How AI and a Global Pandemic led to a $175M Investment: Ardis Kadiu’s Element451 Story
JONES DAY TALKS®: Real Assets Roundup Episode 4: Legal and Energy Challenges of Powering Data Centers
Key Discovery Points: A Gentle Distinction for Agentic AI
Work This Way: A Labor & Employment Law Podcast | How Employers Can Protect Intellectual Property with Bryan Baysinger of Maynard Nexsen
False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
(Podcast) The Briefing: Publicity Rights and the Law – Using Real People in Your Work
AI Today in 5: August 22, 2025, The Angst Episode
The Briefing: Publicity Rights and the Law – Using Real People in Your Work
IP Goes Pop! S6 Ep #3 The (Copy)Right Tool for the Job- The Copyright Tool Kit
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
AI Today in 5: August 21, 2025, The AI Psychosis Episode
Compliance Tip of the Day: Trust and Verify
Great Woman in Compliance: Building Strategic and Effective Risk Assessments
Compliance into the Weeds: The Dark Side of AI in Employee Training
Compliance Tip of the Day: AI Assistant for Compliance
AI Today in 5: August 19, 2025. The AI and Compliance Episode
Innovation in Compliance: Gaurav Kapoor on Risk Management and the Role of AI in GRC
Daily Compliance News: August 19, 2025, The AI Winter Edition
Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time....more
The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more
Medical imaging is one of the most promising fields for use of AI tools, as pattern recognition and large data sets can enhance human diagnosis (e.g., by radiologists) or even compete with them. A review of AI methodologies...more
Artificial Intelligence (AI) continues to revolutionize industries and is poised to bring transformative change in healthcare delivery, drug discovery, diagnostics, and data analysis and communication. This technology is...more
The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s...more
Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more
As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more
On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a...more
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...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
On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more
Evolving regulatory paradigms governing AI use in health care at the U.S. Food and Drug Administration (FDA) have set the pace for AI regulatory frameworks worldwide. Jodi Scott, partner in the Hogan Lovells medical device &...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
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more
News Briefs - States, D.C., File Lawsuit to Block Trump's HHS Restructuring - A coalition of 20 attorneys general is suing to block what they say is the Trump administration's "dangerous dismantling" of the federal health...more
If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more
Join medical device and digital health entrepreneurs, CEOs of venture-backed companies, and business development executives from large Medtech and digital health companies, as well as angels, venture capitalists, and...more
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more
U.S. Senate Artificial Intelligence Caucus co-chairs Mike Rounds (R-SD) and Martin Heinrich (D-NM) recently introduced S. 1399, the “Health Tech Investment Act,” which would establish a Medicare reimbursement pathway for...more