Compliance Tip of the Day – AI and Behavioral Analytics
Key Discovery Points: Don’t Rush in as an AI Fool!
100 Days In: What Employers Need to Know - Employment Law This Week® - #WorkforceWednesday®
5 Key Takeaways | AI and Your Patent Management, Strategy & Portfolio
Upping Your Game: Episode 1 – Meeting Hui Chen’s Challenge
Compliance Tip of the Day: AI and Compliance Education
Innovation in Compliance: Exploring the Fractional COO Model with La Tonya Roberts
FCPA Compliance Report: From Compliance to Commercial Value: Removing Friction with AI
Compliance Tip Of the Day: Using AI to Transform Whistleblower Response
Sunday Book Review: April 27, 2025, The Books on Business for May Edition
10 For 10: Top Compliance Stories For the Week Ending April 26, 2025
Compliance and AI: Transforming Compliance Through AI with Marcelo Erthal
Consumer Finance Monitor Podcast Episode: Private Civil Consumer Financial Services Litigation to Partially Fill CFPB Void - Part 1
Compliance Tip of the Day: Leveraging AI for Real-Time Third-Party Risk Management
Compliance Tip of the Day: AI and Predictive Analytics
Daily Compliance News: April 23, 2025, The R-E-S-P-E-C-T Edition
Hospice Insights Podcast - But Wait: Things to Consider Before Adopting AI Tools In Your Hospice
JONES DAY TALKS®: Women in IP – AI and Copyright Law Need-to-Knows
AI in Employment: Navigating the Legal Landscape with Lessons from I, Robot — The Good Bot Podcast
Daily Compliance News: April 22, 2025, The Upping Your Game Edition
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
Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...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
Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more
On October 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House...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
Nowadays, artificial intelligence (“AI”) is all around us. Previously, we took a look at the approaches being proposed to regulate AI at a pan-EU level and in the UK. In this part 2 article, we take a look at what...more
This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...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
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
A spurt of letters from California Attorney General Rob Bonta to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms...more
The federal government continues to weigh in on artificial intelligence, algorithmic fairness and related issues. In the latest artificial intelligence briefing, we analyze recent events in Washington, D.C., and also track...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
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