HHS to Launch Campaign Promoting Wearable Devices

Akin Gump Strauss Hauer & Feld LLP

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon launch an advertising campaign encouraging Americans to use wearable health devices. The campaign is set to be “one of the biggest advertising campaigns in HHS history.”

As described by Secretary Kennedy, wearables enable individuals to take responsibility over their health and make informed decisions: “People can take control over their own health. . . They can see what food is doing to their glucose levels, their heart rates and a number of other metrics as they eat it. And they can begin to make good judgments about their diet, about their physical activity, about the way that they live their lives,” Secretary Kennedy said.

Secretary Kennedy went on to state that he has observed the positive impact of wearables (like glucose meters) for weight loss and diabetes management. He noted that the wearables were cost-effective—contrasting the expense of a wearable with the cost of a drug such as Ozempic—and said that the department was “exploring ways of making sure that those costs can be paid for.”

“We think that wearables are a key to the MAHA agenda—Making America Healthy Again, and . . . my vision is that every American is wearing a wearable within four years,” added Secretary Kennedy.

This announcement reflects the growing role of digital and wearable health tools in U.S. public health strategy. However, current law draws a significant distinction between wearables used only for “wellness” and wearables that are intended for use in health care decision-making. The latter are generally regulated by the Food and Drug Administration (FDA) as medical devices (or, in some cases, a certain software function available through a wearable is regulated as a medical device). Typically, medical devices need FDA clearance or approval to be covered by federal health programs. Wearable devices also raise data protection and privacy concerns, as they collect large volumes of personal and sensitive health data, which may be shared by third party apps and services. Connectivity and interoperability will also be important considerations, to the extent the objective is for consumers to be able to share this data with their providers. One of the core impediments to leveraging health metric data from wearables has been the lack of consistent approaches to incorporate such data into a patient’s health care records and treatment.

Nevertheless, as the Secretary’s comments before the Energy and Commerce Committee and the House Ways and Means Committee hearing on digital health this week underscore, digital health continues to be an active area of interest for policy-makers that resonates with the MAHA agenda.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

© Akin Gump Strauss Hauer & Feld LLP

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