Artificial intelligence (AI) can have a significant positive impact on health and healthcare. AI can be used to improve the quality, efficiency and equity of health care. However, AI has the potential to have significant negative impacts. Therefore, AI medical applications should be designed and deployed in accordance with established guidelines and legislation. There may be gaps or questions in the current regulatory framework related to the interpretation and application of the existing regulatory framework to healthcare applications that include artificial intelligence solutions. Global standardization maintains a consistent approach and can reduce the burden on stakeholders when it comes to establishing regulatory frameworks, interpreting and complying with regulatory requirements. While AI is far from new, it has only recently become mainstream. This chapter outlines the research of the authors who are members of the Hoc Group on Application of AI Technologies in Health Informatics (ISO AHG2 TC215), which was formed by ISO Technical Committee 215 to define goals and directions for standardization in the field of AI in health care.