Why Wearable Technology Could Become the ‘Stethoscope’ for SMI Care

This is an exclusive BHB+ story

Treating serious mental illnesses (SMI) is still a task in the behavioral health industry that not all providers want to engage in or feel comfortable navigating, but the growing popularity of wearables and their enhanced capabilities could make that easier.

Currently, about 41% of adults in the U.S. and Canada own and use wearable devices. U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. wants to make the use of these technologies even more widespread, too.

During a June 24 hearing before the House Energy and Commerce Committee, Kennedy said his goal is “that every American is wearing a wearable within four years.” He plans to accomplish this via “one of the largest HHS campaigns in history to encourage their use.”

Even so, wearables are unlikely to be a silver bullet, especially for tackling complex challenges like SMI, experts told Behavioral Health Business. And even if wearables can help providers capture more data and outcomes measures over time, they are also not expected to move the needle on value-based care.

“I think the biggest issue with trying to do more value-based care is the silos of physical and mental health. And wearables won’t solve that issue,” Stas Sokolin, CEO and co-founder Amae Health, told BHB. “I think that is a much more limiting factor for value-based care. I don’t know if wearables would really make much of a difference in those agreements as things currently stand.”

Adoption of wearable technologies in the mental health space is limited, and so is research around them being in use for this purpose. These devices can also be expensive to distribute, own and use, with no clear pathways for reimbursement.

Still, smart watches, rings, fitness bands and interoperability with smartphones can offer providers a deeper understanding of what is going on with their patient physiologically between sessions. It’s something that could be pivotal for how SMIs can be treated and triaged over time.

There’s evidence that the prevalence of SMIs is rising, especially among younger adults. Nearly 12% of adults between 18-25 have been diagnosed with an SMI. In total, across age groups, SMIs occur in 15.4 million adults, or 6% of the population, according to data from the National Institute of Mental Health (NIMH).

Despite hesitancy around data sharing in other parts of health care, among individuals who use wearable devices, 80% say they would be willing to share that data with a clinician or doctor to support health monitoring. If patients with SMIs participated in this practice, real-time monitoring could allow for prompt interventions and care engagement that prevent hospitalizations or lower the frequency of them.

“If enough people were really using them and the data was standardized, it would make a lot of sense to use them to then build these treatment pathways,” Dr. John Torous, director of digital psychiatry at Beth Israel Deaconess Medical Center in Boston, Massachusetts, told BHB. “But in essence, what we have to understand first is what is a common health care standard for wearables and when do we know that the data is of good enough quality?”

Capital is pouring into the health wearables space and is expected to catapult from more than $103 billion in 2025 to more than $324 billion by 2032.

As sensors become more sophisticated, battery life increases and technology overall grows more intelligent with advances like AI, wearables could become “the first part of a stethoscope for measuring mental health,” Sonia Garcia, co-founder and chief growth officer of Amae Health, told BHB.

Part of the mental health stethoscope

Amae Health, an SMI treatment provider headquartered in San Francisco, is actively using wearable devices to some extent for patients already. The company began use of these devices after receiving a grant to study how adherence to the ketogenic diet affected patients with SMI. Quickly, these devices became helpful for care teams to see sleep patterns, activity, stress levels and heart rate variability.

“It was really informative for providers to see and understand what we should do more of and what we should do less of,” Sokolin said.

Instead of relying on patient-reported information between care sessions about how sleep, stress and activity have been, wearables can bring a window for providers to have clarity about how treatment is working and how things may change day by day.

“Let’s say it’s a bipolar patient and we’re getting real-time data that their sleep is declining and that their activity data is increasing,” Sokolin said. “Maybe that activity is occurring late at night for a bipolar patient. That’s a pretty clear sign of mania, and wearables allow us to pick up on that before the patient may have an unfortunate event – and before they get re-hospitalized.”

While these devices may provide clinicians with “a picture of how measurement can really impact health care and patient progress with insights that have never been that accurate in the past,” as Garcia explained, it’s important to consider the insights as just one piece of the holistic-health puzzle, she said.

Feel Therapeutics, also based in San Francisco, develops digital precision medicine tools for mental health. By building unique sensors for biomarkers that are embedded into a wristband, the company continuously tracks and analyzes the data to improve patient engagement and outcomes.

Most recently, the company has been working on getting FDA clearance to pursue medical device classifications for some of its products so they can be used more widely.

George Eleftheriou, the company’s CEO and co-founder, said when it comes to SMI, for wearable devices to be effective, they “need medical grade sensors,” something the company anticipates getting clearance for sometime during the first half of 2026.

“For those struggling with serious mental illness, the need is even more profound,” Eleftheriou told BHB. “This can help us identify risk of relapse early on and bring people back to the providers before they relapse, before they need another treatment. … It’s critical to be integrating wearable data with clinical guidelines, and unless this happens, it will be harder to use for groups like individuals struggling with severe mental illness.”

More data, greater burden?

Even if integration with clinical guidelines occurs, some experts like Torous and Dr. Bethany Bracken, director of physiological systems at Charles River Analytics, say there will still be many hurdles to adoption and effectiveness broadly.

“You definitely can get an early warning sign of relapse or symptom change, of course,” Torous said. “But the question is, what are you going to do with that early warning sign? Is it that every person has to come to the hospital for a visit, or does everyone have to do a telehealth visit? It’s almost as if the field isn’t prepared to handle more visits or respond in a personal way. There’s already a shortage of staff. And here we’re saying this technology can identify the need for more care, for more people, which is a wonderful thing, but what if that [care] doesn’t exist?”

Bracken, an expert from Cambridge, Massachusetts-based AI, robotics and technology company Charles River Analytics, explained that the industry is still far off from defining the ethics around wearables and the data they produce.

“We need to always make sure we consider how the technology can be used in ways we don’t plan,” Bracken told BHB. “For example, can the information about their mental health be used to hospitalize them, potentially against their will, if they become a danger to themselves or others? What is the threshold to determine that the technology is correct in its assessment, so that we don’t hospitalize people who have not met that threshold?”

Both Torous and Bracken echoed that digital solutions like wearables require more oversight. They also noted it’s a bit too early to tell if these options can definitively be helpful for complex patient needs.

“Any software that is making a conclusion about mental health needs to be FDA approved,” Bracken said. “A huge consideration is figuring out the amount of evidence that is needed to trust that a technology is making correct assessments.”

Technology is going to continue to advance, and tools like large language models and AI can help clinicians more easily and quickly analyze complex data and find patterns. However, the jury is still out on where these devices may fit into the larger picture of personalized health.

“At this point, we know enough that digital solutions can definitely be helpful, but it’s unclear if they can help some of SMI avoid relapse,” Torous said. “So the different discussions need to be around where do digital interventions have a role?”

Money is also in question. Currently, reimbursement pathways for providers who use wearables for mental health do not exist. Sokolin said Amae Health is “not planning on getting any reimbursement at all from wearables.” For Amae, it’s about value add, not fiscal add.

However, without clear fiscal reimbursement options for these devices more broadly, there may not be an incentive to invest in it from a provider standpoint or to spend time really analyzing the data, Sokolin said.

For wider adoption across the mental health space, he projects the field may be “looking at this in a much longer term of decades, not in years.”

An explosion of wearable options can create barriers too. While the innovation may be promising, “for payers, it’s likely difficult to decide which new products on the market are worth covering,” Bracken said.

“There have been a few companies that have vastly overstated their ability to provide information on physical or mental health outcomes, or to provide therapy, that have then underperformed,” Bracken added.