Artificial intelligence (AI) and machine learning covers a broad set of technologies that are increasingly being used across the healthcare sector. These solutions can provide earlier diagnoses and targeted treatments for individual patients, whilst driving efficiency and effectiveness in healthcare services.
Governance and regulation of AI solutions in healthcare are recognized as significant challenges. BSI and AAMI are exploring the role for standards in supporting the deployment of novel AI technologies within this highly regulated sector.
This paper summarizes key discussion points from the collaborative activities undertaken by BSI and AAMI, with support from MHRA. It analyses the role that standardization can offer and sets out recommendations for future standardization activities that will assist deployment of AI solutions in healthcare. MHRA and the U.S. Food and Drug Administration (FDA) have a shared interest in seeing the recommendations from this report implemented, and new standards developed in the future.