Belgium has joined Europe's frontrunners in the field of digital healthcare with the announcement (20 January 2021) by the National Institute for Health and Disability Insurance (INAMI-RIZIV) of its health app reimbursement scheme.
The launch is a significant step by Belgium in its adoption of mHealth, which refers to the use of medical software applications to allow users to monitor, evaluate, and improve their health using data recorded via wearables, sensors, or other health tracking applications, usually under the guidance of a healthcare professional.
The technology enables, for example, remote medical diagnostics and remote monitoring of the patient during treatment and rehabilitation. The Covid-19 pandemic has emphasised the need for digital health technologies and the importance of remote monitoring.
Apart from the temporarily granted reimbursement for teleconsultation in light of Covid-19 measures, Belgian law did not until very recently provide for the reimbursement of patients' telemedicine purchases, including mHealth applications.
The possibility for reimbursement is an important milestone, and it forms the final piece of the so-called validation pyramid of the mHealthBelgium platform, created in 2018 and managed by the Belgian Federation of the Medical Technology Industry (beMedTech) and the Belgian Federation of Technology Companies (Agoria).
This validation pyramid consists of three levels that enable access to reimbursement for mHealth apps. The first level, M1, requires manufacturers of mHealth apps to meet certain basic requirements (for instance, CE-marking, compliance with European data protection regulations, and product notification in the Federal Agency for Medicines and Health Products of Belgium database. At the second level, M2, mHealth app manufacturers must demonstrate all the requirements of level M1 as well as compliance with quality criteria such as user identification and authentication and data protection.
On 20 January 2021, the third and highest level of the validation pyramid, M3, was rolled out. M3 regulates reimbursement of mHealth apps. Consequently, once the first two levels are achieved, purchase of an mHealth app that reflects specific socio-economic added value can now be submitted to INAMI-RIZIV for reimbursement. So far, 23 mHealth apps have attained level M1 and seven of those have also been validated for level M2.
Information is available on the INAMI website (NL FR) explaining to manufacturers the necessary steps for submitting an mHealth app (which has achieved levels M1 and M2) for reimbursement approval (level M3). The reimbursement approval process can be summarised as follows:
- Application process. Manufacturers are required to complete an application form and provide more information about how the app works, the existing healthcare process and future implications of using the mHealth app, as well as budgetary impacts.
- Assessment by a workgroup. The aim is to evaluate the extent to which integrating the mobile application into the healthcare system is a valuable addition to or replacement for current practice. This step also provides an opportunity for the manufacturer to further explain the mobile application.
- Advice from the workgroup (positive/negative). The special working group will submit its advice (positive/negative) to the insurance committee. The decision will be based on the evaluation of clinical evidence in the file, the mHealth app’s potential for integration into the healthcare system (feasibility), the app’s possible improvement of and potential to complement current practice (added value), and the budgetary impact.
• Decision by the insurance committee. Based on the advice of the workgroup, the insurance committee will make a decision as to whether to proceed with integrating the mobile application into the healthcare system and, by extension, the reimbursement system. In the event of a positive decision, the committee then instructs the relevant bodies to do so. The reimbursement received by the patient for the purchase of an mHealth app is not a taxable for the patient.
While this Insight highlights the key considerations, if you would like assistance with the necessary requirements to achieve the required level of accreditation (for example, CE-marking, data privacy, identification and authentication, etc.), please contact one of our experts below.