The Biden administration’s executive order issued on October 30, 2023, includes a number of initiatives relating to the development and use of artificial intelligence (AI), including in healthcare. As AI becomes a […]
Globally, the rapid advancement of artificial intelligence (AI) and machine learning (ML) raises fundamental questions about how the technology can be used. Drug approval authorities are now also taking part […]
The U.S. Food and Drug Administration (FDA or Agency) has issued new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device […]
In 2022, many if not most pharmaceutical, medical device, and other life sciences companies established strategies to innovate digital health technology complementary to their existing strategic focus. The digital transformation […]