Podcast - Regulating AI in Healthcare: The Road Ahead
AI and the False Claims Act
Key Discovery Points: Detecting AI is Difficult and Tricky!
The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
From OCR to AI The Future of Media and Image Analysis in eDiscovery
Hospice Insights Podcast - AI in Action: Exploring How AI Is Helping Hospices Do Things in New Ways
AI in eDiscovery Today: An Open Conversation
The Authenticity Advantage: How Runbin Dong’s Scale Social AI Helps Small Businesses Shine
Podcast - FTC to Focus on Deceptive AI Claims: Compliance Management Strategies
Upping Your Game: Crowd - Sourcing Risk Management Intelligence with AI
Innovation in Compliance: Real-Time Fraud Prevention Strategies for Financial Loss Prevention with Vince Walden
Episode 373 -- Christian Focacci on Current Developments in AI and Risk Management
Work This Way: A Labor & Employment Law Podcast | Episode 48: Opportunities & Risks with Artificial Intelligence in HR with Chingwei Shieh of GE Power
Meet Phil Leslie, Cornerstone Research's New Chief Technology and Innovation Officer
The Future of Supply Chains: Chris Andrassy on Using AI to Predict & Prevent Disruptions
Compliance and AI: Using AI for Data Loss Prevention Systems with Vinay Goel
Compliance and AI: Revolutionizing Risk Management with John Byrne
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Regulatory Ramblings: Episode 69 - Human Intelligence vs. Machine Judgment with Nigel Morris-Cotterill and Patrick Dransfield
Early Returns Podcast - Oliver Roberts: AI and the Law, and an Education
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more
At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more
In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history...more
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more