Digital Health, SaMD, and AI/ML Devices

Course Description

Formerly "Mobile Health, SaMD, and AI/ML Devices."

Wearable technology and AI-powered digital health products are reshaping healthcare in real time—from performance wearables navigating the line between wellness and medical claims, to smart glasses highlighting new questions about safety, data use and privacy. This instructor-led course equips you to understand how innovation actually makes it to market—safely, compliantly, and at scale.

You will gain a practical, hands-on understanding of the regulations, standards, and guidance governing the rapidly evolving digital health ecosystem, with a focus on mobile health, wearables, Software as a Medical Device (SaMD), and AI/ML-enabled technologies. Through real-world case studies, interactive lectures, and applied assignments, you will learn to develop regulatory strategies, classify products, manage post-market changes, and address privacy and data governance.

This course explores how digital health solutions span the full spectrum—from general wellness and consumer devices to clinical decision support, chronic disease management, and digital therapeutics. It also provides an in-depth review of current FDA policies and guidance, including general wellness, mobile medical applications, SaMD, and AI/ML-based medical devices-arming you with the tools to confidently assess emerging technologies and make informed regulatory decisions in a fast-moving industry.