WASHINGTON—The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) are advancing coordinated pilot programs aimed at expanding the use of digital health technologies for chronic disease management, as federal officials move to evaluate how technology-enabled care can be integrated into Medicare while generating real-world evidence on safety and effectiveness.
The FDA's Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, launched in late 2025, is being developed alongside the CMS Innovation Center's Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, which began implementation in July 2026. Federal officials said the initiatives are designed to test how eligible digital health devices and technology-supported care models perform in routine clinical practice while maintaining patient safety.
Under the voluntary TEMPO pilot, participating manufacturers may request that the FDA exercise enforcement discretion for certain regulatory requirements, including selected premarket authorization obligations, while collecting and submitting real-world performance data. The agency said it will determine eligibility on a case-by-case basis and only for devices meeting specified risk and clinical criteria.
FDA Commissioner Marty Makary said when the program was announced that the pilot is intended to encourage the use of digital technologies that can improve care for people managing chronic diseases while maintaining appropriate safeguards. CMS Administrator Mehmet Oz said the collaboration would help the agencies better understand how technology-enabled care can support Medicare beneficiaries and inform future payment models.
The ACCESS model focuses on people enrolled in Original Medicare with chronic conditions including hypertension, diabetes, chronic musculoskeletal pain and depression. Rather than reimbursing specific clinical activities, the 10-year demonstration emphasizes outcome-based payments, allowing participating organizations to combine in-person, virtual and asynchronous care supported by digital technologies such as remote monitoring devices, software applications and wearable sensors.
According to the FDA, the TEMPO pilot is intended to generate real-world evidence on how eligible digital health devices perform outside traditional clinical trials. The agency has said the program is part of its broader effort to modernize oversight of digital health technologies while supporting innovation that can safely expand access to care.
The FDA began accepting statements of interest from U.S.-based manufacturers in January 2026 and started requesting additional information from selected applicants in March. The agency said it continues to review submissions and plans to work with participating manufacturers as the pilot progresses, while CMS continues implementation of the ACCESS model for Medicare beneficiaries.
