Medical devices and artificial intelligence: FDA issues first guidelines for developing Good Machine Learning Practices
On October 27, 2021, the U.S. Food and Drug Administration (“FDA”), in collaboration with the Canadian regulatory agency, Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (“MHRA”), released a document containing 10 guiding principles to promote the development of Good Machine Learning Practice (“GMLP”).
Artificial Intelligence and Machine Learning in Clinical Trials: Regulatory attempts by European and national authorities
In the last few years, use of Artificial Intelligence and Machine Learning systems in the performance of Clinical Trials has increased.
Artificial intelligence and medical devices: The potential impact of the proposed Artificial Intelligence Regulation on medical device software
The recent proposal for a regulation on artificial intelligence (the Artificial Intelligence Regulation) might add a new piece to the regulatory puzzle governing medical device software and other medical devices that incorporate software based on AI algorithms.
Artificial Intelligence in healthcare between opportunities and new challenges
Artificial Intelligence (AI) is becoming an increasingly important protagonist in the healthcare sector, undoubtedly gaining its place among tomorrow’s main challenges.
Artificial intelligence software: FDA news
On April 2, 2019, a discussion paper describing a proposal for a regulatory framework for modifications to Artificial Intelligence-based medical devices that are already on the market, was published by the Food and Drug Administration (FDA), in view of the future formulation of guidelines that relate to this issue.