The Japan Association for Advancement of Medical Equipment has launched a website called “The Basics of Medical Program Development,” even though the site has Japanese pages only.
The development and dissemination of medical apps and software is a hot topic in Japan, with the Japanese government, including MHLW, considering various measures.
This website is aimed at people considering new entrants into the medical field, and is expected to be useful in complying with the Pharmaceutical and Medical Device Act, and in particular in checking whether an app is a medical device.
This website was created and is operated using a research grant from the MHLW.
There is a page called “Practice determining whether an app is a medical device,” which shows examples. By looking at this page, you can get a sense for what apps and software fall under the category of medical device programs (Software as Medical Device; SaMD) and are subject to regulation on medical devices.
When determining whether an app or software falls under the category of medical device or SaMD, the purpose of the app or software (such as contributing to the diagnosis, treatment, or prevention of disease) and the degree of risk (the impact on patients if the expected performance is not achieved) are important factors. (See the MHLW’s page on SaMD in Japanese.)
The “Basics of Medical Program Development” page includes information on applicability, as well as the importance of setting development objectives and goals, and warnings for appropriate advertising and sales promotion activities, making it a good site for new entrants to get started.
However, it does not mention how to generate revenue, which is an important element of the business model. As with Apple’s atrial fibrillation history program, it could be used for home use by the general public at their own expense, or it could be used within the national health insurance system (medical fee) and patients would be required to pay a certain amount of out-of-pocket, or the SaMD portion would be excluded from insurance as a selected medical treatment.
There is a debate going on about insurance coverage for SaMD, and the framework is highly uncertain, but it would be difficult to continue providing medical apps and software without this point, so we think that it would be good to mention how to generate revenue on this site as well.
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