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Thursday, 20 August 2026 |
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Try first, evaluate later |
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| The FDA has been quietly selecting participants for its TEMPO pilot. A third, the behavioral health company Limbic, was just added to the pilot’s webpage, following remote monitoring company Cadence and Dexcom, the maker of continuous glucose monitors for diabetes. |
| TEMPO (Technology-Enabled Meaningful Patient Outcomes) is a program that allows digital health companies to distribute devices to seniors with chronic diseases through the CMS ACCESS program — without needing FDA authorization. In exchange for waiving those authorization requirements, the device makers are supposed to collect and report data on how the device is performing in the real world. But the FDA will have no idea if these devices will work as intended until the data come in. |
| The point of the pilot is to encourage innovation and get promising tools to patients faster. But is leaving evidence for later the smartest choice? |
| It’s an approach the FDA seems to be taking in other areas as well. This week, the FDA’s Center for Devices and Radiological Health released a discussion paper on regulating generative AI-enabled medical devices. Notably, because evaluating AI devices is challenging, it’s considering whether to “accept greater premarket uncertainty
regarding a GenAI-enabled device’s benefit-risk profile through greater reliance on postmarket monitoring.” |
| Historically, regulators haven’t reviewed many health tech tools that the agency considers low-risk “wellness” tools (and what’s considered “low risk” is often in debate). The FDA now seems to be acknowledging that the evolving world of digital health tools needs more oversight. But the new frameworks kick the data
collection and evaluation down the road, rather than asking for it up front. Unlike pharmaceutical drugs that go through rigorous clinical trials before landing on pharmacy shelves, this approach is one that relies heavily on what happens after products are already in patients’ hands. |
| It’s completely possible that this strategy unleashes total duds into the market, wasting taxpayer money and potentially putting patients at risk. On the flip side, postmarket monitoring may be better than nothing. |
| - Shelby and Nicole Wetsman |
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Epic’s state fair |
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Epic founder and CEO Judy Faulkner takes the stage at this year’s fairground-themed UGM, after kicking off the keynote by bringing a cow on stage. Attendees were also treated to a skit that alternated between a Ferris wheel and a doctor’s office, as well as a carousel to ride. |
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Worldwide made. Thanks for reading.
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