{"id":4328,"date":"2021-10-29T10:03:00","date_gmt":"2021-10-29T10:03:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4328"},"modified":"2025-12-02T10:21:23","modified_gmt":"2025-12-02T10:21:23","slug":"guiding-principles-for-good-machine-learning-practice","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/guiding-principles-for-good-machine-learning-practice\/","title":{"rendered":"Guiding Principles for Good Machine Learning Practice"},"content":{"rendered":"\n<p class=\"has-black-color has-text-color has-link-color wp-elements-5037854b72f22739685e624ff9cc52e8 wp-block-paragraph\">The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom\u2019s Medicines and Healthcare Products Regulatory Agency (MHRA) have jointly outlined ten guiding principles to support the development of Good Machine Learning Practice (GMLP). These principles aim to advance the creation of medical devices that incorporate artificial intelligence and machine learning (AI\/ML) in a manner that ensures safety, effectiveness, and high quality.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Guiding Principles<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Multi-Disciplinary Expertise Is Applied Across the Total Product Life Cycle &#8211;<\/strong> Effective integration of machine learning within clinical workflows requires a thorough understanding of intended use, clinical context, patient benefits, and potential risks. This ensures that AI\/ML-enabled medical devices perform safely and effectively.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Strong Software Engineering and Security Practices Are Followed\u00a0&#8211;<\/strong> Device development must incorporate robust software engineering, strong data quality controls, comprehensive data management, and cybersecurity protections.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Clinical Study Participants and Data Sets Reflect the Intended Population\u00a0&#8211; <\/strong>Data collection processes should ensure that the characteristics of the target patient population and clinical use scenario are adequately represented in training, testing, and clinical datasets. This supports generalizable performance, reduces bias, and identifies conditions where the model may not perform as expected.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. Training Data Sets Remain Separate from Test Data Sets &#8211; <\/strong>Training and test datasets must be independently selected and maintained to ensure objective evaluation of model performance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5. Reference Datasets Use the Best Available Methodologies &#8211;<\/strong> High-quality reference datasets should be developed using accepted, validated methods. These datasets must contain clinically meaningful, well\u2011characterized information, along with clear documentation of any limitations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6. Model Design Aligns with Available Data and Intended Use\u00a0<\/strong>&#8211; The model should be designed to mitigate known risks such as overfitting, loss of performance, and security vulnerabilities while supporting its intended clinical purpose.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>7. Emphasis Is Placed on Human-AI Team Performance\u00a0&#8211;<\/strong> For systems involving human interaction, human factors engineering and interpretability of outputs are essential. Overall performance should be evaluated based on the combined effectiveness of the human-AI team rather than the model alone.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>8. Testing Shows Device Performance Under Realistic Clinical Conditions &#8211;<\/strong> Testing should evaluate how the device performs in conditions that closely match clinical use, including consideration of patient subgroups, environments, input variability, and possible confounding influences.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>9. Users Receive Clear and Essential Information &#8211;<\/strong> Users should be informed about device indications, intended use, data sources used for model training and testing, known limitations, workflow integration considerations, and any updates resulting from ongoing real\u2011world monitoring. Mechanisms for users to report concerns should also be provided.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>10. Deployed Models Are Monitored and Re-Training Risks Are Managed &#8211; <\/strong>Once deployed, models must be continuously monitored under real-world conditions to ensure that safety and performance are maintained or improved. Risks associated with model updates or retraining must be proactively managed.<\/p>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-063c43e30005e18537946fce2c4d9b3a wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><strong><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\">Tags:<\/mark><\/strong> <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/artificial-intelligence-and-machine-learning\/\" rel=\"tag\">artificial intelligence and machine learning<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/fda-artificial-intelligence\/\" rel=\"tag\">fda artificial intelligence<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/guiding-principles-for-good-machine-learning\/\" rel=\"tag\">Guiding Principles for Good Machine Learning<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/machine-learning-enabled-medical-devices\/\" rel=\"tag\">Machine Learning-enabled medical devices<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medical-devices\/\" rel=\"tag\">Medical Devices<\/a><\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom\u2019s Medicines and Healthcare Products Regulatory Agency (MHRA) have jointly outlined ten guiding principles to support the development of Good Machine Learning Practice (GMLP). These principles aim to advance the creation of medical devices that incorporate artificial intelligence and machine learning (AI\/ML) in [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1885,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[647],"tags":[416,414,417,415,101],"class_list":["post-4328","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-standards","tag-artificial-intelligence-and-machine-learning","tag-fda-artificial-intelligence","tag-guiding-principles-for-good-machine-learning","tag-machine-learning-enabled-medical-devices","tag-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Guiding Principles for Good Machine Learning Practice<\/title>\r\n<meta name=\"description\" content=\"The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom\u2019s 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).\" \/>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/guiding-principles-for-good-machine-learning-practice\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"Guiding Principles for Good Machine Learning Practice\" \/>\r\n<meta property=\"og:description\" content=\"The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom\u2019s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). 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