Artificial Intelligence, Digital Health, Transparency

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

Ropes & Gray LLP on 1/31/2025

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

What’s Hot in Healthcare: Digital Health Regulatory Update

BakerHostetler on 10/2/2024

As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more

FDA On Use Of AI/ML In Drug Development: Five Key Takeaways

MoFo Life Sciences on 5/12/2023

On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more

FDA Joins Other Regulators in Focus on AI and Machine Learning

Sheppard Mullin Richter & Hampton LLP on 11/23/2021

The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more

Coverage of FDA’s AI/ML Medical Devices Workshop - Part 3: A Summary of the Panel Discussions

Mintz - Health Care Viewpoints on 10/20/2021

In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more

FDA’s Action Plan for Artificial Intelligence: Highlights and Insights for Developers

Sheppard Mullin Richter & Hampton LLP on 1/13/2021

The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for...more