A number of medical mobile applications are integrated into the NIHDI's reimbursement system. The FAMHP takes part in assessing these applications.
The Belgian authorities are working together to assess medical applications using a validation pyramid. This pyramid is made up of three levels: M1, M2 and M3.
These three levels are validated by the FAMHP, the eHealth Platform and the NIHDI respectively. The three validation levels are:
- M1 (FAMHP) :
- the application is approved as a medical device;
- the device is registered on the FAMHP's web portal.
- M2 (eHealth Platform) :
- the application meets the basic criteria for level 1;
- the application is validated for interoperability with the basic services of the eHealth Platform.
- M3 (NIHDI) :
- the application meets the basic criteria for levels 1 and 2;
- the application is recognised as having socio-economic added value and can be integrated into the NIHDI's reimbursement system.
How to notify your medical mobile application to the FAMHP?
Applications for M1 validation can be submitted through the FAMHP's web portal.
The FAMHP will check whether the mobile medical application complies with the following requirements:
- The mobile application must be CE-marked as a medical device;
- It must allow patients to share from their own environment health related information (by means of sensors e.g.) with a healthcare professional.
To apply, please send following documents by email (notifications.meddev@fagg-afmps.be) with "notification - mobile application - application name" in the subject line:
- the instructions for use;
- the declaration of conformity;
- the EC certificate (si applicable).
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