Driving up artificial intelligence standards for medical devices - Digital Journal

The U.S. Food and Drug Administration (FDA), Health Canada, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles are intended to help promote safe, effective and high-quality medical devices that use artificial intelligence and machine learning (AI/ML). There is a great deal of interest with these technologies in the medical field, especially with the design and operation of medical devices. This is to the extent that regulatory guidance is required and the opportunity has arisen for a transatlantic protocol to be fashioned between three national regulatory agencies. Artificial intelligence and machine learning technologies have the potential to transform healthcare.