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
No Password Required: CEO of HACKERverse.ai, Disruptor of Cybersecurity Sales and Most Other Things
5 Key Takeaways | AI and Your Patent Management, Strategy & Portfolio
Compliance Tip Of the Day: Using AI to Transform Whistleblower Response
JONES DAY TALKS®: Women in IP – AI and Copyright Law Need-to-Knows
The FinReg Frontier: AI and Machine Learning in Consumer Finance — The Consumer Finance Podcast
Key Discovery Points: AI Says AI Will Replace Paralegals… But Not So Fast!
Compliance and AI: Ali Khan on Implementing AI Risk Management Systems
Key Discovery Points: Get Your Copy of the 2025 eDiscovery State of the Industry Report
Approach to Responsible AI
AI and Compliance
Bridging the Gap: How CivicReach is Revolutionizing Government Customer Service
Episode 358 - Ethics and Compliance Trends for 2025: Is Your Company Prepared?
Consumer Finance Monitor Podcast Episode: The Patterns of Digital Deception
No Password Required Podcast: Senior Security Researcher at Nokia and Guardian of Secure AI Networks
Episode 354 -- The New Era of Compliance: Generative AI, Data and Innovation
The Growing Role of State AGs in AI Regulatory & Enforcement Issues — The Good Bot Podcast
Crafting an Effective Law Firm Generative AI Policy for Responsible Business Use: On Record PR
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
Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions. This hot topic was...more
I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more