The FDA Just Made It Easier to Get Digital Health Tools to You—Here's What That Means

The Food and Drug Administration (FDA) just announced two major changes that could dramatically speed up how quickly you get access to cutting-edge digital health tools. These shifts address long-standing barriers that have kept promising technologies—from chronic disease monitoring apps to AI-powered diagnostic tools—stuck in regulatory limbo while patients waited.

What Exactly Did the FDA Change?

The agency made two key announcements in December 2025. First, they launched the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program, which allows up to 10 digital health companies to request that the FDA temporarily waive certain regulatory requirements while their technologies are tested in real-world settings. Second, they eliminated a major barrier by accepting de-identified real-world evidence for medical device applications, meaning companies no longer need to include private patient information in their submissions.

The TEMPO pilot specifically targets companies participating in Medicare's new payment model for chronic disease management, covering conditions like diabetes, high blood pressure, chronic pain, and depression. These are exactly the areas where digital health tools—like continuous glucose monitors, blood pressure tracking apps, and mental health coaching platforms—could make the biggest difference.

Why Was This Change Needed?

The previous system created frustrating bottlenecks. Since 2016, only 35 drugs, biologics, or vaccines have successfully incorporated real-world evidence into their FDA applications, largely because the agency required identifiable patient data that made it impractical to use large databases. Meanwhile, digital health technologies often struggled with a different problem: even after getting FDA approval, they couldn't get Medicare reimbursement, leaving patients unable to afford them.

The new approach unlocks access to massive datasets that were previously off-limits, including:

• National Cancer Registries: The Surveillance, Epidemiology, and End Results (SEER) Program tracks millions of cancer patients and their treatment outcomes over time
• Hospital System Databases: Electronic health record networks containing comprehensive patient care information across multiple healthcare facilities
• Insurance Claims Databases: Real-world usage and outcome data from actual patient treatments and interventions

"We're removing unnecessary barriers that have prevented us from using powerful real-world evidence to get life-changing treatments to patients faster," said FDA Commissioner Marty Makary in announcing the changes.

What Does This Mean for Your Healthcare?

These changes could accelerate access to digital health technologies that have shown promise but were stuck in regulatory processes. For chronic disease management specifically, this opens doors for technologies like telehealth software, wearable devices that monitor sleep and heart rate, blood sugar tracking systems, and apps that provide personalized lifestyle coaching.

However, there are important caveats. The TEMPO pilot is limited to just 10 participants and focuses specifically on companies already working with Medicare's new chronic care payment model. The enforcement discretion is also temporary—companies will eventually need to obtain full FDA authorization. Additionally, many digital health technologies already fall outside FDA regulation or under existing policies that don't require formal approval, so the impact may be more limited than it initially appears.

The FDA is also considering extending similar changes to drug and biologic applications, which could further expand the use of real-world evidence across healthcare. This represents a broader shift toward using data from actual patient experiences, rather than just controlled clinical trials, to understand how treatments work in everyday settings.