Regulation of AI in health care: a cautionary tale considering horses and zebras

Abstract

The introduction of Artificial Intelligence (AI) into health care has been accompanied by uncertainties and regulatory challenges. The establishment of a regulatory framework around AI in health is in its infancy and the way forward is unclear. There are those who argue that this represents a concerning regulatory gap, while others assert that existing regulatory frameworks, policies and guidelines are sufficient. We argue that perhaps the reality is somewhere in between, but that there is a need for engagement with principles and guidelines to inform future regulation. However, this cannot be done effectively until there is more clarity around the reality of AI in health and common misconceptions are addressed. This paper explores some of these misconceptions and argues for a principled approach to the regulation of AI in health.