How AI and a Global Pandemic led to a $175M Investment: Ardis Kadiu’s Element451 Story
Key Discovery Points: A Gentle Distinction for Agentic AI
False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
AI Today in 5: August 22, 2025, The Angst Episode
The Briefing: Publicity Rights and the Law – Using Real People in Your Work
Compliance Tip of the Day: Using AI to Embed Your Compliance Program
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Who Owns AI Innovation? IP in the Age of Artificial Intelligence
Operationalizing Trust at Scale: Evolving Compliance: Neta Meidav on the Diligent Acquisition and AI Integration
Compliance Tip of the Day: Trust and Verify
Compliance into the Weeds: The Dark Side of AI in Employee Training
Compliance Tip of the Day: AI Assistant for Compliance
Innovation in Compliance: Gaurav Kapoor on Risk Management and the Role of AI in GRC
AI Today in 5: August 18, 2025, The AI Music Episode
Compliance Tip of the Day: Costs and Benefits of AI
12 O’Clock High, A Podcast on Business Leadership – Leadership in Cybersecurity and Privacy with Robert Meyers
AI Today in 5: August 15, 2025, The AI as Boss Episode
The LathamTECH Podcast — Turning a London Eye Toward International Tech Growth
Compliance Tip of the Day: Co-Thinking with AI
AI Today in 5: August 12, 2025, The Creating Billionaires Episode
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
Medical technologies incorporating artificial intelligence (AI) are an emerging area of innovation with the potential to transform healthcare. Employing techniques such as machine learning, deep learning and natural language...more
Further to the guiding principles on the use of artificial intelligence (AI) and machine learning (ML) technologies jointly published by the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s...more
On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change Control Plan (PCCP) in a marketing...more
On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more
On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding principles meant to aid the...more
On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more
Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more
On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses...more
Key Points - FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. - FDA plans to pilot Real-World Performance...more
On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that...more
On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more