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.

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.

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.