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Objectives: Evidence-based decision-making is the sine qua non for safe and effective patient care and the long-term functioning of health systems. Since 2020 Digital Health Applications (DiHA) in Germany have been undergoing a systematic pathway to be reimbursed by statutory health insurance (SHI) which is attracting attention in other European countries. We therefore investigate coverage decisions on DiHA and the underlying evidence on health care effects, which legally include both medical outcomes and patient-centred structural and procedural outcomes., Methods: Based on publicly available data of the Institute for Medicines and Medical Devices searched between 08/2021 and 02/2022, all DiHA listed in the corresponding registry and thus reimbursable by the SHI were systematically investigated and presented descriptively on the basis of predefined criteria, such as clinical condition, and costs. The clinical trials on DiHA permanently included in the registry were reviewed with regard to their study design, endpoints investigated, the survey instruments used, and whether an intention-to-treat analysis was performed. Risk of bias was assessed using the ROB II tool., Results: By February 2022, 30 DiHA had been included in the DiHA registry, one third of them permanently and two thirds conditionally. Most DiHA were therapeutic applications for mental illness based on cognitive behavioural therapy. For all permanently included DiHA, randomised controlled trials were conducted to demonstrate the impact on health care effects. While medical outcomes were investigated for all of these DiHA, patient-centred structural and procedural outcomes were rarely investigated. The majority of clinical trials showed a high risk of bias, mainly due to insufficient reporting quality. Overall, the prices for DiHA covered by SHI are on average around € 150 per month (min. € 40; max. € 248)., Conclusions: Evidence-based decision-making on coverage of DiHA leaves room for improvements both in terms of reporting-quality and the use of patient-centred structural and procedural outcomes in addition to medical outcomes. With appropriate evidence, DiHA can offer an opportunity as an adjunct to existing therapy while currently the high risk of bias of the trials raises doubts about the justification of its high costs., (© 2022. The Author(s).)

In Germany, some digital health applications (DiHA) became reimbursable through the statutory health insurance system with the adoption of the Digital Healthcare Act in 2019. Approaches and concepts for the German care context were developed in an iterative process, based on existing concepts from international experience. A DiHA categorization was developed that could be used as a basis to enable the creation of a reimbursed DiHA repository, and to derive evidence requirements for coverage and reimbursement for each DiHA. The results provide an overview of a possible classification of DiHA as well as approaches to assessment and evaluation. The structure of remuneration and pricing in connection with the formation of groups is demonstrated., Competing Interests: VS was employed by HelloBetter—GET.ON Institut für Online Gesundheitstrainings GmbH. DS and KK were employed by fbeta GmbH. CP was employed by D+B Rechtsanwälte. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Lantzsch, Panteli, Martino, Stephani, Seißler, Püschel, Knöppler and Busse.)