From the end of October 2018 onwards, companies can apply for publication of their mobile health-applications (mhealth apps) on the governmental website “mhealthbelgium.be“. The website aims to encourage mobile health and make mhealth patient care an integrated pillar of the healthcare sector. It has been created through cooperation among Belgian authorities for food, medicines and health products (including the Federal Agency for Medicines and Health Products) and relevant associations (in particular, beMedTech the Belgian federation of the Medical Tech industry).
In order to be published on the website, an mhealth app must comply with certain criteria. Depending on the number of criteria that are fulfilled, the app will be granted a level 1 (lowest) to level 3 (highest) recognition:
- Level 1. Legal compliance: the mhealth app complies with applicable legislation (CE-marking, medical devices laws and regulations, and the EU General Data Protection Regulation ((EU) 2016/679).
- Level 2. Interoperability: the mhealth app is able to interact with other digital healthcare solutions such as the basic services of the eHealth platform.
- Level 3, Reimbursement: the cost of the mhealth app is refundable within the framework of certain broader treatments, because it is demonstrated that it provides financial added value in the healthcare sector.
As a result of publication, patients, healthcare providers and tech professionals will find detailed information on the mhealth apps on ‘mhealthbelgium.be’, in particular, the advantages of each app, both for patients and healthcare providers.
The Belgian government expects that the expanded use of mhealth apps will connect patients and healthcare providers thus resulting in clear advantages for the healthcare system: patients can collect and share relevant health data with healthcare providers, and healthcare providers can better monitor and provide insights on patients’ health status remotely, enabling patients to feel more supported during treatment.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2018 Issue (Thomson Reuters).