Millions of Americans struggle with mental health disorders, but research and treatment in this field often stumble over the same roadblock: the lack of precise, objective tools to measure outcomes.
On Wednesday, the Digital Medicine Society (DiMe) — a nonprofit that connects experts to advance the safe and effective use of digital tools in healthcare — unveiled a new initiative to address this sweeping problem.
The organization, in partnership with FDA, is launching the project within its Digital Measurement Collaborative community (DATAcc). More than 20 organizations — including telehealth providers, digital health startups, biotech companies and research collectives — will work together to establish a standardized set of digital measures for the evaluation of common mental health disorders. These measures will include specific features of sleep, speech and physical activity that are scientifically proven to reflect a person’s mental health status.
Some of the participating organizations include the American Psychological Association, BetterHelp, Mass General Brigham, Otsuka, Talkspace and the UCLA Depression Grand Challenge.
The ultimate goals of the new project are to improve patient care, enable better reimbursements for providers and accelerate the development of new tools.
Moving beyond checklists
There has been a proliferation of digital treatments for mental health over the past decade — but the tools to measure whether these actually work are outdated, often relying on blunt, subjective questionnaires like the PHQ-9 for depression or the GAD-7 for anxiety, explained DiMe CEO Jennifer Goldsack.
Questionnaires don’t capture day-to-day patient changes, making it difficult to guide clinical decisions or prove effectiveness for reimbursement, she noted.
“Any clinician that would say we don’t yet have the necessary tools in the toolbox to really know how a patient is doing — to really know whether a drug that they’ve prescribed or a treatment pathway is working. But there’s an enormous opportunity to use the high-resolution streams of data that we are capturing from sensor technologies to deeply understand the impact of a mental health condition on a patient with and without therapy,” Goldsack remarked.
This type of sensor-based data — such as changes in sleep patterns, physical activity levels, stress responses or speech cadence — can give real-time insights into a patient’s mental health, she said.
For example, an anxious patient might consistently sleep fewer hours, or a depressed patient’s speech patterns might slow and flatten. These concrete, quantitative measures can be tracked over time — and that helps reveal whether or not treatment can deliver measurable improvement.
There are several companies participating in DiMe’s new project that sell devices that collect this type of data — including Emteq Labs, which sells wearable sensors to measure things like facial muscle movement and heart rate; Linus Health, which offers cognitive assessments that incorporate speech and eye tracking; Ksana Health, which collects data on patients’ activity, sleep and phone usage; and Feel Therapeutics, which provides technology to monitor the mental state of participants in clinical trials for behavioral drugs.
Creating shared measures
Sharon Kaplow, vice president of clinical operations at Feel Therapeutics, said her company is thrilled to join DiMe’s initiative.
She noted that current mental health measurement methods are episodic and subjective.
“They often rely on patient self-reports, which can be biased and require considerable time and effort from both patients and clinicians. As a result, these methods fail to monitor patients remotely or detect subtle, early changes in a patient’s condition, which are critical for timely intervention,” Kaplow stated.
In seeking to establish a standardized set of digital measures that allow for passive and continuous monitoring of mental health patients in a more objective manner, DiMe is taking a big swing to solve an issue that the mental health space has been struggling with for a while, she declared.
Feel Therapeutics, which formed 10 years ago, has been dedicated to helping solve this same problem for its entire existence. The company uses wearable and mobile sensors to monitor physiological data such as electrodermal activity, heart rate variability, skin temperature and physical activity, along with behavioral data from users’ mobile phones, to track changes in their emotional states, mood, sleep, psychomotor activity and social activity, she explained.
Another mental health executive involved in DiMe’s project — Erin Boyd, chief growth officer at Talkspace — noted that while her company and many others in the space pride themselves on providing “outcomes-based care,” there has never been industry standards for measuring the outcomes of mental health care.
“It’s not like the range your blood pressure should be in or the range your cholesterol should be in,” she remarked, noting that each company tends to operate on its own set of standards.
For years, Talkspace and other mental health providers have been publishing peer-reviewed research on how they are measuring the outcomes of their care, Boyd pointed out. By uniting these independent efforts under one collective, she believes the industry will quickly be able to come up with a common language for digital standards.
Boyd noted that DiMe’s initiative features a diverse group of organizations, calling it “a good mix that you don’t see come together very often.”
Turning consensus into action
DiMe plans to release its core set of digital measures for mental health conditions by the end of the first quarter of 2026, Goldsack said.
“We want to understand if the treatment pathway that they’re on is actually working. One, so if it is, we can reimburse for it. And two, if it’s not, we can course correct and get them onto another therapeutic pathway. That’s the gap that this project is going to address,” Goldsack declared.
The creation of a common “measurement ontology” will ensure that all industry stakeholders’ methods are consistent and trusted — as well as suited for various uses, whether they be for clinical, regulatory or reimbursement reasons, she stated.
She pointed out that while today’s sensor technologies can measure almost anything, the industry is still figuring out which measures are the most clinically relevant and valuable.
Too often, digital health tools focus on what they measure rather than how well they measure it or how easily the data fits into care and research workflows, Goldsack said..
DiMe’s initiative brings together experts from across the industry to agree — upfront and in a precompetitive setting — on a set of digital measures for mental health that works for all players in the space. Goldsack noted that the measures will likely have to do with things like sleep, physical activity, speech and body language.
The team will go beyond plain-language definitions — instead creating detailed technical standards and data requirements so product developers, clinicians, researchers and payers can all use the measures “off the shelf” with confidence, she explained.
This approach seeks to remove the R&D burden from individual companies, as well as create market clarity around the metrics that truly matter for clinical care, reimbursement and regulatory approval, Goldsack added.
Another mental health executive involved in DiMe’s project — Russell DuBois, vice president of clinical quality, operations and innovation at BetterHelp — said he hopes the set of digital measures allow most people to easily understand their mental health in a way that feels accurate and honest to them.
“Not a lot of people know what a PHQ-9 or GAD-7 is or what their results mean, but introducing wearables data, like how an effective virtual therapy session might lead to increased physical activity or improve heart rate variability, helps people more easily connect how what they do affects how they feel,” he declared.
He said he also hopes that the measures unlock the ability for mental health to be measured and managed at a much larger scale than it is today.
In his view, using behavioral data from wearables as a proxy for our traditional patient-reported outcome measures will allow providers to better understand how their populations are really doing — as well as improve their ability to get people the appropriate level of care.
Ultimately, the project’s participants believe a set of new digital standards should replace traditional patient-reported outcome measures like the PHQ-9 and the GAD-7.
In addition to developing a core set of digital measures, DiMe’s collaborative will also produce a three-part series of implementation playbooks. These will explain how to use the measures for clinical trials, digital phenotyping and post-market use.
Why now?
Now is the perfect time for DiMe to launch this initiative, Goldsack believes. She pointed out the Peterson Health Technology Institute recently issued a report that identified the urgent need for better measures to track the clinical and economic value of digital mental health solutions.
Additionally, CMS’ proposed rule for the 2026 Medicare Physician Fee Schedule supports broader use of digital measures to track outcomes in specialty and value-based care, and the White House’s new “Make Health Tech Great Again” agenda also calls for better national infrastructure around digital measurement in healthcare.
DiMe’s project also aligns with FDA and White House priorities to expand remote monitoring, shift to preventive care and focus on evidence-backed tools, Goldsack added.
She said she is pleased to have the FDA as a partner organization for the initiative, as the regulatory agency is ensuring the project’s work meets requirements for clearance and use in trials.
By establishing a shared language for mental health outcomes measurement, DiMe and its partners hope to bring clarity to a space long plagued by subjectivity. If successful, their work could redefine how mental health is understood, treated and paid for.
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