Читать книгу DiGA VADEMECUM - Jörg F. Debatin - Страница 15

We’ll explain areas that are critical in the healthcare system and how they vary significantly from how digital products are normally distributed, used, and paid for. Whether your product is Fast-Track material or not, in this chapter we summarize the requirements that all digital health tools must meet if they are to succeed in the first healthcare market (with formal reimbursement) or the second healthcare market (of self-paying users).

In many areas, it is enough for two businesspeople to have a good idea and get started. This is fundamentally different in the healthcare context. You should have medical expertise in your team as early as possible, or tie experts closely to your work. Patients in Germany rarely pay privately for (digital) healthcare services, but instead expect their health insurer to cover all health-related costs. However, the health insurers usually only cover such costs for services that are prescribed by a doctor. And physicians rarely prescribe such services unless they support the physician’s own work or they are convinced of their benefit to patients.

Just as important as understanding healthcare providers motivations and behaviors is understanding the actual target group for digitals health tool(s): patients. Only by addressing their needs and their (disease)-specific requirements at an early stage can a digital health tool and a DiGA be developed that not only fulfill formal requirements, but are also wanted and used by patients—because such products provide tangible benefits.

The German inpatient sector (hospitals) functions significantly differently than the outpatient sector, i.e., the care provided in in doctors’ offices. If your digital medical device has points of contact with the inpatient sector, or even if it is to be used primarily in the context of discharge management, the background and specifics of the inpatient sector summarized here should be taken into account.

Digital health applications (DiGA) thrive on collecting and communicating data or having data available from other sources. But this is only possible if everyone adheres to a framework that defines how and which data is exchanged. The magic word is “interoperability”. This chapter explains what it is, what ingredients you should have on board, and what role international standards play. Above all however, it is clear that one is not alone in these questions, but can participate in and learn from a large community of experts.

There are many good reasons why data protection and data security are such valuable commodities in the healthcare system. You will spend a considerable amount of time setting up the development process and your organisation in a data protection compliant manner. You will need good— and when in doubt, external—data security experts to interrogate and continuously improve the existing practices and processess. It is best to pay attention to data protection and data security specifications from the start during the development of the DiGA (Privacy by Design and Default). We summarize the most important points for you.

An essential feature of a DiGA is that certification as a medical device has already taken place. This process will keep you busy both just as long and just as as intensively as the later Fast-Track application and will probably already begin in the first year after founding your company. You should deal with this topic as early as possible during product development in order to avoid costly adjustments of your product and especially to your development process at a later stage. We give an overview of the most important aspects of software as a medical device.