디지털 치료기기 관련 법제 동향과 시사점

Abstract

With the development of the digital healthcare sector, the software itself has now become a medical device. Digital Therapeutics(DTx) are defined as “providing evidence-based treatment interventions driven by high-quality software programs to prevent, manage, or treat medical disorders or diseases.” With the spread of digital therapeutics(DTx), major countries are expanding government-level support and investment, and overhauling related laws.
 This study examined the current status of domestic and foreign digital therapeutics and identified related laws and regulatory trends. Based on this, domestic legal and institutional improvement measures were proposed.
 According to the results of the study, major countries, including Korea, defined medical devices based on the Medical Device Act and regulated medical devices by classifying them according to the degree of risk.
 In the case of digital therapeutics, they are classified into low-risk grades and stipulate processes such as licensing and test evaluation of devices. In addition, a separate fast track was applied or the digital therapeutics was supported with individual guidelines. However, for the safe development of digital therapeutics in the future, it is necessary to systematically reorganize the regulations of digital therapeutics by reflecting the core contents of the guidelines in the law or enacting separate laws.
 In addition, the compensation method and level for the application of the health insurance system should be improved. In other words, doctor fees and patient compensation methods should be considered by reflecting the characteristics of digital therapeutics. Various discussions are needed in consideration of health insurance finance issues.
 Finally, due to the nature of digital therapeutics, it is necessary to strengthen data security measures and establish a management system for this.