Читать книгу DiGA VADEMECUM - Jörg F. Debatin - Страница 16

You have developed your product, CE-certified it as a medical device, prepared a scientific evaluation, gained initial practical experience, understood your clinical target group—and now feel ready for the Fast-Track? In this chapter, we explain key facts about the application process, based on the Federal Institute for Drugs and Medical Devices (BfArM) guide.

First, we turn to the legal definition of what constitutes a digital health application and explain its four essential criteria.

In addition to meeting the definitional requirements of a DiGA, there are a number of other fundamental requirements, most of which are already relevant in the medical device certification process, but which must be met in a differentiated manner in the (DiGA) Fast-Track process.

Rarely given much thought in the early stage product development, the production of scientific evidence becomes more important the closer your product gets to the statutory healthcare market. Data collection in initial “pilot studies” should be planned in parallel with product development, as should approaching renowned scientific institutions as partners for generating scientific evidence, at the latest in the run-up to Fast-Track application submission. In this chapter, we explain what is already known about positive care effects. In the coming months, more will emerge as best practice, and some scientific methods that are specific to the requirements and possibilities of digital health applications will be tested at scale for the first time through the Fast-Track.