Hannah van Kolfschooten.

Dr. Hannah van Kolfschooten is an international speaker and legal scholar specialising in artificial intelligence, healthcare and law, based between Basel (Switzerland) and Amsterdam (the Netherlands). Her speaking topics include AI governance and regulation in healthcare, clinical responsibilities when using AI, the EU AI Act, AI liability and accountability, patients’ rights in the age of AI, and AI in mental healthcare.

Dr. Van Kolfschooten is an Assistant Professor of Law at Tilburg University and researcher at the University of Basel. She holds a PhD in Law on the regulation of medical artificial intelligence in the European Union and previously worked as a lecturer at the University of Amsterdam. She was a visiting researcher at Harvard Law School, the University of Verona and Fondation Brocher. She is a member of the World Health Organization’s Technical Advisory Group on AI in Health (WHO TAG-AI) and the European Commission’s AI Act Advisory Forum.

Her speaking experience includes keynotes and invited presentations at the World Health Organization’s Global Conference “Shaping AI in Health,” an Amsterdam UMC conference on AI in mental health, the Institute of Tropical Medicine Antwerp and the Danish Association for Industrial Property Protection’s annual conference. She has also delivered expert talks for the European Commission, the Dutch Parliament, the Dutch Ministry of Health, the European Cancer Organisation, the European Oncology Nursing Society and Guy’s & St Thomas’ NHS Foundation Trust.

She has been invited to speak at Harvard Law School and the Universities of Geneva, Lausanne, Amsterdam, Lund, Copenhagen, Trier, Turin and Roma Tre. In Switzerland, she teaches health professionals and entrepreneurs through the University of Bern’s sitem-insel School and the University of Basel Innovation Office.

Her audiences span healthcare professionals and executives, policymakers, international organisations, technology and legal professionals, researchers, entrepreneurs and interdisciplinary innovation communities. Her work is particularly relevant to healthcare, pharmaceutical, life-sciences and technology organisations navigating the legal, ethical and governance implications of AI. She speaks primarily in English and Dutch and is available for events in Switzerland and internationally.

SIGNATURE KEYNOTES

1. When Clinicians Use AI: Rethinking Professional Responsibility

Healthcare professionals increasingly use AI for diagnosis, treatment recommendations, documentation, risk prediction and clinical decision support. But what does responsible AI use actually require from the clinician? This keynote examines how AI reshapes professional responsibilities around appropriate reliance, human oversight, patient information, clinical judgment and liability, including emerging obligations under the EU AI Act.

It also looks beyond legislation to the growing importance of professional standards and clinical guidelines for AI use. As AI becomes embedded in everyday practice, hospitals and professional bodies will increasingly need to translate broad legal and ethical principles into concrete rules for clinicians: when AI may be used, when its outputs should be questioned, what patients should be told, and when human alternatives or additional oversight are necessary.

Key takeaways:
- How AI changes clinical responsibilities without replacing professional judgment and accountability.
- What responsible reliance, meaningful human oversight and appropriate patient information mean in clinical practice.
- Why hospitals and professional bodies should develop clear professional guidelines for clinical AI use, and which questions those guidelines need to address.

Ideal for: hospitals, healthcare professionals, medical associations, healthcare executives, pharmaceutical and life-sciences companies, medtech companies, insurers.

2. Governing AI in Healthcare: From the EU AI Act to Patients’ Rights

Europe is building an increasingly complex regulatory framework for artificial intelligence in healthcare. The EU AI Act adds new rules for AI developers and deployers, but it operates alongside medical-device law, data protection, health law and patients’ rights. This keynote cuts through this regulatory complexity and asks a more fundamental question: what does good AI governance in healthcare actually require?

Key takeaways:
- How the EU AI Act fits within the wider European framework governing healthcare AI.
- Why legal compliance alone may not be enough to protect patients and healthcare professionals.
- How organisations can move from fragmented compliance towards responsible AI governance.

Ideal for: healthcare organisations, pharmaceutical and life-sciences companies, medtech companies, policymakers, regulators, legal and compliance professionals, and executives working with AI and digital health.

3. Shadow Health Systems: When ChatGPT Becomes Healthcare

Millions of people increasingly turn to ChatGPT and other general-purpose AI systems for health information, advice and support. These systems can influence how people interpret symptoms, choose treatments and decide whether to seek professional care, yet they operate largely outside traditional healthcare systems. This keynote explores the rise of these emerging “shadow health systems”, the risks they create for patients and society, and whether existing regulation is equipped to govern AI when it effectively begins to function as healthcare.

Key takeaways:
- How general-purpose AI is becoming an informal layer of the healthcare system.
- Why health-related use of ChatGPT creates new challenges for safety, responsibility and patients’ rights.
- Where existing AI, healthcare and digital regulation leaves important governance gaps.

Ideal for: healthcare organisations, pharmaceutical and life-sciences companies, technology companies, policymakers, regulators, patient organisations, insurers, and AI and digital-health conferences.