What if the next step in managing your diabetes or heart failure wasn’t a new pill but a piece of software that learns, nudges and reports outcomes? On Dec. 5, 2025, the Food and Drug Administration moved a little closer to that reality.
The agency unveiled the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary, risk‑based program built by the FDA’s Center for Devices and Radiological Health. TEMPO is designed to expand access to certain digital health tools used to improve outcomes for chronic conditions — and to do so while collecting real‑world evidence about how those tools actually perform when patients are at home, at work, or out in the world.
How TEMPO will work
TEMPO pairs the FDA with the Centers for Medicare & Medicaid Services Innovation Center’s new ACCESS payment model (Advancing Chronic Care with Effective, Scalable Solutions), announced earlier in December. Under the arrangement, participating manufacturers can offer devices intended to provide care covered by the ACCESS model and gather real‑world performance data while the agency considers whether to exercise enforcement discretion for specific regulatory requirements — for example, premarket authorization or investigational device exemptions — during the data‑collection period.
The pilot is explicitly aimed at digital health solutions across four clinical use areas tied to common chronic problems: cardio‑kidney‑metabolic conditions (from prediabetes to heart failure), musculoskeletal issues like back strain, and behavioral health conditions such as depression. The FDA plans to solicit statements of interest in January 2026 and expects to select roughly up to 10 manufacturers in each area.
FDA leaders framed TEMPO as an attempt to match regulation to the iterative nature of software‑based care. "We are piloting an approach to encourage the use of digital technologies that meet people where they are," said FDA Commissioner Marty Makary. Michelle Tarver, director of CDRH, added that the effort builds on lessons from earlier advisory and lifecycle programs focused on early engagement and sprint‑style conversations between regulators and developers.
Why industry is paying attention — and why safeguards matter
For device makers and digital‑care platforms, TEMPO is attractive: it offers a path to wider patient access and an alternative, real‑world route to demonstrate safety and effectiveness. It also dovetails with CMS’s ACCESS model, which reimburses providers for technology‑enabled care — a powerful incentive to integrate digital tools into chronic‑care pathways. Modern Healthcare and the AHA have highlighted how payment and regulatory alignment like this can accelerate adoption.
Unsurprisingly, companies are already positioning themselves for the opportunity. Small vendors and established players alike will try to show they can deliver clinically meaningful outcomes and data collection at scale; some vendors have publicly signaled early collaboration intentions with CMS’ new model.
At the same time, observers stress the need for guardrails. The American Hospital Association has previously urged frameworks that balance flexibility with protections for privacy and patient safety — a position that will be tested as AI and software increasingly influence clinical decisions. Rapid advances in consumer and enterprise AI — from new agentic features in search and apps to proprietary image models — underscore how fast the underlying technologies are evolving. For context, see recent developments such as Google’s AI Mode and Microsoft’s new image model launch in the industry conversation MAI‑Image‑1.
The FDA says devices in TEMPO will be suitable for low‑acuity to more complex chronic conditions and that the pilot will help the agency and CMS understand real‑life performance — not just results from tightly controlled clinical trials. That emphasis on real‑world data is central: TEMPO participants will monitor and report outcomes as devices are used in everyday settings.
Practical questions ahead
How will the agency decide when enforcement discretion is appropriate? What metrics will manufacturers submit to demonstrate benefit? How will data privacy and interoperability be assured, especially when devices collect continuous streams of physiologic or behavioral data? The FDA plans to use early engagement, sprint discussions, and post‑market evidence to answer some of those questions, but many details will emerge only as the pilot unfolds.
For clinicians and health systems, the change could be meaningful: a clearer regulatory and payment pathway may make it easier to prescribe technology and get reimbursed for the care it enables. For patients, the potential upside is more choices and tools that fit day‑to‑day life. For regulators and policymakers, TEMPO will be a live experiment in balancing access, innovation and safety.
TEMPO is also part of a broader push by the FDA to treat the home as a hub of care — a shift that requires rethinking both risk assessment and how evidence is gathered. The agency’s move to coordinate with CMS’ ACCESS model is one of the clearest attempts yet to line up incentives, coverage and regulation around digital health.
Expect a busy first quarter of 2026: solicitations open, manufacturers decide whether to join, and regulators begin shaping what evidence will count. The pilot won’t answer every question about software in medicine, but it will produce real‑world experiments that regulators, payers and providers can learn from — and that may reshape how chronic disease is managed over the next decade.