HealthDARES - Day 3

The morning session kicked off with a presentation by Timo Minssen from the University of Copenhagen who outlined how medical devices and AI are currently regulated in the European Union (EU). His presentation touched upon questions such as: Which tensions and limitations characterize the current legal frameworks? And where do we go from here? Following this, Eva von Mühlenen from Sidley Austin LLP presented the Swiss and US approaches to AI regulation, outlining current limitations and debates of these two major economies’ models, whilst also shedding light on which direction we are going. The morning session then concluded with a presentation from Barry Solaiman of Hamad Bin Khalifa University on how medical AI is regulated in the MENA region (Middle East and North Africa) and what unique challenges the MENA region faces.

A panel discussion with the above speakers, moderated by Elettra Ronchi, then examined how innovators are being impacted by AI regulation and the contrasting approaches to cooperation and the industrial competitiveness of the EU and the US. While the EU's stringent, cross-sectoral framework aims for ethical AI development, the US favours a more flexible, sector-specific approach prioritizing innovation. Key concerns included the "Brussels Effect" of EU regulations, the rise of "algorithmic feudalism," and the need for collaborative frameworks to balance innovation with ethical considerations.

The day concluded with a lively discussion about how to go from ethical principles to practice. Two tools were examined – one a high-level guidance, the other a prescriptive checklist. Participants debated how these differing approaches serve varying audiences (e.g. smaller vs. bigger companies) and questioned to what extent they really support ethical awareness or compliance. While some participants found the prescriptive guidance more useful, others argued in favour of concrete tools. The group then reflected on ethics washing, the question of quality assurance, and the emerging ethics consultation industry, and debated on whether existing educational resources could be better drawn upon to promote ethics literacy. The conclusion was that these tools can work in complementary ways and that ethics should not necessarily be about compliance – that is the role of law – but should collaborate in a complementary way.