'The Council of Europe's AI Convention (2023-2024): Promises and Pitfalls for Health Protection' by Hannah van Kolfschooten and Carmel Shachar in (2023) Health Policy comments
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 the first legally-binding international treaty on AI. In this article, we highlight the implications of the proposed AI Convention for the health and human rights protection of patients. We praise the following characteristics: Global regulation for technology that easily crosses jurisdictions; The human rights-based approach with human rights assessment; The actor-neutral, full-lifecycle approach; The creation of enforceable rights through the European Human Rights Court. We signal the following challenges: The sector-neutral approach, The lack of reflection on new human rights,Definitional issues, and The process of global negotiations. We conclude that it is important for the Council of Europe not to compromise on the wide scope of application and the rights-based character of the proposed AI Convention.
In the medical field, physicians, patients, and tech developers are calling for regulation of Artificial Intelligence (AI). There are questions and concerns about doctors using ChatGPT, the liability of increasingly autonomous surgical systems, and the persistent racial biases exhibited by medical AI systems. Worldwide, legislators are rushing to regulate AI, while new applications keep popping up at an unprecedented speed. On the European continent, multiple regional legislative instruments are being negotiated in parallel. In June 2023, the European Parliament finally agreed on the content of the EU Artificial Intelligence Act (AI Act). Concurrently, the Council of Europe (CoE), Europe's most important human rights organization, is developing a legally binding instrument for the development, design, and application of AI systems: the “Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law” (AI Convention). The Convention will apply to the medical context.
Unlike the AI Act – that only applies to the 27 EU Member States – the AI Convention has the potential of becoming the first legally-binding international treaty on AI. We argue that, with its clear focus on fundamental rights protection, the AI Convention has the potential to fill the currently existing regulatory gaps in the protection of patients against the harms of medical AI. We first briefly outline the challenges posed by medical AI. Then we explain how the AI Convention is different from the AI Act and provide an overview of the current text of the AI Convention. Subsequently, we highlight the most important implications for the health and fundamental rights protection of patients. We conclude with recommendations on how to strengthen the protection of health in the ongoing legislative drafting of the AI Convention.
