The Role of the Belgian Health Data Agency

The Belgian Health Data Agency (“HDA”) was established by the Law of 14 March 2023, which became effective on 13 April 2023. The Belgian HDA was, however, only officially launched on 17 January 2024.

The Belgian HDA intends to facilitate the secondary use of health data and healthcare data and to enhance access and availability of health(care) data.

Pharmaceuticals companies, medical devices companies, healthcare professionals, researchers or other interested party (i.e. “data user") wishing to access certain health(care) data will be able to use the following services provided by the Health Data Agency, among others:

• The HDA will help them locate and identify data from a centralized data catalog. This catalog will provide an overview of diverse datasets available from partner institutions (currently the Federal Agency for Medicines and Health Products (FAMHP), the Federal Public Service Health Food Chain Safety and Environment, the National Institute for Health and Disability Insurance (NIHDI) and Sciensano). In the data catalog, data will be described through its metadata, i.e. where the data is located, under what conditions the data is accessible, the quality of the data, the frequency of data updates, data classification, agreed-upon terms and their definitions, the origin of the dataset, data providers, etc.
• The HDA can assist, among other things, the Belgian Information Security Committee and the data user in analysing compliance with the legal conditions for accessing health(care) data for the purposes intended by the data user.
• The HDA will facilitate access to health(care) data, including by contacting data holders and guiding data users in preparing the request for access to health(care) data, in accordance with the conditions provided by law. This service also includes assistance in the process of requesting opinions from the ethics committee, preparation and support during the request for opinions from the Information Security Committee, and assistance in complying with the provided opinions.
• The HDA will also provide assistance in drafting agreements between data holders and data users.
• The HDA will contact data users to improve and exchange knowledge about data and analyses conducted on data used.
• The HDA will provide technical support, if necessary, during the transfer of data from the data holder to the data user, as well as for the storage of this data (without the data ever being transferred to the Health Data Agency).
• The HDA will formulate recommendations for structuring, making data FAIR and usable, improving data quality, enhancing data update frequency, aligning and harmonizing with (international) standards, possibly based on the infrastructure provided by the Health Data Agency itself.

The pharmaceutical and health technologies sector, along with SMEs and start-ups, may gain significant advantages from accessing this internal data market, especially, in today's landscape where the availability of good-quality data is key, particularly for the development of AI systems.

Interaction with the Belgian Data Protection Authority

The HDA is not a supervisory authority within the meaning of Article 51 of the General Data Protection Regulation. It is not intended to replace the Belgian Data Protection Authority or to undermine its powers. The HDA's remit does not include any specific processing of sensitive personal data. It simply acts as a facilitator for access to healthcare data for secondary processing. Responsibility for the processing will always assumed by those who have obtained legal responsibility for it and who are designated by the controller for this processing.

Belgian HDA aligned with the future European Health Data Space

With the creation of the HDA, the Belgian lawmaker also anticipates the forthcoming adoption of the Regulation on the European Health Data Space (“EHDS Proposal”) which among other aspects, aims to set principles for the secondary use of electronic health data, e.g. for research, innovation, policy making, patient safety or regulatory activities. The HDA will be a health data access body for secondary use of electronic health data as defined by the EHDS Proposal. The operational framework of the HDA is intentionally designed to align with the EHDS Proposal and forthcoming initiatives, ensuring ongoing compliance with European legal requirements.

As a reminder, the EHDS Proposal aims at giving control to the EU citizens to their health data (primary use of health data), including regarding cross borders purposes, and at facilitating the uptake of the re-use of health data (secondary use) for research, innovation and public policy purposes. During its presidency of the EU Council, Belgium aims to finalize the EU Health Data Space dossier, before the conclusion of the current term of the European Parliament in June 2024. However, navigating negotiations with the Members of the European Parliament on this matter may be challenging.

Next steps

The focus of the Belgian HDA is currently on developing further the data catalog and request process, advancing towards streamlined data access, improved data quality, and the adoption of FAIR (Findable, Accessible, Interoperable, Reusable) data principles.

Our team closely monitors the developments in relation to the EDHS and the Belgian HDA. Please do not hesitate to reach out for more information if you have any questions.