Taking an important first step in developing artificial intelligence (AI) and machine learning standards for much of the healthcare industry, clinicians, and regulators, AAMI is launching a new AI standards committee. Consisting of representatives from the British Standards Institution (BSI), the U.S. FDA, and developers of machine learning technology, the AAMI AI committee will be responsible for developing the guidance documents and other work identified in the white paper, Machine Learning AI in Medical Devices: Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance

What’s more, the AAMI AI committee and a mirroring BSI AI committee are pooling experts to draft risk management guidance for AI and machine learning in medical devices. This new document will repurpose key lessons from an internationally known standard, ANSI/AAMI/ISO 14971, Medical devices—Application of risk management to medical devices, while leveraging the joint drafting committees’ international AI expertise.

“When we talk about AI in healthcare, we’re talking about machine learning, data-driven systems that reach conclusions that we can’t necessarily predict,” says Joe Lewelling, senior advisor on content and strategy at AAMI. “These are disruptive technologies in that they will change the way healthcare is designed, delivered, maintained, and even regulated.”

In May 2020, AAMI joined forces with BSI to publishthe position paper, Machine Learning AI in Medical Devices: Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance, which examines how machine learning is different from traditional medical devices and software. It outlines a need for new standards and regulator initiatives to promote the safety, effectiveness, and availability of AI and machine learning in healthcare.

Call for Participation

AAMI AI is currently accepting applications to participate in future discussions. “The best time for stakeholders to join these efforts and add their perspectives and expertise to shaping the standards is at the beginning of the work,” says Amanda Benedict, vice president of standards at AAMI.

There is no deadline for committee applications, and they will be accepted on a rolling basis. Interested parties, including representatives of clinical practices, academia, regulatory authorities, and industry can find out how to get involved at AAMI.org.