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Digital health applications are digital medical products (e.g. apps, web applications) that are prescribed to insured persons by physicians or psychotherapists and reimbursed by health insurances. For manufacturers, fulfilling the regulatory requirements for approval of a digital health application is challenging. This can be seen in the number of pulled and rejected applications from manufacturers for listing in the register of digital health applications. As of May 2022, a total of 61 applications have been pulled back by manufacturers and 8 have received negative decisions from the German Federal Institute for Drugs and Medical Devices. Manufacturers want support to fulfill the requirements for approval of a digital health application. Based on a literature review and a sighting of relevant regulations, a roadmap was developed to represent the approval process for a digital health application to manufacturers in a visual and simplified flowchart. The roadmap consists for example the submission of the application, the verification of the application and listing of the digital health application in the register. The roadmap simplifies the approval process of a digital health application, enables early identification of requirements, and helps determine the right strategy. A field trial is essential to confirm its effectiveness and improvements are needed based on feedback. The roadmap is being tested with startups and small businesses to evaluate its applicability in different contexts.

Roadmap to Approval of a Digital Health Application: A simplified guide for manufacturers