FDA’s TEMPO Pilot Paves the Way for Digital Health in Chronic Disease Care
A new regulatory pathway for digital health technologies
The U.S. Food and Drug Administration (US FDA) has announced the launch of the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot - a first-of-its-kind, voluntary initiative to expand patient access to digital health technologies for chronic disease care.
Developed under the FDA’s Center for Devices and Radiological Health (CDRH), TEMPO takes a risk-based, pragmatic regulatory approach to support digital health devices intended to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
What TEMPO aims to achieve
⦿ Improved access to innovative technologies: The pilot aims to accelerate the introduction of digital health tools such as wearables, connected sensors, software-based therapeutics, and remote monitoring platforms into real-world care for conditions like prediabetes, heart failure, chronic pain, anxiety, depression, and other chronic diseases.
⦿ Regulatory flexibility with safeguards: Manufacturers who take part in the program can ask the FDA to exercise “enforcement discretion” temporarily; thus, they will be exempted from holding standard approvals like premarket authorization or investigational device approvals while the gadgets are under controlled conditions of use.
⦿ Real-world data gathering and proof generation: Manufacturers will be the ones to report and collect performance data from the real world (RWD) as part of the TEMPO project. This will give the regulator a chance to evaluate the device's safety, efficiency, and long-term value. Data can serve as a basis for later FDA clearance or authorization, thus making it formal.
⦿ Alignment with reimbursement models: TEMPO is coordinated with the Centers for Medicare and Medicaid Services (CMS) Innovation Center’s ACCESS Model (Advancing Chronic Care with Effective, Scalable Solutions). Under ACCESS, providers offering technology-enabled chronic care may receive outcome-aligned payments, creating a pathway for digital therapeutics and remote monitoring tools to be reimbursed, not just offered as standalone solutions.
Scope and participation
The FDA will begin accepting “statements of interest” from device makers on January 2, 2026. In the first phase, the agency plans to select up to about 10 manufacturers per clinical use area, across four condition areas defined by CMS:
⦿ Early cardio-kidney-metabolic conditions (e.g., hypertension, prediabetes, obesity)
⦿ Cardio-kidney-metabolic conditions (e.g., diabetes, chronic kidney disease, atherosclerotic cardiovascular disease)
⦿ Chronic musculoskeletal pain and related disorders
⦿ Behavioral health conditions (e.g., depression, anxiety)
Given this selection framework, TEMPO could bring as many as ~40 digital health solutions into real-world use.
Why TEMPO matters: implications for digital health
Digital health technologies, including software-based therapeutics, remote monitoring devices, and AI/ML-enabled solutions, are rapidly transforming how chronic diseases are managed. However, frequent use of the traditional regulatory and reimbursement routes has always taken too long and consequently led to patient access delays. The TEMPO pilot, on the other hand, marks a significant shift in the paradigm by integrating regulatory flexibility with the real-world evidence generation and reimbursement incentives.
By allowing manufacturers to utilize technologies under supervision, TEMPO will quickly bring the adoption of remote patient monitoring tools, behavior-modification apps, teletherapy, and other chronic-care solutions, etc. to the market. Over time, evidence generated through TEMPO could support broader FDA clearance and pave the way for mainstream integration of digital health in chronic disease management.
What TEMPO means for organizations and developers
Digital health companies, med tech manufacturers, and start-ups developing Software as a Medical Device (SaMD), digital therapeutics (DTx), wearables, or AI-integrated health applications will find TEMPO to be an excellent opportunity: a fast-track, real-world market access, along with the validation based on data and a possible reimbursement route through CMS’s ACCESS Model. But, if a company wants to be part of the program, it must be prepared: companies are required to have strong data gathering, privacy- compliant analytics, clinician oversight plans, and a clearly defined safety/risk-mitigation strategy. The success of digital health tools under TEMPO will depend not just on technical innovation but also on thoughtful clinical integration and real-world performance.
How Elexes Can Support Your Digital Health Strategy
At Elexes, we guide medical device and digital health companies through regulatory compliance, including FDA submissions, ISO 13485 quality management systems, and CE marking. The future of chronic-disease digital health tools by TEMPO, opening up a new regulatory pathway, is now. Our regulatory affairs and clinical trial expertise can assist you in the following: assessing your company’s situation, drafting a strong Statement of Interest, designing data-collection plans, and supervising the submission of real-world evidence.
Contact Elexes today to understand how your digital health product can leverage this regulatory shift and accelerate access to chronic care markets.
