BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis
Enhancing interoperability and data harmonisation
of digital health and data sharing strategies in Belgium. Data donation for research The concept of “data donation” for scientific research is being actively promoted, support- ed by the Coalition Agreement. This aims to enable citizens to voluntarily share their health data, including anonymised or pseudonymised information from medical records, genetic data, and lifestyle information, for scientific research. This practice must be in full compliance with the GDPR, the EHDS Regulation, and the Data Gov- ernance Act (2022/868) (the Belgian implement- ing law for which was adopted on 15 May 2024). Such data is viewed as a valuable resource for advancing medical understanding and innova- tion. Initiatives like the European Brain Data Hub, in which Belgium participates, already exemplify data altruism for specific research areas like brain health. Belgian authorities continue to study and refine the legislative framework surround- ing medical data donation to ensure adequate safeguards, patient control, and transparency. The Role of Multi-Stakeholder Partnerships Another essential factor driving healthcare inno- vation in Belgium is the rise of multi-stakeholder partnerships. Diverse stakeholders play a role: government bodies such as FPS Health and the Walloon Agency for a Life of Quality (AVIQ), healthcare providers from hospitals to primary care centres and individual professionals, tech- nology companies from multinational corpora- tions to local startups, and research institutions including universities and academic medical centres. Patient organisations also play a pivotal part, advocating for patient needs. These stakeholders combine to co-create digi- tal health solutions that address real-world chal-
Despite significant progress, the full harmonisa- tion of health data and comprehensive interoper- ability of digital systems remain ongoing objec- tives. Difficulties in exploiting data persist due to a lack of standardised data input and system compatibility, a concern highlighted by Belgian hospitals and research institutions. The Belgian government encourages the adoption of har- monised systems for structuring and encrypting medical data, such as SNOMED CT. To address these challenges, FPS Health has launched initiatives like the “cross-over” call for projects. This programme is designed to finance projects aimed at strengthening the interoper- ability of digital systems within Belgian general and psychiatric hospitals. It seeks to overcome limitations of previous pilots, such as prototypes not reaching operationalisation, restricted scope, and insufficient transferability of solutions. Data protection and patient trust The protection of sensitive health data is par- amount and is governed by a comprehensive regulatory framework in which the GDPR plays a central role. Public concern over data privacy remains a significant consideration in the devel- opment and implementation of data sharing initiatives. This sensitivity was underscored in February 2025 when patient associations, sev- eral psychologists’ associations, and the League of Human Rights (LDH) lodged an appeal with the Belgian Council of State. The appeal raised concerns regarding the government’s manage- ment of digitalised health data sharing, medical confidentiality, and the processes for informed consent. Ensuring robust data security meas- ures, transparent governance structures, and maintaining public trust are therefore critical preconditions for the successful advancement
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