Digital Health mobile apps and connected medical devices are rapidly changing how patients learn, monitor, diagnose and treat disease. Even in these early days of the digital transformation of healthcare, connected medical devices and digital services are winning reimbursement as “digiceuticals” by payors and insurers. However, the critical need going forward is how to measure, compare and prove these new tools and digital biomarkers are safe, effective and valuable at scale, not just in the USA but globally, across geographies, cultures and health systems.