The Belgian Minister of Health has announced in a press release that she is seeking to integrate mobile medical applications (e-health apps) into the Belgian healthcare system. In order to ensure the quality of such e-health apps and the safety of patients, these apps will be evaluated under a specific scheme (Evaluation Scheme) and some will be eligible for government financing.
The Evaluation Scheme is a first step to providing a legal framework on the use of e-health apps and aims to review whether a medical app should be integrated into the “mainstream” Belgian healthcare system and if so, how it should be integrated. The Evaluation Scheme consists of three levels:
- Level 1: minimum requirements. Any application that wishes to be integrated into the Belgian healthcare system must meet certain standards, function correctly (for example, precisely and correctly monitor a patient’s heartbeat), bear a CE mark, and comply with the applicable regulations on privacy and the protection of data.
- Level 2: communication with official e-health apps. The app must be able to communicate with other official Belgian e-health apps.
- Level 3: added value. If demonstrated that an app provides added value to healthcare and meets the requirements of the first two levels, a tailored investment scheme will be made available for its implementation.
Further details on the Evaluation Scheme will be developed in the coming weeks together with other stakeholders.
The Minister of Health has been working with the minister responsible for the digital agenda and telecoms on the Evaluation Scheme which forms part of the larger “Digital Health Valley” initiative. Since 2017, 24 pilot e-health apps projects have been implemented (see our previous post here) and will be evaluated shortly.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2018 issue (Thomson Reuters).