Germany’s DiGA: Key Characteristics and Mechanisms8Innovations in Digital Health and Software-based Medical Devices—A Comparative Analysis of Germany and Japan, which integrated online consultations and digital health applications (DiGA: Digitale Gesundheitsanwendungen) into the healthcare system, making them eligible for insurance reimbursement. This paper first examines the framework, evaluation standards, and background of DiGA in Germany, followed by a discussion of the current status and challenges of digital health in Japan. It then concludes with an analysis of the differences between the two countries’ approaches and the future outlook for digital and conforming to GDPR standards for data protection and security. Additionally, the “DiGA Fast-Track” program enables developers to receive approval within a maximum of three months after submitting an application. Even if robust clinical evidence is not yet available, a one-year provisional registration is possible, providing opportunities to verify efficacy using real-world data. This system lowers the barriers to entry for innovative startups and effectively enhances the quality and efficiency of healthcare services.A representative example is Deprexis, an online cognitive behavioral therapy program for patients with depression. By allowing individuals to manage their treatment at home, Deprexis can be used in tandem with in-person consultations, thereby improving treatment outcomes and streamlining the use of therapists’ resources. Furthermore, Deprexis incorporates AI-driven personalization features and offers the convenience of anytime, anywhere access.confronted with multiple challenges, including population aging, the rise in chronic diseases, and shortages in healthcare professionals. In this context, improving the efficiency and quality of healthcare services has become imperative. Against this backdrop, the adoption of digital technologies in healthcare has garnered significant global attention. Notably, Germany saw a major policy shift in 2019 with the enactment and implementation of the Digital Healthcare Act (DVG: Digitale Versorgung Gesetz), and implemented in 2019, facilitated a system in which physicians and psychotherapists can prescribe DiGA alongside online consultations. Under this framework, once a medical professional prescribes a DiGA, the patient submits the prescription to their health insurance provider, receives an activation code, and can access the application on a smartphone. This process empowers patients to actively manage their own health and fosters the digitization of healthcare settings. DiGA refers specifically to software-based medical devices targeting clear medical objectives, such as managing chronic diseases, supporting psychotherapy, or facilitating rehabilitation. Accordingly, DiGA must comply with stringent requirements, including obtaining CE marking (demonstrating safety and quality under the European Medical Device Regulation, MDR), meeting the quality, functionality, and efficacy criteria set by the Federal Institute for Drugs and Medical Devices (BfArM), Daiki Wakabayashi In recent years, healthcare systems worldwide have been In Germany, the Digital Healthcare Act (DVG), enacted Goethe University, Germanyand Prospects for the Future—
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