The role of the Belgian Medical Data Agency
The Belgian Health Data Agency (“HDA”) was established by law of 14 March 2023 and entered into force on 13 April 2023. However, the Belgian HDA was officially launched on January 17, 2024.
The Belgian HDA aims to promote the secondary use of medical and healthcare data and to enhance access and availability of health (care) data.
Pharmaceutical companies, medical device companies, medical professionals, researchers, or other interested parties (i.e., “data users”) who wish to access certain health (care) data may, among other things, use the following information provided by the Health Data Agency: services are available.
- HDA helps you find and identify data from a centralized data catalog. This catalog is produced by partner institutions (currently the Federal Agency for Medicines and Health Products (FAMHP), the Federal Public Service for Health Food Chain Safety and Environment, the National Health and Disability Insurance Institute (NIHDI), and Ciensano). In a data catalog, data is described through metadata. That is, where the data is located, the conditions under which the data can be accessed, the quality of the data, the frequency of data updates, the data classification, and the agreed terms and definitions. , the origin of the dataset, the data provider, etc.
- HDA can assist the Belgian Information Security Commission and data users in analyzing compliance with the legal conditions for accessing health (care) data for the purposes intended by data users.
- HDA facilitates access to health (care) data, including by contacting data owners and instructing data users to prepare requests for access to health (care) data, in accordance with the conditions established by law. Masu. This service also includes support for procedures for hearing opinions before the Ethics Committee, preparation and support for hearing opinions before the Information Security Committee, and support for responding to opinions provided.
- HDA also assists in drafting agreements between data owners and data users.
- HDA communicates with data users to improve and exchange knowledge about the data and the analyzes performed on the data used.
- HDA will provide technical support, as required, during the transfer of data from data owner to data user and for the storage of this data (without data being transferred to the Health Data Authority).
- The HDA will likely build on the infrastructure provided by the Health Data Agency itself to help structure data, improve data fairness and availability, improve data quality, increase data update frequency, and align with (international) standards. Develop recommendations for coordination and harmonization.
The pharmaceutical and medical technology sectors, along with small and medium-sized enterprises and start-ups, could greatly benefit from accessing this internal data market, especially today when the availability of high-quality data is key in the development of AI systems. In some situations, accessing this internal data market can provide significant benefits.
Interaction with the Belgian Data Protection Authority
HDA is not a supervisory authority within the meaning of Article 51 of the General Data Protection Regulation. It is not intended to replace or undermine the Belgian Data Protection Authority. The HDA’s powers do not include specific processing of sensitive personal data. It only acts as a facilitator for accessing medical data for secondary processing. Responsibility for the processing shall always rest with the person who obtains legal responsibility for the processing and is designated by the controller for this processing.
Belgium’s HDA aligns with future European health data space
With the creation of the HDA, Belgian legislators also expect that the European Health Data Space Regulation (the “EHDS Proposal”) will be adopted soon. The proposal aims, inter alia, to establish principles regarding the secondary use of electronic medical data. research, innovation, policy development, patient safety or regulatory activities; The HDA will be the health data access authority for secondary uses of electronic health data as defined in the EHDS proposal. HDA’s operational framework has been deliberately designed to align with the EHDS proposal and future initiatives, ensuring continued compliance with European legal requirements.
As a reminder, the EHDS proposal aims to give EU nationals control over their health data, including for cross-border purposes (primary use of health data), and the reuse of health data. The purpose is to promote the use of (secondary use). For research, innovation and public policy purposes. During its term as EU Council President, Belgium aims to complete the EU Health Data Space document by the end of this term of the European Parliament in June 2024. However, negotiations with members of the European Parliament on this issue may prove difficult. challenging.
next step
The Belgian HDA is currently working to further develop its data catalog and request processes, streamline data access, improve data quality and adopt FAIR (searchable, accessible, interoperable, reusable) data principles. Masu.
Our team is closely monitoring developments regarding EDHS and the Belgian HDA. If you have any questions, please feel free to contact us.
