Abstract  

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.