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
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
Business Better Podcast Episode: Cyber Adviser – Financial Services 2024 Privacy and Cybersecurity Preview
DE Under 3: Complaint Dismissed Alleging an Applicant Screening Tool Discriminated Based on Race, Age, & Disability
Roundup of 2023 Entertainment Law Cases: Analysis SAG/AFTRA and WGA contracts, No Parody of Iconic Sneaker, AI Copyright Highlights China vs US law; SCOTUS Bad Spaniel and Warhol/Prince.
SAG AFTRA Strike Ends; AI Roundup of Cases and Proposed Law Making; Podcasting Live from Austin, Texas
Podcast - The Briefing: The AI Copyright Conundrum Continues – An Update
The Briefing: The AI Copyright Conundrum Continues – An Update
12 Tips to Help Your Business Address Generative AI Risks
Podcast - Unlawful Discrimination by Artificial Intelligence
Una conversación con ChatGPT
AI Takes the Stand - Speaking of Litigation Podcast
Algorithmic Data in The Workplace | What Should Employers Consider?
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
The Current Status of Privacy Laws Across the United States - Unlike the General Data Protection Regulation (GDPR) in the European Union (EU), the United States does not have a nationwide comprehensive data privacy law....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
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
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
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
Our latest briefing dives into the Senate’s exploration of transparency and accountability to prevent bias in algorithmic decision systems, new guidance from the U.S. Copyright Office regarding works including content...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
Artificial intelligence (AI) is expanding into more industries (often in surprising ways) and has inevitably caught the attention of federal and state regulators. Our Privacy, Cyber & Data Strategy Team summarizes the...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
Publication of an algorithm prevents the algorithm from being a trade secret, right? Not necessarily. The Federal Circuit just reminded us that under certain circumstances that may not be the case. ...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
Researchers from the University of Washington have developed a system that uses smart speakers and machine learning algorithms to monitor heartbeats without the need for physical contact. The system was described in a study...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