Digital health standards overview

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.

The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and in particular machine learning, pose unique challenges to the current body of standards and regulations governing medical technologies. Its aim is to determine what additional guidance or standards might be needed to promote the safety and effectiveness of medical AI technologies.

The first white paper in this series, The emergence of artificial intelligence and machine learning algorithms in healthcare: Recommendations to support governance and regulation, was published in 2019 and is available to download here

This second paper builds on the initial work set out in the first white paper. It examines how AI is different from conventional medical device software, explores the implications of these differences, and discusses the controls that may be necessary to ensure AI in healthcare is safe and effective. The paper also provides some recommendations for evolving standards and guidance for medical AI technologies in the future.