Industry Expectations and Challenges for SaMD in Utilizing Medical Data

Abstract

With the development of AI technology, research on its use as SaMD is progressing rapidly. Amid this development, it is necessary to use medical information as learning data. Secondary use of data is an important perspective throughout R & D and after social implementation. Three points need to be considered: (ⅰ) Personal Information Protection Law; (ⅱ) Ethical Guidelines for Life and Medical Sciences; and (ⅲ) Pharmaceuticals and Medical Devices Law. With regard to the Personal Information Protection Law, the provision of pseudonymized information is being developed. However, practical procedures and standards have not yet been established. In addition, the Ethical Guidelines face issues such as inconsistencies with relevant laws and regulations. We believe the Pharmaceutical Affairs Agency Law still leaves some questions unanswered with regard to the specific methods of reliability assurance used during the approval process. Nevertheless, the government has recently been acting swiftly to address this issue, and the industry has high expectations for the future. Talking about prospects, the government has released new systems such as two-step approval, and we are hopeful that the use of real world data (RWD) will pave the way for things that have been difficult to put into practical use or build evidence for insurance applications. As an industry, we would like to work toward a virtuous cycle of SaMD development and social implementation by accumulating instances of such social deployment and real-world cases that lead to positive patient outcomes, and by fostering public understanding.