Category: Digital Health Law
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The European Health Data Space: give patients real control over their data
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)…
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The EU Artificial Intelligence Act (2024): Implications for healthcare
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…
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A health-conformant reading of the GDPR’s right not to be subject to automated decision-making
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…
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Reinforcing Stereotypes in Health Care Through Artificial Intelligence–Generated Images: A Call for Regulation
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…
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A Human Rights-Based Approach to Artificial Intelligence in Healthcare: A Proposal for A Patients’ Rights Impact Assessment Tool
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…
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The prospects of using AI in euthanasia and physician-assisted suicide: a legal exploration
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…
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The AI cycle of health inequity and digital ageism: mitigating biases through the EU regulatory framework on medical devices
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…
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The Council of Europe’s AI Convention (2023-2024): Promises and Pitfalls for Health Protection
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.…
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Women’s Health Rights can Guide International Climate Litigation: KlimaSeniorinnen v. Switzerland before the European Court of Human Rights
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.…
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The Council of Europe’s Artificial Intelligence Convention: Implications for Health and Patients
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…
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Five “Big MedTech” Myths about Medical AI Debunked
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…
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Health protection is non-negotiable in the AI Act negotiations
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…
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Call for Action: High Time to Prioritise Health in the EU Artificial Intelligence Act
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…
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A Health-Oriented Approach to the Declaration on European Digital Rights and Principles
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…
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Van verplichte geestelijke gezondheidszorg naar verplichte anticonceptie?
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…
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EU Regulation of Artificial Intelligence: Challenges for Patients’ Rights
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…
Hannah van Kolfschooten 