eBRAIN-Health is a Horizon Europe-funded research project which will develop a data privacy-compliant research platform to support the development of digital representations of the human brain. These digital brain twins use artificial intelligence (AI) models to simulate some of the brain’s complex neurobiological phenomena, and aim to facilitate research into neurodegenerative conditions such as dementia. On 16 October, Lukas Faymann (University of Vienna) and Daphne Lamirel (Alzheimer Europe) co-presented their work on regulatory, legal and ethical issues relating to digital brain twins and AI, in a parallel session entitled “Ethical and Legal issues”. Lukas kicked off the presentation by outlining the goals of eBRAIN-Health, setting the scene for this ambitious project by describing EU legal frameworks including the AI Act, Medical Devices Regulation (MDR) and the General Data Protection Regulation (GDPR).
Lukas asked whether these interconnected regulations sufficiently equip individuals, whose personal data is used to train and run AI, with rights to protect themselves. He also highlighted possible solutions to legal challenges raised by this new regulatory landscape, such as accountability mechanisms, increasing digital literacy, and increasing the frequency of post-market surveillance. Next, Daphne presented their critical evaluation of ethical concerns about the AI Act, related to the accessibility of AI systems for people with disabilities, stakeholder participation in AI design and development.
Drawing on consultations with the eBRAIN-Health Public and Patient Advisory Group (PPAG), which is composed of members of the public, people with or at risk of dementia, and relatives of people with dementia, Daphne emphasised that specific actions are needed to ensure broad accessibility to health-related AI systems (e.g. adopting universal design principles) and that stakeholder participation in the design and development of health-related AI systems is essential. eBRAIN-Health is currently developing guidelines for professionals on how, after demonstrating compliance with the new legal framework, they can promote trustworthy and ethical use of AI. Learn more about the eBRAIN-Health project: https://ebrain-health.eu/vision.html
