TEMPO: A New Regulatory Springboard for Digital Health Innovation in Chronic Disease

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 and Radiological Health (CDRH), works in tandem with the Centers for Medicare & Medicaid Services (CMS) ACCESS Model to bridge long-standing gaps between technological innovation, regulatory review, reimbursement, and real-world impact. U.S. Food and Drug Administration TEMPO Program

Chronic diseases such as diabetes, heart failure, behavioral health conditions, hypertension, and musculoskeletal disorders continue to affect millions of Americans, driving morbidity, hospitalizations, and health care costs. Digital health technologies, from sensor-enabled monitoring tools to AI-driven software, are reshaping how care can be delivered, especially in home and community settings. However, traditional regulatory pathways and reimbursement frameworks have struggled to keep pace with rapid innovation, often slowing commercialization and limiting patient access to impactful tools. TEMPO aims to change that. smgconferences.com

What Is TEMPO and Why It Matters

At its core, the TEMPO pilot is a voluntary, risk-based enforcement discretion program that allows up to about 40 digital health technologies, including software as a medical device (SaMD) and connected digital tools, to be used in real-world clinical practice while manufacturers collect, monitor, and share real-world performance data as part of the CMS ACCESS Model. Traditionally, such devices need FDA authorization (e.g., through 510(k), De Novo, or PMA pathways) before being widely deployed, a process that can take years to complete. Under TEMPO, selected manufacturers can request that the FDA temporarily not enforce certain regulatory requirements, such as premarket authorization, for use of the device within this structured pilot, even as evidence is generated.

This is not a shortcut around safety or efficacy, rather, it is a proactive, real-world evidence (RWE) enabled pathway that balances patient access with oversight. Participating devices are intended for clinician-supervised outpatient use and are selected based on potential to improve patient outcomes in conditions with high public health burden.

Accelerating Time-to-Market Without Compromising Safety

One of the biggest hurdles for digital health innovators, especially SaMD developers, has been the lengthy and resource-intensive process of building clinical and regulatory evidence before commercialization. TEMPO offers a new model:

• Rather than waiting for full FDA authorization before patients can use a device in routine care, companies can generate structured real-world evidence in parallel with early use under TEMPO.

• The FDA provides defined expectations around data collection, labeling, and risk monitoring, ensuring that real-world deployments happen safely and transparently. Federal Register

  
  

For startups and emerging technologies, particularly those with disruptive AI or remote monitoring capabilities, this means getting real-world performance data sooner, which can fundamentally accelerate learning cycles, reduce business risk, and inform later regulatory submissions.

Aligning Regulatory and Reimbursement Incentives

A perennial barrier to commercialization has been the disconnect between regulatory clearance and payer coverage. Companies may achieve FDA authorization yet still struggle to secure sustainable reimbursement pathways, especially under traditional fee-for-service models.

The TEMPO pilot is intentionally tied to the CMS ACCESS Model, a 10-year outcomes-based payment initiative designed to reward technology-enabled care that improves health outcomes for people with chronic conditions. Under this model, organizations receive payment tied to measurable outcomes, not simply provision of services. This linkage unleashes several advantages:

• Innovators can test their technologies in a payment environment that values patient outcomes, rather than billing codes alone.

• Evidence generated through TEMPO’s real-world data framework can help build stronger value propositions for payers beyond the pilot, informing broader coverage decisions.

• Aligning regulatory flexibility with reimbursement incentives creates dual drivers toward adoption, smoothing commercialization pathways that historically stalled in the “valley of death” between clearance and coverage. CMS

This integrated regulatory–reimbursement ecosystem could become a model for future digital health and device innovation strategies.

Real-World Data and Outcome-Driven Innovation

TEMPO places real-world data (RWD) and real-world evidence at the center of product evaluation. Unlike controlled clinical trials that may not capture everyday usage patterns or health system variability, real-world evidence reflects how devices perform in diverse care settings and patient populations, a critical factor for managing chronic disease.

Under the pilot:

• Companies must collect, monitor, and report RWD related to clinical performance, safety, and patient outcomes.

• Data collected can support future FDA submissions, potentially shortening regulatory timelines and strengthening evidence dossiers. www.hoganlovells.com

This emphasis on evidence generation in living health care environments aligns with broader regulatory and payer trends, including the FDA’s increasing use of RWE in regulatory decision-making and CMS’s focus on outcomes rather than volume-based billing.

Looking Ahead: A New Paradigm for Chronic Disease Innovation

TEMPO represents more than a pilot, it signals a paradigm shift in how regulatory agencies and payers can support health technology innovation that meets patients where they live. By combining risk-based regulatory flexibility, real-world evidence generation, and outcomes-oriented reimbursement models, the initiative fosters an environment where digital tools can truly scale and deliver value.

For innovators, manufacturers, clinicians, and patients alike, TEMPO reflects a future-ready framework: one that could dramatically improve access to transformative technologies that enhance chronic disease management, support longitudinal care, and reduce the overall burden of chronic illness across populations.