독일 디지털 헬스케어법의 주요 내용과 정책적 시사점 = Implementation of the German digital healthcare act and Its Political Implications

다국어 초록 (Multilingual Abstract)

The “Digital Health Care Act(DVG)”, which came into effect in December 2019 in Germany, above all, made health apps to be included in the pay list of statutory health insurance, and this legislation has a legislative meaning, as the first in the world to implement so-called digital medical care, creating a new concept for future medical care. The health insurance regulations for health apps were fundamentally reformed. This has triggered widespread changes in the regulatory framework under the Health Insurance Act. In particular, it can be regarded as a ground-breaking legislation to broaden the perspective to include the overall health and medical service supply conditions.
In this study, which regulatory approach was selected by the Digital Healthcare Act against this background, and what special functions it has is examined. Accordingly, it explains the criteria for receiving health insurance benefits through the digital health app. The digital health app must meet the requirements for safety, function and quality of medical products, comply with data protection requirements and ensure data security according to the latest technology, a positive health benefit effect. Of course, health app costs have recently been introduced into health insurance, only if you comply with data protection regulations. Health apps for health insurance benefits must completely stop advertising, and are particularly characterized as being subject to other restrictions in terms of permitted processing purposes.
To this end, as the main contents of the Digital Health Care Act, it explains the scope of application, requirements for permission, and requirements for health insurance registration. Accordingly, the purpose of this study is to analyze the extent to which this balance has been achieved through the legislative and policy implications and innovations made in the context of the Digital Healthcare Act in relation to health apps. It also presents new effects for digital health apps(DiGA) as a result of the new legal framework, and the remaining legal issues and assessments.

참고문헌 (Reference)

1 김기영, "현대의학의 전망과 법적 책임의 변화" 법학연구소 25 : 5-42, 2021

2 장세균 ; 김현창 ; 김소윤, "정밀의료에서의 개인정보와 정책방향에 관한 연구 : 미국, EU, 일본과의 비교법제도 분석을 중심으로" 한국의료법학회 25 (25): 133-154, 2017

3 김기영, "의료부분 클라우드 규제현황과 개선과제" 정보통신산업진흥원 121-, 2021

4 최철호, "우리나라 의료기기 부작용에 따른 피해구제시스템 도입방안 연구" 한국의료법학회 25 (25): 49-77, 2017

5 식품의약품안전처, "스마트 헬스케어 의료기기 기술･표준 전략 보고서" 2018

6 박정원 ; 심우현 ; 이준석, "디지털 헬스케어 발전을 위한 규제 개선 방안에 관한 연구" 한국지능정보사회진흥원 25 (25): 60-81, 2018

7 서경화, "디지털 헬스의 최신 글로벌 동향" 대한의사협회 의료정책연구소 2020

8 김기영, "데이터기반의학에서 의료수준의 정립과 법적 책임" 한국의료법학회 25 (25): 49-69, 2017

9 윤기영, "뉴노멀: 우리가 알던 세상은 끝났다" 책들의정원 2021

10 이한주, "가명정보 개념 도입을 통한 의료정보 활용 활성화 가능성의 법적 검토" 한국의료법학회 28 (28): 97-127, 2020

11 Czettritz, Peter, "“Beam me up, Scotty” – die Klassifizierung von Medical Apps als Medizinprodukte" 433-, 2017

12 Jakobs, "Software als Medizinprodukt: Haftungs- und versicherungsrechtliche Aspekte" 1-, 2019

13 Zezschwitz, Friederike von, "Neue regulatorische Herausforderungen für Anbieter von Gesundheits-Apps" 196-, 2020

14 Gaßner, Maximilian, "Mobile Health Applications – haftungsrechtlicher Standard und das Laissez-faire des Gesetzgebers" 1219-, 2015

15 Strömer, Jens M, "Mobile Health Applications – haftungsrechtlicher Standard und das Laissez-faire des Gesetzgebers" 1219-, 2015

16 Lücker, Volker, "Medizinprodukterechtliche Rahmenbedingungen für E‑Health-Produkte im europäischen Wirtschaftsraum" 61 : 278-, 2018

17 Terhechte, Arno, "Medizinische Software/Medical Apps" 61 : 321-, 2018

18 Gassner, Ulrich M, "MedTech meets M-Health" 73-, 2015

19 Pohl, "MedTech digital: Zugang digitaler Gesundheitslösungen in die Regelversorgung?" 127-, 2019

20 Specht-Riemenschneider, "Herstellerhaftung für nicht-datenschutzkonform nutzbare Produkte – Und er haftet doch!" 73-, 2020

21 Münkler, Laura, "Health-Apps im gesundheitsrechtlichen Regulierungsgefüge" 41-, 2021

22 Europäische Kommission, "Grünbuch über Mobile-Health-Dienste (“mHealth”) vom 10.4.2014, COM"

23 Backmann, Ben, "Gesundheits-Apps im Durchbruch – Regulatorische – und haftungsrechtliche Aspekte zu “mobile Health”" 73-, 2011

24 Thranberend, "Gesundheits-Apps" Bertelsmann Stiftung 2016

25 Schreiber, "Gesundheits-App auf Rezept" 385-, 2020

26 Sträter, Burkhard, "Europäische Regulierung des Medizinprodukterechts, Was können die Medizinprodukte-Verordnung der EU und ein ungeregelter Brexit für die GKV verändern?" 530-, 2020

27 Pfannstiel, "Digitale Transformation von Dienstleistungen im Gesundheitswesen I" 2017

28 Kemmner, Carolin, "Die digitale Gesundheitsanwendung auf dem Weg in die Erstattungsfähigkeit – Fast Track-Verfahren mit Hürden" 80-, 2020

29 Braun, Julian, "Die Versorgung mit digitalen Gesundheitsanwendungen nach den Regelungen des Digitale-Versorgung-Gesetzes" 757-, 2019

30 Braun, Julian, "Die Förderung der Entwicklung digitaler Innovationen durch Krankenkassen nach dem Digitale-Versorgung-Gesetz" 894-, 2019

31 Sehnert, "Die Bindungswirkung der Einkommensfeststellung eines Sozialversicherungsträgers" 437-, 2000

32 Katzenmeier, "Big Data, E-Health, M-Health, KI und Robotik in der Medizin" 259-, 2019

33 Rämsch-Günther, Nicole, "Abgrenzung und Klassifizierung von Medical Apps" 61 : 304-, 2018

34 식품의약품안전처, "2020년 신개발 의료기기전문분석 보고서" 2020