HIRA

독일의 디지털치료기기 보상체계와 시사점

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Type
Article
Author(s)
최효정동재용김은미장준호
Issued Date
2022-05-31
Keyword
DiGA directoryDigital therapeuticsDiGA fast-track
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.
Publisher
심사평가연구소
DOI
10.52937/hira.22.2.1.24
URI
https://repository.hira.or.kr/handle/2019.oak/2978
Alternative Title
Digital Therapeutics Reimbursement System in Germany and Its Implications
Publisher
심사평가연구소
Location
KOR
Citation
[1]최효정, 동재용, 김은미, and 장준호, “독일의 디지털치료기기 보상체계와 시사점,” HIRA Research, vol. 2. 심사평가연구소, pp. 24–35, May 31, 2022. doi: 10.52937/hira.22.2.1.24.
ISSN
2765-6764
Appears in Collections:
HIRA 발간 > 1. HIRA Research
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