With HAL (Hybrid Assistive Limb) as an example, we will discuss how to establish evidence for new medical devices. The use and evaluation method of HAL was constructed through a physician led clinical trial (NCY 3001) of the HAL medical lower limb type (CYBERDYNE Inc.). Since HAL has been shown to be effective and safe in 8 neuromuscular diseases in NCY 3001, the treatment with HAL has been covered by general health insurance Currently, we are exploring how the best long term effect can be obtained dependin g on the combination of other therapies, frequency and number of use of HAL, disease state, etc in the real world.