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Daily Compliance News: April 22, 2025, The Upping Your Game Edition
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more
Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and 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
Use of algorithms and artificial intelligence (AI) in prior authorization and utilization management is facing growing criticism and litigation. Notable lawsuits include alleged automatic authorization denials for tests that...more
Artificial intelligence and healthcare are hardly strangers, as machine learning programs have been aiding in the diagnosis of disease, drug discovery, the streamlining of clinical workflows and the analysis of medical data...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
We’ve all heard troubling stories involving emerging tools powered by artificial intelligence (AI), in which algorithms yield unintended, biased, or erroneous results. Here are a few examples: - A monitoring tool for...more
ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more
You've likely seen the headlines. Online recruiting tools that unfairly screen out women and minorities. Facial recognition tools used in law enforcement that misidentify specific demographic groups. Algorithms that place...more
Be Part of the Only Virtual Event that Unites Women Leaders in Life Sciences Law for Candid Discussion, Valuable Collaboration and Meaningful Networking. Join a remarkable group of senior level women executives along with...more