On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.Continue Reading ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI
AI/ML
FDA Publishes Principles for AI and ML in Medical Devices
By Jodi G. Daniel on
Posted in FDA
On October 27, 2021, the U.S. Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices. The principles are designed to support good machine learning practices (GMLP) and to help promote safe, effective, and high-quality medical devices that use AI/ML. The FDA is accepting public comment on these principles on an ongoing basis.
Continue Reading FDA Publishes Principles for AI and ML in Medical Devices