Earticle

초록

영어

Digital wellness products delivered via smartphones and wearable devices increasingly collect, analyze, and provide health-related information, including lifestyle patterns and physiological signals. Even without explicit diagnostic or therapeutic claims, some products can influence risk perceptions, care-seeking, and the timing of screening, testing, or clinical visits. This creates a regulatory “grey zone” at the boundary of medical device definitions, where intended use is formally non-medical but real-world effects may still raise public health and consumer protection concerns. This study compares how Korea, the United States, the European Union (EU), and Japan regulate such boundary products. We conducted a document-based comparative legal and policy analysis of statutes, regulations, and official guidance. The analytical framework comprised three domains: (1) regulatory scope and definitions, (2) market entry pathways, and (3) quality/performance assurance mechanisms. The United States clarifies boundaries through statutory exclusions for certain software functions and enforcement discretion for low-risk wellness products. The EU regulates software with a medical intended purpose under the Medical Device Regulation (MDR) via qualification, risk-based classification, and conformity assessment, while non-medical wellness products are primarily governed by horizontal regimes such as product safety and data protection. Japan improves predictability by delineating the SaMD–wellness boundary through guidance and publicly available interpretation examples. Korea establishes a distinct legal category—digital medical and health support devices—combining notification with optional performance certification, thereby institutionalizing a managed middle ground between full medical device authorization and market autonomy. This design aims to reduce regulatory blind spots by enabling administrative traceability while offering a public signal of performance through voluntary certification. Because Korea’s key provisions for this category are scheduled to take effect from January 24, 2026, its real-world impact should be assessed after implementation, including certification uptake, market adoption by key purchasers, disclosure effectiveness, and the practical functioning of postmarket oversight and corrective actions.

목차

Abstract
I. 서론
II. 연구방법
1. 연구설계 및 자료원
2. 분석 틀
III. 연구결과
1. 한국
2. 미국
3. 유럽
4. 일본
IV. 고찰
1. 국가별 규제 선택의 배경과 입법 의도
2. 한국 ‘중간지대 관리모델’의 정책조합: 기대효과와 정책리스크
3. 이해관계자 관점 내 쟁점: 제도수용성과 운영가능성을좌우하는 변수
4. ‘경계선(의도된 사용목적)’ 관리의 역설
V. 결론
참고문헌

키워드

저자

• 강민석 [ Min-Seok Kang | 동국대학교 의료기기산업학과 ]
• 김성민 [ Sung-Min Kim | 동국대학교 의료기기산업학과, 동국대학교 바이오헬스의료기기규제과학과 ] 교신저자

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]

• 간기

  반년간

• pISSN

  2799-8940

• 수록기간

  2006~2025

• 십진분류

  KDC 518 DDC 615