In a significant regulatory shift for healthcare technology, the U.S. Food and Drug Administration (FDA) has launched a first-of-its-kind pilot program called Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices, aimed at accelerating access to digital health solutions that can improve chronic disease management.
This voluntary pilot, developed by the FDA’s Center for Devices and Radiological Health (CDRH), is designed to explore a risk-based enforcement approach that supports digital health devices intended to enhance patient outcomes in areas such as cardio-kidney-metabolic conditions, chronic musculoskeletal pain and behavioral health disorders like depression and anxiety. With chronic diseases accounting for a significant global health burden, the TEMPO initiative represents a meaningful effort to align regulatory oversight with the rapid innovation seen in digital health technologies.
What TEMPO Means for Digital Health Innovation
Unlike traditional regulatory pathways that can take years before patients benefit from new technologies, the TEMPO pilot seeks to balance speed of access with patient safety. Under the program, manufacturers of certain digital health devices — including wearables, apps, connected sensors and software programs — may request that the FDA exercise enforcement discretion for premarket requirements such as premarket authorization or investigational device exemptions while still collecting real-world performance data.
This means that selected devices might be used in real-world clinical settings before formal clearance, provided manufacturers comply with ongoing monitoring and data reporting requirements. That real-world evidence can then be used to support future regulatory submissions, potentially shortening the timeline to broader market availability.
Collaboration With Medicare Innovation
The TEMPO pilot is closely linked with the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Under ACCESS, healthcare providers may receive outcome-aligned payments for integrated care that leverages digital health tools to improve patient outcomes, such as managing heart disease or diabetes more effectively outside the hospital setting.
By coordinating regulatory flexibility with payment incentives, regulators hope to create a pathway where digital health technologies are both used safely in real practice and financially supported — a combination that has long eluded many digital therapeutics and remote monitoring solutions.
Eligibility and Participation
The FDA began accepting statements of interest from manufacturers on January 2, 2026, and plans to select up to about ten manufacturers per clinical focus area, spanning early cardio-metabolic to behavioral health domains. Eligible devices must be intended for clinician-supervised outpatient use and pose no serious risk to patient safety, while demonstrating potential to improve measurable outcomes in real-world care.
Participating manufacturers are expected to collect and share real-world data about their devices’ performance — a key component in generating evidence that may support future marketing authorization and broaden access beyond the pilot.
A New Paradigm for Digital Care Delivery
For patients and healthcare providers alike, the TEMPO pilot represents a major evolution in how digital health tools may be deployed in the near term. With remote monitoring technologies, connected software and AI-support tools rapidly proliferating, traditional regulatory timelines have often lagged behind innovation. TEMPO’s pragmatic, real-world evidence approach offers a bridge between innovation and access, ensuring that promising technologies reach people who need them most — particularly those managing chronic conditions where continuous tracking and behaviour-supporting tools can make a tangible difference.
Moreover, by aligning regulatory oversight with real-world performance data, the FDA is signalling a shift toward a more adaptive framework that embraces continuous learning and innovation. As digital health solutions become more central to care delivery around the world, the TEMPO pilot may serve as a model for other regulatory agencies seeking to balance innovation, access and safety in patient-facing technologies.
With the enrollment period now underway and the first devices expected to be selected soon, the digital health community is watching closely — as the outcomes of the TEMPO pilot could shape not just access and regulation in the U.S., but inform global approaches to overseeing digital health technologies in the years to come.
