The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs) after clearance or approval without submitting a new marketing application for each covered change.
The guidance is a practical how‑to for getting the FDA
Recently, a federal court issued the first ruling on the closely watched issue of fair use in copyright infringement involving AI. The court ruled in favor of the plaintiff on its direct infringement claim, and ruled that the defendant’s use of plaintiff’s material to train its AI model was not a fair use.
Colorado has become the first state to pass legislation (SB24-205) regulating the use of artificial intelligence (AI) within the United States. This legislation is designed to address the influence and implications, ethically, legally, and socially, of AI technology across various sectors.
Any person doing business in Colorado, including developers or deployers of high-risk
Judges are beginning to address the increasing use of AI tools in court filings—including reacting to instances of abuses by lawyers using it for generative purposes and requiring disclosures regarding the scope of AI use in the drafting of legal submissions. Now JAMS, the largest private provider of alternative dispute resolution services worldwide, has issued
On November 16th, the Federal Communications Commission (“FCC”) and Federal Trade Commission (“FTC”) announced new independent initiatives regarding the use and implications of AI technologies on consumers in the context of telephone and voice communications. Learn more about these initiatives on our sister blog, the Consumer Finance Monitor.