Adler Archer · Teaching

Digital Health Innovation & Regulatory Science

BIDS · INNOVATION & REGULATION · Intensive

Instructor: Adler Archer, JD Venue: Johns Hopkins BIDS Format: Intensive

This intensive connects AI-driven digital health innovation with the regulatory reality behind it. Students map how regulators, product teams, clinicians, and patients interact; dig into Software as a Medical Device (SaMD), classification, and FDA submission pathways; and follow products into post-market obligations, promotion, privacy, and security.

Case studies, expert sessions, and applied assignments stress ethical leadership and what it takes to move ideas from concept to compliant use in practice—not just what slides well in a pitch deck.

Offered through BIDS, the course complements the lab's regulatory and innovation work with trainees, fellows, and external partners building deployable digital health tools.