Abstract
Under the former Pharmaceutical Affairs Law（PAL）, embedded software which is intended to operate the medical device is regulated as unbroken part of the Hardware. PAL was revised and enacted on November 20 and promulgated on 27, 2013, and stand‐alone software programs are defined as a medical device.
On the other hand, “the Medical Software Study Group" was set up by the Ministry of Economy, Trade and Industry（METI）, and relevant Japanese industry associations, 3J（JAHIS/JEITA/JIRA）, joined it. As a result of argument in the Study Group, they pointed out the risk caused by the so‐called health software that is outside of the scope of the regulation, and 3J established Good Health Software Promotion Council（GHS）to plan and apply an industry voluntary standard and rule for health software that is outside of the scope of the regulation.
