Regulators in the UK, USA, and Canada have identified 10 guiding principles to be addressed when medical devices use artificial intelligence (AI) or machine learning software.

These principles are intended to lay the foundation for developing good machine learning practices (GMLP) and aim to help guide future growth in the rapidly progressing field.

They cover key elements of GMLP, for example: having an in-depth understanding of a model’s intended integration into clinical workflow, and the desired benefits and associated patient risks as well as selecting and maintaining training and datasets to be appropriately independent of each other.

The government said that the principles may be used to:
• adopt good practices that have been proven in other sectors
• tailor practices from other sectors so they are applicable to medical technology and the health care sector
• create new practices specific for medical technology and the health care sector

These guiding principles further identify areas where the International Medical Device Regulators Forum (IMDRF), international standards organisations and other collaborative bodies could work together to advance GMLP.

Areas of collaboration include research; creating educational tools and resources; regulatory policies and regulatory guidelines; international harmonisation; and consensus standards.

“We know that strong international partnerships will be essential part of empowering the wider sector to advance responsible innovations,” said the Medicines and Healthcare Products Regulatory Agency. We look forward to our continued collaborative work and engagement with the FDA and Health Canada and wider international health partners in this area.”

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