Global Rulemaking Strategy for Implementing Emerging Innovation: Case of Medical/Healthcare Robot, HAL by Cyberdyne (Japanese)

Under the Fourth Industrial Revolution, innovations using emerging technologies (artificial intelligence, robotics, the internet of things), are said to improve productivity and quality of life. On the other hand, the diffusion of such innovation can involve risks and uncertainties regarding safety. Generally, these risks are managed by government by means of regulation. However, it may pose challenges to firms for commercialization because emerging innovations often do not come under existing product categories nor corresponding regulations. This study answers (1) how products based on emerging technology can be commercialized, overcoming existing regulatory barriers on safety, and (2) what is the role played by standards, one type of regulation, through an examination of the case of Cyberdyne, a successful medical/healthcare robotics company in Japan. Cyberdyne developed and commercialized the world's first product using Cybernics in a wearable medical/healthcare device. The case illustrates the increasing complexity of safety regulations and a new role for standards, which is to enable firms to implement emerging technologies. It concludes with an exploration of policy considerations from a regulatory perspective in dealing with emerging technologies.