The health market is so heavily regulated and interspersed with so many different conditions to an extent to which almost no other target market can compare. A central regulation for giving medical applications access to statutory insurance policyholder markets was overdue. The entry route for digital solution products into standard care is now clearly laid out, but the previous, alternative access routes have not been replaced. Our experts pinpoint and facilitate alternative market access options for your DiGA. You can read more about this in our blog post.
There are no specific regulations for software or apps to be approved as aids. The German National Association of Health Insurance Funds (Spitzenverband Bund der Krankenkassen) decides whether an app is included in the list of medical aids. Manufacturers are obliged to prove that it functions properly, is safe, meets the quality requirements according to the legal requirements and to demonstrate the medical benefit.
According to Sections 63, 64 of the German Social Code, Book V, (Sozialgesetzbuch, SGB V), health insurance providers can agree to improve the quality and efficiency of their care models to further develop the procedural, organisational, financing and remuneration forms of the service they provide. Among other things, this addresses models that were not previously anchored in standard care offerings. This makes it possible for medical apps with and without CE approval to be financed by health insurance providers.
Health insurance providers can provide their members with a range of health information, hold health education sessions and offer apps to optimise communication and administration. These types of information apps are used to retain and/or acquire customers.
Find out how adesso also identifies, opens up and facilitates alternative business models in addition to the usual process support it provides.
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‘140a agreements’ deal with different types of care scenarios. According to the corresponding paragraph of the German Social Code, Book V, app-based forms of care that are cross-sector or interdisciplinary are eligible for funding. If the relevant agreements are concluded directly between the health insurance provider and the app manufacturer, special requirements apply to the manufacturer in terms of the new Medical Device Regulation (Regulation (EU) 2017/745 on medical devices).
App solutions that promote rehabilitation or measures that support rehabilitation and directly follow hospital stays can also be covered by health insurance providers according to Section 43 SGB V. This may concern, for example, rehabilitation, aftercare or even training.
In principle, hospital and clinic services are invoiced using what’s known as the DRG system (diagnosis-related groups). Accordingly, hospitals are free to choose and pay for an app. Agreements are negotiated directly between service providers and app manufacturers. Whether an app has to be a medical device or not depends on the care process in question and the medical benefit it generates.
In principle, standard care is a collective agreement between the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung) and the National Association of Health Insurance Funds. It applies to outpatient and office-based care and can be provided and billed by all suitable GPs and panel doctors.
We are happy to use our expertise in IT architecture and mobile architecture to advise and support you in alternative market access. As your expert partner, adesso is with you every step of the way and develops the perfect solution that meets both your needs as well as those of your customers.
As well as developing your brand, it is crucial that you implement the right marketing measures to make your digital health application a success. You will find out how to do this in the fourth stage.