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Level 2 of the validation pyramid for health apps is now activated in Belgium
On 05 June 2020, mHealthBelgium announced the activation of Level 2 of the validation pyramid. This indicates that health applications that meet certain criteria can achieve Level 2. The National Institute for Health and Disability Insurance (INAMI) is working on the next step (level 3) - to introduce a structural framework for funding.
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
- Data protection
After achieving M2 health application, developers will get access to more options, like risk assessment framework, test centers, a lot of useful information.
MoveUp Coach and Comunicare are the first health apps on mHealthBelgium, accomplished M2 validation. RemeCare, Well@Home, and AirView have already initiated the validation process.
BeMedTech, Agoria, and the National Institute for Health and Disability Insurance (INAMI) collaborated in recently created Telemedicine Working Group to accelerate the introduction of a structural framework for funding -next step (level 3).
See the full details here
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