The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
Artificial intelligence and machine learning technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare 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. But they also present unique considerations due to their complexity and the iterative and data-driven nature of their development.
The 10 principles lay the foundation for developing Good Machine Learning Practice. They also will help cultivate future growth in this rapidly progressing field.
Areas of collaboration include research, creating educational tools and resources, international harmonization, and consensus standards, which may help inform regulatory policies and regulatory guidelines.