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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 30/09/2026

Our new paper “High-risk without safeguards? The EU AI Act and the push for deregulation of medical AI” is out in BMJ Digital Health & AI. We examine the Digital Omnibus&Health Innovation Package, and what regulatory “simplification” could mean for safeguards for medical AI. doi.org/10.1136/bmjd...

doi.org

High-risk without safeguards? The EU AI Act and the push for deregulation of medical AI

Artificial intelligence (AI) is increasingly embedded in clinical decision-making, yet recent proposals to simplify the European Union (EU) Artificial Intelligence Act (AI Act) have reopened the quest...

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The Lancet Reg Health-Europe @lancetrh-europe.bsky.social · 18/08/2026

🎧New podcast: We discuss #AI prominence in the European Commission's #SafeHeartsPlan, opportunities that AI will bring, and the need for robust legal, institutional, and operational frameworks @hvkolfschooten.bsky.social Apple: shorturl.at/Psz66 Spotify: shorturl.at/n2HOh

shorturl.at

Artificial intelligence in the EU Safe Hearts Plan with Giulio Stefanini and Hannah van Kolfschooten

Podcast Episode · The Lancet Regional Health Europe in conversation with · August 17 · 23m

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University of Basel @unibas.ch · 14/08/2026

A new EU strategy is placing greater emphasis on the use of artificial intelligence in heart disease management. However, @hvkolfschooten.bsky.social believes this is premature. In an interview, she criticizes the lack of demonstrated benefits for patients and the gaps in the legislation.

unibas.ch

AI in cardiology: The path to practical application carries risks

A new EU strategy is placing greater emphasis on artificial intelligence in the management of heart disease. Legal researcher Hannah van Kolfschooten believes this is premature. Among other things, sh...

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 29/06/2026

New paper in Frontiers in Public Health! We argue that AI chatbots are giving rise to shadow health systems: privately governed AI infrastructures that increasingly shape how people make health decisions and seek care, without being regulated as healthcare. doi.org/10.3389/fpub...

doi.org

Frontiers | Emerging shadow health systems: regulating health-focused generative AI chatbots from a European perspective

ChatGPT Health and other health-focused generative AI chatbots increasingly function as alternative first points of contact that may mediate—and in some case...

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Reposted by Hannah van Kolfschooten

The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 18/06/2026

New open-access: "Prohibited AI Practices in Healthcare under the European Artificial Intelligence Act" by @hvkolfschooten.bsky.social. "Understanding how these categorical prohibitions and their exceptions interact is crucial for sectors like healthcare..." #AIAct www.cambridge.org/core/journal...

Prohibited AI Practices in Healthcare under the European Artificial
Intelligence Act
Hannah van Kolfschooten
Centre for Life Sciences Law, University of Basel, Basel, Switzerland
Abstract
The European Union’s Artificial Intelligence Act introduces a novel regulatory category of“unacceptable risk,” prohibiting specific AI practices
that are deemed fundamentally incompatible with human rights and ethical principles. While much attention has focused on the regulation of
high-risk AI systems, particularly in medical contexts, the AI Act’s outright bans under Article 5 have received far less scrutiny. This paper
addresses that gap by examining how these prohibitions apply to healthcare and public health, which are domains defined by rapid
technological uptake, structural vulnerability, and ethically sensitive decision-making. Drawing on the European Commission’s 2025 interpret-
ative Guidelines, the paper argues that several health-related AI applications, such as emotion recognition tools, biometric categorisation systems,
and technologies that influence or target vulnerable populations, may fall within the scope of the bans. It also shows that the Act’s medical and
safety exceptions risk weakening the vulnerability protections that the prohibitions aim to secure. By integrating legal analysis with real-world
health examples, the paper offers a framework for interpreting these prohibitions and assesses how they should guide the ethical boundaries of AI
in healthcare, within and beyond the European context.
Keywords: Artificial Intelligence; AI regulation and ethics; EU AI Act; health technology; digital health

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Health Action International @hai-org.bsky.social · 02/07/2025

Period tracking apps raise considerable risks & challenges to rights, including data privacy. In countries where reproductive rights are threatened this data can have serious consequences. @hvkolfschooten.bsky.social & @aliceebeck.bsky.social explain more: haiweb.org/period-track...

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 07/05/2025

In a @bmj.com Response, @nicolegross.bsky.social, @aliceebeck.bsky.social &I argue that important gaps remain in the EU AI Act when it comes to the protection of patients' rights. Such regulatory pitfalls risk undermining public trust, safety, and equity ➡️ Read lnkd.in/eedZMKZY @hai-org.bsky.social

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 22/04/2025

Out now in EYHR: 𝐀 𝐇𝐮𝐦𝐚𝐧 𝐑𝐢𝐠𝐡𝐭𝐬-𝐁𝐚𝐬𝐞𝐝 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡 𝐭𝐨 𝐀𝐫𝐭𝐢𝐟𝐢𝐜𝐢𝐚𝐥 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞 𝐢𝐧 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞: 𝐀 𝐏𝐫𝐨𝐩𝐨𝐬𝐚𝐥 𝐟𝐨𝐫 𝐚 𝐏𝐚𝐭𝐢𝐞𝐧𝐭𝐬’ 𝐑𝐢𝐠𝐡𝐭𝐬 𝐈𝐦𝐩𝐚𝐜𝐭 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐓𝐨𝐨𝐥. How can doctors & informal carers make informed decisions about AI tools in a way that respects patients’ rights? papers.ssrn.com/sol3/papers....

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Health Action International @hai-org.bsky.social · 22/04/2025

Before using AI tools for mental health, ensure you understand their privacy policies. We heard privacy concerns raised when we talked to people on the streets of Amsterdam. What steps can we take to ensure our private information stays private? 🎬 Watch the full video: lnkd.in/eKqn3dNU

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 19/03/2025

Vandaag in @volkskrant.nl: een interview over mijn proefschrift. “Juist patiënten die minder gezond zijn, of niet goed met een chatbot overweg kunnen, komen op grotere gezondheidsachterstand. Omdat zij niet de doelgroep van zo’n AI-systeem zijn.” Lees meer: www.volkskrant.nl/wetenschap/d...

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 17/03/2025

In #SwissMedicalWeekly, I raise concerns about the growing reliance on genAI systems, such as ChatGPT, in medicine. Unlike purpose-built healthcare chatbots, these tools are not specifically designed for healthcare.They lack the safeguards of certified medical chatbots. 📖 smw.ch/index.php/sm...

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Health Action International @hai-org.bsky.social · 07/03/2025

What an incredible milestone for our colleague, @hvkolfschooten.bsky.social, who earned her well-deserved PhD yesterday! Hannah’s research delves into how patient rights can be safeguarded amid the rapid advancements of AI technologies in healthcare. Congratulations, Dr. Van Kolfschooten!

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 27/02/2025

I spoke with the @uvalawschool.bsky.social about my dissertation "Patients' Rights Protection and Artificial Intelligence in the European Union". We talked about ambulance software, prediction of intellectual development in babies, hypes, risks, and rights. Read more 👉 www.uva.nl/en/shared-co...

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Law Centre for Health and Life @lawhealthlife.bsky.social · 21/02/2025

Is AI in healthcare outpacing legal protections? In Digital Society, @hvkolfschooten.bsky.social from Law for Health and Life proposes an EU Charter of Digital Patients’ Rights—adapting privacy & consent and introducing new safeguards for AI-driven care. 🔗 Read more: bit.ly/4gUBb2Z

bit.ly

Towards an EU Charter of Digital Patients’ Rights in the Age of Artificial Intelligence - LHL

Hannah van Kolfschooten recently published an article in Digital Society titled “Towards an EU Charter of Digital Patients’ Rights in the Age of Artificial Intelligence”.

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 05/02/2025

Out today: the sixth and final paper of my PhD dissertation on patients' rights protection & AI. In this paper in #DigitalSociety🔓 I propose an 𝑬𝑼 𝑪𝒉𝒂𝒓𝒕𝒆𝒓 𝒇𝒐𝒓 𝑫𝒊𝒈𝒊𝒕𝒂𝒍 𝑷𝒂𝒕𝒊𝒆𝒏𝒕𝒔’ 𝑹𝒊𝒈𝒉𝒕𝒔 to address the specific challenges presented by AI technologies in this sector. Read more 👉 doi.org/10.1007/s442...

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 01/02/2025

Counting down the days for my PhD defence @ University of Amsterdam! 🌟@uvalawschool.bsky.social

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Greenpeace International 🌍 @greenpeace.org · 22/01/2025

Although the #WEF25 claims to be a place for tackling issues like climate change, poverty and inequality, participants continue to drive environmental degradation and climate breakdown both with their #privatejets lifestyles. This has to change. act.gp/taxthesuperrich

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 23/01/2025

Interesting panel (or should I say MANel - where are the women?) about improving efficiency in healthcare with AI at #AIHouseDavos. The panellists named regulation as the biggest constrain for AI implementation. I would like to argue the opposite. #WEF2025

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 21/01/2025

#AIRA is a three-year project with the aims of mapping the uses of artificial intelligence that affect the lives of autistic people, and building up the capacity of autistic people to advocate for themselves. Join today's webinar! ⭐ eucap.eu/aira/

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 14/01/2025

#AI in #mentalhealthcare offers interesting opportunities. Yet, AI also introduces a set of new risks that extend beyond individual patients to broader societal concerns. Read our policy brief with (legal) recommendations here 👉: lnkd.in/eFzWXK_Q 🤖 @hai-org.bsky.social

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 13/12/2024

Curious about the implications of the EU AI Act for healthcare? In #HealthPolicy we give an overview of the new legal obligations for relevant stakeholders (doctors, hospitals, developers…) 🌟 doi.org/10.1016/j.he...

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Angela Hefti @angelahefti.bsky.social · 06/12/2024

Bringing this over: our paper on health, intersectionality and climate litigation in the @HarvHumRtsJ! 🍀 Wonderful collaboration with @hvkolfschooten.bsky.social and @amintaossom.bsky.social on this important topic. journals.law.harvard.edu/hrj/current/

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 03/12/2024

Interesting event at the Health Ethics & Policy Lab at @ethzurich.bsky.social. Visualizing digital regulation in an interactive tool for health policymakers is exactly what we need right now. Let’s focus on better regulation for health AI - not less. 💫

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 28/11/2024

Last month, the Sarco suicide pod was first used in Switzerland. On #BioethicsToday I question whether #AI systems will redefine how society navigates #end-of-life choices. Are legal and ethical frameworks ready to respond to this challenge?▶️ bioethicstoday.org/blog/the-sar... #healthAI #medicalAI

bioethicstoday.org

Blog - The ‘Sarco Suicide Pod’ and Beyond: AI in the Future of End-of-Life Decisions? - Bioethics Today

Recent headlines have reignited the debate on assisted dying in light of technological advancements. Last month, the controversial 'Sarco suicide pod’

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Hannah van Kolfschooten @hvkolfschooten.bsky.social · 16/11/2024

I had a wonderful time in Lisbon at #EPH2024 as a EUPHAnxt fellow. The European #public #health community is full of innovative ideas - and I’m happy to work together on the best ways to regulate #AI in public health. 🍀 @eupha.bsky.social

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