Harris Eyre, MD, PhD

There has been a recent revolution in the development of digital health solutions for various chronic conditions. However, there are relatively few examples of digital health solutions that have been widely adopted in real-world health care settings and are measurably improving patient outcomes or helping health care systems deliver efficient and patient-centric care. From our vantage, there are some fundamental reasons for this “translational gap,” which, if addressed, can go a long way in helping realize the full potential of digital health technologies.

We use mental health/illness as an exemplar because brain-related illnesses will be at the forefront of digital health revolution, as their course can be monitored, outcomes can be measured via digital phenotyping, and interventions can be delivered digitally and remotely. Furthermore, the challenges and opportunities in digital mental health have been further highlighted by the ongoing COVID-19 pandemic, which has added fuel to an already brewing mental health crisis.

Mental Illnesses: The Need and the Opportunity

Mental illnesses represent some of the most prevalent and disabling conditions. Depressive disorders ranked number 4 in age group 10-24 and number 6 in age group 25-49 in the list of leading global causes of level 3 disability-adjusted life-years (DALYS)

 and are associated with a wide range of negative outcomes, including loss of occupational function,

 A key barrier to addressing these challenges stems from inadequate metrics to assess disease status, treatment effectiveness, and patient-relevant outcomes.

Mental illnesses do not have a clear outcome measure such as HbA1C in diabetes; instead, efficacy and outcome measures utilized in clinical practice today are complex and subjective, and are only sporadically collected or recorded in databases. As a result, assessment of quality of mental health care often defaults to the more easily measured process and structure metrics, which are distal from true patient outcomes, and, although they are easier to measure, improvement in these metrics does not always translate to improvement in patient-centric outcomes.

 This hampers outcome-relevant assessment of quality, which in turns hampers creation of value-based incentive structures that would lead to true patient-centric care and direct resources based toward the most impactful interventions (“pay for performance”).

The relative value of patient-generated digital data in driving measurement- and outcome-based care will be disproportionately high in mental health since brain-based disorders manifest with changes in behavior, cognition, and mood that are ripe for digital phenotyping. For example, recent and ongoing digital phenotyping efforts in patients with depression are demonstrating correlations between symptom severity and smartphone and wearable-derived features relevant to daily functioning such as physical activity and sleep as measured by actigraphy,

 sociability as measured by blue-tooth handshakes,

 and anxiety or stress as detected in speech features (natural language processing, or NLP) or physiological read-outs such as Galvanic Skin Response (GSR) and Heart Rate/Heart Rate Variability (HR/HRV). Such digital readouts can be more sensitive to real-time measures of symptom severity, functional impairment, and recovery status than episodic clinical assessments. These digital measures may also serve as proxy measures to assess value and efficacy of clinical care and interventions.

Of course, payers and clinicians will require that evidence for this be generated through long-term digital phenotyping studies that relate digital biomarkers with clinical milestones and cost. This will require long-term adherence to digital phenotyping solutions from the ultimate data source: the patient. Adoption and adherence have been challenges

 that can only be addressed if, regardless of the eventual utility for clinicians and payers, digital phenotyping solutions treat the patient as their first and foremost customer.

Using Patient-Generated Data and Digital Tech for Patient-Centric Care

Utilizing digital health technologies and patient-generated data for enabling outcome-based care hinges on developing a “data partnership” with the patient that is built on principles of trust, mutual benefit, and informed data access and use. This will become more urgent as advances in wearable technology and mobile health provide patients greater control over, access to, and use of their personalized health data. In fact, eventually the boundary between health care data primarily housed in electronic health records (EHRs) and so-called patient-generated health data will blur as agency shifts to the patient and we realize that all data—whether in EHRs or generated by wearable devices—is ultimately patient-generated, and thus, is patient owned and controlled.

Matters of privacy, transparent consenting, and, more broadly, trust are clearly “table stakes” for patient participation in a digital data collection regime. Beyond that, in our experience, conducting long-term multimodal digital phenotyping studies in patients with mental illnesses, 3 factors are most important for patient acceptance, engagement, and long-term adherence. First, any sustained digital phenotyping data collection, in the context of research studies or clinical care, must provide immediate “here and now” value and utility back to the patient, over the friction and burden it creates. This equation can be helped by relying on passive data collection and developing bandwidth-frugal applications with minimal impact on smartphone battery life and other factors important to patients.

Furthermore, the end-user interface and visualizations must be engaging and useful to patients.

 Designing such a solution requires a systematic data-driven understanding of patients’ attitudes, motivations, and barriers toward data collection.

 It is important to follow the common tech industry practice of co-designing solutions in close partnership with end-customers (patients), with iterative learn and improve cycles. We may find ourselves surprised at how often the end-users’/patients’ views on which features are important to them diverge from experts’ preconceived notions.

Second, altruism remains a significant motivator; most patients diagnosed with a serious condition are willing—even eager—for their data to be utilized in research that helps their fellow patients, assuming privacy and security safeguards. This propensity to be part of citizen-science efforts should be leveraged to develop “learning engines” wherein pooled, deidentified digital phenotyping data can be used to solve important problems of broad utility and impact.

Finally, we see physicians’ use of patient-generated data to improve clinical care as crucial motivator for patients to adhere to a digital data regime. In fact, this is perhaps the single most important criterion for patients with serious mental illness who are under the care of a clinician. From the physician’s perspective, the data and visualizations should make the clinic visit more efficient and should integrate readily with their current workflows. Such a system will also improve outcomes by improving patient engagement and enabling more measurement-based care,

 We believe digital health solutions that enhance the patient-physician interface and generate near-term value for both may require more effort for initial uptake, but are most likely to stick than direct-to-patient approaches often utilized by insurance companies and digital health solution providers.

While physicians’ awareness of patient-derived digital data and overall digital platforms was already on the upswing prior to COVID, the pandemic has provided further tailwinds for such solutions.

 The initial deployment of digital phenotyping in clinical care settings will necessarily rely on validated self-reported scales of symptoms, function, and quality of life such as the disease set recommendations by the International Consortium for Health Outcomes and Measurement (ICHOM)

 to implement simple, interpretable flags and known treatment algorithms to aid clinical decision making.

Eventually, growing datasets will enable validation of digital biomarkers and predictive algorithms that are leading indicators of disease burden, health care utilization, crises, relapses, and other cost-driving events that could provide payers with real-time, leading quality metrics that can duly reward risk reduction and preemption. The 

 summarizes the framework of a “learning engine”

 digital health solution that we think can be deployed in mental health to bring together patient-derived digital data and clinical data from EHRs to deliver value to all key stakeholders: patients, physicians, and payers.

Digital Health Solution Framework for Filling the Measurement Gap to Enable Outcome-Based Care in Mental Health

The previously described digital phenotyping framework could become an extension of existing EHRs and clinical decision-enabling software systems, but given the already noted challenges in integrating patient-generated health data (PGHD) into EMRs,

 we expect earlier evolution of stand-alone digital phenotyping solutions that are interoperable with multiple EMR systems.

Collection of longitudinal digital phenotyping data at scale in the real world would necessarily imply reliance on data from patient-owned consumer devices. This will require a concerted effort to develop platform-independent data standards and APIs that can ensure that digital biomarker readouts across different devices are comparable.

Increasingly, data will be analyzed and appropriate features extracted in-situ on the device, which will ease privacy concerns and reduce bandwidth requirements, both of which can severely limit scalability and deployment. We should also note that digital phenotyping solutions that collect continuous data for asynchronous use during patient-physician interaction are distinct from—and in fact, complementary to and synergistic with—synchronous telemedicine solutions that enhance physician reach and accessibility.

In addition to lack of actionable patient-generated outcomes data, true patient-centric and value-based care in mental health is also hindered due to fissures between mental and physical care (ie, a lack of a “whole person” approach). For instance, there is mounting evidence that patients suffering from mental health conditions have markedly poorer outcomes while incurring significantly higher direct medical costs for their physical comorbidities.

 However, such comorbid depression is often undiagnosed or otherwise poorly treated, if at all. Remote assessments and digital diagnostics now offer new scalable ways to detect depression and anxiety and set individuals on a path to formal diagnosis. Digital health solutions can also provide evidence-based tools for self-monitoring, self-care, and management of depression, anxiety, and stress for patients with a primary physical health diagnosis.

Furthermore, comorbid patients can be provided access to high-quality behavioral health care virtually. The virtual behavioral health team can work in partnership with primary/secondary providers treating their chronic physical comorbidities. In this context, use of physician-supervised or autonomous digital therapeutics can also be considered to further address behavioral health co-morbidities in a scalable and effective manner.

The COVID-19 pandemic has illustrated the value of digital technology in health care and has created significant momentum that should be leveraged. Although significant advances have been made, we believe digital solutions can play an even greater role in transforming care. This is particularly true in mental health, where there are inadequate objective measures of disease status or progression. These gaps hinder effective measurement-based patient care as well as an opportunity to better align incentives and scarce resources through more meaningful outcomes-based care. We believe an appropriately designed and safeguarded digital health solution can be used to improve patient care and, at the same time, begin to address critical data gaps needed to enable patient-centric, value-based care.

head of strategy and innovation, Davos Alzheimer’s Collaborative. 

 is the founder and CEO of Holmusk Technologies Inc. 

 is chairman of the board at TheSteinberg Institute. 

 is lead of the Brain Capital Alliance, co-lead of the OECD Neuroscience-inspired Policy Initiative in collaboration with the PRODEO Institute, and senior fellow for Brain Capital with the Meadows Mental Health Policy Institute. 

 is director of the San Bernardino County Department of Behavioral Health. 

 is visiting professor, Oxford University and Duke University, and previously global therapeutic head of neuroscience for Janssen Research & Development, LLC.

 Dr Insel is an advisor to Alto Neuroscience, Cerebral, Compass Pathways, Koa Health, and Valera Health. Drs Narayan and Manji are employees of Jansen Research & Development, LLC, and may hold company stock.

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Moving from 'diagnose and treat' to 'predict and pre-empt' in neuropsychiatric disorders

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Articles

Considering challenges and opportunities in digital health solutions for mental health care.

Digital Health as an Enabler for Patient-Centric, Outcome-Based Care

Depression is the leading cause of disability and a major contributor to the overall global burden of disease.

 highlights, despite how common depression is across the life course, critical barriers have prevented depression from receiving sufficient resources and global attention.

 Depression has historically been stigmatized and misunderstood, and it arises due to a combination of biological, social, and psychological factors. Limited access to treatment and lack of cross-disciplinary, collaborative research and care has hindered progress. Additionally, women are disproportionately affected by depression and are twice as likely to have a diagnosis of depression as men, likely due to the combination of health inequities, gender biases, and biological factors.

 when elderly, and it might be a reason more women have dementia than men.

 Developing innovative solutions for depression—especially those focused on women that account for sex and gender differences—are critical to improving individual and collective resilience.

To develop women-focused solutions for depression, it is important to understand the various factors that contribute to women’s greater risk for depression. A health equity and public health lens is imperative. The distinction between sex and gender also needs to be clear, with sex referring to biological differences and gender encompassing socially constructed and enacted roles and behaviors shaped by historical and cultural contexts. Additionally, diagnostic tools, symptom screeners, medications, and other health tools must not have sex or gender bias.

Women in their reproductive years undergo cycle changes in steroid hormones (progesterone/estrogen) over the menstrual cycle. The role of these changes as a factor contributing to depression and mood changes is seen in women with premenstrual dysphoric disorder (PMDD) and premenstrual syndrome (PMS). The estimated prevalence in reproductive women is 5% (PMDD) and 20% (PMS). There is growing evidence that the rise in ovarian steroid hormone production and the effect of their metabolites (in particular allopregnanolone) on central brain receptors as progesterone receptor modulators contribute to the mood symptoms in 

 More research is needed to understand the long-term neurological impacts of birth control and hormone therapy.

 Treatments are now being developed to target these newer proposed actions of hormones on the central brain systems with either 

 (removing the natural fluctuations in hormones) or “correcting” the neurotransmitter or 

 with the use oftargeted specific antidepressants.

The female preponderance in depression occurs largely during the reproductive years, is not evident before puberty, and is less marked after menopause. Societal factors may also play an important role; even in developed countries, women still often take a greater responsibility for child rearing and domestic activities while still being expected to progress their careers—known as a “double day.” Women worldwide are also the majority of caregivers for family members needing health care; often this role is unpaid.

Depression is also linked to intimate partner violence (IPV). 

 globally have experienced physical or sexual IPV.

 Since the outbreak of COVID-19, IPV has escalated and been called the 

 of COVID-19. In numerous countries, there has been a 

, likely fueled by effects and mitigation strategies of COVID-19.

 would be affected by IPV for every 3 months of lockdown.

One particularly devastating yet unaddressed and long neglected impact is the mental and brain health effects—

including traumatic brain injury (TBI) and depression

—resulting from IPV. Numerous studies have found that women exposed to IPV are more likely to develop depression than women who are not exposed.

 This finding is not surprising, given that mental health issues are common sequelae of brain injury that may emerge and worsen years after injury. However, IPV is too often left out of conversations around prevention and treatment of depression.

It is also important to note the connection between depression and chronic health conditions in women, such as heart disease. Since 1989, heart disease has been 

 Women are also more likely than men to die after a heart attack.

Women are more likely to be undiagnosed, misdiagnosed, or poorly treated for their heart disease due to pervasive bias and the male body being the default for biomedical care and research. Additionally, 

the Guidelines for the Prevention of Cardiovascular Disease in Women

 by the American Heart Association show the profound impact of hypertension, diabetes, and depression on women’s hearts.

 It is imperative to understand the huge impact of psychosocial risk factors on women’s hearts and address problems including depression and social isolation.

Understanding the role of depression in dementia for women is also imperative. 

The WHAM Report (Women’s Health Access Matters)

 found that women are 66% of the nearly 7 million people in the United States with Alzheimer disease, and yet just 12% of 2019 NIH Alzheimer disease fund went to projects focused on women.

 Even more, the report showed the following: (1) Doubling the funds for women’s Alzheimer disease research pays for itself 3 times over; (2) this 224% return on investment adds 15% more to our economy than general Alzheimer disease research; and (3) adding $300 million for research on women generates $930 million in economic gains, adds back 4000 years of life, eliminates 6500 Alzheimer disease and related dementias, and saves 3500 years of nursing home care and costs. Depression is 

one of the largest modifiable risk factors

 Thus, understanding the link between depression and dementia and accounting for depression in dementia prevention strategies in women is essential.

Novel, women-focused solutions can reduce the impact of depression and increase global resilience. As a recent 

 finds, women’s health solutions often remain siloed to pregnancy and reproductive-related issues.

There is a dearth of women-focused solutions for chronic health and behavioral health and an even larger gap for solutions at the intersection of both.

 Women-focused solutions that include technology, drug development, and devices are urgently needed. Additionally, convergence solutions that combine multiple domains and technologies, such as blending platform and frontier technologies, are key.

Developing women-focused solutions is not only a medical and moral imperative—there is also significant economic and commercial upside. Emergen Research projects that the global market for women’s health will reach $60 billion in 2027.

 Additionally, women are the chief medical officers of society, controlling 80% of health care decisions in the United States and spending 29% more per capita on health care compared to men.

By developing women-focused solutions for depression that account for various factors, including the relationship between depression with heart disease and dementia in women, we can build a more resilient society and world.

is an Atlantic Fellow for Equity in Brain Health at Global Brain Health Institute, a Thiel Fellow at Stanford University, and a Steering Committee member for OECD-PRODEO Institute Neuroscience-inspired Policy Initiative.

is CEO of PRODEO and cofounder of the PRODEO Institute.

is founder and chief director of the Center for BrainHealth at UT Dallas. She is a distinguished professor at UT Dallas.

is a reproductive endocrinologist at Baylor College of Medicine. He is an active member of the American Society of Reproductive Medicine and the North American Menopause Society, with a special interest in the role of steroid hormones on cognitive function. 

is deputy secretary of public health in the Victorian Department of Health and Honorary Melbourne Enterprise Professor with the University of Melbourne. 

is a NHMRC senior principal research fellow, Alfred Deakin professor of psychiatry at Deakin University, and director of the Institute for Mental and Physical Health and Clinical Translation 

is CEO and cofounder of the Women’s Brain Project.

is colead of the OECD-PRODEO Institute NIPI.He is a senior fellow in brain capital for the Meadows Mental Health Policy Institute. He holds adjunct or advisory roles with IMPACT at Deakin University, the Heka Fund, Brain Health Nexus at Cohen Veterans Bioscience, GBHI, Baylor College of Medicine, Latin American Brain Health (BrainLat), Universidad Adolfo Ibáñez, Chile, University of Texas Health Sciences Center at Houston, the Davos Alzheimer’s Collaborative and the Euro-Mediterranean Economists Association.

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Premenstrual dysphoric disorder symptoms following ovarian suppression: triggered by change in ovarian steroid levels but not continuous stable levels.

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Societal Impact of Research Funding for Women’s Health in Alzheimer’s Disease and Related Dementias

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16. Femtech Market By Type (Devices, Software, Services), By End-Use (Direct-to-Consumer, Hospitals, Fertility Clinics, Surgical Centers, Diagnostic Centers), By Application (Reproductive Health, Pregnancy & Nursing Care, Pelvic & Uterine Healthcare), By Region, Forecasts to 2027. EMERGEN Research. June 2021. Accessed May 12, 2022. 

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https://rockhealth.com/femtech-is-expansive-its-time-to-start-treating-it-as-such/

Here’s why we should be paying special attention to women's depression treatment.  

Mind-Body Resilience for Women: A Focus on Depression

President Biden’s first State of the Union Address

, he announced a strategy to address the national mental health crisis, which critically includes expanding focus on youth mental health.

 Additionally, in December 2021, the United States Surgeon General Vivek Murthy, MD, MBA, issued a 

 on the urgent need to address the nation’s youth mental health crisis.

 Advisories are reserved for significant public health challenges and have priorly included advisories on opiates and smoking. The recent Surgeon General’s Advisory calls for immediate and coordinated responses to prevent youth mental health from becoming a second pandemic.

While youth have been relatively protected from the lethality of the COVID-19 virus itself, they have been more vulnerable to the psychological impact. Additionally, unlike other physical health conditions, 

three-quarters of mental health disorders

 The combination of these dynamics has created conditions ripe for a secondary pandemic for youth. Similar to the lack of preparedness for the COVID-19 pandemic, we are not prepared to face this second threat. In fact, we were failing, as suicide, depression, and addiction among American youth were at all-time highs before the pandemic worsened them further. For example, at least 4.1 million adolescents—

—had at least 1 major depressive episode in 2020.

Mental health challenges have been particularly hard on young women and youth of color. The pandemic has directly correlated with an 

 in emergency room visits by adolescent girls and young women for suicide, rates of need have grown faster for Black and Hispanic youth, and Black and Hispanic children have experienced grief due to the loss of a parent at rates many times higher than White children.

However, unlike in the early days of COVID-19, there is existing guidance on what to do for youth mental health—guidance that we have too long failed to invest in commensurate with the need. Treatments—including psychotherapy, medication, and care coordination—have been robustly validated and proven safe. Prevention across development phases has also been found to be effective. Youth can also help each other, as social support is an especially beneficial intervention. Additionally, as 7-year-old 

, one of the youngest-ever TED speakers, clearly articulated, we must likewise 

prioritize young children’s healthy brain development

 during the 0- to 5-years-old period, preventing further mental and brain health disorders across the lifespan.

Improving access to screening, detection, and early intervention for children and adolescents is key. Signed into law in mid-2019, 

the Texas Child Mental Health Care Consortium (TCMHCC)

 was formed with the state’s 12 publicly funded medical schools.

 TCMHCC is funded with $118.5 million in state funds to provide universal access to child psychiatry consultation in primary care through the Child Psychiatry Access Network (CPAN), urgent access to psychiatric telehealth care and referrals in Texas schools through the Texas Child Health Access Through Telemedicine (TCHATT) program, and expansion of workforce training and the public psychiatry workforce more broadly. Launched in May 2020, TCMHCC engaged 5000 pediatric primary care providers in CPAN and reached nearly 1.7 million Texas students through TCHATT in less than a year, including 12.5% Black and 34% Latino students—numbers proportionate to the broader child population of Texas. TCMHC provides an infrastructure that can be scaled up or down as needs change. The Texas legislature just took advantage of this by adding $113 million in American Rescue Act funds to ramp up all these programs in response to the ongoing mental health surge.

 over a 5-year period to youth mental health to build capacity for prevention and treatment, help schools cope with the demand, and support families.

 Scaling up investments and sharing best practices between states are key to addressing this national issue.

All the programs mentioned are helping children, young adults, families, and schools across the country cope with the growing youth mental health pandemic. As these initiatives demonstrate, youth mental health is more than health care. Just like all health conditions, mental health is shaped by a variety of factors, including genetics, brain chemistry, trauma and violence, social connections, neighborhood safety, access to food, larger social and economic policies, and more. As such, the recent Surgeon General’s Advisory provides recommendations on how to improve youth mental health to a variety of stakeholders including families, educators, health professionals, entertainment organizations, technology companies, governments, communities, funders, and others.

Students’ ability to engage and connect with their schools is critical to improving emotional well-being and enhancing learning outcomes. Young people must also be directly involved with designing solutions to address the youth mental health crisis. Already, youth are speaking up about their mental health challenges and leading change. 

, ranging from starting nonprofits to campaigning for policies to developing apps, have led to reduced stigma and increased access to care for mental health. It is imperative that government policies, technological solutions, and other initiatives that address youth mental health are designed with young people—not for them.

The youth mental health crisis is a public health imperative with enormous implications for America’s future. Our actions now will determine the future trajectory of our nation and have the potential to prevent a second pandemic. Investing in our youth by building our nation’s human capital, or rather 

, is an ongoing process. Addressing the youth mental health crisis is not only a medical and moral imperative, but it is also key to ensuring we have the next generation of leaders needed to build a prosperous future for our nation and world. As Murthy urges in the 

, by addressing the youth mental health crisis, we have an opportunity to “step up for our children and their families” and “lay the foundation for a healthier, more resilient, and more fulfilled nation.”

 It is this future that we must build together.

 is an Atlantic Fellow for Equity in Brain Health at the Global Brain Health Institute.

 is president of the healthcare division of Higher Ed International.

 is president and chief executive officer of the Meadows Mental Health Policy Institute. 

is head of the OECD New Approaches to Economic Challenges Unit. 

 is co-lead of the OECD-PRODEO Institute Neuroscience-inspired Policy Initiative supported by Meadows Institute.

1. Remarks of President Joe Biden – State of the Union Address as prepared for delivery. March 1, 2022. Accessed April 12, 2022. 

We must prioritize youth mental health for a flourishing and resilient American future.

Harris Eyre, MD, PhD

Articles

Digital Health as an Enabler for Patient-Centric, Outcome-Based Care

Mind-Body Resilience for Women: A Focus on Depression

Building a Resilient Future: Addressing Youth Mental Health

Violence Against Women and Acquired Brain Injuries

Disinformation? There are Remedies for That

Brain Capital: An Emerging Investment Opportunity