The new approval process for the reimbursement of digital health applications (DiGA) from the perspective of the German statutory health insurance

Since fall of 2020, the first Digital Health Applications (DiGA) have been available as a service of the statutory health insurance. The National Association of Statutory Health Insurance Funds considers digital applications to have the potential to improve health care, e.g., for people with chronic diseases, and to consolidate the interconnectedness of the provided offers. DiGA can empower the insured persons to help shape their health care actively and to self-contribute to a successful treatment. At the same time, statutory health insurance identifies a number of basic and substantial critical issues regarding the legal requirements for the authorization of DiGA for reimbursement by insurance and the conceptional design of the fast-track process from the Federal Institute for Drugs and Medical Devices (BfArM). This article examines the DiGA, which have been listed in the BfArM directory up to this point, and takes stock after six months of the fast-track process being in place. According to this, the requirements and legal specifications for directory listings and reimbursement via the fast-track process are insufficient from the point of view of the statutory health insurance regarding proven medical effectiveness and economically efficient health care. At present, most of the authorized DiGA, which so far could not provide sufficient evidence about positive healthcare effects, are subsequently only listed provisionally. At the same time, the requirements for proof of medical benefit do not ensure the generation of valid results in studies or clinical trials with regards to routine everyday care. So far, there has been only a moderate qualitative reliability of results. Furthermore, in the context of free pricing by manufacturers, significant price increases can be observed in some cases compared to prices before the BfArM listing. This paper gives recommendations towards further development of the legal basis for the fast-track process, particularly in the subject areas of benefit and patient safety as well as cost effectiveness.