In June 2025, HHS Secretary Robert F. Kennedy Jr. told a House panel he wanted every American using a wearable health device within four years, and said the agency was preparing “one of the biggest advertising campaigns in HHS history” to get there. A year later, that campaign has not materialized, and tracking Americans’ wearable use does not appear to have been part of the plan.
Asked for an update on the initiative, HHS did not address the four-year target or the advertising campaign directly. In a statement to Becker’s, the agency said Mr. Kennedy remains focused on helping Americans understand the relationship between nutrition and health, and that the administration is committed to educating people on resources tied to diet and well-being. Wearable adoption is not something the federal government is currently tracking.
If the standalone wearables campaign quietly disappeared, the underlying push toward paying for chronic care tied to devices and apps did not. CMS unveiled the ACCESS model — Advancing Chronic Care with Effective, Scalable Solutions — Dec. 1, a 10-year pilot that reimburses technology-supported chronic care for patients with traditional Medicare.
CMS Administrator Mehmet Oz, MD, described an outcomes-based structure built around upfront payments to vendors by condition, covering musculoskeletal pain, depression, diabetes and hypertension, with full reimbursement contingent on improved health measures.
The model debuted July 1. The American Medical Association and other physician groups have praised it. A related pilot, MAHA Elevate, is set to fund up to 30 lifestyle-medicine and chronic-disease-prevention projects worth about $3 million each, with wearables and remote monitoring within scope; its first cohort starts Sept. 1.
The FDA built its own companion mechanism. In December, the agency announced TEMPO, or Technology-Enabled Meaningful Patient Outcomes, a pilot that grants device makers enforcement discretion on requirements such as premarket authorization if their products are used to deliver care covered by the ACCESS model.
The agency planned to select up to 10 manufacturers in each of four clinical areas tied to ACCESS: early cardio-kidney-metabolic conditions like hypertension and prediabetes, cardio-kidney-metabolic illnesses such as diabetes, musculoskeletal pain, and behavioral health conditions including depression and anxiety. Dexcom became the first TEMPO participant July 22, offering a glucose-monitoring program aimed at prediabetes and Type 2 diabetes screening. By Aug. 21, the FDA had added three more companies — SonderMind and Limbic for behavioral health tools, and Cadence Solutions for a hypertension-management program.
HHS has also kept investing in the underlying technology even as its public messaging shifted. In March, ARPA-H, the HHS research arm modeled on the Pentagon’s DARPA, launched Delphi, a program funding development of next-generation biosensors that go beyond today’s heart rate and glucose trackers to monitor hormones, inflammation markers and drug levels in real time. Delphi is structured in three phases, from component development through a clinical trial, with a stated aim of eventually reaching tens of millions of devices; no funding total has been set.
The FDA’s broader regulatory posture has stayed deliberately hands-off in the same vein. Then-FDA Commissioner Marty Makary, MD, said in January the agency would not regulate wearables or software offering nonmedical-grade “general health information” — a stance that left the door open for the consumer wearable market Mr. Kennedy’s goal depends on.
A year after Mr. Kennedy’s pledge, the advertising campaign he described has not appeared, and there is no indication anyone at the federal level is counting who owns a wearable. What has taken shape instead is narrower and more bureaucratic: a Medicare payment pilot, a companion FDA pathway granting device makers regulatory relief, early-stage federal research into next-generation biosensors, and a broader hands-off approach to consumer wearable data.
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