독일의 디지털치료기기 보상체계와 시사점

Abstract

Digital therapeutics have attracted worldwide attention due to the current situation aggravated by the coronavirus disease 2019 pandemic. Digital therapeutics refers to a type of “software as a medical device” that provides evidence-based therapeutic intervention to patients for the prevention, control, or treatment of medical disabilities or diseases. The scale of the related industry is gradually expanding, both at home and abroad, and related products are in active development. Therefore, this study reviews the case of Germany, the only country that operates a standardized compensation process for digital therapeutics in its Statutory Health Insurance, to provide the latest information on digital therapeutics in Germany and derive its implications. In Germany, digital therapeutics are registered and managed under BfArM(Bundesinstitut für Arzneimittel und Medizinprodukte) based laws such as DVG (Digitale-Versorgung-Gesetz) and Digitale Gesundheitsanwendungen-Verordnung (DiGAV). Germany also has a system to manage the products listed (provisional or final) in the DiGA directory. The manufacturer’s suggested price for compensation is applied during the first year of listing, then a final price is determined through negotiation. Germany has 175 conditions that must be met for listing in the DiGA directory. In addition, proof of positive clinical effects is required for the final listing, so the issue of compensation becomes a necessary consideration when products do not meet minimum standards. Upon reflection of the study’s results, parts that should be considered when introducing the German system to Korea (in terms of listing, compensation, and acceptance) were also analyzed. Especially, we feel the need to develop the price management mechanism during the beginning of this system by confirming the side effects of applying autonomous prices in situations where there is no evidence. The results of this study outline Germany’s digital therapeutics system for better understanding and provide the implications of introducing such related policies domestically in Korea.