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Growing Opportunities in Belgium for U.S. Companies Offering Mobile Health Solutions

Belgium has a lot of know-how in digital medical technologies.  In 2018, it was one of the first countries worldwide to have a validation system, the ‘validation pyramid’, for mobile health apps.  The aim of this pyramid was to progressively define quality requirements including security, privacy, interoperability, usability, and reimbursement requirements and to facilitate the integration of mobile health apps in the Belgian healthcare system. Companies with applications that ascended to the top of the pyramid could count on financing from Belgium’s Institute for Health and Disability Insurance. But five years after its introduction and several pilot projects, only one app, moveUP, made it to the top and received financing.

Starting October 1, 2023, the Institute for Health and Disability Insurance will implement new measures for evaluating and financing new projects:

  • A working group for the evaluation of mHealth applications will be established with independent health economists to add crucial perspective.
  • The group will meet monthly for a faster approval of digital medtech applications, and it will establish a timeline to track progress in the applications.
  • Hospitals and scientific and trade associations – in addition to companies – will now be allowed to submit mHealth applications.  
  • The Belgian government will also provide for temporary funding of promising innovative solutions that have not yet collected all the necessary data. 

U.S. companies interested in bringing mobile health applications to the Belgian market should be aware of the regulatory requirements such as CE marking as medical device and manufacturers and distributors should be certified by the Federal Agency for Medicines and Health Products. Manufacturers can voluntarily register their CE marked mobile apps with assigned classification under the pyramid on the digital platform mHealthBelgium which is managed by the industry (beMedTech, the federation for manufacturers of medical devices in Belgium, and Agoria, the sector federation of technological industry) with the support of the public authorities. 

To learn more about opportunities in the Belgian mobile health market, contact Danny Dumon (danny.dumon@trade.gov) at the U.S. Commercial Service in Belgium.  
 

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