Frequently asked questions
As a patient, who can I contact if I have questions about the registry?
If you have questions about the Central Registry of Rare Diseases you can in the first place contact your physician at the genetic centre.
The various patient organisations will also be able to answer your questions. For any questions, you can get in touch with the contact person for the patient organisations for your disease, or with the umbrella organisation RaDiOrg. On the RaDiOrg website you can find a list of the different patient organisations (link of the list in NL or in FR) or you can find the patient organisation for your rare disease in Orphanet.
What data are gathered?
The data that are gathered contains the identification details of the genetic centre and the treating physician (NIHDI-numbers), some demographic data about the patient and details of the diagnosis.
The demographic data that are gathered about the patient includes: encoded national register number, gender, date of birth, if applicable the date of death, and the zip code for the place of residence.
In terms of the diagnosis, various data are requested:
- the date of the first symptoms of the rare disease (defined as the date of the first consultation with a physician for this reason)
- the date of the first consultation at the specialist healthcare institution
- the date the current diagnosis was made
- whether this diagnosis is provisional or definitive
- the code for the disease within an existing disease classification system
- the base on which the diagnosis was made (e.g. based on clinical symptoms, genetic test, biochemical test etc.).
The patient data are encoded and are transmitted and stored in a secure manner.
Only anonymised data will be used for reports.
What happens if a patient has two diagnoses of a rare disease?
If a patient has two rare diseases, both diseases should be entered in the registry.
Who gathers the data?
The data are recorded by the physician at the genetic centre.
Who has access to the data?
At the genetic centres only those who have access to your electronic patient record have access to the data, because the data for the Registry are entered in your patient record.
The data are then sent to Sciensano, where a small number of researchers have access to the encoded data under the supervision of a physician.
Where are the data after they have been collected?
The data are stored locally on a secure server at Sciensano.
How long will my data be stored?
The data will be stored indefinitely on the server so that it is possible to carry out longitudinal studies. The encoded data will be anonymised at the latest 30 years after the patient's death.
Who is responsible for processing my data?
Sciensano is responsible for processing the data. This organisation is a scientific institution of the Belgian Federal State, and its main task is to perform scientific research to support policy, with the ultimate aim of improving healthcare services. Sciensano also provides expertise and public services in the field of public health.
For more information about this project you can contact the Healthcare Research service at Sciensano.
Can a patient unsubscribe from the registry?
Yes. The patient should contact his or her physician to do this.
What is the difference between this Central Registry of Rare Diseases and disease-specific registries?
Only few basic data are gathered in the Central Registry of Rare Diseases, however this data are collected for all patients with a rare disease. Disease-specific registries usually gather much more information from a more limited group of patients with a specific disease (or for a group of diseases).
As a result, disease-specific registries can be used to carry out more extensive research. Research using the Central Registry of Rare Diseases will be more general: this registry will provide information about the prevalence of rare diseases in Belgium, the geographical distribution of the patients and the care, the diagnostic process and the quality of the care.
Is there a cost associated with registration in the Central Registry of Rare Diseases?
No, registration does not cost anything.
Is the registry a Belgian initiative?
The Central Registry of Rare Diseases is part of the National Plan for Rare Diseases proposed by the Minister of Public Health at the start of 2014.
As rare diseases are a field of study that particularly benefits from the pooling of data and cross-border networks, the European Commission also emphasises the importance of a multinational approach. In turn, Europe is investing in projects that facilitate or enable this type of collaboration, such as the EPIRARE project (2011-2013) and the expansion of a European platform for rare disease registries by the Joint Research Centre (2014-2015).
What is the Supervisory Committee of the Central Registry of Rare Diseases?
The Supervisory Committee is a multi-stakeholder committee that sets out the priorities and the steps to be taken by consensus. It is made up of representatives of the Insurance Committee of the NIHDI, the eHealth Platform, the Healthcare Department of the NIHDI, the College of Human Genetics, the Belgian Health Care Knowledge Centre (KCE), the Public Health and Social Affairs Policy Unit, the Federal Public Service for Health, Food Chain Safety and Environment, the Federal Agency for Medicines and Health Products, the Rare Diseases and Orphan Drugs Fund, the Committee for advice on healthcare provision in relation to chronic diseases and specific conditions, and the WIV-ISP.