The element helium is often associated with party balloons and novelty uses. However, the shortage of high-grade helium following the commencement of hostilities in the Middle East on February 28, 2026, presents a significant and underappreciated risk for the life sciences sector. The conflict has created a potentially long-lasting impact on the cost and availability of medicinal products and critical inputs such as helium, which is essential for the operation of certain medical devices.

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.