Goeldner, MoritzMoritzGoeldnerGehder, SaraSaraGehder2024-09-042024-09-042024Journal of Medical Internet Research 26: e59013 (2024)https://hdl.handle.net/11420/48927Background: 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.en1438-88712024e59013JMIR Publications Inc.https://creativecommons.org/licenses/by/4.0/Technology::610: Medicine, HealthSocial Sciences::338: ProductionJournal Article10.15480/882.1325710.2196/5901310.15480/882.13257Journal Article