디지털 치료제 기술보호를 위한 기술적·법률적 관리 방안

With the enforcement of the Data 3 Act, data from different industries can be combined and de-identified without the consent of the data subject, and can be used directly or provided to a third party, dramatically improving the value and utility of data in traditional industries. In the medical industry, smart medical and digital healthcare service industries using patient data are growing, and R&D on disease treatment and prevention using digital therapeutics is actively underway. Since digital therapeutics are developed and used in the form of software, unlike conventional therapeutics, duplication and leakage are easy. In addition, as a software drug for disease treatment and prevention, it requires a long R&D and clinical period compared to general software, and complicated procedures and cooperation with related institutions are essential. For this reason, it is difficult to detect or prevent industrial technology leaks, and when damage occurs, the damage scale is very large compared to general software. In addition, as the digital therapeutic industry is a promising next-generation technology that deals with personal sensitive information, security and technology protection are important, but related regulations and technology protection measures are insufficient. In this paper, we analyze the domestic and foreign status of the digital treatment industry, and present technical and legal measures to protect technology and prevent industrial technology leakage.