Category C3
Self-monitoring, self-treatment
What solutions are in category C3?
These are those that contribute toimproving the autonomous management of treatment by people suffering from a disease through self-monitoring of physiological parameters in particular.
Systems that enable diagnosis, autonomous initiation of treatment, automatic transmission of data via a remote monitoring solution are not included in this category.
Is medical CE marking required?
Digital solutions in this categorymust be CE marked.
Target users
This category includes digital solutions used bypatients only.
Existing funding
In order to assess the value of these devices in this category they must be compared with comparable non-connected devices.The funding that results from the HAS scientific assessment therefore depends on the funding of the comparator, for example, a medical device without digital functionality.
Thus, in the case where the comparator is supported on the LPP, support for this type of device may be via the LPP. The value of the digital function may be enhanced if the HAS assessment demonstrates its added value.
The digital solution could also be financed bythe patient or by the intermediary of complementary organizations.
Example
A device that pairs a blood glucose meter with an external insulin pump
This solution enables both self-monitoring and self-treatment. It communicates by radio frequency with the pump designed to store and administer insulin subcutaneously, and therefore has a therapeutic function. The wireless programmer integrating the blood glucose meter controls the pump and suggests insulin bolus doses to be delivered according to the blood glucose level determined by the bolus calculator. The device features patient alerts in the event of pump expiry, when the insulin reservoir is empty.
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