The European Union is on the brink of an artificial intelligence (AI) revolution in the health sector. AI holds the promise of saving billions of lives by improving the quality of healthcare, reducing costs, increasing accessibility of healthcare, and anticipating health emergency threats. At the same time, AI can bring about serious risks to patients’ rights, such as medical privacy, self-determination, and equal access to healthcare. As technology is preceding legal developments, it is doubtful whether the current framework for patients’ rights protection in Europe is sufficiently adapted to the impact of AI technology on patients. Creating an EU regulatory and legislative framework in the field of AI is complex: the EU is faced with the difficult task of striking a balance between innovation and individual interests, rights, and values. This PhD research project, conducted by Hannah van Kolfschooten, examines the ways in which health AI is and will be regulated at the EU level and explores legal challenges through a patients’ rights lens.

Part of this research project was conducted at Harvard Law School as part of a visiting fellowship. Kristina Irion from the Institute for Information Law (IViR) is involved in this project as a co-supervisor.

Researchers involved

Publications

• van Kolfschooten, H. (2022). EU Regulation of Artificial Intelligence: Challenges for Patients’ Rights. Common Market Law Review, 59(1), 81-112. https://doi.org/10.54648/cola2022005 [details]
• van Kolfschooten, H. B. (2022). The mHealth Power Paradox: Improving Data Protection in Health Apps through Self-Regulation in the European Union. In I. G. Cohen, T. Minssen, W. N. Price II, & C. Robertson (Eds.), The Future of Medical Device Regulation: Innovation and Protection (pp. 63-76). Cambridge University Press. https://doi.org/10.1017/9781108975452.006
• van Kolfschooten, H. B., & Wallage, B. (2022). Apps in de gezondheidszorg: een mensenrechtelijk vraagstuk. In B. Aarrass, CLGFH. Albers, & R. Ortlep (Eds.), Digitalisering in de rechtsverhouding tussen burger en overheid: Zoeken naar een balans tussen instrumentaliteit en waarborg (pp. 223-240). Wolters Kluwer Nederland.
• van Kolfschooten, H., Spaander, M., & Legemaate, J. (2021). Rode draad 70 jaar EVRM: De autonome patiënt na 70 jaar EVRM: Van dwangpsychiatrie naar gentechnologie? Nederlands Tijdschrift voor de Mensenrechten, 46(2), 113-130. [12]. http://deeplinking.kluwer.nl/?param=00D5D16B&cpid=WKNL-LTR-Nav2 [details]
• van Kolfschooten, H. B. (Author). (2023). The Council of Europe’s Artificial Intelligence Convention: Implications for Health and Patients. Web publication or website, Bill of Health | Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. https://blog.petrieflom.law.harvard.edu/2023/04/18/council-of-europe-artificial-intelligence-convention/
• van Kolfschooten, H. (Author), & Palmieri, S. (Author). (2022). A Health-Oriented Approach to the Declaration on European Digital Rights and Principles. Web publication/site, The Digital Constitutionalist. https://digi-con.org/a-health-oriented-approach-to-the-declaration-on-european-digital-rights-and-principles/ [details]
• van Kolfschooten, H. (2021). Gegevensbescherming in gezondheidscrises in de EU: apps in de strijd tegen COVID-19. Ars Aequi, 70(7/8), 766-775. https://arsaequi.nl/product/gegevensbescherming-in-gezondheidscrises-in-de-eu-apps-in-de-strijd-tegen-covid-19/ [details]
• van Kolfschooten, H. B. (2021). Eerste stappen in Europese regulering van artificiële intelligentie: algoritmes en patiëntenrechten. Tijdschrift voor Gezondheidsrecht, 45(4), 381-389. https://doi.org/10.5553/TvGR/016508742021045004008 [details]
• van Kolfschooten, H. B. (2020). AB 2020/236. 236. Case note on: Rb. Den Haag, 5/02/20, ECLI:NL:RBDHA:2020:865 AB Rechtspraak Bestuursrecht, 2020(25), 1510-1539. [details]
• Félix Cardoso, J. (Author), van Kolfschooten, H. B. (Author), Nogueira Leite, D. (Author), Petročnik, T. (Author), & Vasconcelos, H. (Author). (2022). How the Parliament’s AIDA Report Misdiagnoses the Risks and Benefits of Health AI. Web publication or website, Euractiv. https://www.euractiv.com/section/digital/opinion/how-the-parliaments-aida-report-misdiagnoses-the-risks-and-benefits-of-health-ai/
• van Kolfschooten, H. (Author). (2021). Conspicuous by its absence: health in the European Commission’s Artificial Intelligence Act. Web publication/site, BMJ Opinion. https://blogs.bmj.com/bmj/2021/07/30/conspicuous-by-its-absence-health-in-the-european-commissions-artificial-intelligence-act/ [details]
• van Kolfschooten, H. B. (Author), van Oirschot, J. (Author), & Nicastro, C. (Author). (2023). Five “Big MedTech” Myths about Medical AI Debunked. Web publication or website, Health Action International/HAI. https://haiweb.org/five-big-medtech-myths-about-medical-ai-debunked/

• van Kolfschooten, H. B. (2020). Technologische hulp uit China is niet gratis. NRC Handelsblad. https://www.nrc.nl/nieuws/2020/03/30/technologische-hulp-uit-china-is-niet-gratis-a3995326

• van Kolfschooten, H. B., & Wallage, B. (2020). Overheid, pas op met gezondheidsdata en het uitvoeren van massasurveillance. Het Financieele Dagblad. https://fd.nl/opinie/1339613/overheid-pas-op-met-gezondheidsdata-en-massasurveillance?fbclid=IwAR0ivt5LsnYIyjgT4YNWaSA3tO12g-ZqQX2FW6C_yxNqYP8noD4Qa4nSlXk