Healthentia is now listed in mHealthBELGIUM, the Belgian platform for CE-marked mobile applications considered as medical device.

The mHealthBELGIUM initiative

The mHealthBELGIUM is an initiative of the Belgian Federal Government managed by beMedTech (sector federation for the industry of medical technologies) and Agoria (sector federation of technological industry). It is also in close cooperation with three national authorities: FAMHP (Federal Agency for Medicines and Health Products), eHealth Platform (a federal government eHealth institution), and NIHDI (National Institute for Health and Disability Insurance).

The mHealthBelgium platform uses a three-level Validation Pyramid structure that reflects the level of validation of every application in the group. Level 1 (M1) determines the basic criteria for an app. Level 2 (M2) is based on the interoperability and connectivity to the basic services of the eHealth platform. In Level 3 (M3) apps demonstrate social-economic added value and are financed, after approval by the NIHDI of their funding request.

Helathentia a Class IIa Medical Device

Healthentia, a product of Innovation Sprint, is an innovative eClinical solution that goes beyond the typical ePRO/eCOA context, blending sensing information with traditional outcomes to discover lifestyle digital biomarkers for certain phenotypes in clinical studies; thus enabling smart eHealth services. Currently, Healthentia is a Class I Medical Device; a Software intended for monitoring of non-vital parameters to support decision making during clinical trials. Further to the current certification, on our roadmap towards a Class IIa Medical Device, Healthentia R&D features include novel approaches towards DTx services that exploit the derived digital biomarkers to feed novel intervention.