Episode 373 -- Christian Focacci on Current Developments in AI and Risk Management
Regulatory Rollback: Inside the CFPB’s FCRA Guidance Withdrawal — The Consumer Finance Podcast
Rethinking Records Retention
Work This Way: A Labor & Employment Law Podcast | Episode 48: Opportunities & Risks with Artificial Intelligence in HR with Chingwei Shieh of GE Power
Compliance Needs are Alive and Well: FTC's Recent Enforcement Activity
From Dashboards to Data-Driven Decisions – The Evolving Role of Technology in Legal Marketing & BD
Regulatory Rollback: Inside the CFPB's FCRA Guidance Withdrawal — FCRA Focus Podcast
No Password Required: Reginald “Andre” Andre, CEO of ARK Solvers and Builder of Human + AI-Driven Culture
AI on the Job: How to Stay Ahead of Employment and Data Privacy Risks
Meet Phil Leslie, Cornerstone Research's New Chief Technology and Innovation Officer
Upping Your Game: Harnessing AI to Revolutionize Third-Party Risk Management
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
Tenant Tales and Reseller Realities: Inside the FCRA Arena With Eric Ellman — FCRA Focus Podcast
Law School Toolbox Podcast Episode 505: Breaking ADHD Barriers with the Help of AI (w/Lindsay Scola)
Compliance and AI: Revolutionizing Risk Management with John Byrne
New Executive Order Targets Disparate Impact Claims Nationwide - #WorkforceWednesday® - Employment Law This Week®
Constangy Clips Ep. 10 - 3 Ways the GDPR Is Evolving with Today’s Tech Landscape
Harnessing AI in Litigation: Techniques, Opportunities, and Risks – Speaking of Litigation Video Podcast
Upping Your Game: Episode 3 - Embedded Compliance: From Gatekeeper to Business Enabler
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
On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...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
As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...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 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
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
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
Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more
Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more
The rapid advancement of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing the healthcare industry. However, as these innovative devices emerge, understanding the complex regulatory landscape becomes...more
Researchers from the National Institutes of Health (NIH) have developed an algorithm that harnesses AI to help accelerate the process of matching potential volunteers for relevant clinical research trials. The algorithm,...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
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...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
Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more
This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more
Would it surprise you if I told you that a popular and well-respected machine learning algorithm developed to predict the onset of sepsis has shown some evidence of racial bias? How can that be, you might ask, for an...more
On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”...more
Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...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