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In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
The US Department of Justice Antitrust Division (DOJ or Division) recently released a revised Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations (Guidance). The Guidance reflects how the Division...more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
In December 2023, the National Association of Insurance Commissioners (NAIC) adopted a Model Bulletin on the Use of Artificial Intelligence (AI) Systems by Insurers. The model bulletin reminds insurance carriers that they...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
On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) released a set of frequently asked questions (FAQs) related to Medicare Advantage (MA) coverage criteria and utilization management (UM) requirements....more
The World Health Organization (WHO) recently released guidelines for the ethics and governance of large multi-modal models (LMMs). In the past year, LMMs like Chat GPT have come to the forefront of the news, and people have...more
The emergence of generative machine learning models, such as ChatGPT, has led to a surge in interest in artificial intelligence (“AI”) over the past year. This increased interest extends to the health care industry, where AI...more
On January 26, 2023, the U.S. National Institute of Standards and Technology (NIST) released the Artificial Intelligence (AI) Risk Management Framework (AI Risk Management Framework 1.0), a voluntary guidance document for...more
On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document entitled, “Good Machine Learning Practice for...more
The National Institute of Standards and Technology (NIST) recently published “A Proposal for Identifying and Managing Bias in Artificial Intelligence,” a special publication that is part of a series of documents and workshops...more
Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more