Recent advancements in sensors, machine learning, and novel regulatory initiatives have fostered a potentially transformative environment for digital medicine. The Harvard-MIT Center for Regulatory Science and Harvard Business School are co-sponsoring a one-day, invitation-only symposium designed to bring together leaders from academia, industry, and government to discuss the current state of this field as well as future directions.

Over the course of the day, the group will discuss:

• Overview and community: What products exist or are in development already? What are the opportunities in this space? Who’s involved in the development of digital medicines?
• Regulatory issues and clinical evidence: What kind of evidence is needed and does the traditional clinical trial framework make sense? How should researchers validate “digital biomarkers”? What new regulatory models exist (e.g. the FDA’s Pre-Certification Program) and what have early experiences shown? How do we ensure international coordination?
• Data and algorithm stewardship, ethics, security and privacy: What types of novel digital data are being generated and how can we ensure data quality and privacy? How do we ensure security with connected medical products? What is good clinical practice for algorithms?
• Paying for remote monitoring, diagnostics, and digital therapeutics: What are the existing paradigms, and are new alternatives needed?
• Distribution, use, and other post-market logistics: How should we think about the distribution of new types of therapeutics?
• Barriers to adoption: what are the current barriers to more widespread adoption, and are these barriers surmountable?