BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis
videos, further supporting patient understanding and engagement. In conclusion, while Belgium shows promising advancement in AI-driven personalised medi- cine, significant challenges remain. The absence of a comprehensive national data and AI strategy creates regulatory uncertainty. Ethical concerns around algorithmic bias and equitable access persist, potentially widening healthcare dis- parities if not properly addressed. Additionally, healthcare professionals face a steep learning curve in integrating these technologies into clini- cal workflows, requiring significant investment and resources in training and in developing skills to interpret AI outputs while maintaining their professional judgement. Without proper sup- port, even the most promising AI technologies may face resistance or implementation chal- lenges. For Belgium to fully realise the potential of AI in healthcare, these technical, ethical, and practical challenges must be addressed through thoughtful policy development and multi-stake- holder collaboration. Regulatory Landscape Efforts to cultivate a robust digital health eco- system in Belgium are often challenged by the need to comply with complex European Union (EU) legal and regulatory frameworks, alongside national implementation and specific Belgian rules. Evolving EU and national regulatory frameworks Compliance with the EU Medical Device Regula- tion (2017/745) (MDR) and the EU In-Vitro Diag- nostic Medical Devices Regulation (2017/746) (IVDR) continues to be particularly challenging for digital health companies, especially small and medium-sized enterprises. These regula- tions demand comprehensive clinical evidence,
robust quality management systems, and con- tinuous monitoring, which can be both resource- intensive and time-consuming. In recognition of these difficulties, the European Parliament adopted a resolution in October 2024 calling for urgent revisions to the MDR and IVDR to ensure the availability and safety of medical devices. The European Commission has subsequently initiated a targeted evaluation of these regula- tions, which closed for feedback on 21 March 2025, to identify areas for improvement and simplification. The European Medicines Agen- cy (EMA) is also playing a growing role, having established a procedure for scientific advice on certain high-risk technologies and an ongo- ing pilot programme (until the end of 2025) for orphan medical devices. A highly significant development is the EU AI Act, with enforcement projected to start mid- 2025 and the Belgian Institute for Postal Ser- vices and Telecommunications as the desig- nated national regulator. The AI Act introduces a risk-based framework for regulating AI sys- tems, imposing stringent requirements for high- risk applications, a category that includes many healthcare AI systems used for diagnosis, treat- ment, or as medical devices. This legislation will notably influence the Belgian digital health sector, mandating specific controls for such sys- tems. The Coalition Agreement sets out the plan to develop national frameworks to complement the AI Act, particularly focusing on care quality, medical confidentiality, and cybersecurity, while also creating safe spaces for experimentation through initiatives like AI regulatory sandboxes. A public tender was launched in late 2024 to study the framework for these sandboxes. The GDPR continues to shape the sector by enforcing strict rules on personal data process- ing, particularly health data. Digital health com-
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