The digital health regulatory pathway has entered a significant new pilot phase with the FDA’s Technology-Enabled Meaningful Patient Outcomes (TEMPO) initiative. Launched on December 5, 2025, by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot is designed to increase responsible access to digital health technologies used in chronic disease management. Some of these health solutions include: remote patient monitoring (RPM), remote therapeutic monitoring (RTM), digital therapeutics, wearables, and AI-enabled software platforms.
This article explores how the FDA’s TEMPO pilot could fundamentally change how RPM, RTM, and other digital chronic care tools are evaluated and adopted under the current digital health regulatory pathway.
TEMPO’s New Approach to the Digital Health Regulatory Pathway
TEMPO introduces a risk-based, in-market deployment model. Select manufacturers will now be allowed to launch their technologies into clinical settings under FDA enforcement discretion. The FDA expects TEMPO pilot manufacturers to collect real-world data on device use, share this data with the FDA, and then use it, with other information, to seek appropriate marketing authorization, while offering devices for care covered by the CMMI ACCESS model. This temporary authorization is contingent on meeting rigorous requirements for safety, clinical oversight, and data reporting.
The evidence and data generated through TEMPO are expected to build a powerful case for broader adoption, payer coverage, and seamless integration into provider workflows. By emphasizing real-world evidence generation, TEMPO shifts the regulatory focus closer to how technologies are actually used, creating a modernized and pragmatic framework for the digital health regulatory pathway with critical patient guardrails.
TEMPO as a Catalyst for RPM and RTM in the Digital Health Regulatory Pathway
The structure created by TEMPO supports the expansion of remote monitoring programs. Crucially, it helps close the notorious gap between technical innovation and a reimbursement-ready deployment.
RPM and RTM technologies depend on continuous data, longitudinal outcomes, and tight clinical integration for conditions that traditional, short-term clinical trials often fail to capture. TEMPO enables these solutions to be evaluated in live care environments and generate evidence needed to show how chronic conditions can be managed effectively over time. The successful implementation of TEMPO could create a viable and expedited digital health regulatory pathway for these specific technologies.
For organizations specializing in cardiometabolic care, behavioral health, musculoskeletal conditions, or integrated chronic care, TEMPO offers a realistic chance to move a product from a closed pilot straight to scalable, reimbursable clinical use.
Bridging Payment: TEMPO, CMS ACCESS, and the Viability of the Digital Health Regulatory Pathway
TEMPO is positioned for commercial success because of its alignment with CMS’s (Advancing Chronic Care with Effective, Scalable Solutions). ACCESS is a value-based care initiative specifically designed to support outcome-oriented, technology-enabled chronic disease management.
By pairing the FDA’s enforcement flexibility with a clear CMS payment framework, TEMPO tackles the industry’s greatest challenge: receiving regulatory clearance without reimbursement, or achieving reimbursement without regulatory certainty. Together, TEMPO and ACCESS signal a coordinated federal strategy to embed digital health tools into the core of reimbursed, outcome-driven care models, solidifying this new digital health regulatory pathway.
Impact on Innovators and Startups Navigating the Digital Health Regulatory Pathway
For startups, TEMPO can potentially lower the barrier to clinical deployment. It enables companies to deploy, measure, iterate, and learn in the market while simultaneously building a robust evidence base for future FDA submissions.
For founders and investors, this approach reduces regulatory uncertainty and shortens the long path between product development and clinical validation. Crucially, smaller innovators can start receiving in-market feedback and validation before committing to large-scale premarket trials, making this an accessible digital health regulatory pathway.
This is a milestone for companies focused on chronic disease management, behavioral health, patient engagement, and low-to-moderate risk monitoring tools that have historically struggled to justify the cost and time of traditional premarket studies.
AI, Real-World Evidence, and the Evolution of the Digital Health Regulatory Pathway
The TEMPO framework is also well-suited for AI-enabled technologies. AI and machine-learning tools require longitudinal, real-world data to demonstrate performance, safety, and clinical relevance. Yet, traditional review pathways often demand that evidence before that data can realistically be collected.
TEMPO provides a controlled setting where AI models can be evaluated in live clinical workflows, monitored for performance “drift,” refined for usability, and assessed across diverse patient populations. For truly adaptive or learning systems, this is arguably the most practical and efficient route to building the evidence needed for future FDA authorization and adhering to emerging AI governance standards, ultimately evolving the digital health regulatory pathway.
Realities of the TEMPO Pilot Program
Participation in TEMPO is highly limited, competition will be intense, and the real-world data requirements are substantial. Companies must be prepared to demonstrate robust data infrastructure, privacy compliance, interoperability, and active safety monitoring.
Enforcement discretion is not an exemption from regulatory responsibility. The FDA’s expectations for labeling, adverse event reporting, and risk mitigation remain fully in force. TEMPO is designed to reward preparedness and maturity, not offer shortcuts within the new digital health regulatory pathway.
A Defining Moment for the Digital Health Regulatory Pathway
TEMPO may represent the clearest federal endorsement yet that the future of care is shifting in favor of RPM, RTM, and chronic-care innovation. For the first time, regulators and payers are jointly backing a model where digital health tools can be evaluated, reimbursed, and scaled as core components of care.
For innovators, providers, and health systems, TEMPO opens the door to creating outcome-oriented, technology-enabled chronic care models that are both clinically validated and financially sustainable.
