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2 I don’t have time for this! An overview

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With the DiGA VADEMECUM we would like to address the whole spectrum of digital health application (DiGA) topics from different perspectives within the healthcare system. Fortunately, as authors we do not have to limit ourselves to theory here, but can draw on our respective experiences in the (inter-)national healthcare system before each of us joined the hih. In addition to advising companies, many of us have worked in a start-up or corporate environment or managed hospitals, pharmacies, or inpatient providers. We have all learned: if you want to develop a digital health application, you have to understand relevant topics in both breadth AND in depth. Reading this chapter will therefore not be sufficient. Our apologies. But to find what you are looking for faster, we have summarized the subsequent chapters for you below. In addition to regulation, a whole range of tasks and challenges await founders and innovators—most of which have to be mastered in parallel—be it the development of a first prototype, securing financing, HR, taxes, recruiting, office hunting and all the other areas that also require your full attention. But without paying close attention to the topics described in this book, your digital health application will not be able to successfully enter the German healthcare system.

Next to the financial sector, the healthcare system is the most regulated market in Germany—and for good reason: It deals with one of the highest value goods we have—health. Not all hurdles are necessary; some were erected by entrepreneurs who started here 20–30 years before you, became successful, and now want to keep out competition—including innovative, digital competition. But the vast majority of regulations exist to ensure that products and services in and around the healthcare system are safe, of high quality, and have been scientifically proven to be effective, and to handle the entrusted (health) data extremely sensitively.


You will have to read through this entire book to understand the connections in detail. There are no shortcuts. Some of it is necessary, sometimes tough, regulation. But much of it is written (hopefully) pragmatically in order to enable people like you to more quickly launch good, innovative digital health applications that will help many thousands, possibly millions, of people manage their disease better. Because that’s what it’s all about.

DiGA VADEMECUM

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