Validation pyramid

 

mhealthbelgium stakeholder en

 

mhealthbelgium pyramid

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:

 

mhealthbelgium pyramidLevel 2 (M2) is based on the interoperability and connectivity to the basic services of the eHealth platform.

Mobile healthcare apps that are approved as M2

  • meet the basic criteria of level 1
  • have been submitted to a risk assessment (developed by an independent organisation and included in mHealthBelgium) after which they have proven to meet all imposed criteria regarding authentication, security and the use of local e-health services by means of standardised tests (if applicable).

Download the technical file that describes the M2 criteria here.

More information about the test centers of the eHealth platform can be found on their website, though only available in French or Dutch

 

mhealthbelgium pyramid

Level 3 (M3) is reserved for apps for which the social-economic added value has been demonstrated and which are financed, after approval by the NIHDI of their funding request.

[Level 3 provides information on the status (submitted, accepted for review, approved, rejected) of the financing request to the NIHDI and on the timeline of the procedure.]

M3 apps always meet all criteria of level 1 and the (applicable) criteria of level 2.

Please note that mobile healthcare apps can also be financed by other means than through the NIHDI. For example, hospitals may have their own financing resources, patients or healthcare professionals may pay for the app themselves or health insurance companies may (partially) support the use of the app.

 

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