthcare effects (i.e., medical benefit or improvements of care structure and processes) in a fast-track process. Manufacturers may provide evidence for the benefits of their DiGA either directly with the application for the fast-track process or generate it during a trial phase that includes temporary reimbursement. After one year of \\]reimbursement, the freely-set manufacturer price is replaced by a price negotiated between the National Association of Statutory Health Insurance Funds and the manufacturer. By February 2022, 30 DiGA had successfully completed the fast-track process. 73% make use of the trial phase and have not yet proven their benefit. Given this dynamic growth of the DiGA market and the low minimum evidence standards, fair pricing remains the central point of contention. The regulatory framework makes the patient-relevant benefits of a DiGA a pricing criterion to be considered in particular. Yet, it does not indicate how the benefits of a DiGA should be translated into a reasonable price. Our evidence-based approach to value-based DiGA pricing approximates the SHI’s willingness to pay by the average cost-effectiveness of one or more established therapy in a field of indication and furthermore considers the positive healthcare effects of a DiGA.The proposed approach can be fitted into DiGA pricing processes under the given regulatory framework and can provide objective guidance for price negotiations. However, it is only one piece of the pricing puzzle, and numerous methodological and procedural issues related to DiGA pricing are still open. Thus, it remains to be seen to what extent DiGA prices will follow the premise of value-based pricing.
- Research Article
3
- 10.2196/66356
- Jan 6, 2025
- Journal of medical Internet research
Health care innovation faces significant challenges, including system inertia and diverse stakeholders, making regulated market access pathways essential for facilitating the adoption of new technologies. The German Digital Healthcare Act, introduced in 2019, offers a model by enabling digital health applications (DiGAs) to be reimbursed by statutory health insurance, improving market access and patient empowerment. However, the factors influencing the success of these pathways in driving innovation remain unclear. This study aims to identify the key performance factors of the innovation system shaped by the patient-relevant structural and procedural improvement (pSVV) pathway within the DiGA model. By examining how this pathway supports the entry of innovative digital health technologies, we seek to uncover the systemic dynamics that influence its effectiveness in fostering patient-centered digital health solutions. This study, conducted from May 2023 to November 2024, used a mixed methods approach. A descriptive analysis assessed how DiGA manufacturers use positive health care effects, giving a market overview of the pSVV technology. A qualitative analysis using grounded theory and Gioia methodology provided insights into stakeholder perspectives, focusing on manufacturers and regulatory bodies. A functional-structural analysis examined how components of the innovation system, such as actors, institutions, interactions, and infrastructure, interact and impact the effectiveness of the pathway. The descriptive analysis showed that only 11 (20%) of the 56 DiGAs available in Germany used the pSVV pathway, with only 1 (2%) provisionally listed DiGA using pSVV as a primary end point; 6 of 9 (67%) pSVV key areas were used. The qualitative analysis revealed that manufacturers prioritize demonstrating medical benefits over pSVV due to evidence requirements and uncertainties around pSVV acceptance. Operational barriers hindered the adoption of pSVV, despite a positive reception among stakeholders. The systemic analysis identified key issues, including a lack of entrepreneurial focus on pSVV, limited regulatory experience, inadequate measurement methods, and entrenched practices prioritizing medical benefits, that hinder market formation and legitimacy. This study identifies key factors for effectively implementing innovation systems through regulated market access pathways, including content and format security, clearer framework specification, active innovation process management, and market formation stimulation. Addressing these factors can reduce uncertainties and promote wider adoption of digital health technologies. The findings highlight the need for future research on patient empowerment and the development of methodologies beyond traditional therapeutic outcomes.
- Supplementary Content
- 10.51866/rv.919
- Dec 2, 2025
- Malaysian Family Physician : the Official Journal of the Academy of Family Physicians of Malaysia
The global rise of digital health is reshaping healthcare delivery and improving outcomes, especially for noncommunicable diseases (NCDs) post-pandemic. Guided by the World Health Organization (WHO) Global Strategy on Digital Health 2020-2025, this study examined digital health applications in Western Pacific Region (WPR) primary care, focusing on NCD management and related challenges. A scoping review following the Arksey and O'Malley framework and Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines was conducted. Using the PICO framework, studies on digital interventions in WPR primary care were identified through PubMed, Scopus, ScienceDirect, Web of Science and the Journal of Medical Internet Research (2022-2024). Eighteen studies were synthesized using the WHO digital health intervention and Health System Challenge frameworks. The review included studies from Australia (n=10), Singapore (n=5), South Korea (n=1), and China (n=2), encompassing randomized, observational, qualitative, and pragmatic designs. Digital interventions-telehealth, mobile health (mHealth) and electronic health (eHealth)-targeted NCDs such as diabetes, mental health, and cardiovascular diseases, addressing information quality, acceptability, efficiency, cost, accountability, and equity. The scoping review identified several digital health interventions, predominantly telehealth, mHealth and eHealth, deployed across Australia, Singapore, South Korea and China for NCD management in primary care. The studies demonstrated improvements in information quality, acceptability and efficiency, while highlighting persistent barriers such as technology integration issues, data quality concerns and inequities.