의료기기 규제 경계에 위치한 디지털 웰니스 제품의 규제 프레임워크 비교연구: 한국·미국·EU·일본을 중심으로

Abstract

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.