Regulating the use of artificial intelligence in the doctor-patient relationship? A primer on supranational and national legal frameworks

Abstract

The paper aims at giving a general overview on the current regulatory frameworks concerning the use of AI systems within the doctor-patient relationship, assessing their effectiveness in minimising opacity and automation bias risks. The first section will focus on the supranational regulatory approach promoted by the Regulation (EU) n° 2024/1689 and will examine its applicative scope in the field of care relationship. The second part will analyse the regulatory solutions adopted at the national level, comparing the French and Italian normative approaches and the specific provision adopted to define doctors’ duties and patients’ rights. Finally, the paper will discuss the integration of various regulatory levels examined to establish a comprehensive regulatory framework for the use of AI in the doctor-patient relationship.