• Medical AI at Risk: Digital Omnibus Amendments Undermine Safeguards in Healthcare

    Medical AI at Risk: Digital Omnibus Amendments Undermine Safeguards in Healthcare

    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

  • Emerging Shadow Health Systems: Regulating Health-Focused Generative AI Chatbots from a European perspective

    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 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

  • Accounting for EU external effects: from clinical trials to data colonialism to AI ethics dumping

    Accounting for EU external effects: from clinical trials to data colonialism to AI ethics dumping

    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

  • Artificial Intelligence in Radiology: Safeguarding Patients’ Rights in the Digital Era

    Artificial Intelligence in Radiology: Safeguarding Patients’ Rights in the Digital Era

    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

  • Legal, ethical, and policy challenges of artificial intelligence translation tools in healthcare

    Legal, ethical, and policy challenges of artificial intelligence translation tools in healthcare

    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

  • AI Medical Devices after the Health Package: Innovation or lack of safeguards for patients?

    AI Medical Devices after the Health Package: Innovation or lack of safeguards for patients?

    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