AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast
AI Legislation: The Statewide Spotlight — The Consumer Finance Podcast
AI in Employment: Navigating the Legal Landscape with Lessons from I, Robot — The Good Bot Podcast
5 Key Takeaways | Artificial Intelligence: What Tax Professionals Need to Know
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!
AI Discrimination and Emerging Best Practices – Part 2 - The Good Bot Podcast
Podcast - Decoding the Future of AI Regulation and Frontier Models
A Conversation with Alexandra Johnson, CEO/Co-Founder of Rubber Ducky Labs, AI Recommender Systems Pioneer
AI Discrimination and Emerging Best Practices – Part 1 — The Good Bot Podcast
Dan Rudoy Examines the Impact of AI on IP Strategy
Seeing into the Future: Moving Beyond AI to Visual Intelligence with Oculi CEO Charbel Rizk
A Brief Overview of Colorado’s Recently Enacted AI Law
Spotlight on Lightmatter, the Photonic (Super) Computing Company Ready to Power the AI Revolution
Podcast - Part 2: An FTC Official Speaks About the Regulation of AI Technology
A Deep Dive into HUD's New Guidance on AI-Driven Targeted Advertising — The Consumer Finance Podcast
[Webinar] AI and Data Privacy: Minimizing Risk and Maximizing Opportunity
AD Nauseam: AI – We Had to Discuss it Eventually – Part 2
(Podcast) The Briefing: Writers, Actors, AI: The AI Centric Changes to the WGA and SAG Agreements
AI Talk With Juliana Neelbauer: Third-Party Risk Management and Legal Perspective
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 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
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...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
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
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
The information age in which we live is reaching a new milestone with the development and ready access to conversational artificial intelligence based on advanced transformer algorithms, or AI chatbots, including their...more
On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software. This guidance follows the draft Clinical Decision...more
In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more
In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s approach to hardware devices. Recently,...more
Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. ...more
As we mentioned in the early days of the pandemic, COVID-19 has been accompanied by a rise in cyberattacks worldwide. At the same time, the global response to the pandemic has accelerated interest in the collection, analysis,...more
U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more
The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for...more
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more
In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical...more