Artificial Intelligence in Healthcare: The Paths For Its Regulation

Abstract

We live in an “artificial intelligence winter”: while humankind witnesses significant advances in the technical capabilities of artificial intelligence, its benefits are inferior to those aspired by society – and often seem to be outgrown by the disadvantages. This scenario of distrust in artificial intelligence is contemporary to a dispute over which actors should be responsible for the regulation of artificial intelligence. Healthcare has been suffering deep reflexes from this debate, due to the increasingly prominent role of these technologies and the fact that it is a highly regulated sector. The present paper aimed to explore the paths for the regulation of artificial intelligence in healthcare, considering the urgency in protecting fundamental rights in view of the development of new technologies and the relative failure of strategies that have prioritized self-regulation. The paper begins as an exposure of the risks associated with the adoption of artificial intelligence in healthcare, to then analyze the ways for the regulatory strategy of the sector in light of a general theory of regulation. We opted for an inductive approach, based on bibliographic and document research with the goal of identifying guidelines for the regulation of artificial intelligence in healthcare. Three principles have shown to be imperative for its construction: (i) the diffusion of knowledge, through informational and procedural duties of the organizations that own and utilize these technologies; (ii) the social role of property, understood as a limiting factor to potential violations to fundamental rights; and (iii) the incentive to cooperation between actors, by means of regulatory frameworks which guarantee the previous principles, promote competition, and stimulate self-regulation in a complementary manner.