Adler Archer · Teaching

Digital Health Laws & Regulations

REGULATION · MEDICINE · Seminar

Instructor: Adler Archer, JD Venue: Johns Hopkins University Format: Seminar

Digital health tools, from wearable apps to AI-driven diagnostics, are transforming medicine, but innovation without oversight creates real risks. This course examines the legal, regulatory, and safety frameworks that govern digital health technologies, including how Software as a Medical Device moves from concept to clinical use.

Students learn to navigate the intersection of FDA regulation, patient safety, and technological possibility—reading guidance, mapping product pathways, and debating where innovation should move faster versus where caution protects patients.

The seminar connects classroom analysis to the lab's work on compliant digital health innovation, civic partnerships, and translation from prototype to practice.