• Commentary: Chatbots in medicine: certification process and applied use case

    Commentary: Chatbots in medicine: certification process and applied use case

    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

  • Mental Health Europe report: Artificial Intelligence in mental healthcare

    Mental Health Europe report: Artificial Intelligence in mental healthcare

    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

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

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

    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

  • When people become data points – the potential impact of AI in mental healthcare

    When people become data points – the potential impact of AI in mental healthcare

    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

  • The European Health Data Space: give patients real control over their data

    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) and to better use health… Read more

  • The EU Artificial Intelligence Act (2024): Implications for healthcare

    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 world’s first extensive legal framework… Read more