The Meaning and Legal Policy Challenges of the Digital Medical Products Act

Korea enacted the world's first Digital Medical Product Act, which came into effect on January 24, 2025. This study aims to analyze the legislative background and key contents of the Digital Medical Product Act and propose policy recommendations for future improvements. According to the findings, the Digital Medical Product Act defines and classifies digital Medical products previously not covered by existing laws, such as the Medical Device Act and the Pharmaceutical Affairs Act. It also establishes regulatory and management systems tailored to the unique characteristics and potential health risks associated with digital Medical products. However, several issues must be addressed to fully achieve the legislative objectives. First, a comprehensive review and harmonization of existing laws are necessary to ensure coherence and consistency within the overall legal framework, thereby achieving the Act's intended objectives. Second, utilizing health and medical data is critical for the development and promotion of digital healthcare products. Therefore, it is necessary to examine a dedicated legal framework for securely handling health data. Additionally, detailed security standards for each type of digital Medical product should be clearly stipulated in legislation, alongside establishing rapid response systems and clarifying responsibilities in the event of incidents. Third, digital Medical products, being software-based, inherently carry risks of errors or malfunctions. Hence, it is essential not only to implement preventive quality control standards but also clearly define responsibilities and damage remediation measures post-incident. Finally, regulatory relaxation during clinical trials and evaluation processes for digital Medical products may conflict with ensuring safety. Considering the potential risks associated with digital Medical products, active management and support from regulatory authorities such as the Ministry of Food and Drug Safety are crucial for balancing innovation and safety. Ultimately, the primary goal of the Digital Medical Product Act is to secure the safety and effectiveness of digital Medical products, contributing to public health enhancement and industry advancement. Continuous efforts and improvements are required to harmonize public health protection with industrial development.