Category C7
Treatment aid
What are C7 solutions?
These are digital solutions that help to optimize a treatment or guide a medical decision. These solutions do not treat patients autonomously. In its classification, the HAS excludes from this category solutions intended for therapeutic decision-making.
Is medical CE marking required?
Digital solutions in this category must be CE marked.
Target users
Digital medical devices in this category are intended to be used bythe patient or by a healthcare professional.
Existing funding
The treatment aid solution should be valued according to the treatment management modality that the digital solution optimizes.
The possibility of financing the digital solution is a function of the substantiated efficiency of the new solution compared to care without a treatment aid solution.
- For a medical device with collective use: care within healthcare establishments is through healthcare establishment budgets.The manufacturer must demonstrate the interest of its solution and its clinical, organizational or medico-economic added value, notably in comparison with available devices, in order to be selected by the healthcare establishment for its use.
- For a medical device forindividual use: the digital solution can be financed via the LPP within Titles I, II or IV.
- For use in the city: funding via the treatment act could also be suitable.
Example
Treatment support solution for patients
This is the case of the insulin dose calculator for a diabetic patient treated with insulin. An algorithm calculates the insulin dose a patient should self-inject based on blood glucose data measured in real time by a sensor supported by the LPP and context data (recent or planned physical activity, amount of carbohydrates from a recent or planned meal...). This solution aids treatment by allowing calculation of the insulin dose, suggesting adjustments according to glycemic trend, and can also generate alerts for the patient in the event of risk of hypoglycemia or hyperglycemia.
This type of software aims to simplify day-to-day diabetes management by providing precise recommendationsbased on real-time data, while enabling advanced personalization to adapt to the specific needs of each user.