The use of wearables in diagnosing and preventing of diseases

The use of wearables in diagnosing and preventing of diseases

The use of wearables in diagnosing and preventing of diseases

10/06/2020 - Vincent Van Fulpen, pharmaceutical consultant and member of QbD’s Medical Device Core Team

Checking your phone to see when you took your last medication? Your watch vibrating and telling you to lay down because you will have a seizure soon, while at the same time notifying your emergency contact with your exact location? This may seem a little futuristic, but it is actually more realistic than you would expect. Both your phone and watch are so-called “wearables”; things that can be worn, that contain computer technology being able to measure vital body functions, in other words: that are “smart”.

The use of these wearables in the diagnosis and prevention of diseases becomes more realistic every day. There are already numerous wearables on the market which are classified as medical devices since they have a function in preventing or diagnosing of diseases. It is not necessarily the wearable device itself that is classified as a medical device, but it could also be the software used with the device which is considered a medical device, so called stand-alone software. The last is the case when the software can be used independently of the device it is installed on. Software, which drives a device or influences the use of a device, falls within the same medical device class as the device.

The combination of data from medical health records, wearables and biosensors could definitely facilitate the focus to preventive healthcare instead of reactive healthcare.

Great example is Apple’s ResearchKit, read further on https://qbd.eu/en/blog/the-use-of-wearables-in-diagnosing-and-preventing-of-diseases/

Raunak Kedar

Finance + Strategy Professional

4 年

Interesting article Simon, was wondering if the FDA regulatory process for wearables is as robust as for pharma?

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