The MHRA has co-produced 10 guiding principles for the use of artificial intelligence or machine learning in medical devices

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The Medicines and Healthcare products Regulatory Agency (MHRA) has co-published 10 guiding principles for developing good machine learning practices (GMLP), in collaboration with regulators in the UK, USA, and Canada. These principles should be addressed when medical devices use artificial intelligence or machine learning software, and are intended to guide future growth in this rapidly progressing field. 

Artificial intelligence and machine learning technologies have the potential to transform healthcare by revealing new and important insights from the vast amount of healthcare data generated every day, says the MHRA. They use software algorithms to learn from real-world data, and in some situations, this information is used to improve the product’s performance. However, these technologies present unique considerations due to their complexity and the iterative and data-driven nature of their development. 

The principles cover key elements of GMLP, including having an in-depth understanding of a model’s intended integration into clinical workflow, and the desired benefits and associated patient risks.

The MHRA propose these guiding principles may be used to:

  • adopt good practices that have been proven in other sectors
  • tailor practices from other sections so they are applicable to medical technology and the healthcare sector
  • create new practices specific for medical technology and the healthcare sector.

The principles also identify areas where the International Medical Device Regulators Forum, international standards organisations, and other collaborative bodies could work together to advance GMLP. This could include research, creating educational tools and resources, regulatory policies and guidelines, international harmonisation, and consensus standards.

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