BELGIUM Trends and Developments Contributed by: Benjamin Docquir and Margo Cornette, Osborne Clarke
Osborne Clarke Bastion Tower Pl du Champ de Mars 5 1050 Bruxelles Belgium Tel: +32 2 515 93 00 Email: lena.tausend@osborneclark.com Web: www.osborneclarke.com
The involvement of artificial intelligence (AI) in the healthcare sector is particularly noteworthy. AI is, and will continue to be, used for diagnos - tics, drug development, treatment personalisa - tion, virtual health assistants, health administra- tion and remote patient monitoring, amongst other applications. It opens up new opportuni - ties for organisations, healthcare professionals and clinics, enabling them to improve their offer - ings, develop new solutions and address various societal challenges. Although AI can generate benefits, it also raises a number of legitimate concerns related to human safety and security, freedom, privacy, integrity, dignity, self-determi - nation and non-discrimination. This article delves into the implications of the EU’s Artificial Intelligence Act (AIA) for healthcare professionals using AI systems in the context of remote patient monitoring. A wide range of stakeholders are covered under the AIA. These include not only the providers and manufactur - ers of AI systems but also the users, such as healthcare professionals. Any healthcare profes - sional using an AI system under their authority will be considered a deployer, unless the AI sys - tem is used in the course of a personal non-pro - fessional activity. As a consequence, healthcare
professionals are – as deployers – required to comply with a long list of obligations, which may notably range from compliance with instructions for use to assigning human oversight and ensur - ing that input data is relevant. How To Qualify an AI System Used in the Context of Remote Patient Monitoring Under the AIA High-risk AI comprises two categories: • AI that is a component of, or is itself, a prod - uct subject to EU product safety regulations that must undergo a third-party conformity assessment, as required by the regulations listed in Annex I (Article 6, Section 1 of the AIA); and • AI that is specifically classified as high-risk, as listed in Annex III (Article 6, Section 2 of the AIA). AI systems used for the purpose of remote patient monitoring may fall under both catego - ries of high-risk AI systems. • AI biometric categorisation systems are listed in Annex III of the AIA. Such categorisation
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