Albrecht Urs-Vito, Kuhn Bertolt, Land Jörg, Amelung Volker E, von Jan Ute
Peter L. Reichertz Institut für Medizinischen Informatik der Technischen Universität Braunschweig und der Medizinischen Hochschule Hannover, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30625, Hannover, Deutschland.
Sonormed GmbH, Hamburg, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Mar;61(3):340-348. doi: 10.1007/s00103-018-2696-0.
For a number of reasons, achieving reimbursability for digital health products has so far proven difficult. Demonstrating the benefits of the technology is the main hurdle in this context. The generally accepted evaluation processes, especially parallel group comparisons in randomized controlled trials (RCTs) for (clinical) benefit assessment, are primarily intended to deal with questions of (added) medical benefit. In contrast to drugs or classical medical devices, users of digital health solutions often profit from gaining autonomy, increased awareness and mindfulness, better transparency in the provision of care, and improved comfort, although there are also digital solutions with an interventional character targeting clinical outcomes (e. g. for indications such as anorexia, depression). Commonly accepted methods for evaluating (clinical) benefits primarily rely on medical outcomes, such as morbidity and mortality, but do not adequately consider additional benefits unique to digital health. The challenge is therefore to develop evaluation designs that respect the particularities of digital health without reducing the validity of the evaluations (especially with respect to safety). There is an increasing need for concepts that include both continuous feedback loops for adapting and improving an application while at the same time generate sufficient evidence for complex benefit assessments. This approach may help improve risk benefit ratio assessments of digital health when it comes to implementing digital innovations in healthcare.
由于多种原因，数字健康产品迄今难以实现可报销。在这种情况下，证明该技术的益处是主要障碍。普遍接受的评估流程，尤其是用于（临床）效益评估的随机对照试验（RCT）中的平行组比较，主要旨在处理（附加的）医疗效益问题。与药物或传统医疗设备不同，数字健康解决方案的用户通常受益于获得自主权、提高意识和专注力、护理提供方面更高的透明度以及更高的舒适度，尽管也有针对临床结果的具有干预性质的数字解决方案（例如用于厌食症、抑郁症等适应症）。评估（临床）效益的普遍接受的方法主要依赖于医疗结果，如发病率和死亡率，但没有充分考虑数字健康特有的额外益处。因此，挑战在于开发既尊重数字健康特殊性又不降低评估有效性（特别是在安全性方面）的评估设计。越来越需要这样的概念，即既包括用于调整和改进应用程序且同时为复杂效益评估生成充分证据的持续反馈回路。当涉及在医疗保健中实施数字创新时，这种方法可能有助于改善数字健康的风险效益比评估。
