Validation pyramid

What do we consider as mhealth or mobile medical application?

As mhealth application we consider within the mHealthBelgium framework a software application with a medical purpose that

• has a CE-markering as medical device and has been notified to the FAMHP
• allows a patient to share from his/her own environment health related information (with or without sensors) with a healthcare professional

To qualify for Level 3 (reimbursement by NIHDI) and submit a reimbursement application (Level 2), the software application must additionally meet 2 aspects:

• a set of ICT criteria to ensure secure connection and integration (see technical details sheet)
• allows a healthcare professional to diagnose, to apply a therapy or to monitor a patient, all  from a distance via a medical device made for use by the patient in his/her own environment

This means that not all applications who got the M1 label also will or can move to the top of the pyramid (M3) hence being reimbursed in the future.

Level 1 (M1) determines the basic criteria for an app. Three criteria are applicable:

• CE declaration as a medical device is submitted
• Voluntary notification of the mobile app to the Federal Agency for Medicines and Health Products (FAMHP), during which the CE marking and the compliance with the rules and regulations for medical devices are confirmed and can be checked.
• The app and the parent company declare that they comply with the EU General Data Protection Regulation (GDPR).

Do you want to know more what this rellay means? We refer to specific  websites of the FAMHP:

• Definition of a medical device.
• Role of FAMHP wrt medical devices.
• Info about CE marking and Notified Bodies.
• Info about classification of medical devices.
• Notification of an incidence with a medical device.

Level 2 (M2) indicates which apps have made a reimbursement request that was declared admissible by NIHDI

Mobile healthcare apps listed under level M2

• meet the basic criteria of level M1 anyway
• are evaluated by NIHDI on the basis of the evidence provided with regard to the socio-economic added value and their importance in the care pathway
• hereby declare that they also inherently comply with a series of ICT criteria that must ensure a secure connection and integration (see sheet with technical details).

This last point relates to ICT requirements regarding a.o.

• identification and authentication of the user
• verifying the therapeutic relationship between patient and healthcare provider
• Providing a data privacy impact assessment in the context of the GDPR regulations.

For all apps below level M2, the following information will be explicitly included:

• the date of the reimbursement request
• the outcome of the evaluation (if available)

Note: those apps that fell under level M2 in the old system (since September 2023) but have no refund request pending and thus no longer fall under level M2 in the new system, will temporarily (until October 1, 2024) still be listed as [2]. They thus meet the ICT criteria as described above (and in the technical sheet).

Level 3 (M3) is reserved for applications funded by NIHDI.

Applications below level M3 meet all the criteria of level 1 anyway and have also provided (partial or complete) evidence of their socioeconomic added value within a specific care pathway.

For each application labeled M3, the following will also be indicated very specifically:

• whether it concerns temporary funding (M3-) or definitive funding (M3+)
• for which care path or care paths this financing applies
• what this financing looks like in detail (reference to the relevant NIHDI page).

More details on the procedure and templates for reimbursement requests can be found on the NIHDI page (in Dutch or French)

Note that mobile healthcare applications can also be funded in other ways than through the NIHDI. For example, hospitals can fund it with their own resources, patients or health professionals can pay for the application out of their own pockets, or health insurance funds can (partially) support the use of the app. This information is not displayed here by default.