UK, US and Canadian regulators identify ten guiding principles to be addressed when medical devices use AI or machine learning software

The UK, US and Canadian regulators have identified ten guiding principles to be addressed when medical devices use Artificial Intelligence (AI) or machine learning software.

AI and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. They use software algorithms to learn from real-world use and in some situations may use this information to improve the product’s performance. They also present unique considerations due to their complexity and the iterative and data-driven nature of their development

These guiding principles:

  • are intended to lay the foundation for developing good machine learning practices (GMLP) and will help guide future growth in this rapidly progressing field
  • will help promote safe, effective and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
  • 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.

It is envisaged that these guiding 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.

It is quite possible that some of the terms used in this post may be unfamiliar to you. If so, please have a read of this post in order to familiarise yourself with the basic terminology and concepts of AI.

Sources: MHRA website; FDA website