In a recent post on this blog, we examined how artificial intelligence (AI) and machine learning (ML) are reshaping the informed consent process in clinical trials—and why the regulatory and legal frameworks surrounding AI in that context are still catching up. That article focused on one corner of the clinical trial lifecycle. This one broadens the lens. Medical devices, and in particular software as a medical device (SaMD) is a different but related category.

In a recent episode of HBO Max’s The Pitt, an emergency-room attending physician shows medical students the time savings that can come from using a generative artificial intelligence (AI) tool to listen to a doctor–patient conversation and populate a medical record in seconds. But the same storyline highlights the downside: the tool invents details, confuses medications, and even swaps “neurology” for “urology”—mistakes that could put a patient at risk.

Previously on the blog, we focused on the regulatory and compliance risks surrounding compounded GLP‑1 products, particularly misbranding, quality concerns, and how quickly the enforcement landscape has evolved. Continuing this discussion, we broaden the lens to the developing litigation environment and additional regulatory scrutiny that can affect manufacturers, pharmacies, telehealth providers, and other stakeholders across the GLP‑1 ecosystem.