Category B1

General user information

What solutions fall into category B1?

These are solutions for providing general, non-personalized information on the patient's state of health, current care protocol, living conditions or training tools. For example, these may include solutions offering hygienic-dietary advice on more or less targeted themes:

  • diet,
  • quitting smoking,
  • physical training.

They differ from category A1 solutions, which have an organizational objective for the patient or professional with the provision of technical support only.
This type of functionality can often be combined with other self-monitoring or treatment functionalities.

Is medical CE marking required?

Software in this category is not necessarily medical CE marked and does not process personal health data.

Target users

Solutions in this category can be used by professionals or by patients.

Existing funding

  • Solutions in this patient-facing category can be funded by the patient or via certain complementary healthcare products.
  • Solutions intended for professionals can be financed by hospital budgets or health centers. Healthcare professionals can also self-finance training courses they deem to be of interest to their training.

Examples

A diabetes education app

This is an example of a digital solution for patient use.
It considers a mobile application available to type 1 diabetic patients that offers questionnaires and modules to improve their knowledge of the pathology to better manage their treatment by explaining the importance of self-monitoring of blood glucose. Some of these applications are made available free of charge by blood glucose meter manufacturers.

A digital training platform

This is an example of a digital solution for use by healthcare professionals.
We're considering an application that provides healthcare professionals with training and educational tools via a mobile app, web platform or virtual reality headset. This application offers to train healthcare professionals in nasopharyngeal sampling through theoretical modules and enables acquired knowledge to be verified.