Regulatory considerations on artificial intelligence for health

Overview

The International Telecommunication Union (ITU) is the United Nation’s specialized agency for information and communications technology while WHO is the United Nation’s specialized agency for health. These organizations partnered to establish an open group of experts to develop a generalizable benchmarking framework for health solutions based on AI – the ITU/WHO Focus Group on AI for Health (FG-AI4H). In order to facilitate the safe and appropriate use of AI technologies for the development of AI systems4 in health care and support its work, the FG-AI4H created a Working Group on Regulatory Considerations (WG-RC) on AI for Health. The WG-RC consists of multiple stakeholders – including representatives from regulatory authorities, policy-makers, academia and industry – who explored regulatory and health technology assessment concepts and emerging “good practices” for the development and use of AI in health care and therapeutic development.

This publication is a general, high-level and nonexclusive overview of key regulatory considerations in topic areas developed by the WG-RC to support the overarching FG-AI4H framework. Recognizing that a single publication cannot address the specifics of the various AI systems that can be used for therapeutic development or health-care applications in general, the WG-RC’s overview will highlight some of the key regulatory principles and concepts – such as risk–benefit assessments and considerations for the evaluation and monitoring of the performance of AI systems developed using AI technologies. Throughout the process of developing this publication, the WG-RC took into consideration different stakeholder perspectives, as well as different global and regional settings. The WG-RC’s overview is not intended as guidance, as a regulatory framework or policy. Rather, it is meant as a listing of key regulatory considerations and a resource for all relevant stakeholders – including developers who are exploring and using AI technologies and developing AI systems, regulators who might be in the process of identifying approaches to manage and facilitate AI systems, manufacturers who design and develop AI systems that are embedded in medical devices, and health practitioners who deploy and use such medical devices and AI system.