In the aftermath of an incident with leaky breast implants in France, it was established that a registration system is needed in Belgium to trace implanted medical implants. The law of 15 December 2013 on medical devices (B.S. 20 December 2013) provides for the establishment of such a register.
In accordance with this law, any distributor who makes an implant available in Belgium, as well as any professional who implantes, removes or replaces an implantable medical device, is obliged to register certain data with the Federal Agency for Medicines and Health Products (FAMHP).
The FAMHP has now submitted a pilot project relating to the communication of personal data relating to health in the context of the "Central Tracing Register" to the Sector Committee. The Sectoral Committee approved the further development of this register via Healthdata dated 7 November 2017.
The register specifically aims to centralize notifications about the lifecycle of an implant by means of the creation of a database, user interfaces and system to system interfaces, which enable the placement and removal of implants to be entered and consulted by the treating care providers (physicians and dentists) of the patient (whether or not within the framework of a healthcare institution), by other registers (Orthopride / Qermid) and by the FAMHP.
In addition to the already existing procedures via SMALS, Healthdata has provided a platform where it is possible to register both sets of implants and the individual components used (via .csv format or by means of manual input).
In time Healthdata will also offer a web service for this register in order to continue the automation of the offered platform (HD4DP).
This pilot starts on July 16 and runs until July 31 (inclusive). Participating hospitals are asked to submit a maximum of 10 'manual registrations' during this period (= 10 forms). These forms are made available on the HD4DP platform. The purpose of the pilot is a final check of the technical aspects of data processing and exchange.
We ask for additional feedback on usability, bugs, error messages, etc. to be reported to our support department. For all other questions regarding this register (purpose, reason, legal basis, etc.) we refer you to your contact person at the FAMHP.
Healthdata thanks the FAMHP, SMALS, and all participating hospitals for the cooperation.
For all information regarding he setup of the Data Collection Definition (DCD), click on the following link. There, you can find the relevant information for encoding data by clicking on the following buttons:
'All View' gives details about all the fields of DCD, i.e. the mapping between technical names and functional names and indicate whether or not the field is required to complete the encoding of a registration;
'CSV Column Names' gives the technical names of the fields in the header of any CSV file to be loaded in the application HD4DP;
'validation rules' gives the cases not supported for some fields;
'Reference Lists' gives the lists of values mapped to some fields, i.e. the values to put in such fields must be available in these lists;
'CSV extract' allows to download a CSV file containing all the technical fields of the DCD.
The HD4DP application enables data providers to collect data within their organization. The RCT data providers have to collect data using this application. HD4DPis a local application that is accessible in a webbrowser, such as Internet Explorer or Chrome, which has a specific link in every organisation.
Open the link for the HD4DP application or contact healthdata.be at firstname.lastname@example.org to get the link for your organisation.
Click on the Request account linkon the login page
Fill out the request form:
Enter a username, first name, last name and email address
Select the organization and data collection(s)
Fill in the Requester email field if a person requests an account for a third person
Submit the request user the Request button
Confirmation emails are sent to the person for whom the account was requested as well as the requester, if the field 'Requester email' was filled
The approval or rejection for the user account is confirmed by mail. Depending on your orginazation, this could take a few hours.
This action will be done by an HD4DP administrator in your organisation
The confirmation mail will include all the necessary information to log in
The HD4DP application enables data providers to collect data.
The medical and professional secret is protected at various levels and through principles such as encoding, encryption, and user-acces management. The combination of these elements guarantees so-called "end-to-end security".
During the data collection process, which is done by this application, all data is securely (= anonymized) transferred to Sciensano, with the use of e-health box:
The data provider never receives the coded identifiers
eHealth has never access to medical data or metadata
Healthdata.be never receives the original identifier, but can reconcile different entries
An overview is given in the video:
We provide more documentation of the different functions and possibilities in the different phases of data collection in the HD4DP application.