Privacy and Data Protection

Is the use of telehealth permitted?

In Belgium, no specific legal framework exists in relation to telehealth.

However, this could change in the near future as the COVID-19 pandemic has brought attention to the range of possible telehealth applications from which patients and healthcare professionals could benefit. In fact, the Belgian National Council of the Order of Physicians (“NCOP”) has already adapted its policy regarding the provision of teleconsultations, which was previously strictly limited. This is explained into more detail below (see the chapter about telehealth Regulation).

There is also a lot of attention going towards other aspects of telehealth, like tele-expertise, telemonitoring, tele-assistance and m-health. An example are the test projects that have been carried out by the national institute for sickness and disability insurance (RIZIV/INAMI) with the purpose of creating a framework to reimburse telehealth applications.

How is telehealth regulated?

Following the COVID-19 pandemic, there have been some recent developments with regard to teleconsultations.

Firstly, the NCOP has issued a new guidance regarding teleconsultations on 18 June 2022, which can be consulted here. From now on, teleconsultations are explicitly recognized and allowed by the NCOP on a permanent basis. However, this guidance contains several conditions (f.ex.: the doctor’s ability to control the patient’s identity, the patient’s free will, …) that have to be met in order to proceed with the teleconsultation. Additionally, a therapeutic or care relationship must exist between the person in need of care and the doctor before the teleconsultation. This will have to be proven in accordance with the regulations on electronic evidence of a therapeutic care relationship.

Secondly, on 1 August 2022, a new framework for the reimbursement of teleconsultations has entered into force. Telephone and video consultations will be unlimitedly reimbursed, if they occur (i) with healthcare professionals with whom the patient already has a treatment relationship, (ii) with a specialist on referral from a general practician, or (iii) within medical guard service.

Are there specific fields of healthcare in relation to which telehealth services are currently available, and do they involve the use of proprietary technology or platforms?

There is no specific limit on which services might be provided by way of telehealth applications.

The main difficulty is the reimbursement of telehealth costs. Regarding this issue, we refer to the test projects that RIZIV/INAMI has been carrying out to assess the feasibility of reimbursement frameworks for telehealth applications (as described under the chapters about telehealth availability, costs and anticipated reforms).

Does the public health system include telehealth services, and if so, are such services free of charge, subsidised or reimbursed? Where the public health system does not include telehealth services, are such services covered by private health insurance?

Since 1 August 2022, digital consultations are financed in the Belgian health system, which means that patients will be reimbursed for the consultations. Doctors can decide which platform they wish to use for the digital consultation and how they collect payment for it.

The number of reimbursed teleconsultations is unlimited. However, certain conditions must be met:

• the teleconsultation must take place with the patient’s regular doctor or a specialist recommended by them, or a general medical on-call service;
• it must take place at the patient’s request, with the doctor's agreement;
• the doctor must have access to the patient’s medical file; and
• the platform or application used must guarantee the security of the information.

Patients only pay a personal contribution of €4 for a video consultation and €2 for a telephone consultation.

Another novelty is the m-health platform (mHealthBELGIUM), which is the result of one of the test projects initatied by RIZIV/INAMI. This platform has been set up in order to grant a "trust stamp" to trusted applications. For each application, the platform stores information regarding its CE marking, data protection, security, data interoperability with other information systems, and also on how the application is financed.

mHealthBELGIUM has been designed as a 3-level validation pyramid. The applications available on the mHealthBELGIUM website will have at least reached level M1 (apps recognised as medical devices) and can gradually climb the hierarchy to level M2 (interoperability and connectivity of the apps with the core services of the eHealth platform) and then level M3 (apps which show a socio-economic added value and which are financed by RIZIV/INAMI, after a positive opinion of their application for reimbursement).

How should the cross-border transfer of personal information collected and processed in the course of telehealth services be carried out to ensure compliance with applicable privacy laws?

No specific rules under data protection Belgian law with regard to telehealth. General rules of the GDPR apply.

Are there any currently applicable codes of conduct on the use of telehealth systems and/or security of telehealth data in your jurisdiction?

Currently, there are no general codes of conduct on the use of telehealth systems and/or security of telehealth in Belgium. Telehealth is subject to the general ethical, legal and deontological rules inherent to the practice of medicine. However, the NCOP has issued specific guidelines with regard to teleconsultations, as described under the chapter about telehealth regulation.

Are any specific laws, regulations, or self-regulatory instruments expected to be adopted in the near future?

We do not have knowledge of upcoming regulations. However, we expect that there will be new developments in the coming months as telehealth and its possibilities have been under a lot of attention following the COVID-19 pandemic.

Additionally, RIZIV/INAMI is currently carrying out (or analysing the results of) test projects in the fields of teleconsultations, tele-expertise, telemonitoring, tele-assistance and m-health in order to assess the development of reimbursement frameworks.