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.