> I'm surprised that this doesn't fall close to the FDA's approval process for medical devices. It will, but it takes a while. So far, medical apps where basic

> I'm surprised that this doesn't fall close to the FDA's approval process for medical devices. It will, but it takes a while. So far, medical apps where basically ignored by regulation, but that is about to change. In Germany, you can now register apps as "digital health apps" with regulators [1]. This created a new market, because now the app can be paid for by insurance policies. Hence, most apps already approved are in the "mental health" category and charge about €2,000 per year. Cheap compared to traditional treatments, expensive for a consumer app. This has benefits and downsides. Main benefits: Apps must comply with regulatory affairs. There must be data to support that the apps work as advertised. App developers must think about risk for the user/patient and how to manage it. Main drawbacks: Considering the replication crisis in psychology, there is incentive to create weak evidence. Apps can claim to work, because they did a bunch of studies, but in reality, the app is useless. Since customers don't have to pay for them, but insurance companies do, there is less pushback from actual customers. Why would they care about a free product not working as advertised? So far, this is something within Germany. I can imagine that other countries will follow. Add the new Medical Device Regulation (MDR), which harmonizes medical device regulations within the EU. The next step will be some global harmonization and thus, enabling these kinds of new markets for prescribed apps. [1]: https://www.bfarm.de/DE/Medizinprodukte/Aufgaben/DiGA/_node.html https://www.bfarm.de/DE/Medizinprodukte/Aufgaben/DiGA/_node....