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
• allows a patient  to share from his/her own environment health related information (with or without sensors) with a healthcare professional

To be eligible for level M3 and to submit a notification, the software application has to fulfill additionally:

• the criteria for level M2
• 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) 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

 

Level 3 (M3) is reserved for apps that are financed by NIHDI, either temporarily (M3 light) or definitely (M3 plus)

M3 apps always meet all criteria of level 1 and the (applicable) criteria of level 2. More details about financing are given on the financing page.

Download the procedure and template for an M3 request:

Dutch    or    French