The FHA Knowledge Hub By Shannon Campbell, PhD, Principal Consultant, Frank Healthcare Advisors On December 5, 2025 , the U.S. Food and Drug Administration (FDA) unveiled a groundbreaking initiative, the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot,  aimed at expanding patient access to digital health technologies that can transform chronic disease management. This first-of-its-kind pilot, developed by the FDA’s Center for Devices an