The U.S. Food and Drug Administration announced the new Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.

The pilot will evaluate a new, risk-based enforcement approach that supports digital health tech intended to improve outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.

“We are piloting an approach to encourage the use of digital technologies that meet people where they are,” said FDA Commissioner Marty Makary, MD, M.P.H. “This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”

Partnering with the Centers for Medicare and Medicaid Services (CMS) Innovation Center (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, under the TEMPO pilot participating manufacturers of certain digital health devices will offer devices for an intended use to provide care covered by the CMMI ACCESS model while collecting, monitoring, and reporting real-world performance data.

FDA and CMS believe the pilot will help them gain better understanding about how digital health tech performs in real-life settings and how they can support efforts to improve care for people with chronic diseases. The pilot supports CMS’s ACCESS Model, which aims to increase beneficiary access to technology-enabled, integrated care.

“CMS is pleased to partner with the FDA on the TEMPO pilot as we work to modernize care for people with chronic disease,” said Centers for Medicare and Medicaid Services Administrator Mehmet Oz, MD. “Insights from this collaboration will support our efforts to build models that expand access to high-quality, technology-enabled care.”

Participating manufacturers can request the FDA exercise enforcement discretion for requirements like premarket authorization and investigational device requirements, which manufacturers collect and share real-world data showing the device’s performance. The FDA will work with participants in the TEMPO pilot to identify the circumstances when enforcement discretion may be appropriate for that manufacturer’s device.

The pilot is designed to align with the rapid and iterative nature of digital health development and expand patient access to innovative technologies. Devices included in the pilot may be intended for low-acuity cardiometabolic conditions like prediabetes, more complex cardiometabolic conditions such as heart failure, musculoskeletal issues like back strain, and behavioral health conditions like depression.

“Digital health technologies are rapidly transforming how people manage chronic conditions, and we want to ensure our regulatory approach keeps pace,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “The TEMPO pilot will allow us to responsibly encourage innovation while collecting real-world evidence that may help us better understand how these devices perform for patients in their everyday lives.”

The TEMPO pilot is a key component of the FDA’s Home as a Health Care Hub initiative, which aims to bring health and wellness to people where they live, work, and play. By fostering access to digital technologies that can be used safely and effectively in the home, the initiative seeks to improve outcomes and reduce the burden of chronic disease for people in the U.S.

Find more information about the pilot here!