Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 245: Using AI to Improve Radiology with Angela Adams of Inflo Health
Podcast - Regulating AI in Healthcare: The Road Ahead
AI and the False Claims Act
Key Discovery Points: Detecting AI is Difficult and Tricky!
(Podcast) The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
Compliance and AI: Navigating Risk Management in the AI Era with Gaurav Kapoor
From OCR to AI The Future of Media and Image Analysis in eDiscovery
(Podcast) The Briefing: Anthropic, Copyright, and the Fair Use Divide
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
Can human beings cure all diseases in our lifetime? For centuries, humanity has strived to cure diseases. With the advent of Artificial Intelligence (AI), the dream of a disease-free world seems more attainable than ever...more
As we noted in our previous blog post, HealthBench, an open-source benchmark developed by OpenAI, measures model performance across realistic health care conversations, providing a comprehensive assessment of both...more
Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more
On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more
What if the key to understanding and improving brain health lies in a breakthrough approach to neurodata? For Rob Cooley, founder and CEO of Nuream, unlocking the potential of brainwave data has the power to transform...more
To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more
The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more
Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more
Every year, 12,000 leaders in the healthcare industry meet at HLTH. This year's conference covered all aspects of the healthcare ecosystem, and here are the nine that we should watch as we enter the new year....more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
This is the third post in a 3-part series. Below, we describe Example 49 which focuses on using AI to assist with a medical treatment....more
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more
As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more
Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more
Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more