JAPAN Trends and Developments Contributed by: Satoshi Ogawa, Yuto Noro, Hitoshi Fujimaki and Yuka Hirata, TMI Associates
• as SaMD they must be developed, manufac- tured and sold in accordance with the PMD Act; • approval to manufacture and sell SaMD in Japan as new medical devices must be acquired from the MHLW after clinical trials have been conducted, which can take several years and be costly; and • as a long period of time is required until the apps are covered by health insurance, it can take considerable time and money until they reach the market. Symptom-recording apps are used for “manag- ing the health condition” of a healthy person and “recording the symptoms” of a patient. A typi- cal app is one that is used for recording health information, such as weight and blood pressure, daily. Their characteristics are as follows: • they cannot express the therapeutic effects of the disease; • since they are not classified as SaMD it is not necessary to perform procedures based on the PMD Act; and • their price can be freely set since they are not covered by health insurance. Such SaMD are programs (software functions) that are intended to diagnose, treat or prevent diseases and are likely to affect a person’s health in the event of a malfunction. Their manufacture and sale are regulated by procedures based on the PMD Act. Therefore, even if they are defined as symptom-recording apps, they may be found to constitute SaMD, depending on their func- tions and their proposed effects. It is necessary to confirm whether such apps constitute SaMD when they are provided. In March 2023, the MHLW updated the guide- lines on the applicability of the term “medical
device” to a program. These guidelines provide a flowchart for determining the applicability of medical devices, outlining the procedures and considerations for making such determinations. Example of a therapeutic app In addition to the above-mentioned app for quitting smoking, Cure App, Inc. also received marketing approval for a therapeutic app for hypertension (accepted name: Hypertension Treatment Assistance Program) in April 2022. This was the first case in Japan in which market- ing approval was obtained for the software itself, and it is the world’s first marketing approval for a therapeutic app in the field of hypertension. In February 2023, SUSMED, Inc. received mar- keting approval for a therapeutic app designed to treat insomnia disorders, marking the third such case in Japan. This app supports cogni- tive behavioural therapy conducted by physi- cians. In February 2025, Shionogi & Co., Ltd. received marketing approval for a therapeutic app for paediatric ADHD patients, and Cure App obtained marketing approval for a therapeutic app for treating alcohol addiction. It is expected that various therapeutic apps and symptom- recording apps will be introduced in the Japa- nese market in the future. Utilisation of healthcare data Growing expectations for utilisation of healthcare data In Japan, there have been growing expecta- tions for the utilisation of valuable data in digit- ised healthcare businesses. In order to promote such utilisation, the government has introduced several mechanisms in the Act on the Protection of Personal Information in Japan (the APPI) and the Act on Anonymised Medical Data That Are Meant to Contribute to Research and Develop- ment in the Medical Field (the “Next Generation Medical Infrastructure Act”).
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