As AI becomes a more prevalent technology in medical devices it’s become clear that the associated risks need special consideration. This article charts the development history of a new, jointly produced document that answers this emerging need.

Artificial intelligence (AI) has a strong role to play in healthcare and medical devices. It can improve clinical outcomes as well as efficiency and healthcare management. That said, it can also bring its own unique risks that can jeopardize patient safety or increase inefficiency.

Recognizing the issues, BSI, the US Standards Development Organization and the Association for the Advancement of Medical Instrumentation (AAMI) have worked together to develop guidance on the use of AI as a medical technology.

Initially we held a series of joint workshops with stakeholders in the US and UK and two whitepapers were published on the topic. One of the key outcomes from this work was a recommendation to develop “risk management guidance to assist in applying BS EN ISO 14971 to AI as a medical technology”.

BS EN ISO 14971: Risk management guidance

BS EN ISO 14971 is the established international standard that provides a methodology for assessing and managing the risks associated with medical devices. It’s been recognized by medical device regulators and adopted as a national standard in countries around the world. It has become the global standard used by medical device manufacturers and regulators to govern risk management – so it made sense to use it as the foundation of the new work.   

It was then agreed that the new standard on applying BS EN ISO 14971 to medical technology with AI should be jointly developed and published by BSI and AAMI. A BSI drafting panel worked in conjunction with an AAMI drafting panel to agree on a common text for publication by AAMI and BSI.

For simplicity purposes, BSI is publishing this joint work as a British Standard in the UK and AAMI is delivering a Technical Information Report (TIR) for the US market. The culmination of this work in the UK is the British Standard now available as BS/AAMI 34971:2023 Application of ISO 14971 to machine learning in artificial intelligence. Guide.

Incidentally, the ambition all along has been for this guidance to become the basis of ISO/IEC guidance on risk management of AI as a medical technology in the future – so it’s been written with that in mind. Also it may be the first of a series of jointly developed work items by AAMI and BSI.  

What’s in BS/AAMI 34971? 

BS/AAMI 34971 provides guidance on applying a BS EN ISO 14971 risk management process to the evaluation of medical technology using artificial intelligence, and in particular, machine-learning.

It tackles how hazards already identified in BS EN ISO 14971 could affect the safety and effectiveness of medical technology incorporating machine-learning AI. It also provides examples, suggests strategies for eliminating or mitigating the associated risk and explores additional unique or emergent hazards/hazardous situations.

It’s important to state that BS/AAMI 34971 doesn’t modify the risk management process—rather it provides information and guidance to inform the application of BS EN ISO 14971 to AI/ML medical technology.

What are the benefits of using BS/AAMI 34971?

The benefit of using the standard is that it will help medical AI software developers and medical device manufacturers to identify the particular hazards relating to AI that need to be considered. 

This will ultimately make devices more compliant and safer, plus it will help manufacturers to:

• enter new markets

• innovate more quickly

• develop their expertise and efficiency

• increase market confidence in their devices. 

Ensure you are managing the AI risks in your medical devices by adding BS/AAMI 34971 to your collection today.

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