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Item type:Publication, Access status: with files , A scoping review on using real-world data to evaluate the effectiveness of mHealth applicationsMobile health (mHealth) applications are increasingly integral to healthcare delivery, yet traditional randomized trials face practical challenges in evaluating these dynamic tools. Real-world data (RWD), collected during routine app use, offers a complementary pathway to real-world evidence (RWE) that may reflect how mHealth applications are used in everyday settings. We conducted a scoping review to map how naturally emerging RWD are currently used in peer-reviewed studies to evaluate patient-facing mHealth applications. We systematically searched PubMed, Scopus, and Web of Science (January 2007–November 2024) and extracted data on application type, RWD characteristics and study design aspects. Study-level, design-centred evidence levels for RWD-based effectiveness evaluations were assigned using a combined Oxford Centre for Evidence-Based Medicine and FDA RWE framework. Seventy-two studies evaluating 61 unique mHealth applications were included. Most studies focused on mental health or metabolic conditions and relied predominantly on data actively reported by users, often via in-app surveys, with comparatively limited use of device-generated data or integration with system-generated data such as clinical or claims data. Single-group pre–post approaches were most frequently observed, while only a minority employed comparative observational, quasi-experimental, or randomized designs. These findings illustrate current patterns in the use of RWD for mHealth evaluation and highlight both opportunities and constraints in longitudinal and comparative assessments of mHealth applications in real-world contexts.Publicationtype: Journal Article35 21 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Access status: with files , Telemedicine adoption for managing chronic and rare diseases in Indonesia during and beyond the COVID-19 Era: qualitative study(Healthcare World, 2026-03-19); ; ; Background: Telemedicine has emerged as a valuable tool for improving health care delivery, especially in low-resource and geographically isolated regions. In Indonesia, the COVID-19 pandemic highlighted the need for digital health solutions to manage chronic diseases and improve access to specialists. Objective: This study aimed to examine the rapid adoption of telemedicine in Indonesia, focusing on its role in managing chronic and rare diseases and highlighting both its benefits and challenges to long-term viability during and post pandemic. Methods: A qualitative study was used, following the Consolidated Criteria for Reporting Qualitative Research 32-item checklist and guided by established theories and frameworks. Recruitment followed a systematic multistage procedure suited to the context of Indonesia, an upper-middle-income country and Group of Twenty member characterized by wide regional and socioeconomic disparities. Data were collected through 15 semistructured interviews conducted between October and December 2024. The interviews were divided into 2 phases: first with physicians from various medical specialties and 6 out of 7 regions within Indonesia, and then with patients diagnosed with autoimmune diseases. All interviews were audio-recorded, transcribed verbatim, and analyzed inductively to identify recurrent themes and subthemes. Results: Before the COVID-19 pandemic, telemedicine adoption in Indonesia was limited, with many physicians recalling its nonexistence before 2015. The pandemic accelerated the adoption of virtual platforms, which became essential for patient consultation, follow-ups, and medication management. Though its use decreased after the pandemic, telemedicine remains valuable, particularly for chronic and rare disease management in remote areas with limited access to specialists. At least three overarching themes were identified: (1) acceleration and normalization of telemedicine (the pandemic catalyzed the integration of virtual consultations into routine care, transforming initial skepticism into broad acceptance); (2) accessibility and cost efficiency (telemedicine reduced financial and travel burdens, especially for patients in remote areas, with several reporting cost savings from hybrid consultation models); and (3) limitations of virtual care (physicians highlighted constraints related to the absence of physical examination). Conclusions: The findings reveal that telemedicine has become a valuable tool in Indonesia for managing chronic and rare diseases, particularly for follow-up care and medical specialist access across diverse geographical areas. While telemedicine has improved health care accessibility and demonstrated significant cost benefits by reducing transportation and consultation costs, challenges such as limited infrastructure and physician burnout remain. Long-term success will depend on the development of sustainable regulatory frameworks, continued investment in digital infrastructure, and a focus on optimizing cost-effectiveness in health care delivery.Publicationtype: Journal Article55 26 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Access status: with files , Regulation for innovation or innovation despite regulation? Lessons from Germany’s DiGA Fast-Track for digital health innovation(2026); Germany’s Digital Health Applications (DiGA) Fast-Track represents one of the first regulated pathways for integrating digital health applications into reimbursed healthcare. It provides a unique setting for examining how regulation shapes innovation in digital health. This dissertation explores the development of the DiGA market and examines two innovative elements of its regulatory framework: patient-relevant structural and procedural improvements (pSVV) as a novel concept of value, and the use of real-world data (RWD) for evaluating the effectiveness of digital health technologies. Combining market and regulatory data, qualitative stakeholder research, innovation systems analysis, and a systematic scoping review, the findings show that regulation can successfully create and structure markets for digital health innovation. At the same time, realizing the potential of novel value concepts and evidence approaches depends on methodological clarity, aligned incentives, and supportive institutional conditions.Publicationtype: Doctoral Thesis43 27 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Access status: with files , Resource-efficient use of single-use surgical textilesOperationssäle gehören zu den ressourcenintensivsten Bereichen des Krankenhauses und verursachen erhebliche Mengen an Abfall und CO2-Emissionen. Einweg-OP-Textilien tragen hierbei wesentlich zum ökologischen Fußabdruck chirurgischer Eingriffe bei. Die Urologie leistet als operativ geprägte Disziplin einen bedeutenden Beitrag zum OP-Aufkommen. Ziel dieser Studie war es, den Beitrag von OP-Textilien zum Ressourcenverbrauch zu quantifizieren und zu analysieren, in welchem Umfang durch eine standardisierte Nutzung ökologische und ökonomische Einsparpotenziale realisiert werden können. Grundlage bildeten Verbrauchs- und Leistungsdaten (OPS-Ziffern, Operationen- und Prozedurenschlüssel) von 25 Krankenhäusern (in 4 Versorgungsstufen) einer deutschlandweit tätigen Klinikkette in privater Trägerschaft. Der tatsächliche Verbrauch aus dem Jahr 2022 wurde einem Soll-Szenario mit vordefinierten OP-Standards gegenübergestellt. Für jeden Standard wurden CO2-Emissionen mittels „life cycle assessment“ berechnet und den jeweiligen Operationen zugeordnet. Im Jahr 2022 wurden in den 25 untersuchten Kliniken 213.048 Operationen durchgeführt. Dabei wurden insgesamt 352,7 t Einweg-OP-Textilien verbraucht, was 1997 t CO2-Äquivalenten entspricht. Rohmaterialien verursachten dabei den größten Anteil der Emissionen, während Transporte nur einen geringen Beitrag leisteten. Durch die konsequente Standardisierung könnte der CO2-Ausstoß um bis zu 8 % reduziert werden. Besonders hohe Einsparpotenziale wurden in orthopädischen (bis zu 23,4 %) und kardiologischen Kliniken (bis zu 20,6 %) identifiziert. Die Ergebnisse zeigen, dass ein Teil des Ressourcenverbrauchs im OP vermeidbar ist. Standardisierte Nutzung von Einweg-OP-Textilien bietet sowohl ökologische als auch ökonomische Vorteile.Publicationtype: Journal Article29 18 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Access status: with files , Struktur- und Verfahrensverbesserungen auf Rezept? Eine qualitative Analyse der Potenziale und Herausforderungen des pSVV-Konzepts bei Digitalen Gesundheitsanwendungen (DiGA)Hintergrund Mit dem Inkrafttreten des Digitale-Versorgung-Gesetzes (DVG) Ende 2019 wurden in Deutschland Digitale Gesundheitsanwendungen (DiGA) in den Leistungskatalog der gesetzlichen Krankenversicherung (GKV) aufgenommen. DiGA sind digitale Medizinprodukte, deren Hauptfunktionen wesentlich auf digitalen Technologien beruhen. Im Rahmen der Definition des Zulassungsprozesses wurde der in der Arzneimittelzulassung zur Nutzenbewertung maßgebliche Begriff des „therapeutischen Nutzens“ zum umfassenderen Konzept des „positiven Versorgungseffekts“ (pVE) erweitert. Konkret wurde ergänzend zum „medizinischen Nutzen“ das Konzept der „patientenrelevanten Struktur- und Verfahrensverbesserungen“ (pSVV) entwickelt, um den Markteintritt von Anwendungen zu ermöglichen, die die Rolle von Patient*innen in der Gesundheitsversorgung gezielt stärken. Dreieinhalb Jahre nach der Einführung von DiGA zeichnet sich jedoch ab, dass das Konzept des pSVV heute noch nicht von den Akteur*innen im Gesundheitssystem akzeptiert wurde. Lediglich eine der 56 zum 1. Juli 2024 gelisteten DiGA nutzt heute pSVV als primären Endpunkt, zehn weitere DiGA nutzen pSVV als sekundären Endpunkt. Methode Ein qualitativer Ansatz wurde gewählt, um die neuen und wenig erforschten Themen DiGA und insbesondere pSVV zu untersuchen. Dabei wurde die Grounded-Theory-Methode in Kombination mit der Gioia-Methode angewendet, die sich besonders für die Analyse innovativer Themengebiete eignet. Durch die induktive Herangehensweise können so neue Konzepte aus den Daten der Untersuchungsteilnehmer*innen entwickelt werden, wodurch eine flexible und dynamische Theoriebildung unterstützt wird. Es wurden Entscheidungsträger*innen aus den Gruppen DiGA-Herstellende mit und ohne pSVV, Herstellende digitaler Medizinprodukte ohne DiGA-Zulassung, Beratungen sowie am Prozess der DiGA-Zulassung beteiligte Institutionen mithilfe der Durchführung qualitativer Leitfadeninterviews in die Untersuchung einbezogen. Die Auswertung erfolgte durch eine mehrstufige Analyse, die zur Identifikation von Erstordnungskonzepten, Zweitordnungsthemen und aggregierten Dimensionen führte. Die entwickelte Datenstruktur wurde durch die Darstellung relevanter Zitate im Anhang A untermauert. Ergebnisse Es zeigt sich, dass eine Schärfung der Nutzendefinition der im DiGA-Leitfaden definierten pSVV-Kategorien erfolgskritisch für die Etablierung des Konzepts der pSVV ist. Auch eine weitere Analyse der möglichen Methoden zum Nachweis des pSVV und geeigneter Messinstrumente sowie die generelle Aufnahme ökonomischer Betrachtungen in die Nutzenanalyse erscheinen sinnvoll. Diskussion Die qualitative Analyse zeigt, dass die Schärfung des pSVV-Konzepts und die Definition geeigneter Messmethoden entscheidend für die erfolgreiche Implementierung im deutschen Gesundheitssystem sind. Eine ökonomische Bewertung könnte die Debatte um die Kosten von DiGA versachlichen und zur Transparenz im Zulassungsprozess beitragen. Weitere Forschung und die Einbindung zentraler Akteure sind notwendig, um die Definition des intendierten Nutzens innerhalb der pSVV-Kategorien zu präzisieren und damit die Einführung digitaler Gesundheitsanwendungen mit besonderem Fokus auf die Stärkung der Rolle der Patient*innen in der Gesundheitsversorgung zu fördern.Publicationtype: Journal Article45 28 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Access status: with files , Unpacking Performance Factors of Innovation Systems and Studying Germany’s Attempt to Foster the Role of the Patient Through a Market Access Pathway for Digital Health Applications (DiGAs): Exploratory Mixed Methods StudyBackground: 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. Objective: 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. Methods: 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. Results: 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 cceptance. 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. Conclusions: 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.Publicationtype: Journal Article36 32 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Access status: with files , Digital Health Applications (DiGAs) on a Fast Track : Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024Background: This 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. Objective: Through 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. Methods: The analysis draws from a range of public data sources, including the DiGA directory, statutory health insurance reports, app store feedback, and clinical study results. Results: As 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. Conclusions: This 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.Publicationtype: Journal Article50 52 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Access status: with files , Looking for a needle in a haystack : how to search for bottom‐up social innovations that solve complex humanitarian problems(Wiley-Blackwell, 2019-08-28); ; ; The worldwide increase in societal challenges is putting pressure on humanitarian organizations to develop sophisticated approaches to leverage social innovations in the humanitarian sector. Since humanitarian problems are complex problems, with the relevant knowledge being hidden, organizational search theory advocates the application of bottom‐up and theory‐guided search processes to identify the social innovations that solve these. Unfortunately, there has been no theoretical attention to understanding which approaches apply in this context. Further, established theory‐guided bottom‐up search processes, such as the lead user method, are unsuitable to the humanitarian sector, and we lack practice examples of adequate search processes. To start addressing this gap in theory and practice, procedural action research was done with the International Federation of Red Cross and Red Crescent Societies to develop a theory‐guided bottom‐up innovation search process for the real‐life humanitarian problem of recurring floods in Indonesia. It revealed that an innovation search process for this context must differ significantly concerning its objectives and the steps to be taken from the lead user method, which was used as a starting point. Further, a comparison of the technical quality and the social impacts of the identified social innovations with social innovations identified through a non‐theory‐guided bottom‐up search process (i.e., an innovation contest) suggests the superiority of this theory‐guided search process. With this conclusion and the insights derived throughout the development of the search process, this study makes important contributions to theory development in the social and open innovation literatures and delivers important recommendations for social innovation practice in the humanitarian sector.Publicationtype: Journal ArticleScopus© Citations 14 349 468