European mHealth Hub | Belgium National Validation platform for digital apps

10 May Belgium National Validation platform for digital apps

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Approach or solution
mHealthBelgium is an initiative of the Belgian Federal Government for the integration of mobile health apps in the Belgian healthcare system. The apps should be CE-marked as medical device and should target patients and healthcare professionals. The platform provides app information in Dutch, French and English on the CE marking, data protection, communication security, interoperability with other IT systems and financing. The validation is done according to a 3 layered pyramid: M1 – CE certified medical device, M2 – Safe connectivity, Interoperability with existing health platform and EHR, M3 – Demonstrate social-economic and clinical evidence and get reimbursed by RIZIV to the patient. An app always enters at level M1, and can climb in hierarchy via M2 to the top level, M3. The criteria for each level haves been established by the Government in collaboration with the industry. This validation framework is mentioned also in the Hub deliverable D2.1 Health Apps Assessment Frameworks.

Approach or solution

mHealthBelgium is an initiative of the Belgian Federal Government for the integration of mobile health apps in the Belgian healthcare system. The apps should be CE-marked as medical device and should target patients and healthcare professionals. The platform provides app information in Dutch, French and English on the CE marking, data protection, communication security, interoperability with other IT systems and financing. The validation is done according to a 3 layered pyramid: M1 – CE certified medical device, M2 – Safe connectivity, Interoperability with existing health platform and EHR, M3 – Demonstrate social-economic and clinical evidence and get reimbursed by RIZIV to the patient. An app always enters at level M1, and can climb in hierarchy via M2 to the top level, M3. The criteria for each level haves been established by the Government in collaboration with the industry.

This validation framework is mentioned also in the Hub deliverable D2.1 Health Apps Assessment Frameworks.

Organisation or initiative
Belgium National Initiative for Validation of mHealth Apps

URL or reference
https://mhealthbelgium.be/ https://mhealthbelgium.be/news/total-number-of-apps-comes-to-25 https://mhealth-hub.org/assessment-frameworks https://www.youtube.com/watch?v=c6OcgfiyiRc&list=PLAqB9r9WORV246MA_qbMNWsoQeLfn7hO8&index=10

Summary of the innovation
A couple of sentences The validation platform is managed and operated by industry through beMedTech, a federation of medical technology, and Agoria, a federation of technological industry, in close cooperation with three national authorities: FAMHP (Federal Agency for Medicines and Health Products), the competent authority for aspects related to quality, safety and efficacy of medical products including the medical devices. Is responsible for level M1 within mHealthBelgium. eHealth Platform is a federal government institution that promotes and supports secured data exchange between all healthcare stakeholders, ensuring data privacy and confidentiality of both patient and caregiver. Is responsible for level M2 within mHealthBelgium. NIHDI (National Institute for Health and Disability Insurance) is responsible for the refunding of of medical devices. Is responsible for level M3 within mHealthBelgium. The Government intervenes only at the level of reimbursement where a more insightful investigation is performed in particular at the level of proving medical outcomes and evidence of health improvement. As of (May 2021) there are 26 apps validated according to this framework., with 8 apps on M2 . The list of apps on each level can be consulted at this link, https://mhealthbelgium.be/apps

Summary of the innovation

A couple of sentences

The validation platform is managed and operated by industry through beMedTech, a federation of medical technology, and Agoria, a federation of technological industry, in close cooperation with three national authorities:

FAMHP (Federal Agency for Medicines and Health Products), the competent authority for aspects related to quality, safety and efficacy of medical products including the medical devices. Is responsible for level M1 within mHealthBelgium.
eHealth Platform is a federal government institution that promotes and supports secured data exchange between all healthcare stakeholders, ensuring data privacy and confidentiality of both patient and caregiver. Is responsible for level M2 within mHealthBelgium.
NIHDI (National Institute for Health and Disability Insurance) is responsible for the refunding of of medical devices. Is responsible for level M3 within mHealthBelgium.

The Government intervenes only at the level of reimbursement where a more insightful investigation is performed in particular at the level of proving medical outcomes and evidence of health improvement.

As of (May 2021) there are 26 apps validated according to this framework., with 8 apps on M2 . The list of apps on each level can be consulted at this link, https://mhealthbelgium.be/apps

Use cases supported

10 May Belgium National Validation platform for digital apps

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