Law, health and artificial intelligence
Dr. Hannah van Kolfschooten is an academic working at the intersection of law, health, and artificial intelligence. She studies how new technologies are reshaping healthcare and society, with a particular focus on human rights, ethics, and responsible governance. She translates complex legal and technological developments into accessible insights for all.
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Artificial intelligence (AI) is already being used to read scans, support diagnoses, and guide treatment decisions. Yet just as these systems are entering everyday clinical practice, Europe may weaken the rules meant to keep them safe. In March 2026, the European Parliament adopted its position on a “digital omnibus” reform that aims to simplify the… Read more ⇢
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Generative Artificial Intelligence (genAI) chatbots have become an important outlet for many people around the world who are experiencing mental health issues. Of its 800 million weekly users, around 10 percent use ChatGPT for emotional support while more than one million use the chatbot to talk about issues such as depression, psychosis and suicidal ideation. For many users,… Read more ⇢
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Members of the European Parliament are about to take a decision that will fundamentally shape how artificial intelligence (AI) is governed in European healthcare. The Internal Market and Consumer Protection (IMCO) and Civil Liberties, Justice and Home Affairs (LIBE) compromise amendments propose deleting Annex I, Section A of the AI Act and shift medical devices… Read more ⇢
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ChatGPT Health and other health-focused generative AI chatbots increasingly function as alternative first points of contact that may mediate – and in some cases substitute – engagement with regulated healthcare systems. At scale, these systems can shape care-seeking behavior, system capacity, trust in clinical expertise, and health equity. We describe this development as the emergence of shadow… Read more ⇢
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Against a backdrop of rapidly expanding health artificial intelligence (AI) development, this paper examines how the European Union’s (EU) stringent digital regulations may incentivise the outsourcing of personal health data collection to low- and middle-income countries (LMICs), fuelling a new form of AI ethics dumping. Drawing on parallels with the historical offshoring of clinical trials,… Read more ⇢
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Please cite as: Hannah van Kolfschooten, ‘Artificial Intelligence in Radiology: Safeguarding Patients’ Rights in the Digital Era’, European Radiology 2026. Artificial intelligence (AI) is now firmly embedded in radiology practice. From automated abnormality detection on chest radiographs to workflow optimisation in triage, AI is increasingly shaping diagnostic processes. Its promise is substantial: improved efficiency, faster… Read more ⇢
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Artificial intelligence (AI) translation tools, such as Google Translate and ChatGPT, are increasingly used in healthcare for medical communication to overcome language barriers between patients and providers. While these tools offer accessible and efficient translation, their use raises significant legal, ethical, and policy concerns. Key patients’ rights, including the rights to privacy, informed consent, and… Read more ⇢
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As someone who has followed the AI Act closely from the very beginning, particularly in the context of healthcare, the European Commission’s new health package immediately raised some questions. Concretely, the Commission proposes to move the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) from Section A to Section B in… Read more ⇢
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Intellectual property (IP) rights and IP-related rights, such as trade secrets and regulatory exclusivities, play a crucial role in the development and deployment of artificial intelligence (AI) technologies. However, possible interactions may be anticipated when comparing the legal relationships formed by these rights with those established by human rights. This study synthesises 53 laws and… Read more ⇢
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Machine learning-based artificial intelligence (AI) chatbots are increasingly used to promote health and encourage individuals to adopt healthier behaviors. Chatbots driven by generative AI (genAI) simulate human interactions through text or voice to generate personalized content with guidance on topics such as smoking cessation, nutrition, managing stress, and sleep improvement. The use of AI chatbots… Read more ⇢
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With digital technologies, your patients have a ‘doctor in their pocket’. But something new is happening when they search online for medical advice. Typing a question such as “Can I take ibuprofen with blood pressure tablets?” or “What helps against chest pain?” into Google no longer produces the familiar list of links. Instead, a confident,… Read more ⇢
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WHO/Europe has formed the Technical Advisory Group on Artificial Intelligence for Health (TAG-AI) to guide the ethical, responsible and equitable use of AI in health across the WHO European Region. The group will serve as an advisory body to the WHO Regional Director for Europe for an initial period of 2 years under the second… Read more ⇢
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Picture a typical teenager waking up. Before even getting out of bed, they’ve already scrolled through TikTok, checked Instagram, and responded to Snapchat notifications. Each swipe delivers content fine-tuned by algorithms designed to maximize attention and engagement. Autoplay keeps the feed going. Notifications prompt more interaction. Autoplay keeps content flowing. Sleep, focus, and mental health… Read more ⇢
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Last week, reports emerged in the UK of concerned public health experts calling for public alternatives to commercial period tracking apps. Their research shows that women’s personal data is at great risk. More and more people who menstruate make use of period tracking apps, also referred to as ‘cycle tracking apps’ (CTAs). The European market for these… Read more ⇢
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Artificial Intelligence (AI) presents unprecedented opportunities to transform healthcare worldwide, from improving diagnostic accuracy to expanding access in underserved regions. Despite this potential and growing investment, a significant gap persists between AI’s theoretical promise and its realised benefits in healthcare settings. This article examines the complex barriers impeding AI benefits realization in global health contexts,… Read more ⇢
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Nicole Gross, Hannah van Kolfschooten & Alice Beck Response to BMJ 2025;388:r27 Dear Editor, In response to the BMJ article titled ‘AI in medicine: preparing for the future while preserving what matters’, we agree that an AI-driven future in healthcare is inevitable, and we must be prepared. The article emphasizes AI’s inherent limitations and risks, the… Read more ⇢
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The article by Nehme et al. [1] provides a comprehensive analysis of the regulatory and certification challenges faced by healthcare chatbots. Using the confIAnce chatbot as a case study, the authors explore its classification as a non-medical device under the EU Medical Device Regulation (MDR) and the Swiss Medical Devices Ordinance (MedDO). They outline the processes required… Read more ⇢
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This study explores the opportunities, risks, and ethical considerations surrounding the use of artificial intelligence (AI) systems in mental healthcare and provides recommendations for their responsible implementation and regulation. Healthcare forms one of the most popular sectors for AI deployment in the EU. In mental healthcare, AI systems are used in diverse ways, from administrative… Read more ⇢
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Abstract The rapid advancement of digital health innovation, including Artificial Intelligence (AI), is transforming healthcare. The growing role the European Union (EU) plays in regulating the use of AI in healthcare renders national laws insufficient to safeguard patients from unique AI-related risks. This underscores the urgent need for the recognition of a canon of patients’… Read more ⇢
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Hannah van Kolfschooten & Janneke van Oirschot Introduction Artificial intelligence (AI) holds great promise for transforming mental healthcare. From personalized treatment plans to early detection of mental health conditions, AI could make mental health services more accessible and effective. AI systems are already being developed for various applications, including diagnostic tools, therapeutic support (such as… Read more ⇢
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Janneke van Oirschot & Hannah van Kolfschooten Give patients real control over their data within the EHDS The aims of the European Commission’s European Health Data Space (EHDS) are twofold: to improve people’s access to, and control over their personal electronic health data in the context of healthcare (primary use) and to better use health… Read more ⇢
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Hannah van Kolfschooten & Janneke van Oirschot. In August 2024, the EU Artificial Intelligence Act (AI Act) entered into force. This legally binding instrument sets rules for the development, the placing on the market, the putting into service, and the use of AI systems in the European Union. As the world’s first extensive legal framework… Read more ⇢
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Abstract As the use of Artificial Intelligence (AI) technologies in healthcare is expanding, patients in the European Union (EU) are increasingly subjected to automated medical decision-making. This development poses challenges to the protection of patients’ rights. A specific patients’ right not to be subject to automated medical decision-making is not considered part of the traditional portfolio of… Read more ⇢
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Hannah van Kolfschooten & Astrid Pilottin In March 2024, the European Parliament formally adopted the European Union Artificial Intelligence (AI) Act (EU AI Act), establishing harmonized rules on AI systems placed on the European market. It is the first legal framework to regulate Generative AI (GenAI). Generative AI deploys machine learning techniques based on user… Read more ⇢
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Europe is ageing and the health workforce crisis puts the quality and availability of healthcare at risk, especially in elderly care. Artificial Intelligence (AI) solutions may alleviate the health workforce crisis and contribute to the highest attainable standard of physical and mental health for all in an ageing Europe. At the same time, however, these… Read more ⇢
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The Netherlands was the first country to legalize euthanasia and physician-assisted suicide. This paper offers a first legal perspective on the prospects of using AI in the Dutch practice of euthanasia and physician-assisted suicide. It responds to the Regional Euthanasia Review Committees’ interest in exploring technological solutions to improve current procedures. The specific characteristics of… Read more ⇢
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The use of Artificial Intelligence (AI) medical devices is rapidly growing.Although AI may benefitthe quality and safety of healthcare for older adults,it simultaneously introduces new ethical and legal issues. Many AI medical devices exhibit age-related biases. The first part of this paper explainshow ‘digital ageism’ is produced throughout the entire lifecycle of medicalAI and may… Read more ⇢
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The Council of Europe, Europe’s most important human rights organization, is developing a legally binding instrument for the development, design, and application of AI systems. This “Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law” (AI Convention) aims to protect fundamental rights against the harms of AI. The AI Convention may become… Read more ⇢
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Hannah van Kolfschooten and Angela Hefti All over the world, individuals are taking governments to court for their role in climate change, or rather, their “climate inaction”. The 2022 Global Trends in Climate Change Litigation Policy Report shows that strategic litigation cases to enforce climate laws and policies have doubled since 2015. On 29 March 2023, the… Read more ⇢
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The Council of Europe, the most important international human rights organization on the European continent, currently is drafting a Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law (AI Convention). The Convention aims to protect fundamental rights against the harms of Artificial Intelligence (AI), and is expected to become a global leading convention, as non-European states such… Read more ⇢
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Criticism of the European Union’s AI Act by the HealthTech Industry is often based on incorrect assumptions, and is in conflict with health and fundamental rights principles, write Hannah van Kolfschooten, Janneke van Oirschot, and Claudia Nicastro. The European Union’s Artificial Intelligence (AI) Act is a world-first attempt to create comprehensive AI regulation, to protect both the… Read more ⇢
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In April 2021, the European Commission proposed the Artificial Intelligence Act, which is now debated in the EU parliament. The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical… Read more ⇢
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A health-centric approach to the Artificial Intelligence (AI) Act is essential for the protection of health and fundamental rights of European citizens, write Hannah van Kolfschooten and Janneke van Oirschot. The European Commission’s proposal for an Artificial Intelligence (AI) Act has been the topic of a heated debate since its publication in April 2021. Civil society organisations… Read more ⇢
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Last year, the European Commission published its long awaited legislative proposal on artificial intelligence (AI): the Artificial Intelligence Act (AIA). Since then, a heated debate has been going on about its contents, as many civil society organisations believe the proposal falls short on fundamental rights protection. Various committees within the European Parliament have proposed amendments to the Commission’s AI proposal… Read more ⇢
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Hannah van Kolfschooten and Sofia Palmieri Europe is in the midst of a digital revolution transforming many aspects of daily life. In the healthcare sector, digitalisation may change today’s values and rights. Health tech developments range from relatively simple digital solutions—such as online appointment systems and digital health records—to artificial intelligence (AI) applications—such as AI-powered… Read more ⇢
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Met de inwerkingtreding van de Wet verplichte geestelijke gezondheidszorg (Wvggz) is de jarenlange ethisch juridische discussie omtrent preventie van onverantwoord ouderschap nieuw leven ingeblazen. Inmiddels is er een heel aantal uiteenlopende rechterlijke uitspraken gewezen over de (on)mogelijkheid om verplichte anticonceptie op te leggen op grond van de Wvggz. Deze bijdrage bespreekt de betekenis van die… Read more ⇢
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In order to create a well-functioning internal market for Artificial Intelligence (AI) systems, the European Commission recently proposed the Artificial Intelligence Act. However, this legislative proposal pays limited attention to the health-specific risks the use of AI poses to patients’ rights. This article outlines that fundamental rights impacts associated with AI such as discrimination, diminished… Read more ⇢
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In November 2021, the European Parliament’s Special Committee on AI in a Digital Age (AIDA Committee) put forward its draft report on artificial intelligence (AI) in a digital age. The report advocates for a very permissive approach to the regulation of AI to stimulate innovation and foster the competitiveness of the EU. With this, however, it… Read more ⇢
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The use of artificial intelligence (AI) in healthcare is becoming increasingly common. This development holds great promise for the quality and accessibility of healthcare, but is not without risks. On the one hand, AI has its advantages: it facilitates accurate diagnosis of patients and it makes it possible to hold e-consults. On the other hand, it… Read more ⇢
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Earlier this year, the European Commission published its long awaited legislative proposal on artificial intelligence (AI): the Artificial Intelligence Act. With the proposed Artificial Intelligence Act, the European Commission has taken the first steps towards uniform rules on AI in the EU. The act aims to take a balanced approach to regulating AI, which ensures effective protection… Read more ⇢
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Mobile technology is increasingly being used to manage crisis situations, such as the corona pandemic. Apps process large quantities of personal data, which has consequences for the right to data protection. In the battle against COVID-19, millions of European citizens entrust Covid-apps with their sensitive personal data. To what extent may the right to data… Read more ⇢
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Hannah van Kolfschooten & Bastiaan Wallage On 25 May 2018, the General Data Protection Regulation (GDPR) entered into force. From then on, the lawfulness of processing personal data within the European Union has been harmonised. The right to personal data protection, an important part of the human right to privacy, is thus one of the… Read more ⇢
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Information for early detection of health emergencies can save lives. In the COVID-19 crisis, we see that national governments in the European Union (EU) turn to widespread surveillance and contact tracing in order to gather information on the spreading and risks of the virus. Contact tracing is the tracing of individuals and their contacts, who… Read more ⇢
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My interest in health emergencies was sparked when reading Saramago’s novel Blindness at age 16. It tells the story of a sudden blindness pandemic afflicting nearly everyone and I loved every word. Since then, I’ve seen countless post-apocalyptic movies on pandemics, ranging from classic contagion to zombies. I’ve played the video game Plague Inc. so… Read more ⇢
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