News and Blog

In a recent post on this blog, we examined the U.S. Food and Drug Administration's (FDA) core regulatory framework for artificial intelligence (AI) and machine learning (ML) enabled medical devices — the Predetermined Change Control Plan (PCCP), the clinical decision support boundary question, cybersecurity mandates, and what the framework means for company legal and regulatory teams. This article examines converging obligations that extend beyond that foundation.

Digital health is rapidly reshaping how healthcare is delivered, expanding access while introducing new clinical, regulatory, and liability risks. Technologies such as digital therapeutics (DTx) and telehealth platforms are at the forefront of this transformation, enabling more personalized, scalable, and data-driven care models.

At the same time, these innovations place increasing responsibility on companies operating in the space. As more of the patient experience moves to digital platforms, maintaining trust becomes central to how these technologies are adopted and scaled.

This year, as the nation celebrates the 250th anniversary of the American Revolution, the U.S. Food and Drug Administration (“FDA”) is engaged in a revolution of its own: a broad-based effort to forge an alternative pathway for new medical products to reach the public in an expedited fashion.

Spanish explorer Ponce de Leon’s “fountain of youth” is legendary. In St. Augustine, Florida, visitors still flock to a tourist attraction named for that mystical spring, hoping that a drink from the city’s natural waters might turn back their biological clocks.

At least the only consequence of indulging in the Ponce de Leon fantasy is a mouthful of sulfur‑smelling water. Today’s pursuit of the “fountain of youth” carries greater risk. Increasing numbers of consumers are injecting themselves with unapproved peptides based on unsubstantiated claims that these compounds bestow regenerative properties. Many of these products are purchased from online sellers operating outside traditional regulatory oversight, where they have not been tested for either efficacy or safety.

The pharmaceutical industry is in the middle of a meaningful shift in research strategy. For many years, research teams pursued blockbuster drugs—compounds designed to treat common conditions shared by large segments of the population. Novel treatments for high blood pressure, diabetes, elevated cholesterol, and other widespread ailments were the gold standard.

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.

The new year has brought notable changes on the regulatory front for life science companies seeking to expand their portfolio of digital health products. In January 2026, the U.S. Food & Drug Administration (FDA) published updated guidance documents addressing two broad product categories: (1) low-risk digital health devices for general wellness use; and (2) clinical decision support (CDS) software.

As previously reported on our blog, the rise of compounded GLP-1 medications has sparked both excitement and concern across the healthcare and legal landscapes. As demand for weight-loss treatments increases, some pharmacies have begun offering compounded versions of popular drugs like semaglutide and tirzepatide.