What You Should Know: 

– Evidation has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services (HHS), to fund the 2023 Influenza-like Illness (ILI) Detect & Protect Studies.

– This contract will also fund research to expand and better understand the potential impact of Evidation’s FluSmart program to encourage protective health behaviors. FluSmart pairs machine learning predictions with behavioral nudges, education, and personalized insights to help people better understand their risk of flu-like illness and take early action to help prevent transmission and severe disease.

Detect & Protect Studies

The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices. This research will take place during the 2023-24 cold and flu season and bring together new devices and data types, serial PCR testing, and Evidation’s health measurement and engagement platform to create next-generation models for earlier and pre-symptomatic detection of COVID-19, influenza A and B, and respiratory syncytial virus (RSV).

The expanded partnership is the third BARDA award issued to Evidation to advance understanding and detection tools for respiratory infections. The first award funded the Home Testing of Respiratory Illness Study, a prospective flu monitoring study and benchmark dataset that used consumer wearables, self-reported symptoms, and PCR testing to understand and characterize respiratory virus onset. 

“Since our first study with BARDA in December of 2019, with the participation and consent of hundreds of thousands of Americans nationwide, we’ve learned how high-resolution data from consumer grade wearables–heart rate, sleep, physical activity and other more specific signals–can help identify when someone may be experiencing symptoms of flu-like illness,” said Christine Lemke, co-founder and CEO of Evidation. “We are excited to expand, validate, and improve our models, and find new ways to prompt people to take appropriate action when it matters most.”

What You Should Know:

• iRhythm Technologies, Inc. today announced the U.S. launch of its next-generation Zio® monitor and enhanced Zio® long-term continuous monitoring (LTCM) service.
• Zio monitor is iRhythm’s smallest, lightest and thinnest cardiac monitor, enhancing the cardiac monitoring experience for patients and healthcare providers together with new service enhancements. The new Zio monitor is a prescription-only ECG monitor, which is an integral part of the Zio LTCM service. The Zio LTCM service consists of a patch ECG monitoring device (Zio monitor), the ZEUS (Zio ECG Utilization Software) System – iRhythm’s advanced AI algorithm which supports the capture and analysis of ECG data recorded by Zio monitor – and a comprehensive end-of-wear report which is reviewed by certified cardiographic technicians. This end of wear report has a 99% physician agreement.

Improving Long-Term Continuous Monitoring Modalities for Better Cardiac Outcomes

“We’ve made our best product even better – early clinical and patient experience shows that Zio monitor has even better wear times, comfort and patient experience,” said Mintu Turakhia, MD, MAS, Chief Medical Officer, Chief Scientific Officer and Executive Vice President, Product Innovation at iRhythm. “When you combine our new Zio monitor with our advanced AI, efficient workflow, patient and clinician apps, and easy-to-read and actionable clinical reports, we continue to lead the way in the field.”

The Zio monitor aims to enhance diagnostic accuracy and provider efficiency while providing an improved patient experience with extended wear for up to 14 days. It builds upon the successful Zio® XT monitor with the following key features:

1. Enhanced Patient Comfort: It boasts a 23% thinner, 62% lighter, and 72% smaller form-factor compared to its predecessor, weighing less than a pencil.
2. Consistent Patient Adherence: The Zio monitor maintains an impressive 99% patient compliance with prescribed wear times, ensuring healthcare providers can achieve accurate diagnoses on the first attempt.
3. User-Friendly Design: Its design incorporates breathability, a hydrocolloid adhesive, and a waterproof housing. Moreover, it requires no device or adhesive manipulation or battery replacement throughout the entire 14-day wear and monitoring period.

iRhythm is launching a redesigned MyZio® patient app alongside the new Zio monitor. The app offers a better user experience with easier symptom tracking, educational content, and an improved help center. iRhythm is also enhancing patient support for insurance-related inquiries. These updates aim to elevate the overall experience for patients and clinics using the Zio service. 

iRhythm’s FDA-cleared AI employs a highly accurate deep-learned algorithm, matching the precision of expert cardiologists. The CAMELOT study, presented at the American College of Cardiology’s Annual Scientific Session, encompassing 287,789 patients, revealed that the Zio long-term continuous monitoring (LTCM) service, prescribed for up to 14 days, offers the highest diagnostic accuracy, lowest retesting rate, and the lowest likelihood of acute care hospitalization compared to all other monitoring services, including long-term continuous monitors.

The Zio LTCM service aids physicians in the identification, diagnosis, and management of cardiac arrhythmias. Approximately 5% of the U.S. population, nearly 16 million people, experience arrhythmias. Left untreated, these conditions can harm vital organs, increase stroke and mortality risk. Timely detection and treatment are crucial to reducing the cardiac disease burden.

What You Should Know:

• Evidation, the company creating new ways to measure and improve health in everyday life, today announced a partnership with USC’s Dornsife Center for Economic and Social Research to incorporate wearable device data into the landmark Understanding America Study.
• The goal of the partnership is to power research that will generate insights into healthy aging. Evidation and USC will collaborate to integrate a robust wearables dataset into extensive survey data that has been collected as part of the Understanding America Study for almost two decades. Evidation and USC have been working together since 2017 and this work expands upon the NIH-funded American Life in Realtime (ALiR) study, an initiative that achieved a nationally representative digital health benchmark dataset. 

Making Healthcare More Accessible by Data-Driven Improvements in Wearable Devices

Launched in 2014 and supported by the National Institute on Aging (NIA) and the Social Security Administration (SSA), the Understanding America Study is a nationally representative panel of over 12,000 people across the United States. Administered by USC, UAS offers rich data from a demographically diverse set of participants on topics varying from health and wellness, work, leisure, retirement, social issues, and aging.  

Evidation will facilitate the collection of prospective wearable data from thousands of individuals to better understand and analyze activity and sleep data from everyday life. Layered on top of extensive survey data, this longitudinal wearable data will help unearth answers to key questions regarding how to extend life span, as well as healthspan – the duration someone can be healthy without chronic and debilitating disease or disability.

“Evidation’s decade plus experience consenting, curating, and making sense of wearable data makes them the ideal partner for this important expansion of the Understanding America Study. We’re excited to build on the foundation of data already available as part of UAS to uncover insights that will make it possible to extend and improve healthspan,” said Arie Kapteyn, Professor of Economics and the founding Executive Director of the Dornsife Center for Economic and Social Research at the University of Southern California. “We know that Evidation shares our commitment to use the most advanced technology in service of improving people’s health and welfare, and will bring tremendous value to this collaboration.”

What You Should Know: 

• Movano Health (Nasdaq: MOVE), a purpose-driven healthcare solutions company at the intersection of medical and consumer devices and makers of the Evie Ring, announced the formation of its Medical Advisory Board. 
• The initial panel is composed of healthcare industry subject matter experts in women’s health, mental health, and sleep, who will serve as trusted advisors to the Evie team regarding the development of its medical-grade smart ring for women and provide insights to establish Evie as a highly credible health and wellness resource.

Medical Advisory Board Membership

The inaugural members of the Medical Advisory Board include:

Dr. Mary Claire Haver, MD, FACOG, CCMS is a board-certified OB/GYN, author and entrepreneur who has devoted her practice to women’s health. She has helped thousands of women going through perimenopause and menopause actualize their health and wellness goals by creating The Galveston Diet integrated wellness program. With the goal of empowering and educating women, Dr. Haver took a deep dive into the science of menopause, aging, and inflammation beyond what she was taught in medical school and residency. She emerged with an evidence-based program so women could wisely invest in their most undervalued asset, their health.

Dr. Ruth C. White, PhD, MPH, MSW, RSW is a mental health expert, stress management advocate and diversity trainer. She authored the book, The Stress Management Workbook: De-stress in 10 minutes or Less, and has written articles on mental health for Harvard Business Review, Fast Company, Modern Healthcare, and more. Throughout her career, she has spent more than 20 years teaching social work at the University of Southern California, Seattle University, UC Berkeley, Fordham, and San Francisco State. Her holistic, science-based, prevention-focused approach is grounded in her experience as an elite athlete and her personal mental health journey.

Dr. Andrea Matsumura, MD, MS, FACP is a sleep medicine specialist at the Oregon Clinic who has helped thousands of people improve their sleep. She focuses specifically on sleep in women and how their sleep differs from that of men. She practiced medicine as a primary care physician for 12 years until she realized that the root of managing chronic conditions hinges on getting a good night’s rest. She graduated from the University of Texas Medical School in San Antonio and completed her internship and residency at Providence Portland Medical Center. She completed her fellowship in sleep at Oregon Health and Science University. Dr. Matsumura has appeared in countless webinars, articles, and conferences.

To certify the accuracy of Evie Ring’s heart rate and SpO₂ data and earn the trust of users and doctors alike, the Company recently submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Evie Ring’s pulse oximeter. 

What You Should Know: 

• Movano Health, makers of the Evie Ring, the first medical-grade wearable smart ring for women announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA). 
• The submission has passed the first milestone of the review process, an initial review for completeness, and is now under full review by the FDA.

Medical Grade Wearable Designed Specifically for Women

The Evie Ring combines health and wellness metrics to give a full picture of one’s health: resting heart rate, heart rate variability, SpO₂, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and calories burned, sleep stages and duration, and mood tracking. This data is delivered through a mobile app that aims to simplify how data is presented, moving away from complex graphs and charts, and turning biometric data into actionable insights that will help women make manageable lifestyle changes and take a more proactive approach to mitigating the risks of chronic disease.

Evie Ring’s Clinical Performance

One of the most critical components of the FDA submission is the ring’s clinical performance. In Q4 2022, Movano Health completed a successful pivotal hypoxia trial with the University of California, San Francisco (UCSF) to assess the accuracy of Evie’s blood oxygen saturation (SpO₂). In comparing the overall accuracy of the ring’s data with data from arterial blood gas data, the Evie Ring achieved an approximate 2% margin of error, well below the FDA guidance of 3.5% for SpO₂. In a separate nonclinical test completed by Movano Health per the standard and FDA guidance, pulse was tested over the range of 40 to 240 beats per minute (BPM) and the Evie Ring margin of error was 1 BPM, also exceeding FDA’s requirements.

“From the outset, our vision for Evie has been to develop a consumer wearable that is beautiful, accessible and personalized, as well as be cleared by the FDA as a medical device. This first submission to the FDA marks a momentous milestone for our team and sets the stage for future FDA filings,” said John Mastrototaro, CEO of Movano Health.  “The effort associated with becoming a medical device company is certainly significant, but we believe it’s a highly competitive differentiator and a strong asset when compared to existing wellness solutions. It also is expected to enable significant partnership opportunities with healthcare and other enterprises. We look forward to working with the FDA through the review process.”

What You Should Know: 

– Aevice Health, a Singapore-based provider of remote respiratory monitoring solutions today announced that its AI-powered, smart stethoscope wearable, the AeviceMD, has received clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device under the 510(k) route. 

– This clearance empowers the company to market and provide their novel remote monitoring platform to health systems across the country, expanding access to a hassle-free and convenient solution for assessing lung health in clinical and home settings.

Remote Respitoring Monitoring Platform

The AeviceMD is an integral part of the broader AeviceMD Monitoring System, a comprehensive patient management platform targeted towards chronic respiratory disease management. Leveraging cutting-edge proprietary algorithms, the AeviceMD Monitoring System continuously monitors biomarkers of interest acquired by its smart wearable stethoscope and detects early signs of respiratory exacerbation. The robust platform has completed trials in the emergency department for the analysis of abnormal lung sounds like wheezing against the current standard of care — the clinicians’ own stethoscope-based analysis. The results from these trials are currently being collated and will be disclosed in a separate and forthcoming announcement.

How AeviceMD Works

With the AeviceMD, the clinic can now be brought home. The AeviceMD elevates the ubiquitous stethoscope – an essential tool in every clinic – into a smart, digital, and easily accessible device. Caregivers and patients can simply conduct auscultations using the AeviceMD sensor and conveniently share them with their healthcare professional. Through analysis of these recordings, healthcare providers can accurately identify abnormalities and promptly advise patients, enabling proactive management of lung health.

What You Should Know: 

– A team of Japanese researchers has developed a wearable device that can measure how hard one is exercising by analyzing their sweat. 

– Their findings have been published in the journal ACS Sensors. The device continuously monitors the level of lactate in our sweat, which is a good indicator of exercise intensity. This technology can be valuable for athletes and fitness enthusiasts to manage their training and monitor their overall health.

Leveraging Lactate Level in Sweat as a Biomarker

Human sweat is a rich source of health information, offering insights into a person’s hydration level, electrolyte balance, and overall physiological state. For instance, lactate level in sweat is a useful biomarker of exercise intensity. Its measurement can help estimate the amount of lactic acid in the blood and, in turn, predict muscle fatigue.

Today, wearable sensors make it possible to continuously monitor biomarkers such as sweat lactate. Using the latest microfluidics technology, scientists have developed devices that convey minuscule amounts of sweat to tiny chemical sensors, which can transmit their measurements in real time wirelessly. However, one common problem in such devices is that their microfluidic channels tend to trap air bubbles present in the sweat. If these bubbles cover the sensor’s electrodes, the measurements get interrupted, interfering with the continuous monitoring of the target biomarker. 

Research Background/Protocols

To address this issue, a research team, led by Associate Professor Isao Shitanda from Tokyo University of Science (TUS) in Japan, has come up with a novel microfluidic sweat lactate sensor whose measurements remain unaffected by the air bubbles. Their study, made available online on 22 May 2023 and published in ACS Sensors on 23 June 2023, was co-authored by Dr. Masahiro Motosuke, Dr. Tatsunori Suzuki, Dr. Shinya Yanagita, and Dr. Takahiro Mukaimoto from TUS.

The proposed wearable device consists of a relatively simple layered structure—a conventional lactate oxidase sensor attached via double-sided tape to a microfluidic system made of a silicone polymer. When the person wearing the device begins to perspire, the sweat enters the microfluidic channels via four inlets and flows toward a reservoir near which the electrodes are located. Old sweat exits the system through an outlet as new sweat enters, and a small wireless transmitter reports the measured lactate levels.

The key innovation in the proposed design was the use of a larger-than-usual sweat reservoir. “By increasing the length of the reservoir in the microfluidic channel, a space of approximately four microliters was created for trapping any air bubbles that infiltrate the device, thereby preventing them from contacting the electrodes of the sensor,” explains Dr. Shitanda. 

The researchers tested their sensor in a series of laboratory experiments. They verified that the bubble-trapping region worked as intended by injecting bubbles into the device while measuring lactate levels in artificial sweat. In addition, the measurements were not affected by the sweat flow rate, and the response of the sensor remained stable for approximately two hours. Lastly, the researchers tested the device on a male volunteer who exercised on a stationary bike for almost an hour. The sensor showed a lactate concentration correlation ranging from 1 to 50 mM as well as a correlation between sweat and blood lactate levels.

Overall, the results of this study hint at the potential of wearable microfluidic sensors for monitoring sweat biomarkers during exercise. 

“Since the microfluidic system of the proposed lactate sensor is fabricated from a soft, flexible, and non-irritating material, it could be used to continuously monitor lactate levels in sweat, especially in sports and medicine,” remarks Dr. Shitanda. “Wearable lactate sensors may become useful condition management tools in sports such as soccer and basketball, allowing team managers to know when it’s best to replace a player.”

What You Should Know: 

• TRIPP, a global XR wellness company, announced the completion of TRIPP PsyAssist’s Phase 1 Proof Of Concept (POC) Feasibility Study. 
• The first phase of the breakthrough study shows virtual reality (VR) as an effective tool to help patients prepare for ketamine-assisted therapy

Research Background

The study focuses on investigating the effects of a Virtual Reality (VR) experience before Ketamine dosing and was conducted at the esteemed Kadima Neuropsychiatry Institute in San Diego, with analysis provided by Valis Biosciences. The Journal of Psychopharmacology reports 50% of participants who received ketamine treatment showed significant improvement in their PTSD symptoms. Despite psychedelics gaining ground in mainstream medicine, patients still need help managing pre-session anxiety, onboarding effectively, and integrating their experiences after treatment, whether in a clinic or at home. 

Phase 1 of the TRIPP PsyAssist study aimed to determine the feasibility and acceptability of guided, meditative imagery delivered in virtual reality on the Pico Neo 3 Pro Eye headset as a pre-treatment program in a real-world clinical context. Participants for the study were recruited from patients who had already consented to receive ketamine treatments for their depression or anxiety at Kadima. The study also assessed participant satisfaction, engagement and usage to determine the feasibility and acceptability of this approach prior to these consciousness-altering experiences. 

Key preliminary findings* from the data gathered include: 

• 80% of users reported wanting to use the system frequently. 
• 100% of users found the various functions in the system well integrated. 
• 90% of users imagine most people would learn to use this system quickly. 
• 100% of users felt very confident using the system. 

What You Should Know: 

• Samsung announced today that the Irregular Heart Rhythm Notification (IHRN) feature will be available to users in 13 markets starting this summer. Combined with the app’s Electrocardiogram (ECG) [3] monitoring, the IHRN feature, detects heart rhythms suggestive of atrial fibrillation (AFib), helping Galaxy Watch users understand their heart health more comprehensively.
• According to the American Heart Organization, there will be more than 12 million people living with AFib by 2030. This new feature will allow over 15 million Galaxy Watch users to further monitor their cardiovascular health by detecting inconsistent heart rhythms and alert users of potential atrial fibrillation.
• The Irregular Heart Rhythm Notification will be initially introduced on Galaxy Watch devices later this year with the new One UI 5 Watch update and later expanded to previous editions.

What You Should Know: 

• Wolters Kluwer Health and Laerdal Medical have officially launched vrClinicals for Nursing. The virtual reality (VR) based learning solution helps address today’s gaps in nursing education and the nursing workforce, allowing students to go from the classroom to a busy hospital ward where they encounter true-to-life challenges such as prioritizing care among multiple patients and the demands of practice.
• vrClinicals for Nursing was designed with instructors and students from a dozen leading nursing programs in collaboration with Laerdal Medical and evolving multi-patient scenarios authored by the  National League for Nursing (NLN). Together, these organizations executed on a vision to bring the benefits of VR to nursing education, going beyond the inherent limitations of real-life clinical practice students and nursing educators face today.

VR Training for Nurse Education

A recent study found that 55% of new nurses have made medical errors, as result of inexperience and rushing, to name a few reasons. Facing the pressures of practice without the skills to recover and build resilience is also creating a high dissatisfaction for young nursing professionals. In fact, nearly one-third (32.8%) of registered nurses left their job within the first year. With VR, nursing students can build and practice the skill sets needed, mimicking clinical practice decision-making in a busy hospital setting, prioritizing multiple patients and competing care demands. These new technologies also allow for scalability that was previously unattainable for nursing schools. An entire cohort of students can now run through multi-patient scenarios and receive feedback immediately after from their instructors.

“Unlike any other simulation modality, VR provides students with a sense of immediacy and realism from being in the moment, because all of your senses are engaged,” said Julie Stegman, Vice President, Nursing Segment, Health Learning, Research & Practice at Wolters Kluwer, Health. “We know the transition from school into practice can be extremely difficult and it’s our responsibility to work with nurse educators to help students truly prepare for their real-life jobs. By better preparing nurses through their transition to practice, they can become more clinically confident – which allows for higher job satisfaction and better patient care.“

vrClinicals not only helps nursing students build the key skills to transition from education to practice, but the solution is also built to help prepare students for the National Council Licensure Examination (NCLEX®) – which is the required adaptive test for nursing graduates to successfully pass to be licensed as a Registered Nurse. Starting this year, students taking the Next Generation NCLEX® exam, won’t just be tested on what they know, but how they think. The new test is now focused on evaluating the student’s ability to demonstrate the use of clinical judgment when responding to clinical questions, much like how they would need to think on the job.

Nursing school testers for vrClinicals for Nursing included Villanova University, Indiana University, University of Rochester, University of Massachusetts Boston, University of Central Florida, University of Virginia, and more.

What You Should Know:

• Today, STAT Health emerges from stealth to introduce a 24/7 in-ear wearable that measures blood flow to the head to better understand symptoms such as dizziness, brain fog, headaches, fainting, and fatigue that occur upon standing. These are common symptoms for illnesses like long COVID, postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), and other orthostatic (caused by standing) syndromes that affect more than 13 million Americans.
• Clinically tested at Johns Hopkins and peer-reviewed in the March 2023 issue of Journal of the American College of Cardiology (JACC), the device has been shown to predict fainting minutes before it happens. The company is backed by $5.1 million in seed funding from J2 Ventures, BonAngels Venture Partners, and a diverse group of prominent angel investors. The company has also received grant funding from the U.S. Air Force.

Using the Ear as a Biometric Gold Mine to Better Understand Symptoms

Many people with illnesses like long COVID, POTS, and ME/CFS suffer from symptoms caused by reduced blood flow to the brain upon standing. While theoretically understood, this has been difficult to experimentally prove, until now. Doctors at Johns Hopkins, Brigham and Women’s, and Harvard Medical School have used ultrasound to demonstrate that Cerebral Blood Flow (ultrasound-measured flow in cerebral arteries as a method of quantifying blood flow to the head) is a key biomarker that objectively measures the presence and severity of many of these “invisible illnesses.”

“Cerebral Blood Flow (CBF) is the critical missing vital sign – poor CBF is the cause of common orthostatic symptoms such as dizziness and brain fog. My Dutch colleagues have measured this with ultrasound on over a thousand patients.” said Peter Rowe, M.D., Sunshine Natural Wellbeing Foundation Professor of Chronic Fatigue and Related Disorders, Johns Hopkins Medicine. “However, it’s not easy to measure CBF, so most clinics approximate using secondary metrics of Heart Rate and Blood Pressure, which often mislead. Unfortunately, this frequently leads to the wrong conclusion that the symptoms are just psychological, when in fact, there are physiological abnormalities.”

To fit into a wearable form factor, STAT uses an optical sensor instead of ultrasound and taps into a shallow ear artery to measure a proxy to ultrasound-derived Cerebral Blood Flow. 

What You Should Know:

• Researchers at the Icahn School of Medicine at Mount Sinai found that applying machine learning models to data collected passively from wearable devices can identify a patient’s degree of resilience and well-being. The study, published in JAMIA Open, supports the use of wearable devices, such as the Apple Watch, to monitor and assess psychological states remotely.
• The researchers note that mental health disorders account for 13 percent of the burden of global disease and that there are disparities in access to mental health care. Therefore, a better understanding of who is at psychological risk and improved means of tracking the impact of psychological interventions are needed. Wearable devices could provide an opportunity to improve access to mental health services for all people. “Wearables provide a means to continually collect information about an individual’s physical state. Our results provide insight into the feasibility of assessing psychological characteristics from this passively collected data,” said first author Robert P. Hirten, MD, Clinical Director, Hasso Plattner Institute for Digital Health at Mount Sinai. “To our knowledge, this is the first study to evaluate whether resilience, a key mental health feature, can be evaluated from devices such as the Apple Watch.”
• The study analyzed data from the Warrior Watch Study, which comprised 329 healthcare workers in New York City who wore an Apple Watch Series 4 or 5 and completed surveys on resilience, optimism, and emotional support. The metrics collected were predictive in identifying resilience or well-being states, supporting the further assessment of psychological characteristics from passively collected wearable data. The researchers intend to evaluate this technique in other patient populations to improve its applicability.
• In essence, the study highlights the potential for wearable devices and machine learning models to monitor and assess psychological states remotely, improving access to mental health services for all people. Further research is needed to refine the algorithm and improve its applicability in a range of physical and psychological disorders and diseases.

What You Should Know:

• Today, Samsung announced today its Irregular Heart Rhythm Notification feature of the Samsung Health Monitor App has been cleared by the FDA. With this new feature, Galaxy Watch users can be alerted when heart rhythms suggestive of atrial fibrillation (AFib) – a type of arrhythmia – are detected.
• The Irregular Heart Rhythm Notification works with the app’s existing on-demand Electrocardiogram function to proactively monitor heart rhythms suggestive of AFib, and will be introduced with the One UI 5 Watch update available on future Galaxy Watch devices later this year, with expansion to previous editions.  

How It Works

Galaxy Watch offers tools to help users better understand their heart health using the Samsung BioActive Sensor, including on-demand ECG recording and HR Alert function4 that detects abnormally high or low heart rates. The addition of the new IHRN feature enables Galaxy Watch users to monitor another aspect of their health. Once activated in the Samsung Health Monitor app, the feature will check for irregular heart rhythms in the background via Galaxy Watch’s BioActive Sensor. If a certain number of consecutive measurements are irregular, Galaxy Watch warns the user of potential AFib activity, prompting them to take an ECG using their watch for a more accurate measurement.

What You Should Know:

• The Department of Defense and Philips announced a $10M ​award​ to ​expand the readiness of our service members with the Rapid Assessment of Threat Exposure (RATE) AI wellness tool.
• The first group in this new cohort are the​Air Force First Sergeants, who are responsible for overall squadron health and wellness.
• RATE is an AI algorithm, trained on clinical data from hospital-acquired infections to work with any off-the-shelf wearable to detect possible infection, acting like a “check engine light” for your body. By measuring 164 different biomarkers in the body, research shows the RATE algorithm can effectively detect infection as early as six days prior to diagnostic testing, with an average of 2.3 days.   
• The plan is for RATE to be device agnostic, but the current deployment of wearables will include Garmin watches and Oura rings. As the Philips-DIU team continues to prove out the new dataflow, the effort aims to add three additional popular wearable devices. The 11,000 former RATE users will also be able to re-affiliate with the projects if they still have the hardware.

Gone are the days when healthcare information was only available to us at the doctor’s office or through the office’s online portals, and that’s in part due to the rapidly growing popularity of wearable technology devices. It’s estimated that 1 in 5 adults in the U.S. use a fitness or health tracker to monitor things such as heart rate, blood pressure, sleep cycle, and stress. But this information is being used beyond just monitoring specific conditions. Take me, for example; I personally use my wearable tech to track my glucose levels throughout the day. I’m not diabetic, but I do find this information useful when looking at how to modify my diet throughout the day to minimize the impact of glucose spikes.

For someone monitoring a health condition, such as diabetes or high blood pressure, these technologies offer additional peace of mind. Prediabetes, for instance, is plaguing the United States and affecting at least 33% of U.S. adults. Having early insight into abnormal blood sugar activity or body functioning can help individuals prevent health conditions from worsening. We continue to see news about young athletes experiencing complications from undiagnosed conditions and students generally facing increased anxiety due to the stresses of life. The ability to monitor heart rate and blood oxygen levels enables users to identify changes and abnormalities in their vitals, which can serve as an early warning of possible panic attacks or can help determine when a visit to the doctor is needed. 

This shift towards digitally-enabled care has driven consumers to become more engaged in their day-to-day health and has provided better access to care services and leading physicians, regardless of factors that have historically hindered care access, like geographical location or lacking availability and overstretched resources. With the rise in digital health services, we have a wide variety of data at the tip of our fingers – accessible from nearly anywhere on a smartphone or computer. While the benefits of this digital health revolution are undeniable, there are associated risks with tracking health data that digital health companies need to understand to protect themselves. That being said, there is no one-size fits all solution. Every company has unique challenges, concerns, and vulnerabilities and therefore requires a tailored approach to risk management. 

The Evolution of Digital Health-Tracking

Health tracking devices and their capabilities have significantly evolved since the original pedometers and heart monitor straps came to market. Today, health-tracking wearables span a wide range of applications and have become less niche and more commonly adopted. There’s a high demand for health and fitness monitoring devices, and the original models have been replaced by smart devices such as rings, watches, clothing, belts, shoes, and smart sensing technologies that have the capability of tracking blood oxygen saturation and notifying if irregular heart rhythms are detected; some are even capable of taking an ECG reading directly from your wrist and tracking ovulation cycles through temperature sensing. As the population ages globally, monitoring various chronic and acute diseases has become increasingly important, and the medical industry is changing rapidly in order to meet today’s point-of-care (POC) and real-time monitoring needs. 

Outside of the advantages of managing and understanding your own body better, these capabilities come with concerns and challenges regarding access and security of personal health data, as well as prescribing practices. Although users of wearable tech are able to be better in tune with their current health state, the validity of the data analysis and recommendations paired with individual readings are dependent on the digital health companies and healthcare professionals that are evaluating and providing these recommendations. Improper recommendations or guidance can lead to new risks of bodily harm or negligence to the user. 

Risks Associated with Wearables 

Companies need to understand the risks at hand. Data collected by fitness applications are not protected under the law like health information is, making it critical for users to fully understand how best to set up social and location settings, as well as login credentials. Cyber security risks are reportedly on the rise, with an uptick in data breach lawsuits, which are becoming increasingly more common within the healthcare space. The latest data security incident report showed increased duplicative lawsuits, often resulting in steep defense and settlement costs. If a company is dispensing medical advice, providing guidance or therapy, or prescribing or selling products, there are additional risks spanning from medical malpractice to bodily injury claims associated with these services that are often overlooked. 

Despite acknowledging cyber and regulatory concerns as the top risks, a survey of 300 digital health and wellness industry leaders indicated that 76% of those surveyed didn’t have a single insurance policy tailored to the risks they face, despite 99% of surveyors reporting plans to expand and 72% noting growth in demand. Insurance brokerages are able to assist in addressing risk management by gaining an understanding of a company’s inner workings in order to identify how best to protect them. When selecting a partner, it’s important to choose a company that specializes in these specific areas of risk to evaluate best how these risks can be transferred or mitigated. 

Understanding Exposures and Mitigating Risk 

Users of wearable technology rely on doctors and healthcare experts to provide recommendations. Similarly, digital health companies tracking this information and providing these recommendations rely on insurance experts to provide guidance when it comes to identifying and appropriately managing risks. Company leaders must fully understand vulnerabilities and exposures and how best to address them while protecting balance sheets. Cyber liability, errors and omissions, and medical malpractice liability are key exposures. When it comes to cyber insurance, most companies are often grossly underinsured. In my experience, it’s also common for companies to request the wrong information, especially in regard to complex issues such as limit adequacy (i.e., how much insurance is enough?). 

You can’t properly evaluate your own risk by comparing your risk program to others, so taking a benchmarking or comparative approach versus a ground-up analysis of risk often produces suboptimal results. It can be dangerous to rely too much on comparisons, preventing companies from having a holistic view of their individual needs. Just as consumers receive tailored recommendations for how many steps they should take in a day or how much water or calories they should be consuming before they end their day, insurance companies need a customized risk management checklist of sorts unique to their own needs, challenges, and future goals. Focusing internally on a ground-up analysis enables the focus to solely analyze your own risk assessment, avoiding the adoption of unnecessary solutions or lacking areas of coverage. 

Third-party contracts are critical for companies and can help protect balance sheets by working with an experienced team and providing the necessary data to inform proper decision-making. Reviewing contracts can be a difficult task for companies to outsource. Not all attorneys are specialized in insurance, and when it comes to insurance, it’s important to receive the appropriate recommendations for proper protection. Insurance brokerage experts can, in that instance, step in to provide thorough contract reviews focused on their insurance obligations. With the varying level of risk management needs vs. available solutions, partnering with a risk management expert can offer valuable insights and the knowledge necessary to identify solutions best suited to address specific needs.

Why Do Businesses Need a Customized Approach? 

There isn’t a solution that will adequately cover every business, which is why a customized approach is best. Every company is unique in its own individual needs, so it’s important to partner with a risk analyst who is hyper-focused on your specific areas of need. Within risk management, there are specialized teams equipped with actionable advice within their niche area of expertise. For digital health companies, selecting a partner with a dedicated Digital Health/Telemedicine Practice team would be an optimal fit to ensure their approach to risk management covers their vulnerabilities. 

In the instance of digital health and telemedicine companies, a successful partnership should demonstrate the ability to navigate complex organizational structures – often including professional corporations (PCs), physician owner(s), management services organizations (MSOs), and more operating in various states. Managed Care Errors & Omissions (E&O), coverage provided in the event of allegations of negligence in the administration of managed care contacts, is a prime example of insurance often overlooked since policies cover the services provided by MSOs to the PCs, and if exposure doesn’t fall under traditional Managed Care E&O, then a Miscellaneous Errors & Omissions Policy may need to be obtained. 

Helping clients navigate various state requirements is another factor supporting customization when it comes to risk management solutions. For instance, Pennsylvania has active Patient Compensation Funds (PCF) that include MCARE, a special state fund, which is an additional required filing. Kansas is another state with stringent requirements. Navigating varying regulations and license requirements is critical, and as companies grow rapidly, executives may be unaware that they’re not compliant with regulations. Having regular communication with an insurance broker can help avoid any missteps or growing pains relating to compliance. An experienced insurance broker can also assist with services such as claims advocacy, risk control, and quarterly or semi-annual stewardship reviews, which can inform necessary steps to avoid new exposures. 

Managing Risk in a Consumer-Centric Model 

Health technologies and wearables will continue to push the boundaries on what they can track and how they can improve day-to-day health habits and well-being, and the companies that are best protected have invested in solutions specifically designed to address these challenging areas. While health tracking and digital health companies continue to work to help users navigate data, provide services and products, and offer insights on how to improve, what to change, by how much, and by which methods, so too must the risk analyst ensure precautions and solutions are properly in place. As digital health tools and wearable health technology continues to evolve, risks associated with privacy, cyber security, bodily injury, regulations, and technology will continue to be top of mind. Looking to experts who can not only help assess and analyze current risks but also future risks that could be on the horizon will become the standard for meeting modern-day risk management needs. 

About Cristina Varner

Cristina Varner currently serves as Senior Vice President and National Life Science & Healthcare Practice Leader at Newfront, a modern insurance company transforming the delivery of risk management, employee experience, insurance, and retirement solutions. With 25 years of healthcare and life science industry experience, Cristina is one of the founding members of Newfront and has built practices serving 300+ companies, helping them grow and scale by solving issues around global expansion and new product launches. With expertise in product liability, professional liability and clinical trials insurance, Cristina is a recognized thought leader providing companies with a valuable understanding of how they can accelerate growth and avoid unnecessary risk.