mHealthBelgium, also known as mobile health Belgium, is the Belgian platform for mobile apps that are CE-marked as a medical device.
This unique platform centralises all relevant and required information on mobile apps for patients, healthcare professionals and healthcare institutions in three language (Dutch, French and English). The information is related to CE marking, data protection, communication security, interoperability with other IT systems and the way in which the app is financed. mHealthBelgium consists of a validation pyramid with three levels. An app always enters at the lower level, M1, and can climb in hierarchy via M2 to the top level, M3.
mHealthBelgium is an initiative of the Belgian Federal Government. Multiple stakeholders are involved. This platform is managed by beMedTech (sector federation for industry of medical technologies) and Agoria (sector federation of technological industry), in close cooperation with three national authorities:
- The FAMHP (Federal Agency for Medicines and Health Products) is the competent authority for all things related to the quality, safety and efficacy of medicines and health products, including medical devices. Is responsible for level M1 within mHealthBelgium.
- The eHealth Platform is a federal government institution with the mission to promote and support the providing of a well-organised, mutual electronic service and exchange of data between all healthcare stakeholders with safeguards in the areas of data security, the privacy of the patient and the caregiver, respecting medical professional confidentiality. Is responsible for level M2 within mHealthBelgium.
- The NIHDI (National Institute for Health and Disability Insurance) is responsible for the refunding of medicines, medical devices and medical provisions. Is responsible for level M3 within mHealthBelgium.