Taiwan-France Digital Health Forum on Software as a Medical Device
The first Taiwan-France Digital Health Forum: “Fostering the Best Digital Health Ecosystem in Taiwan” was led by government health officials and industry leaders such as Sanofi, Asus cloud, Wistron Medical Technology andheld
Germany took a bold move in late 2019 for digital health applications
“Germany established a platform for ‘digital health applications’ and in this platform they allow certain software medical device manufacturers to obtain a preliminary approval admission to be listed on the platform directory so that they can be commercialized.
After three months, the product is put on the market and can be prescribed by doctors and also obtain full reimbursement by the national health insurance at the price imposed by the manufacturer. So it is really quite a bold measure. And to be on the preliminary admission, you don’t need to demonstrate or prove effectiveness you need to show levels of security of the device, patient safety as well as data privacy and interoperability requirements instead.
And then it is put on the market for twelve months, prescribed by doctors and fully reimbursed while collecting information on the effectiveness of this solution. And then after the period of time, reassessment is made for final listing decision on the directory, and whether there is a disagreement on the price at which it has been reimbursed.
So far it’s been quite successful. Data as of end of March shows there has been about 65 applications with positive 12 positive decisions.”