Digitale Gesundheitsanwendungen (DiGA) als innovativer Baustein in der digitalen Gesundheitsversorgung in Deutschland – Informationen, Erfahrungen und Perspektiven

Lauer, Wolfgang; Löbker, Wiebke; Sudhop, Thomas; Broich, Karl

doi:10.1007/s00103-021-03420-y

Cited by 10 publications

(6 citation statements)

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“…At the same time, it should be noted that the hurdles for inclusion in the directory are high: Of the 89 applications submitted by August 2021, only four were rejected, but 42 were initially withdrawn by manufacturers due to data analysis problems, not enough evidence or unsuitable endpoints. 14 Despite the high quality standards required by law, healthcare providers, health insurers, and manufacturers see room for improvement when it comes to the practical implementation of DiGA. 15,16 BfArM evaluates DiGA mainly in the context of the preexisting service portfolio rendered by healthcare providers accredited by the statutory health insurances.…”

Section: Fast Track Experience So Farmentioning

confidence: 99%

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The German Fast Track Toward Reimbursement of Digital Health Applications: Opportunities and Challenges for Manufacturers, Healthcare Providers, and People With Diabetes

Schliess

Dicenzo

Gaus³

et al. 2022

J Diabetes Sci Technol

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Background: Digital health applications (DiGA) supporting the management of diabetes are among the most commonly available digital health technologies. However, transparent quality assurance of DiGA and clinical proof of a positive healthcare effect is often missing, which creates skepticism of some stakeholders regarding the usage and reimbursement of these applications. Methods: This article reviews the recently established fast-track integration of DiGA in the German reimbursement market, with emphasis on the current impact for manufacturers, healthcare providers, and people with diabetes. The German DiGA fast track is contextualised with corresponding initiatives in Europe. Results: The option of a provisional prescription and reimbursement of DiGA while proving a positive healthcare effect in parallel may expedite the adoption of DiGA in Germany and beyond. However, hurdles for a permanent prescription and reimbursement of DiGA are high and only one of 12 that have achieved this status specifically addresses people with diabetes. Conclusion: The DiGA fast track needs to be further enhanced to cope with remaining skepticism and contribute even more to a value-based diabetes care.

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Section: Fast Track Experience So Farmentioning

confidence: 99%

Section: Fast Track Experience So Farmentioning

confidence: 99%

The German Fast Track Toward Reimbursement of Digital Health Applications: Opportunities and Challenges for Manufacturers, Healthcare Providers, and People With Diabetes

Schliess

Dicenzo

Gaus³

et al. 2022

J Diabetes Sci Technol

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“…While greater benefits and the possibility of more effective treatment suggest acceptance and demand, reliable studies are lacking. In Germany, it is possible to obtain reimbursement of a health app's cost by the health insurance company if effectiveness of the application has been proven for the specific indication and the application has passed a dedicated approval process [21]. Then, the health app is officially called "Digitale Gesundheitsanwendung" (DiGA).…”

Section: Introductionmentioning

confidence: 99%

Usage Behaviour and Adoption Criteria for Mobile Health Solutions in Patients with Chronic Diseases in Gastroenterology

Wiest,

Sicorello,

Yesmembetov

et al. 2024

Visc Med

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Introduction: Mobile Health (mHealth) applications allow for new possibilities and opportunities in patient care. Their potential throughout the whole patient journey is undisputed. However, the eventual adoption by patients depends on their acceptance of and motivation to use mHealth applications as well as their adherence. Therefore, we investigated the motivation and drivers of acceptance for mHealth and developed an adapted model of the Unified Theory of Acceptance and Use of Technology (UTAUT2). Methods: We evaluated 215 patients with chronic gastroenterological diseases who answered a questionnaire including all model constructs with 7-point Likert scale items. Our model was adapted from the Unified Theory of Acceptance and Use in Technology 2 and includes influencing factors such as facilitating conditions, performance expectancy, hedonic motivation, social influence factors, effort expectancy, as well as personal empowerment and data protection concerns. Model evaluation was performed with structural equation modelling with PLS-SEM. Bootstrapping was performed for hypothesis testing. Results and Conclusion: Patients had a median age of 55.5 years, and the gender ratio was equally distributed. Forty percent received a degree from a university, college, technical academy, or engineering school. The majority of patients suffered from chronic liver disease, but patients with inflammatory bowel diseases, GI cancers, and pancreatic diseases were also included. Patients considered their general technology knowledge as medium to good or very good (78%). Actual usage of mHealth applications in general was rare, while the intention to use them was high. The leading acceptance factor for mHealth applications in our patient group was feasibility, both in terms of technical requirements and the intuitiveness and manageability of the application. Concerns about data privacy did not significantly impact the intention to use mobile devices. Neither the gamification aspect nor social influence factors played a significant role in the intention to use mHealth applications. Interpretation: Most of our patients were willing to spend time on a mHealth application specific to their disease on a regular basis. Acceptance and adherence are ensured by efficient utilization that requires minimum effort and compatible technologies as well as support in case of difficulties. Social influence and hedonic motivation, which were part of UTAUT2, as well as data security concerns, were not significantly influencing our patients’ intention to use mHealth applications. A literature review revealed that drivers of acceptance vary considerably among different population and patient groups. Therefore, healthcare and mHealth providers should put effort into understanding their specific target groups’ drivers of acceptance. We provided those for a cohort of patients from gastroenterology in this project.

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“…With approximately 74 million insured individuals, Germany has one of the largest statutory health insurance (SHI) systems in the world ( 5 ). In late 2019, the Parliament passed the Law for Better Care through Digitalization and Innovation, also referred to as the Digital Healthcare Act (Digitale-Versorgung-Gesetz) ( 6 ). The legislative process was accompanied by the “I.DiGA project” funded by the Ministry of Health which involved experts from academia as well as the private sector, including entrepreneurs and managers active in the digital health industry ( 7 ).…”

Section: Introductionmentioning

confidence: 99%

Covering digital health applications in the public insurance system: how to foster innovation in patient care while mitigating financial risks—evidence from Germany

Groene,

Schneck

2023

Front. Digit. Health

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ContextDigital health applications that support patients in managing their condition can have a positive impact on patients' health and improve the overall care process. In late 2019, as the first country worldwide, Germany included digital health applications in the benefit basket of the statutory health insurance (SHI) system to enable fast, broad-scale patient access and encourage innovation in the digital health industry. While the policy is widely recognized as a pioneering step toward improving patient care through digital technologies, there are concerns regarding the mechanics of the policy and the resulting financial risks for the SHI system.GoalsThe primary objective of this article is to provide a comprehensive and balanced overview of the German policy by evaluating its success in achieving its goals and by reviewing challenges that have emerged. The secondary objective is to delineate prospective policy options and areas warranting future research.ApproachThe article analyzes publicly available data of the Federal Institute for Drugs and Medical Devices collected between February 1st and July 17th, 2023, and complements it with empirical findings published by academic institutions and sickness funds. It discusses policy options and related areas of future research to overcome the identified challenges without jeopardizing the purpose of the legislation to encourage innovation in the digital health industry to improve patient care.ConclusionIn line with the goals of the reimbursement policy, the inclusion of digital health applications in the SHI benefit basked has entailed new digital treatment options for patients across multiple disease areas. However, from a health policy perspective, the policy has several shortcomings, including low prescription rates, the temporary reimbursement of digital health applications that lack proven benefit, and a pricing framework that does not take into account the efficacy and efficiency of a treatment and may lead to a suboptimal allocation of public resources. Rather than the public system covering digital health applications without proven benefit, the authors suggest giving SHI organizations more budget authority to directly incentivize research and development activities and to introduce value-based pricing. More research is needed to determine the details of these mechanisms.

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Digitale Gesundheitsanwendungen (DiGA) als innovativer Baustein in der digitalen Gesundheitsversorgung in Deutschland – Informationen, Erfahrungen und Perspektiven

Cited by 10 publications

References 0 publications

The German Fast Track Toward Reimbursement of Digital Health Applications: Opportunities and Challenges for Manufacturers, Healthcare Providers, and People With Diabetes

The German Fast Track Toward Reimbursement of Digital Health Applications: Opportunities and Challenges for Manufacturers, Healthcare Providers, and People With Diabetes

Usage Behaviour and Adoption Criteria for Mobile Health Solutions in Patients with Chronic Diseases in Gastroenterology

Covering digital health applications in the public insurance system: how to foster innovation in patient care while mitigating financial risks—evidence from Germany

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