FDA Announces TEMPO: Revolutionary Digital Health Pilot Transforms Chronic Disease Management

The U.S. Food and Drug Administration has launched a groundbreaking initiative that promises to revolutionize how millions of Americans manage chronic diseases. The Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot represents the agency's first comprehensive effort to accelerate patient access to innovative digital health technologies while maintaining rigorous safety standards.

Understanding the FDA TEMPO Initiative

The FDA announces TEMPO as a voluntary pilot program designed to promote access to certain digital health devices while safeguarding patient safety. Developed by the FDA's Center for Devices and Radiological Health (CDRH), this initiative evaluates a new, risk-based enforcement approach that supports digital health devices intended to improve patient outcomes across multiple chronic conditions.

The pilot program targets four critical clinical areas that affect millions of Americans: cardio-kidney-metabolic conditions, complex cardiometabolic diseases, musculoskeletal issues, and behavioral health disorders. By focusing on these areas, the FDA addresses some of the most prevalent and burdensome chronic conditions facing the healthcare system today.

How TEMPO Integrates with Medicare's ACCESS Model

The FDA announces TEMPO in collaboration with the Centers for Medicare and Medicaid Services (CMS) Innovation Center Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. This partnership creates a comprehensive ecosystem where digital health innovation meets payment reform, ensuring that beneficial technologies reach patients who need them most.

Under this collaborative framework, participating manufacturers offer digital health devices for care covered by the CMMI ACCESS model. The ACCESS model introduces Outcome-Aligned Payments, which are recurring payments for managing qualifying conditions with payment tied to achieving measurable health outcomes. This alignment ensures that digital health technologies deliver real value to patients while providing financial sustainability for healthcare providers.

CMS Administrator Dr. Mehmet Oz emphasized the significance of this partnership, stating that CMS is pleased to work with the FDA on modernizing care for people with chronic disease. This collaboration represents a shift toward value-based care that prioritizes patient outcomes over volume of services.

Target Conditions and Clinical Applications

The FDA announces TEMPO with a clear focus on conditions that significantly impact quality of life and healthcare costs. The pilot encompasses four distinct clinical use areas, each addressing urgent healthcare needs:

• Early Cardio-Kidney-Metabolic Conditions: Digital health devices targeting hypertension, dyslipidemia, obesity or overweight with markers of central obesity, and prediabetes fall into this category. These conditions represent critical intervention points where technology-enabled care can prevent progression to more serious diseases.
• Complex Cardio-Kidney-Metabolic Diseases: The pilot includes devices for managing diabetes, chronic kidney disease, and atherosclerotic cardiovascular disease. These conditions require ongoing monitoring and intervention, making them ideal candidates for digital health solutions that provide continuous care outside traditional clinical settings.
• Musculoskeletal Issues: Chronic musculoskeletal pain, including conditions like persistent back strain, represents a significant burden on patients and the healthcare system. Digital therapeutics and monitoring devices offer new approaches to managing these conditions without relying solely on medication.
• Behavioral Health Conditions: Depression and anxiety disorders affect millions of Americans, yet access to care remains limited in many areas. Digital health technologies can bridge this gap by providing accessible, evidence-based interventions and ongoing support.

The Home as a Health Care Hub Vision

The FDA announces TEMPO as a key component of its broader Home as a Health Care Hub initiative. This strategic vision recognizes that effective chronic disease management happens not just in clinics and hospitals but where patients actually live their lives. By fostering access to digital technologies that patients can use safely and effectively at home, the initiative seeks to improve outcomes while reducing the burden of chronic disease.

This approach acknowledges the reality of modern healthcare: patients spend only a fraction of their time in clinical settings, yet their health requires continuous attention. Digital health technologies enable this continuous engagement by providing monitoring, intervention, and support between clinical visits.

The home-centered approach also addresses healthcare access disparities. Patients in rural areas, those with mobility limitations, and individuals balancing multiple responsibilities can all benefit from technology-enabled care that doesn't require frequent travel to healthcare facilities.

Regulatory Innovation and Enforcement Discretion

One of the most innovative aspects of the TEMPO pilot involves the FDA's willingness to exercise enforcement discretion for certain regulatory requirements. Manufacturers of digital health devices that haven't yet received FDA authorization for specific intended uses may request to participate in the pilot.

The FDA will work with participants to identify circumstances when enforcement discretion may be appropriate. This approach allows manufacturers to offer devices for intended uses to improve patient outcomes while collecting real-world performance data. The agency can then use this data to better understand how these technologies perform in everyday settings.

This regulatory flexibility reflects lessons learned from CDRH's experience with the Total Product Life Cycle Advisory Program (TAP). That program demonstrated how early collaboration and proactive input can streamline device development. The FDA applies these insights to TEMPO through emphasis on early engagement, "sprint" discussions, and robust real-world data collection.

Real-World Evidence Collection

The FDA announces TEMPO with a strong emphasis on collecting real-world evidence about digital health technology performance. Participating manufacturers will collect, monitor, and report comprehensive performance data while their devices are used in actual care settings. This approach provides the FDA and CMS with invaluable insights into how digital health technologies perform beyond controlled clinical trials.

Real-world evidence collection serves multiple purposes. It helps regulators understand whether devices deliver promised benefits in diverse patient populations and real-world conditions. It provides manufacturers with data to improve their products continuously. Most importantly, it ensures that patients receive technologies that truly work for them in their daily lives.

The pilot's data collection requirements align with modern approaches to medical device oversight that emphasize post-market surveillance and continuous improvement. Rather than relying solely on pre-market studies, this approach recognizes that device performance in real-world settings provides critical information for ensuring patient safety and effectiveness.

Selection Process and Timeline

The FDA announces TEMPO will begin accepting statements of interest in January 2026. The agency plans to select up to approximately ten manufacturers in each of the four specific clinical use areas, creating a diverse cohort of participating technologies.

The selection process will evaluate devices that meet the statutory definition of a medical device, including artificial intelligence-enabled technologies. Eligible devices must be intended for use in conjunction with clinician-supervised outpatient treatment for patients with conditions in the designated clinical areas.

Selected devices may rely on off-the-shelf platforms such as general-purpose computing platforms or wearable products. This flexibility recognizes that effective digital health solutions often build on existing consumer technologies, adding medical functionality and clinical validation.

Expert Perspectives on TEMPO's Impact

FDA Commissioner Dr. Marty Makary emphasized the patient-centered philosophy behind the initiative, explaining that the FDA is piloting an approach to encourage the use of digital technologies that meet people where they are. He noted that the pilot supports innovative tools and a healthcare delivery model that could improve care for millions of Americans managing chronic disease.

CDRH Director Michelle Tarver highlighted the transformative potential of digital health technologies, stating that these tools are rapidly transforming how people manage chronic conditions. She emphasized the FDA's commitment to ensuring its regulatory approach keeps pace with innovation while collecting real-world evidence about device performance for patients in their everyday lives.

Implications for Healthcare Delivery

The FDA announces TEMPO at a pivotal moment in healthcare transformation. The pilot addresses fundamental challenges in chronic disease management: improving access to effective interventions, supporting continuous rather than episodic care, and aligning payment with outcomes rather than services.

For healthcare providers, TEMPO creates opportunities to offer technology-enabled care models that extend their reach beyond traditional clinical encounters. Clinicians can leverage digital health devices to monitor patients continuously, intervene proactively when needed, and provide support between visits.

For patients, the initiative promises expanded access to innovative tools that help them manage their conditions more effectively. Whether monitoring blood glucose levels, tracking physical activity and pain patterns, or accessing digital therapeutics for mental health conditions, patients gain agency in managing their health.

For device manufacturers, TEMPO offers a pathway to bring innovative technologies to market more rapidly while demonstrating real-world value. The pilot's emphasis on outcomes and real-world evidence aligns with broader healthcare trends toward value-based care and personalized medicine.

Looking Ahead

The FDA announces TEMPO as a major step in supporting technology-enabled care, strengthening chronic disease management, and expanding healthcare access nationwide. As the pilot moves forward, it will provide valuable insights into regulatory approaches that balance innovation with safety, access with quality, and efficiency with effectiveness.

The initiative represents more than a regulatory experiment; it embodies a vision of healthcare where technology empowers patients, extends clinician capabilities, and delivers measurable improvements in health outcomes. For the millions of Americans managing chronic diseases, TEMPO offers hope for better tools, better access, and better health.

As statements of interest open in January 2026, the healthcare community will be watching closely to see which manufacturers participate and which technologies receive the opportunity to demonstrate their value in real-world settings. The success of this pilot could pave the way for broader regulatory reforms that accelerate beneficial innovation while maintaining the rigorous standards patients deserve.