In August 2020, mHealthBelgium announced two more health application accomplished M2 validation - Well@Home and AirView. After achieving M2 level, developers will get access to more options, like risk assessment framework, test centers, a lot of useful information.
The mHealthBelgium platform, created in 2018, is managed by the Belgian Federation of the medical technology industry (beMedTech) and the Belgian Federation of Technology Companies (Agoria). The platform includes health applications according to a 3-step validation pyramid. The Federal Agency for Medicines and Health Products (FAMHP) is responsible for Level 1 (M1). Health application can be published on the platform with level 1 when it meets the basic requirements (recognition as a medical device (CE marking) and compliance with European data protection regulations, as well as product notification in the FAMHP database).
Level 2 (M2) can be achieved if health application meets certain quality criteria in:
- Identification and authentication of a user
- Verification of the therapeutic relationship and informed consent
- Interoperability
- Data protection
The health apps MoveUp Coach and Comunicare accomplished M2 validation in July 2020. As of August 2020, two more applications - Well@Home and AirView - are on Level 2 of the validation pyramid.
Well@Home is an application that allows a detailed follow-up of the patient at any time of his pathological cycle. The on-board functions allow the healthcare team to have an instant and detailed view of the daily health situation of patients.
AirView allows remote monitoring of ResMed diagnostic and/or treatment devices.
See the full details here.
Subscribe to our newsletter delivered every second week not to miss important reimbursement information.