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Our Take: The barriers to adopting wearable technology still persist notwithstanding its consistent advancement and growing demand for health monitoring. Barriers such as cost effectiveness, accessibility, maintenance, and privacy limit the usability of wearables and addressing these barriers would enhance its utility to the general public. Below is a breakdown of each of these barriers and ways technology developers and health professionals are dealing with them. Key Takeaways: The wearable technology market is expected to grow from USD 116.2 billion in 2021 to USD 265.4 billion by 2026, at a CAGR of 18.0%. Developers like MFine are working towards making basic health assessments universal, easy, and free to use for millions of people by enabling monitoring through smartphones. Wearable sensor technology can vary broadly in price from individual Bluetooth sensors that cost as little as $35 to RFID sensors which cost over $1,000 apiece. Wearable devices have made health assessments easier for patients by monitoring vitals such as blood pressure, heart rate, oxygen levels, etc. through smartphones, smartwatches, laptops, and tablets. The Problem: Despite wearable technology’s increasing popularity, barriers such as cost, usability, maintenance, and privacy still remain. The cost of individual sensors which ranges from $35 for Bluetooth devices to over $1,000 for radio frequency identification (RFID) excludes people who might need it but cannot afford it. Besides cost, the perceived utility of popular wearable gadgets is poor, and consumer loyalty is low. Poor consumer loyalty is due to reluctance to adapt to new technologies, skepticism regarding the result’s reliability, electromagnetic field (EMF) exposure, and privacy concerns. This is the case notwithstanding the real time data monitoring value that wearable devices provide. Interestingly, medical and health care employees rated the devices higher and had a higher level of acceptance for wearable device usability than internet employees. This might be because wearable gadgets’ help in alleviating the clinicians’ burden through continuous monitoring of health data that facilitates diagnosis and disease identification. Maintenance of wearable devices is another challenge because over time with usage of the sensor irreparable issues or damages can develop. When glitches occur due to sensory failure or low battery life the device is no longer reliable for recording data such as tracking movement for exercising. While some wearable technologies offer device service and protection, it is usually for a limited time frame after which the user becomes liable to pay out of pocket for repairs or a replacement. Privacy concerns and the slow pace of passing policies and regulations for data protection adds to consumers’ uneasiness. For example, as we noted in “Health App Regulation Needs A New Direction-The HSB Blog 4/12/22, “while the markets and technology are moving at a rapid pace, policies and efforts around regulation move extremely slowly and have generally lagged behind advancement.” In addition, while we noted precautions developers of wearables can take in our blog, 8 Steps To Protect Against Ransomware When Developing Or Deploying New Apps-The HSB Blog 7/26/21, digital healthcare applications remain a target of cyberattacks and data privacy is generally not well protected. The Backdrop: The wearable technology industry has gained traction over the years and is projected to grow exponentially. According to a blog post from Appinventiv entitled, “How Much Does Wearable App Development Cost”, “the wearable technology market is expected to grow from USD 116.2 billion in 2021 to USD 265.4 billion by 2026, at a CAGR of 18.0%.” In part, this is due to innovative interfaces and improved user experience that have made these devices more accessible. As a result, wearable technologies and sensors have made health assessments easier for patients by monitoring vitals such as blood pressure, heart rate, oxygen levels, etc. through smartphones, laptops, and tablets. While there are a number of wearables in development, a number of devices are already on the market with many practical applications. For example, the Amrita Spandanam wearable device developed by Amrita's Centre for Wireless Networks and Applications employs a finger clip to assess blood glucose, blood pressure, heart rate, blood oxygen, respiratory rate, and 6-lead ECG. It is constructed with unique AI algorithms that process differential light signals to offer important bodily metrics. MFine, an Indian digital health business, has updated its mobile health app with blood pressure and glucose monitoring capabilities. After two years of research and clinical studies involving around 3,000 patients, the health tech firm released its latest vital measuring capabilities in early March of 2022. Last year, Samsung gradually added blood pressure measuring and ECG monitoring features to its consumer smartwatches throughout the world. Recently, Peloton released an armband that doubles as a Bluetooth heart rate monitor. The gadget detects heart rate using optical sensors and includes five LED lights that represent the heart rate zone, Bluetooth connectivity status, and battery charge. Implications: As the usage of wearable devices increases over time, there is one question that needs to be asked; do the benefits of these wearable devices outweigh their disadvantages? First and foremost, the cost effectiveness of the devices must be evaluated. For example, the continuous monitoring of basic physiologic readings such as blood pressure can potentially help alleviate a number of long-term health risks with proper monitoring since most people actually do not know or regularly monitor their blood pressure until their annual visit to their primary care physician. As noted in “Blood pressure, glucose monitoring tools now live on MFine app” The readings for blood pressure on wearables are now close to 90% in accuracy, while still not perfect, they do provide helpful data. This type of data can give patients crucial insights into their health data. Over time as technology improves and becomes less expensive, the ability to translate this method of body function measurement to smartphones will be far more cost effective than current wearable devices allowing it to be more effectively accessed by many more people. Apart from affordability, the ability to understand and translate the information provided by the wearable devices into relevant clinical data is another barrier to its widespread usage.. Currently, clinicians often find it difficult to separate meaningful and insightful metrics from the volumes of raw data that wearables provide as well as easily incorporate it into data in the EHR and care plans. Over time this data has to become easier to integrate and more insightful. Furthermore, accessibility, usability, maintenance and privacy are equally also [JE1] [JE2] barriers.. In terms of data privacy, as noted in Healthcare Drives articles, “More than 1/3 of health organizations were hit by ransomware last year” The report quoted found that “ransomware was relatively prevalent in the healthcare sector, with 34% of organizations hit by such an attack in the past year. Of those not hit, 41% said they expected an attack in the future, while just 24% said they felt safe from future attacks.” Data privacy and security have been and will be continue to be an issue with healthtech and wearable. In terms of accessibility and usability, solutions like MFine app are addressing accessibility and usability for blood pressure and glucose monitoring tools by enabling vitals monitoring through smartphones. While the technology is still early and it is difficult to determine whether or not the barriers to the adoption of wearable devices outweigh the advantages, it is safe to say that by addressing the barriers noted above the benefits of wearable devices will increase and will more than likely have meaningful impact on the health of populations and decrease of cost of care. Related Reading: Blood pressure, glucose monitoring tools now live on MFine app | MobiHealthNews Amrita University launches wearable health monitoring device | MobiHealthNews Wearable Technologies for Improved Safety and Health on Construction Sites | Blogs | CDC How Much Does Wearable App Development Costs? Usability Study of Mainstream Wearable Fitness Devices: Feature Analysis and System Usability Scale Evaluation - PMC

Earlier this year we wrote a piece on how virtual care my be one anwer to healthcare’s labor shortages, please see: Virtual Care May Be One Answer to Healthcare’s Labor Shortages-The HSB Blog 1/31/22. This week in honor of Nurses Appreciation Week we have revised and updated it with a focus on the nursing shortage. Our Take: Leveraging virtual care is one way to deal with a number of the issues that healthcare’s workforce shortages have brought to light due to the Pandemic. Following huge spikes in demand in almost every part of the country as it deals with COVID, the industry has had to deal with countless labor issues and shortages due to burnout and the overwhelming physical and mental demands placed on caregivers. While healthcare workers are experiencing elevated levels of stress, patients may also experience a different type of stress when it comes to patient quality and overall care. It is important to understand the dynamics of the overlapping crisis we currently face as nursing professionals quit in overwhelming numbers and healthcare systems look to other solutions such as virtual care. As an alternative, many providers opted to provide virtual care. Although the future of telehealth is unpredictable, the flexibility and convenience that virtual care provides for both the patient and the provider may be here to stay. Key Takeaways: Hospitals lost approximately 2.5% of their nursing workforce in 2022, resulting in the average hospital losing between $5.2M-$9.0M according to the NSI Solutions 2022 NSI National Health Care Retention & RN Staffing Report There is predicted to be a shortage of over 500,000 RNs by 2030 with the greatest shortages seen in the South and West, according to one 2018 study. More than 1M registered nurses will leave the workforce by 2020 according to a 2017 article in Health Affairs, which was prior to the extreme stress and burnout of the Pandemic. A study conducted by Wheel found that clinician burnout impacts 80% of patients and 1 in 3 patients believe burnout impacts their quality of care The Problem: The challenges of the pandemic have exacerbated and crystalized labor challenges and the preexisting labor shortages in healthcare. Nurses, like many health care workers, are physically and emotionally exhausted after working in what has been described as a “war zone” for the better part of the past two plus years. As noted in an article in The Conversation, “the global pandemic has only worsened problems that have long existed within the nursing profession…widespread stress and burnout, health and safety issues, depression and work-related post-traumatic stress disorder, and even increased risk of suicide.” In addition, the relatively non-stop confrontation with the Virus and its variants has forced clinicians to work long hours donning layers of PPE, which often can take 20 minutes or more each time to put on and remove. In addition, units are often short-staffed due to illness caused by COVID itself as well as employees who refuse to comply with vaccine mandates and other hospital protocols. Consequently, the stresses on clinicians such as the increased administrative burden and inability to focus on patient care have reached a breaking point. For example, according to a February 2022 report from McKinsey entitled, “Surveyed nurses consider leaving direct patient care at elevated rates”, 32% of registered nurses stated they may look to leave their current role, an increase of 10% compared to the prior year. The survey noted that the main reasons behind nurse’s desire to leave “included insufficient staffing levels, seeking higher pay, not feeling listened to or supported at work, and the emotional toll of the job.” In light of the heightened demand during COVID, issues around the healthcare labor shortages have garnered nationwide attention. For example, during the so-called “Great Resignation,” where large numbers of working-age people have simply dropped out of the labor force, approximately half a million healthcare workers have quit since February 2020 according to a recent article in Forbes. Along those lines, per the NSI Nursing Solutions Report, 62% of hospitals are reporting a nurse vacancy rate of almost 8%. Understandably the stress of dealing with a continuous overburdened workload over two-plus years has taken a great toll on clinicians' emotional, and physical health leading to burnout. For many, this has left them with two options–either to step away or go digital. Many have chosen to go digital and work in telehealth or start their own virtual practices which provide flexibility and a work/life balance that many so desperately desire. The Backdrop: Healthcare is a service industry that depends on the dedication and manpower of the individual clinicians and support staff responsible for maintaining the facilities, diagnosing and treating t illnesses, and caring for the lives of patients. A key element in this equation is the hiring and support systems that go into creating a physically and emotionally safe environment for clinicians to operate in where they feel their concerns can be heard and addressed. If not, the burnout and stress associated with working long hours under severe emotional stress, such as those experienced during COVID, can negatively impact the quality of patient care. For example, while the medical profession has long been sought after for its high wages it had also enjoyed significant professional prestige which helped attract a growing labor pool. That may no longer be the case. For example, according to “Amid Rampant Provider Burnout, Marketplace Platform Companies Focus on Clinician Experience” a survey conducted by Wheel, approximately forty percent of respondents would not want their children to go into the field of medicine as it is not worth their time or investment.” In addition, in the aforementioned McKinsey study nurses cited safety, flexibility (ex: work-life balance, work schedule), and environment (a trusting/caring team, feeling valued by employer) as the top factors on which they based their decision to stay in their current role. Those factors are changing. In addition to the stressors noted above, many practitioners are facing a working environment that is filled with aggression and constant abuse. According to “Nursing Shortages” approximately eight to thirty-eight percent of health care workers are at accelerated risk of facing emotional and physical abuse, which some attribute to insufficient staffing ratios. Following the explosion in digital care during COVID, digital has emerged as an option for many nurses and physicians. Going virtual is a way to create work-life balance and still practice their craft, optimizing the benefits for everyone involved. Many digital and virtual-first solutions are specifically designed to address administrative inefficiencies inherent in current electronic medical record systems (EMRs) and are designed to improve information flow for patients and providers. Implications: Addressing the void between provider flexibility and patient care is the future of telehealth. While there is still room for improvement in the delivery of virtual care such as patient privacy and broadband access, virtual platforms have the potential to move healthcare to a more consumer-centric omnichannel experience and address many of the issues of burnout. As we noted in “The Nursing Shortage Shows Why Industries Must Choose Tech Carefully” a number of studies have found that “nurses spend between 26%-41% of their time on documentation activities and that is a major source of what burdens them.” As a result, the article recommends providers consider technologies like natural language processing (NLP) to capture and search clinical notes as well as AI-based tools such as predictive analytics, to help risk stratify patients so they can focus on “providing human care for patients” and not paperwork. In addition, treating patients holistically and funneling them to the proper sites of care should help clinicians work “at the top-of-their” licenses and focus less on certain types of routine or chronic care which can be handled by other providers in the system or even prevented by higher quality care. Also, as some of the technical hurdles to providing these care delivery mechanisms are addressed, underserved communities and seniors can be given access and training on the technologies, so that virtual care can broaden the scope of care delivery, theoretically increasing provider satisfaction. However, in attempting to design solutions it is increasingly important to emphasice that nurses need to be brought into the process to ensure that this is done correctly and with patients in mind. As noted in a recent article in the Journal of Clinical Nursing, the “pandemic highlighted the urgent need for nurses to become involved in technology design, acquisition and implementation, and to provide considerations for the complexities of technology use within all levels—micro, meso and macro—of the healthcare system.” As the authors go on to point out, “technology developers and those who implement the technology within hospitals need a deep understanding of the complexity of the care processes within an acute environment. Establishing the means to develop a shared understanding between developers and end-users has become increasingly important considering that COVID-19 may have permanently shifted many aspects of care to a virtual setting, which will likely usher in the use of more technology.” Importantly, product designers and developers need to recognized the role of nurses as closest to the voice of the patient in the clinical system and embrace the knowledge they have in delivering and improving care. In looking at how to design and develop products to reduce burnout and improve nursing satisfaction, product developers would do well to keep 3 things from a recent HIMSS roundtable in mind: Consider deploying data-driven approaches to manage workforce scheduling and staffing. Leverage technology to improve patient care and empower nurses to do their most fulfilling work. Develop new approaches to patient care that improve the patient experience and support nurses. Related Readings: Now more than ever, nurses need to be involved in technology design: lessons from the COVID-19 pandemic The Nursing Shortage Shows Why Industries Must Choose Tech Carefully United States Registered Nurse Workforce Report Card and Shortage Forecast: A Revisit Surveyed nurses consider leaving direct patient care at elevated rates

The Driver: RNA platform company Mirvie recently raised $60 million in a Series B funding led by Decheng Capital with participation from funds managed by BlackRock, Foresite Capital, General Catalyst, GV, Khosla Ventures, Mayfield, and Olympic gold medalist Allyson Felix. Mirvie’s machine learning, messenger RNA (mRNA) platform focuses on creating precise, actionable, and non-invasive tests for maternal-fetal health. The company is currently developing a blood test designed to identify the risk of preeclampsia before symptoms occur. Mirvie announced in May that they have received FDA breakthrough device designation for their blood test. The funds acquired will be used to help fund a 10,000-person clinical trial to validate Mirvie’s technology, increasing clinical evidence as it gets closer to commercialization. Key Takeaways: Around 4% of the approximately 3.6 million women who will give birth in the U.S annually will be diagnosed with preeclampsia according to Forbes. John Hopkins University stated the overall prevalence of preeclampsia among all women was 9.5%, with Black women having the highest age-adjusted prevalence of preeclampsia (12.4%) compared with Hispanic (8.2%) and white women (7.1%). The estimated total incremental costs of preeclampsia were approximately $29,000 in total (approximately $3,000 for mothers and $25,000 for infants) according to The American College of Obstetricians and Gynecologists. Preeclampsia encompasses 2% to 8% of pregnancy-related complications, greater than 50,000 maternal deaths, and over 500,000 fetal deaths annually worldwide according to StatPearls. The Story: Mirvie was founded by the CEO and Co-Founder Maneesh Jain in 2018 and a team of scientific and business pioneers that have an extensive track record innovating, developing and commercializing non-invasive and liquid biopsy tests used by millions of individuals today. After experiencing complications during their own children's births, CEO Jain and Mirvie’s scientific advisory board chair Dr. Stephen Quake both committed the rest of their professional careers to helping other parents avoid unexpected conditions during pregnancy and, hopefully, any stay in the neonatal intensive care unit. As they knew, research shows that 1 in 5 pregnancies is impacted by unexpected complications such as preeclampsia, preterm birth, and gestational diabetes, impacting more women each year than all forms of cancer. Preeclampsia affects the arteries carrying blood to the placenta and can cause the inadequate blood and oxygen flow to the fetus or even preterm birth. However, as noted by Forbes, “ the main tools to identify who’s at risk [for preeclampsia] haven’t changed in decades'' and generally include whether you have had preeclampsia before and risk factors such as : high blood pressure, weight, age, and race. With the costly consequences of pregnancy complications impacting both the mental health of the mother and physical health of the child. Mirvie aims to address these disparities through early detection with an mRNA platform study and the development of their blood test. While prior tests have attempted to look at the human genome, as noted by Forbes, Mirvie’s founders felt that exploring the RNA “could indicate whether you have a particular condition at that moment in time (or may be at risk for developing it).” In early May 2022, Mirvie’s preeclampsia test received breakthrough device designation from the FDA. The Differentiators: One of the main differences between Mirvie and other biotech companies is that Mirvie focuses on prenatal testing based on a blood sample and RNA sequencing. This process is non-invasive and helps identify potential complication pregnancy risks in advance. In addition, Mirvie’s tailored blood test can detect early signs of preeclampsia that are not associated with common risk factors currently reviewed, some of which would be unknown to first time mothers. Mirvie’s test is a new application of “liquid biopsy” testing, which had previously been used mostly with cancer. As noted by the American College of Pathologists, “while definitions [of the term liquid biopsy] vary, it can broadly be thought of as collection of a body fluid sample to test for relevant biomarkers to inform patient management. While the current focus is predominantly on detection of cfDNA, additional components of a liquid biopsy could include... ribonucleic acids (RNA), circulating tumor cells, extracellular vesicles or exosomes, and tumor educated platelets.” Mirvie’s technology could potentially help reduce the racial disparity of minority women with preeclampsia and other pregnancy complications through the use of their platform. The use of preeclampsia testing in underserved communities with high minority populations could improve patient health outcomes, as well as reduce long-term healthcare costs and burden on the patients. The use of this product as a primary prevention measure may also reduce overall healthcare expenditures by helping to address any known risks in advance. The Big Picture: Mirvie’s goal is to predict pregnancy complications months before they occur using a simple blood test, using a combination of artificial intelligence and samples of RNA proteins in blood. In fact, in a recently published study in the American Journal of Obstetrics & Gynecology, entitled “ Predictive RNA profiles for early and very early spontaneous preterm birth”, Mirvie’s technology was able to predict three out of four preterm births an average of two months in advance of other methods, thereby helping to “identify those at risk for spontaneous preterm birth by revealing the underlying pathophysiology, creating an opportunity for more targeted therapeutics and effective interventions.” As a result, Mirvie’s solution could help change the way that OB/GYN’s assess the risk of preterm delivery, help physicians diagnose complications sooner, and relieve maternal stress during pregnancy. In addition, Mirvie’s Jain hopes that in the future their company can also predict other pregnancy issues such as gestational diabetes or placenta accreta, which can lead to severe blood loss. As the CEO noted to Forbes, “even if we can make a small impact, it'll be huge just considering it's almost approaching a million women every year in the U.S. experience these complications.” Mirvie raises $60M to develop early preeclampsia detection and more digital health fundings; Mirvie mRNA study predicts premature births 2 months in advance; Mirvie Raises $60 Million For Blood Test To Predict Pregnancy Complications

Incenting or Mandating Downside Risk Is Key to Population Health “Our Take”: To simultaneously decrease cost and improve quality of care, providers must share in downside risk. This pushes them to adopt new strategies of meeting patient needs, discouraging a volume-centered approach to treatment. Providers in alternative payment models (APMs) operating under a framework of value-based care are driven to pursue new methods of coordinating care, aiming to reach a higher level of quality with a less resource-intensive approach. Population health management tools are key in achieving this. The more targeted holistic care philosophy that population health management fuels, is what will make APMs viable for providers of all sizes. These strategies for care coordination include data integration from multiple sources, keeping physicians engaged, and educating the patient population, among others . Description: According to Lumeris, total health care spending reached $38 trillion in the United States, and the Congressional Budget Office estimated that it will increase at 5.4% annually, reaching $6 trillion in 2028, an estimated 19.7% of GDP. The Center for Medicaid and Medicare Innovation (CMMI) has created over 50 alternative payment programs, but much of the existing reimbursement structure in the United States operates on a fee-for-service (FFS) basis. The incentives providers face under FFS are toward volume in services billed, rather than toward positive health outcomes or cost efficiency. The concept of value-based care is rooted in the notion that care should be motivated by a patient’s needs, and financial incentives should reflect that. Population health management is a key set of tools for improving performance that offers cost saving potential. Providers in APMs, such as accountable care organizations (ACOs) and bundled payment arrangements, are already embracing population health techniques, because they enable focus on preventive care and consideration of physical, social, and economic conditions that affect health, according to Modern Healthcare. These two dimensions align with the value-based care ethos, prioritizing patient needs and resource management over reimbursement optimization. Modern Healthcare reports that three technological advancements drive the availability of population health management: 1) interoperability, which is the access to comprehensive patient data across health care systems; 2) predictive and prescriptive analytics, which can identify patient health risks before complications arise; and 3) patient engagement solutions, including digital tools such as virtual and remote care, that make it easier for people to participate in their own care. The COVID pandemic has laid bare the failings of the FFS system and highlighted the potential for population health to improve care at lower costs. For example, in it’s spring 2020 survey Premier Inc. identified that APM’s reported higher rates of population health management techniques than those not participating in APMs in 4 areas: 1) a head start on telehealth, allowing capacity to be kept open for those in need of inpatient care; 2) care management techniques, which kept lower acuity patients at home and the ability to monitor for suspected and confirmed COVID cases from afar; 3) partnerships with post-acute care networks which facilitated connections allowed health systems to work together to understand post-acute capacity and ensure successful care transitions from acute care hospitals; and, 4) data systems that facilitated population health by using analytic tools to make data actionable and meaningful in determining needs and creating protocols. As illustrated by the Premier survey, providers in APMs rely more on advanced population health management strategies and can improve care coordination, lower costs and are better equipped to serve the health needs of a community. Implications: Moving to population health will be essential to help bend the cost curve in healthcare and moving to models that require two-sided risk will be critical to the adoption of population health. However, sponsors of two-sided risk arrangements must take the proper steps to ensure that clinicians have the appropriate tools to succeed in population health arrangements. For example, the Health Care Payment Learning & Action Network (HCPLAN), a public-private health care policy group, notes as part of it’s Resiliency Framework report that APMs are key to building health system resiliency to deliver coordinated, high-quality person-centered care after a crisis like the COVID-19 pandemic. In the report, HCPLAN outlines four steps to work towards more resilient APM’s including advocating for models with two-sided risk. In moving models towards two-sided risk establishing and maintaining a clear path of communication with clinicians is key. As a recent article in In Healthcare Executive entitled, “Achieving ACO Savings: A Case Study” noted, keeping primary care physicians engaged and invested in the value-based care process from a culture of mutual respect and providing constant feedback and education is essential. In a similar vein, research has shown that information was best communicated to physicians by peers or clinical leadership, rather than from administration. In addition, providers should leverage information technology to overcome challenges in care coordination by integrating multiple data sources through electronic health records (EHRs) as well as financial, and operational tools that promote the sharing of information between clinicians. Importantly, while having necessary information on hand is essential to care coordination and the success of ACOs as a report in Healthcare Business and Technology entitled, “the ‘path to success’ for ACOs requires data they can use”, emphasizing the need for “clean, usable data” that can help providers reach “deep interoperability,” something 86% of those surveyed reported they had not done. For example, of those surveyed, 68% of ACO respondents said data use and analytics helped them achieve cost savings, and 50% noted it helped them improve utilization, but “access to outside data” and data integration remained challenges for about two-thirds of respondents or more. Interestingly, breaking through data silos requires cooperation and collaboration from other providers as well as within their own staff. Finally, constant innovation and organizational commitment to keep iterating new approaches is needed as well as constant participation and oversight by senior levels management in the governance structure of any population health initiatives. As demonstrated by the vulnerabilities in care delivery exposed by the COVID pandemic, the FFS system continues to underperform and is poorly equipped to handle large scale health issues such as pandemics. The techniques employed under population health management must be more strongly incentivized (and perhaps even mandated) as to what structures providers must enact to ensure stability and viability of the healthcare system long-term. Their widespread adoption will further the feasibility of two-sided risk APMs and value-based care by providers would likely drive more rapid and sustainable change in the system. How Experience in Alternative Payment Models Put Providers a Step Ahead in Pandemic Response How the Most Successful ACOs Act as Factories of Innovation The Role of Population Health in Value-Based Care Patient Characteristics Associated With Telemedicine Access for Primary and Specialty Ambulatory Care During the COVID-19 Pandemic Event: On December 29th, JAMA network published a study regarding the usage of telemedicine platforms among minority populations during the COVID pandemic. As telemedicine use has increased during the pandemic, the question about whether telemedicine exacerbates or helps address disparities in the delivery of healthcare has arisen. This study of approximately 150,000 patients at a large academic medical center found that older, Asian and non-English speakers as well as Medicaid patients were less likely to use telemedicine services. Description: Prior to the COVID pandemic, a previous JAMA study of telehealth utilization found that only 4% of respondents had used videoconferencing visits for healthcare. In addition, that study found that while approximately half reported being willing or very willing to use videoconferencing visits, those who were Black, older than 65 years old or had less education (high school or less vs advanced degrees) were less likely to be inclined to use videoconference visits. The study of telemedicine use during COVID found that patients who completed telemedicine visits were more likely to be younger, English-speaking, females with commercial insurance with a higher median household income and were less likely to be Asian. Compared with White respondents, Asian respondents were associated with fewer completed telemedicine visits whereas those of Black race and Latinx ethnicity were associated with more telemedicine visits compared to Asians. Implications: There is a significant difference between pre-COVID usage of telemedicine platforms and usage during the early phases of the pandemic. Due to the lack of education, funding, and access amongst Black individuals, rural residents, and those of a lower income status, usage of telehealth platforms was extremely limited in comparison to higher income, educated White individuals. While use of telehealth by underserved communities did increase during COVID, with the percentage of Black patients indicating they had used telehealth equaling almost 25%, that number was still less than half of the percentage of Whites who had used telehealth (23.8% for Blacks vs. 62% for Whites). In addition, the limited usage amongst Asian populations (3.2% vs. 62%) during the pandemic is attributed to lack of access, poor patient-physician relationships, more frequent negative interactions with providers and increased racism due to fear of racism created regarding the origin of COVID. The results showing the age difference in usage is consistent with evidence that older age is associated with lower internet availability,lower use of digital health technology, and slower rates of technology adoption. Moreover, language barriers continue to be a limiting factor in both studies, despite the installation of translation options to combat the disparity. The shifts in usage show that although great efforts have been made to address disparities in the delivery of telemedicine “inequities in accessing telemedicine care are present”. As such, barriers and challenges for minority groups still need to be addressed to ensure better access and more comprehensive solutions to meeting the health needs of all populations. Patient Characteristics Associated With Telemedicine Access for Primary and Specialty Ambulatory Care During the COVID-19 Pandemic & Prevalence and Characteristics of Telehealth Utilization in the United States Medtronic, GE, Philips, Embrace AI Amid Regulatory Limbo Around Algorithms. Event: HealthcareDive recently reported that GE Healthcare, Medtronic, and Philips are investing heavily in artificial intelligence (AI) and machine learning (ML) technologies despite the fact that the FDA has yet to finalize a regulatory framework for machine learning-based software as a medical device (SaMD). The article noted the companies see the potential for the technologies to improve diagnosing, managing, and treating a wide variety of diseases and health conditions. The article noted that the CEO of Medtronic recently stated that the integration of medical technology with innovative robotics, sensors, and the computational power of AI could be among some of the greatest advances in medical technology unfolding right now. Description: The article noted that 3 medtech giants are each taking a slightly different tack.Medtronic has initiated technology support such as robotics, navigation, advanced imaging, and pre-operative planning aided by AI to support its spine surgery portfolio. For example, Medtronic recently completed a tender offer for French AI spinal surgery specialist Medicrea whose platform uses predictive modeling algorithms to measure and digitally reconstruct a patient’s spine. With the acquisition, Medtronic claims it will be the first company in spinal surgery offering AI-driven planning, personalized implants, and robot-assisted delivery. Philips’ is focusing on AI-enabled informatics to help clinicians identify actionable insights and bring greater precision to radiology diagnosis (with the goal of expanding to cardiology, pathology and other areas over time). GE Healthcare’s Edison Marketplace is “working with third-party AI developers to address all the security, privacy and application programming interface (API) issues with the goal of reducing overhead and software administration issues for hospital providers. GE’s Edison Marketplace apps are meant to work within a hospital’s existing workflow using an “Open AI Orchestrator” that simplifies the selection, deployment, and usage of AI in imaging workflows at scale (akin to app stores for Smartphones). Implications: While the emergence of big datasets, combined with innovation in robotics, sensors, computational power, and AI, could put the medtech industry on the verge of some of the greatest advances in medical technology, the regulatory environment remains clouded. As noted, there is little regulatory clarity regarding “adaptive AI” where machine learning algorithms continuously learn on their own and don’t need human modification to incorporate learning [please see our 10/27/20 blog article “FDA Patient Engagement Advisory Committee (PEAC) Meeting on Adaptive AI and ML” Link Here . Currently the FDA has only approved devices using “locked” algorithms and while “unlocked” learning algorithms have been allowed in consumer self-diagnosis apps, diagnostic efficacy seems to worsen over time, potentially complicating longer-term approval of adaptive AI products. In addition, although the FDA appears to be considering a total product lifecycle-based regulatory framework for continuously learning AI, this could have ramifications for ongoing informed consent with patients. AI and continuous learning algorithms have tremendous potential but progress will be limited until a clearer regulatory pathway is established. Medtronic, GE, Philips Embrace AI Amid Regulatory Limbo Around Algorithms & Evaluation of Four Artificial Intelligence–Assisted Self-Diagnosis Apps on Three Diagnoses: Two-Year Follow-Up Study U.S. Healthcare Fintech Lendeavor Rebrands to “Provide”; Raises $34 Million Through Series A & B Investment Rounds Event: Recently healthcare finance startup Provide (formerly Lendeavor) raised $34 million. Founded in 2013, Provide helps healthcare practices open business bank accounts and get insurance. According to the company, their mission is to offer a fully integrated suite of financial products that makes starting and running a healthcare practice easier – giving providers more time to care for their patients. Description: Provide earns the trust of healthcare entrepreneurs by solving their most challenging financial problem: getting the funding to start their practices. The company has built software to streamline the loan application process by essentially eliminating data entry in the application process and relying on optical character recognition (OCR) to get data directly from tax returns and other documents. The company claims that this can cut the approval time for transactions from 30 days with traditional banks to 2-3 days for those that use their product. Since 2016 the company has originated $800 million for more than 1,000 practices, 80% of which are dentists (the company also markets to veterinarians and doctors). Provide also arranges insurance coverage providers needed to run their practices. The company makes money through the fees it earns by bringing business to its banking partners. Implications: Provide allows healthcare practices and entrepreneurs to financially get on their feet. By raising $34 million, Provide could open a new market for under-financed or under-resourced healthcare companies that need extra support to run. This could help smaller health companies with niche business models be more accessible to the public. By being more responsive and flexible Provide can help practices better navigate the uncertainties of today’s uncertain economic environment. For example, when a number of its dental clients had to shut down during the pandemic, Provide was able to offer customers deferred payments as well as a $200 million subsidized refinancing facility to help their practice partners remain afloat. Also, by removing some of the stresses associated with financing operations, providers can dedicate more time to care for their patients. U.S. Healthcare Fintech Lendeavor Rebrands to “Provide”; Raises $34 Million Through Series A & B Investment Rounds & S.F. Fintech for Dentists, Vets Raises $34M, Changes Name to ‘Provide’ 5 Digital Health Trends That are Here to Stay Event: On December 29th, an article from Entrepreneur magazine highlighted five digital health trends that stemmed from the pandemic that are here to stay in 2021. As the article noted, “the [COVID] crisis, with all its overwhelming tragedy, also ushered in tremendous intellectual energy and freedom. ...Healthcare organizations, technologists, and government agencies proved for the first time that speed, innovation, and safety were indeed possible in healthcare” Description: According to the article there were 5 trends in healthcare due to the pandemic which will be difficult if not impossible to reverse. These are: 1) The “consumerization of healthcare” encompassing everything from home delivery of prescription medication to sleek wearable electronics that can monitor an array of patient vital signs, 2) “telehealth”, which opened up a range of communication options between patients and doctors from video visits to phone calls to texting, 3) “virtual reality,” as a powerful tool for the medical community to train future doctors and surgeons, 4) “interoperability among vendors,” which by necessity broke down information silos between healthcare systems to work with each other and makes it easier for patients and providers to exchange and manage information, and, 5) “cloud infrastructure”, specifically cloud storage, which facilitates the storage and exchange of the large amounts of healthcare data generated daily both within and among organizations. Implications: The article highlights that technology was a slow-growing trend hampered by regulations, security issues, and privacy concerns, but once the pandemic made in-person visits problematic, all trends highlighted above exploded in popularity. HIPAA requirements were waived, and social distancing measures urged patients to seek remote access to healthcare by downloading apps and using virtual communication modes. Technology is becoming more affordable and more commonly adopted in the healthcare setting. It has also boosted convenience, improved access to care, and reduced hospitalization rates for issues that can be addressed remotely. Organizations should ensure that their strategic goals and mission are aligned with improved patient care, day-to-day workflow solutions for physicians, and maintaining regard to privacy and security regulations. As we move into 2021, physicians and patients also need to be open to telehealth technology, as it is here to stay. 5 Digital Health Trends That are Here to Stay

Hospital Digital Tools Increase Risk of Cyberattack Our Take: Hospital cybersecurity controls need to be stronger. Early last year as the COVID pandemic started, hospital cyberspace gained vulnerability as healthcare workers went remote and cross-border licensure rules were eased to deal with the pandemic. While government and private hospitals were warned of an increased risk of ransomware attacks, according to a report from Check Point Software Technologies , there was a 45% increase in cyber attacks targeting global health care organizations from the beginning of November 2020 through the end of the year. These cyberattacks did not just impact their primary targets (hospitals) but also impacted their patients given the breach of patient data, confidentiality and research. While cybersecurity controls in hospitals are high priority, healthcare organizations need to be even more vigilant and agile in taking precautionary measures to safeguard themselves and their data from attacks. Description: For some time, cybercriminals have seen medical providers and hospitals as fruitful sites for hacking given the broad amount of personal information they maintain on patients. Given clinicians' need for immediate access to patient data during the pandemic, data, applications, and systems may become even more targeted due to potential lapses in normal security measures. For example, due to the global shortage of ventilators during the pandemic, public health agencies undertook emergency procurement efforts to obtain them. However, given the urgency of the situation, they may have exposed organizations to security break ins or potentially exposed sensitive data since many devices went unchecked for any ePHI that had already been stored on them. In addition, the dramatic increase in the use of telehealth caused a similarly dramatic increase in the number of potential exposure points for providers. According to a study published in the JAMA Network, reported telemedicine services grew by more than 1000% in March and more than 4000% in April of 2020. As the reliance on healthcare technology has increased, so has the risk with U.S. healthcare data breaches increasing 14% in 2020, compared to 2019. Among the forms of malware used for these cybercrimes the most common were worms (a type of computer software that spreads copies of itself from computer to computer and can replicate itself without any human interaction); a rootkit (typically malicious, designed to give a person or computer access to software or a portion of a system to which it normally wouldn’t be allowed), and rogue security software such as ransomware (software that affects an infected computer system in some way, and demands payment to bring it back to its normal state). Due to the life and death nature of hospitals work hackers use malware to target the most critical parts of the organizations in order to give them a higher chance of getting paid. According to a report on CBS News, during September ransomware attacks targeting U.S. hospitals, ransom demands went well above $10million per target, and criminals on the dark web were reported to be discussing plans to attempt to infect more than 400 hospitals, clinics, and other medical facilities. Healthcare organizations can be infected in many ways but three very common methods include: 1) phishing emails where a malicious link or attachment infects the computer systems; 2) weak infrastructure/ legacy systems- in general, many systems fail to install security patches and available updates, and, 3) misappropriated vendor/supplier credentials, security credentials that are stolen by vendors/suppliers or their employees that can provide physical access as well as access credentials for technological systems and data repositories.. Implications: With the increase in cybercrimes targeted at the healthcare system, healthcare systems need to take critical actions to safeguard themselves. As the old saying goes, “an ounce of prevention is worth a pound of cure”, 1) It’s better to invest in cybersecurity than to have to pay the ransom after a breach in the system. Stay on high alert for certain types of malware and have playbooks for different types of attacks using tabletop exercises; 2) Establish an anti-phishing strategy, which includes training employees to recognize malicious emails and sites or use email systems with integrated anti-phishing solutions.; 3) Use two-factor authentication where possible and have unique passwords for different services; 4) Make sure automatic system updates and patching is performed routinely, and deploy ransomware protection as well as antivirus systems; 5) Actively scan each new medical device added to your network making sure the device is input into the hospital’s inventory system and restored to the manufacturers default settings to prevent the release of any PHI that might be stored on the device. With the rapidly growing dependence on healthcare technology and virtual platforms, cybersecurity threats will only continue to increase. As healthcare systems more broadly deploy technology in clinical medicine healthcare providers, government bodies, and regulatory experts must ensure that all aspects of patient safety, data protection, and privacy, are the highest priority. “Cybersecurity Forecasts for 2021: The Good, Bad and Ugly in Healthcare” (HIMSS NY Webinar);FBI Warns of "Imminent" Ransomware Attacks on Hospital Systems; 10 Quick Cybersecurity Tips for Hospitals in the Midst of COVID-19 Pattern Health Collects $1.5M to Scale Platform for Increased Adoption Event: On February 16th, a report in the Triangle Business Journal stated that Pattern Health had raised $1.5 million to increase growth particularly in marketing, sales and engineering. Founded in 2016 by CEO Ed Barber, Pattern Health is a user-friendly way to research, develop and validate new and novel digital health programs. Cofounders Capital and The Launch Pad, provided the funds. Description: According to the firm, Pattern Health’s no code platform enables researchers and clinicians to create and deploy their digital tools, including condition specific digital health programs, rapidly and efficiently. In addition, Pattern’s tools allow organizations to collect data more rapidly, validate evidence and “when appropriate translate programs into real-world, highly scalable solutions.” The company states that it’s turn-key connected care platforms promise faster, more scalable and economic innovation than custom developed mobile health apps given the lack of development costs (which average over $400K), dramatically quicker development time (which can take from 12-24 months) and potential to share costs. Implications: The ability to develop and deploy evidence-based digital tools rapidly will be key to monitoring, assessing and eventually improving the care of populations in the near-future. As demonstrated by the Coronavirus, healthcare tools which provide the flexibility and agility to respond to health crises will prove invaluable in an ever more interconnected and global world. In addition, the ability to easily customize tools based on patterns of care and validated by evidence of their ability to motivate behavior change and promote adherence should allow the providers and payers the ability to design applications for specific patient populations, thereby improving adherence. Despite the labyrinth of data privacy and security laws and regulations as well as all the never-ending complexity of healthcare IT environments, healthcare needs to find a way to make digital tools much more user friendly, consumer oriented and responsive to the market. Innovative Health Care Firm in Durham Plans to Double Headcount Backed by Big Hospitals, a Former Microsoft Executive Wades into the Messy Business of Selling Patient Data Event: On February 17th, STAT+ published an article highlighting a new for-profit venture named Truveta that aggregates and sells de-identified patient data and will be used to create new medical devices and treatments to tackle ongoing issues like COVID and cancer. The company is led by former Microsoft software engineer Terry Myerson, CEO and was formed by a partnership of 14 U.S. health systems Description: Truveta aims to bring scientific integrity and health inequities to the forefront by adding de-identified patient data to train artificial intelligence tools. Truveta will function as a public utility, parsing out data from electronic medical records. The company's goal is to use the data to benefit patients by providing solutions to public health problems and building research datasets representative of a diverse population. Data will be stored with a third-party cloud provider, and health providers will maintain control of how data is used and what the use cases are. Myerson and executives at hospitals investing in Truveta explained that patient data used from electronic medical records would be carefully stripped of its identifiers, as required by HIPAA. Moreover, Truveta will use the data for "ethical" research projects, not for advertising. Health data experts concluded that several important decisions would determine Truveta's success or failure, including: (1) which entities will Truveta share data with? (2) how much will it charge? (3) how will it interact, if at all, with patients whose data is being used to power research products and the products derived from them? Implications: The article noted that "patient data is a commodity that can be bought and sold," which has and continues to be an issue for providers, payers and patients. Stakeholders consider patient data as something owned by the individual, who has the inherent right to direct how it is being used. Loss of control over patient data is dangerous and can lead to a loss of privacy, discrimination, and many other problems. Although Truveta is using de-identified data, pieces of information could be used to re-identify patients by those who have malicious motives. The most ethical way to utilize patient data to improve outcomes is to be transparent with patients and ask for their consent in sharing the data. Conversely, because Truveta is a for-profit entity, there is a potential that the lure of money could lead one to stray from the path of the highest ethical standards. As such they must ensure that standards are updated regularly, data privacy controls and de identification methods are routinely tested for weakness and that all policies and procedures are subjected to regular internal and external audits. Backed by Big Hospitals, a Former Microsoft Executive Wades into the Messy Business of Selling Patient Data The Coronavirus is Here to Stay - Here’s What That Means Event: On February 16th the journal Nature published an article that attempts to envision what life will look like in the future as the Coronavirus continues to linger throughout the population. According to the article, despite the discovery of many vaccines, scientists think the virus will continue to exist in certain regions but will eventually be classified as endemic (instead of a pandemic), if several important measures are adopted. Although it is difficult to make concrete predictions at this time, telemedicine, vaccination, and herd immunity are key essentials that will be needed to return to some form of normalcy in the future. Description: Given the dramatic impact that COVID has had on human life, as well as the recent discovery of several vaccines to help eradicate it, Nature asked 100 immunologists, infectious disease researchers, and virologists who have worked with the Virus whether it could be completely eradicated. Ninety percent of those asked do not think so. According to the article, over time, these researchers believe the virus will transition from a pandemic (an epidemic that spreads over multiple countries) into an endemic (a disease that belongs to a particular person or country and which can have a constant presence in a particular location). For example, while select areas of the world such as Western Australia, have been coronavirus free for this past year, this was only achieved through heavy restrictions on travel and imposing lockdowns at any point when case counts rose. Although this may seem like the best alternative, many scientists do not think this is likely or sustainable. When considering the impact of vaccines, many countries have begun distribution and expect to see a reduction in severe illness, but the vaccines’s longer term impact still needs to be understood. Unfortunately, it will take longer to see how effectively vaccines can reduce transmission of the virus from person to person. Although early data from clinical trials have suggested that the vaccines that prevent symptomatic infection might also prevent asymptomatic people from passing on the virus, which is essential to protect the entire population, the data is not conclusive. Although distribution is in full swing, scientists are heavily considering additional steps needed to completely experience some relief. Implications: As noted in the article, there are many things that need to occur to transform this pandemic into an endemic. First, there needs to be a reduction in transmission through vaccination. Once vaccinated, individuals will both build antibodies to fight off future infection but also contribute to the development of herd immunity from this virus. In addition, researchers must closely monitor the wild animal population to ensure that the virus does not establish itself in wild animals. According to the article, several diseases once thought to be brought under control, such as yellow fever, Ebola, and chikungunya virus, persist because animal reservoirs, such as insects, provide opportunities for pathogens to spill back into people. Lastly, the use of technology to continue to track and monitor individuals is needed. Through the tracking of any symptoms such as a rise in body temperature, cough, chills, etc., people will be more attuned to the signs of COVID and can quarantine. This will help diminish the spread of the virus to outside populations. If other regions, aided by these factors, aimed for a similar zero COVID strategy, then the world may rid itself of the virus. In the meantime, the key to transforming this pandemic into an endemic is to promote testing, using technological monitoring devices, vaccination, and herd immunity. The Coronavirus is Here to Stay — Here’s What That Means Addressing Mental Health in the Workplace in 2021: Three Ways to Give Support Event: A recent article on the MarketingProfs website, addressed the need for increased resources and attention to the mental health needs of employees during 2021. The article noted that during the pandemic, millions of workers have faced higher than usual stress on their mental health due to a number of factors. It noted that employers can take an active role in combating stress and improving mental health for their employees. Description: According to the article, many workers have been met with atypical conditions that strain their mental health during the pandemic, such as having no division between work and living space, needing to provide care for vulnerable relatives, or stepping in to educate their children. The article also highlighted that according to AARP’s 2020 Report on Caregiving, one in four caregivers found it difficult to take care of their own health, and 23% reported that having to provide care for others had made it worse. Employers have a responsibility to take a role in improving the mental health of their employees, and can use their platform within an entity to bring employees together and foster a supportive environment. MarketingProfs, employers can use three approaches to help support employees mental health: 1) Provide tangible mental health resources to workers, which they define as services workers can use such as giving employees free counseling sessions annually, or launching benefits specific to working parents; 2) Invest in workplace mental health training. A 2020 survey by Vyond suggested 45% of employees who are isolated at home want education in mental health strategies from their employers which should include real-world examples of work-related stress management as well as tools to help managers lead their teams in reducing stress; and, 3) Prioritizing ongoing communication, this should include leaders opening up about the individual challenges they are facing and sharing how they are implementing their own wellness routines. Implications: Moving forward through the pandemic, mental health and wellness should be a primary concern for internal communication from management and leadership. It is essential that employers utilize their resources to take care of their workers to preserve both the productivity and health of their employees. During an international crisis, it is essential that people receive proper support from their workplaces to ensure their health and safety in the future. Moreover, deploying these resources can have practical impacts on employee satisfaction and productivity. According to a Gallup poll, when people feel inspired and motivated, they do more work and the work they do takes less of a toll on their health and energy. Moreover, the same poll also noted that lack of communication from managers was a top 5 reason for burnout, a key driver of turnover. Addressing Mental Health in the Workplace in 2021: Three Ways to Give Support

Event: Venture Beat reported that Medisafe, “a personalized medication management platform to help patients stay on top of their prescriptions”, announced it had raised $30 million.” According to Medisafe it uses “digital drug companions” to improve medication adherence and compliance for patients. VentureBeat noted 20%-30% of prescriptions are never even filled costing the U.S. healthcare system approximately $100 billion to $300 billion per year. Description: Medisafe was founded in 2012, and has raised approximately $52 million, including this round. The company has operations in Boston, Israel and London, with 50 employees and revenue of several million dollars. As noted by VentureBeat, once a patient enters their medication into Medisafe’s smartphone app, it guides them through a process to collect patient release forms and help them with drug titration schedules. Once entered into the app, Medisafe’s “Just-in-Time-Interventions” (JITI) applies its artificial intelligence algorithm to: 1) help patients administer medication, 2) evaluate whether they qualify for financial support programs, 3) assist with refill ordering, and, 4) collect information for providers via surveys. Medisafe claims that its analytics and real-time behavioral assessments can boost adherence by up to 20% and that the technology drives average adherence rates of almost 90%, compared to an industry average of approximately 50%. Medisafe competes with the MyTherapy app by Apotheke of the Netherlands, Walmart’s Care Zone, Healthprize and ZappRx among others. Implications: Medication adherence and compliance have long been a significant problem for patients, often leading to ineffective treatment and poor outcomes. Services like Medisafe’s in-app Care Connector feature, create a convenient way to facilitate communication between patients and doctors around concerns or issues with their medications that may ultimately lead them to discontinue use. Not only does this help patients maintain their medication schedules, it also allows physicians to be alerted to issues, some of which are easily addressed, that without intervention may lead to non-compliance (ex: patients inability to tolerate medication or side effects). In addition, when platforms contain additional features like Medisafe’s Maestro which provides information on patient census, program reporting and integrations with pharmaceutical company data, additional insights are gained and improve the effective prescribing and post-approval surveillance of medications. However, they must always be implemented with strict safeguards to ensure this isn’t abused for marketing purposes. Mobile medical apps like Medisafe as well as medtech tools such as smart pill bottles, smart packaging systems, smart pill dispensers and even smart pills have the potential to greatly improve compliance at low cost all while supplying practitioners and researchers with real-time data on usage patterns. Medisafe Raises $30 Million for Predictive AI That Reminds People to Take Their Pills & Medisafe Raises $30 Million in Series C Led by Pharma Giant Sanofi Editors Note: Beginning this week, each Friday we are going to profile a healthtech prospect, an interesting, up-and-coming healthtech company. This is not an endorsement, nor are we getting compensated for the profiles. Instead, we want to highlight an intriguing company that may have caught our eye due to the friction it eliminates, the space it's in, or the ingenuity of its solution, etc.

MedPAC Commissioners Hint at Telehealth Policies that May Stick Post-COVID-19 Event: (9/08) A recent article in Healthcare Dive discussed MedPAC’s 9/4/20 public meeting which reviewed the expansion of telehealth delivery in Medicare. The key point of discussion was which changes in Medicare telehealth payment policies, waived during the COVID-19 public health emergency (PHE) would lawmakers and regulators allow to become permanent after the COVID-19 PHE ends. Description: During the pandemic Federal regulators relaxed many rules and payment policies surrounding telehealth to provide an alternative avenue of care, including the addition of 80 additional codes for Medicare covered telehealth services (from the then existing 100). When considering the issue some commissioners expressed concerns that expanding access could increase use of low-value services and also unwittingly widen the so-called digital divide with underserved populations (with two recent JAMA studies showing nearly 25% of older adults on Medicare lack access to computers with high-speed internet or a smartphone with a wireless data plan). In addition, commissioners appeared to dismiss the idea of continuing to allow the use of non-HIPAA compliant video platforms past the PHE but did appear inclined to continue coverage for audio-only services. Implications: The easing of regulations during the pandemic dramatically increased the speed and breadth of telehealth usage, rapidly expanding penetration and acceptance. While growth has slowed recently, how and which PHE waivers will be made permanent will dictate the pace of growth going forward. Given some commissioners were more willing to allow broader telehealth flexibility if they were delivered under some type of alternative payment model, blanket changes to the rules are likely to take longer than market participants expect initially and could be more limited in scope than many have suggested. For example, final payment policies and reimbursement at facility vs. non-facility rates may depend on CBO scoring. [Please contact us for our article “Not So Fast on the Future of Telehealth” published in PE Hub for more details] MedPAC commissioners hint at telehealth policies that may stick post-COVID-19 FCC Nears Launch of $100M Connected Care Telehealth Pilot Program: 5 Things to Know Event: (9/08) A recent article in Becker’s Hospital Review noted that the FCC had recently published application details on its $100 million Connected Care Pilot Program, which aims to enhance telehealth access for low-income Americans and veterans (originally introduced in 2018). Description: This three-year program provides $100M in grants to fund about 85 percent of telehealth programs’ connectivity costs, including patient broadband internet access services, provider broadband data connections and other network equipment. Under the program, users must have their own telehealth devices to participate and areas such as network deployment and construction of network and connectivity between healthcare providers will not be funded. Additionally, Connected Care is available in rural and non-rural areas, but is limited to nonprofit and public providers Implications: The funding and access to telehealth resources is extremely important for rural and underserved communities such as low income Americans and veterans. Making these resources readily available helps address the health disparities that exist in these communities and gives them better access to address their needs. Additionally, making this program available to nonprofit and public providers can help broaden usage of these resources to other vulnerable populations. FCC nears launch of $100M Connected Care telehealth pilot program: 5 things to know HHS Issues Plan to Improve Rural Health, Leaning on Telehealth Event: (9/04) On September 4th the U.S. Department of Health and Human Services (HHS) released an 84-page plan to address rural healthcare barriers, particularly due to the COVID-19 crisis. The plan details steps to expand telehealth services, emergency care consultations, and EMS training through a series of approximately $9M grants for up to 29 providers over the next four years. Description: Rural areas are not only plagued by a shortage of providers, but also suffer from lower incomes and higher incidence of chronic health conditions compared to urban areas. The 57 million rural residents are significantly more likely to die of heart disease, cancer or stroke compared to urban dwellers. The plan would allow rural health clinics and federally qualified health centers to furnish Medicare telehealth services and be reimbursed for virtual care at similar rates as comparable telehealth services under Medicare. The rural health plan would also allow Indian Health Service and facilities to receive compensation even if telehealth services are provided over state lines. Additionally, $12.4 million has been pledged to expand a pilot project to improve care for rural maternity and obstetrics patients, with expanded telehealth services. Implications: The health and geographic disparities in rural areas has been an existing, but heavily neglected issue for many years. HHS’s plans rely on telehealth and while telehealth has potential to help reduce geographic disparities in access to care, this may not be as helpful for addressing these issues in rural health. Telehealth relies on digital infrastructure that's largely not in place in non-metro regions and one-third of rural households say they don't have a broadband connection at home. HHS issues plan to improve rural health, leaning on telehealth Seattle Health Tech Startup Optimize.health Raises $15.6M for Remote Patient Monitoring Service Event: (9/09) A recent article from Geekwire noted that the Seattle health tech startup Optimize.health had raised $15.6M for remote patient monitoring service. The article noted that Optimize.health has raised more than $21 million in total funding to date. Description: Founded in 2015, Optimize sells a remote end-to-end patient monitoring service used by independent practices, hospital systems, and more. When health providers see that a patient at home needs support because a device such as a blood pressure cuff or a pulse oximeter indicates a potential health issue, the Optimize software provides a variety of communication methods for contacting the patients, including text messages and video calls. The company’s dashboard also provides a way to trigger a bill to the insurer for the clinician monitoring. The system integrates with Electronic Health Record (EHR) software. Implications: As COVID-19 outbreak continues, consumers are managing their health remotely. Optimize.health is allowing patients to receive regular care and updates through text message and voice calls in the comfort of their own home. This enables more accessible, convenient, and cost-effective healthcare. Seattle health tech startup Optimize.health raises $15.6M for remote patient monitoring service 5 CTA Members Leading the Digital Therapeutics Frontier Event: (8/25) In late August the Consumer Technology Association (CTA) launched a new initiative with 25 health technology companies to develop standards for the use of digital therapeutics. The goal of the initiative is to recommend best practices for the definition, application, use and performance requirements for the field to help educate the industry and, eventually, consumers to advance the adoption of the technology. As part of the launch, CTA profiled 5 of the companies in the initiative. Description: AppliedVR reshapes pain management care with its virtual reality platform aimed at alleviating a number of ailments, from labor pains to discomfort during infusions for cancer treatment. Ginger offers on-demand mental health support with trained behavioral health coaches, therapists, and psychiatrics with personalized skills building activities. GlucoseZone provides workouts, education and coaching to help users of the app reach their fitness and diabetes control goals. Healium leverages virtual and augmented reality (AR/VR) travel to allow users to biometrically alter their virtual environment through emotions and decrease their own stress. Implications: As the world continues to grapple with the effects of the COVID-19 outbreak, consumers have begun taking more control of their health care in the comfort and safety of their homes. Digital therapeutics, a relatively new branch of digital health, enables this socially distant health care delivery. The technology uses software applications to enhance clinician decision making, optimize the dose and delivery of other forms of medical treatment through patient monitoring, or even act as a stand-alone intervention. The standards from the CTA will help educate the industry and eventually consumers, to advance the adoption of the technology. 5 CTA members leading the digital therapeutics frontier A Buyer’s Guide to AI in Health and Care Event: (9/09) Last week, the NHSX, a unit of Britain’s National Health Service, published “A Buyer’s Guide to AI in Health and Care” proposing 10 questions on how to make the right decision purchasing products using Artificial intelligence (AI). AI has become desirable in advanced medical settings because it has the capability to interpret and classify test results more rapidly than physicians, allowing physicians to direct attention to more complicated issues facilitating improvements in the health of patients. Description: When purchasing products that use AI, consideration should be given to the type of problem you want to solve, the appropriate scale for addressing the problem, ensuring regulatory standards are met, and what the intended uses are for the product(s). The Buyer’s guide, linked below, does not provide a comprehensive treatment of commercial contracting, but proposes questions that are classified under the following categories: problem identification, product assessment, implementation considerations, and procurement, and delivery. Implications: Since there is a shortage of clinicians in health care, a range of AI-powered innovations will allow physician time to be freed up for analysis of more complex cases and grant more time for direct patient care. This will help decrease costs, improve outcomes and create more positive health experiences. “A Buyer’s Guide to AI in Health and Care” points out important questions to consider when purchasing products that use AI to assure they are safe and effective for the organization being served. A Buyer’s Guide to AI in Health and Care

Uber Health forays into prescription drug delivery Event: (8/20) Uber and on-demand prescription platform NimbleRx, announced they are entering a partnership in the on-demand prescription drug delivery business. Description: The Uber-NimbleRx partnership comes with big drugstore chains CVS Heath and Walgreens. With almost 30% of people never picking up their prescription medication from the pharmacy, the partnership with Uber allows effective and timely delivery of medications. Nimble has completed over 15,000 deliveries via partnership with Uber Health (currently a HIPAA- secure service with 1,500 partners for non-emergent medical transport). Implications: Uber Direct provides easy delivery of medications which will promote medication adherence. Adults who lack transportation to medical care are much more likely to have chronic conditions, moreover, with absence of receiving medication, their conditions may escalate. NimbleRx offers next-day delivery to 40% of the population in the U.S and same-day delivery to an additonal 30%, with the increase in demand due to the pandemic, the new partnership will work to better meet the needs of patients. Uber Health forays into prescription drug delivery Lyra Health hits $1.1 billion valuation, as Coronavirus boosts need for teletherapy Event: (8/25) Lyra Health, a provider of mental health care benefits for employers became the latest healthcare technology startup to hit unicorn status by raising $110 million in Series D funding at a $1.1 billion valuation. Background: Lyra, which offers an easy-to-use digital platform to connect people with mental health providers, has around 1.5 million members so far, adding more than 800,000 people since the start of the pandemic. Lyra’s solution combines one-on-one video sessions with digital exercises to reinforce cognitive behavioral therapy sessions. Implications: Around one in four U.S. adults suffer from a diagnosable mental health condition. Depression is one of the leading causes of disability worldwide. Because of COVID, economic uncertainty, and conversations around racial injustice, people are suffering from anxiety and depression even more. According to Rock Health, the digital health industry has raised $588M in the first half of 2020, which is 29% more than 2019, 42% more than 2018, and is on track to set annual records for overall funding and number of deals. Lyra health hits $1.1 billion valuation, as Coronavirus boosts need for teletherapy PatientPop raises $50M and adds three to board of directors Event: (8/25) PatientPop, a healthcare tech company trying to automate many of the touch points of doctor-patient interactions, has raised $50 million in Series C funding. Background: PatientPop helps practices attract patients online through a customized website and search engine optimization. It also offers a fully-digital experience with online scheduling, telehealth options and electronic medical record integration. Implications: PatientPop will use these funds to continue to provide practices with the tools they need to enhance patient care in-person and online. Allowing providers to quickly adapt their digital strategy and presence to attract and retain patients, by deploying appropriate technology and tools to successfully operate their practices during COVID, will help maintain and replace volumes lost during the pandemic. PatientPop raises $50M and adds three to board of directors BJC HealthCare's experience-based strategy for digital transformation: Insights from CIO Jerry Fox Event: (8/25) BJC’s healthcare team in St. Louis is working on experience-based strategies for developing digital solutions that will improve health experiences for stakeholders (patients, families, and caregivers). Description: With the growth of COVID and the increase in virtual visits, BJC healthcare partnered with Washington University School of Medicine to transform user experience. This includes improving patient-provider telehealth platforms for scheduling, processing payments, and interactions, targeting patient experience, enhancing workflows that eliminate barriers for clinicians delivering care, and support for non-clinical care givers to enhance productivity and experience. Implications: Curating technology to ensure that stakeholders (clinical and non-clinical) have optimal experience and outcomes has grown as digital care has increased. With the growing use of technology platforms during COVID, expectations are changing and expanding, pushing digital teams to ensure that they are meeting the growing needs of their users. BJC HealthCare's experience-based strategy for digital transformation: Insights from CIO Jerry Fox Tenet California hospitals launch telehealth ER screenings: 5 things to know Event: (8/25) Tenet Health Center Coast, part of Tenet Healthcare, launched a new telehealth emergency room screening resource for patients suspected to have COVID or other medical emergencies, who are unsure of whether to seek medical attention or not. Description: This Tele-ER service helps address concerns and challenges with going to the hospital during the pandemic. Patients can communicate with ER physicians for registration via video conference, smartphone, or computer to assess whether they need to come in for in-person care, diagnostic procedures, labs, or if the visit can be conducted virtually. The service is covered by Medicare. Implications: The availability of this tele-ER platform will have a significant impact on healthcare delivery, especially during this COVID pandemic, where many patients have delayed care due to concerns of visiting healthcare facilities. With reimbursement provided through Medicare and commercial insurance services like this could expand the breadth of telehealth delivery while aiding accessibility of care particularly for seniors who are at risk. Tenet California hospitals launch telehealth ER screenings: 5 things to know USPS service delays are hitting some mail-order pharmacies and telehealth platforms harder than others Event: (8/19) Recent reforms and services changes created by recently appointed Postmaster General Louis Dejoy have led to widespread service delays. These service delays are hurting certain mail-order pharmacies and telehealth platforms which rely on the USPS to fulfill orders given its relative cost-effectiveness to other methods. Description: There have been many service disruptions for telehealth platforms due to recent reforms and administrative changes which have resulted in long-term concerns about prescription drug shipments handled by the USPS. Timely delivery and access to medications are extremely important for Americans especially during the pandemic, in order to avoid hospitalization, unnecessary emergency room visits, and increased costs if there is a need to use different carriers. Implications: Changes in post office policies have created broad service issues for certain telehealth and online pharmacy platforms leading to later than anticipated or complete lack of delivery for platforms relying on first-class mail delivery. These USPS delivery issues have led to service issues, complaints, and replacements or refunds of as much as 5%. This could dramatically increase costs and threaten these companies’ business models as customers turn to other providers for their medications. USPS service delays are hitting some mail-order pharmacies and telehealth platforms harder than others

Hims, A Direct-to-Consumer Health Company, is Going Public via SPAC Event: (10/1) On October 1st, 2020 Hims. Inc., a direct to consumer digital healthcare company, agreed to merge with a Special Purpose Acquisition Company (SPAC) formed by Oaktree Capital Management to go public. As a result of the transaction, Hims may raise up to $280M in cash, be valued at $1.6B and trade on the NYSE under the symbol HIMS. Description: Hims, Inc., is a direct to consumer company that sells health products targeted at Millennials. for both men’s and women’s health brands. Their focusing is on a variety of everyday issues and products such as skincare, hair-loss, sexual health and more recently primary care. Hims is fairly unique in that most of its products are sold via a monthly subscription and a high percentage (approximately 90% according to the company) is recurring. The transaction is expected to close by the end of 2020. Hims is the second digital health company to go public via a SPAC according to Fierce Healthcare, following acute care telemedicine company SOC Telemed’s July deal announced with Healthcare Merger Corp. Oaktree Acquisition Corp, is a SPAC formed by Oaktree Capital Management that went public in July with the intent of using the proceeds to make one or more acquisitions. A SPAC is a “blank-check” company that has the intention of buying or merging with one or more companies with the caveat that if the capital raised from investors is not invested within two years it must be returned to them. SPACs are also seen as an easier way for private companies to go public more rapidly and have less regulatory paperwork than the typical initial public offering (IPO) process. Implications: SPACs are an increasingly popular way for companies, typically those that may be earlier in their lifecycle, to come public with approximately 115 SPACs raising approximately $43B through October according to Bloomberg. SPACs also have the advantage of allowing companies coming public to make financial forecasts and raise greater amounts of capital. This can be especially attractive for competitive and financial purposes in an emerging industry such as digital health. As a result, SPACs could provide an avenue for some smaller and less mature digital health companies to go public and keep pace with many of the larger players in the space who came public via IPOs. (ex: Teladoc, Amwell, Oak Street Health, One Medical, etc). [As we were going to publication Clover Heatlh agreed to go public via a SPAC in $3.7B merger with Social Capital's Hedosophia Holdings III per Bloomberg]. Hims, a direct-to-consumer health company, is going public via SPAC Q3 2020: A New Annual Record for Digital Health (already) Event: (10/5) On October 5th, Rock Health released it’s Q3 2020 Digital Health Funding report which highlighted the surge in digital health funding so far this year. According to the report, the $4.0B that has been invested in digital healthcare companies in Q3 ‘20 means the U.S. digital healthcare companies are on pace to raise an estimated $12B this year, almost 46% higher that the record $8.2B raised in 2018. In addition, deal volumes rose nearly 22% compared to all of last year with the average deal size of $30.2B being 1 ½ times greater than the average of $19.7M seen in 2019. Description: The report noted that while the uncertainty and changes at the beginning of COVID caused a dip in funding, “since April the ...pandemic has accelerated digital health adoption by several years”. Through the third quarter of 2020, three categories of digital health investments have gained the most investment interest: on demand healthcare services, which deliver real-time or near-time health care services, saw 48 deals with approximately $2.0B invested; so called R&D catalyst companies, that support life sciences R&D, drug discovery and clinical trial management, saw 25 deals and just over $1.3B invested, while fitness and wellness companies that support fitness, nutrition and sleep, say 21 deals and just under $1.3B has been invested. While the trends in on-demand healthcare and fitness were similar to prior history, the rise in capital allocated to R&D catalysts or the life sciences was notable as it was only the 7th most funded category in 2019 according to Rock Health. Implications: As the pandemic drove patients and providers to seek new ways to access previously in-person services, opportunities for digital health exploded and funding followed close behind. While the levels of adoption have receded from their peaks, they are likely to remain significantly above pre-COVID levels. Latent resistance among both patients and clinicians was eventually overcome strictly as a matter of necessity and circumstance. However, as society seeks to deal with COVID longer term, digital health providers will face a more demanding business environment with providers dealing with depleted budgets, payers facing declining roles of commercially insured customers and government payrors facing increased demand for coverage amidst budget shortfalls of their own. As a result this period of easy money may be followed by a period of its own challenges including legitimization of business models, justification of economic returns and development of risk and regulatory controls that could ultimately lead to additional consolidation. Q3 2020: A new annual record for digital health (already) What Do CIOs Want to See from Telehealth Apps? More Than a Dozen Weigh In Event: (9/28) A recent article from Healthcare IT News highlighted the remarkable progress of telemedicine innovations since the start of the COVID pandemic and surveyed fourteen healthcare Chief Information Officers (CIOs) on what they'd like to see from telehealth platforms in the future. Description: People’s needs for telehealth services have skyrocketed and virtual care platforms are looking for ways to enhance their products in order to meet the needs of the consumer. Some features CIOs desire in virtual care include: remote monitoring tools tied into the telehealth app, real-time monitoring of vitals from home that can trigger immediate responses or alerts, more advanced AI bots that can be used to systemize the severity of a patient's concern, the ability to have simultaneous visits with multiple providers for one patient, voice recognition technology that transcribes what the doctor is saying into the EHR, and even using fictional characters during pediatric telehealth visits so children are more comfortable. Additional access issues that need to be addressed in virtual care settings include language barriers, difficulty navigating technology for telehealth appointments, and lack of availability of high-speed internet because of one’s physical location or economic situation. Implication: CIOs realize there is a demand for those seeking care through telehealth platforms, as a result, they want to integrate more optimal features into virtual care platforms. As we continue to embrace digital solutions with greater use of virtual and remote care, telehealth innovations will be taken to a new level in order to deliver timeliness, efficiency, and positive patient outcomes. A patient’s digital experience should afford synchronized communication efforts in one tool, however, the usage of all elements enlisted above will be dependent upon patient choice and clinical need. What do CIO’s want to see from telehealth Apps? More than a dozen weigh in Seizure Prediction Device Can Send Mobile Alerts Event: (9/29) Engadget released an article stating that researchers from Ben-Gurion University of Negev have developed a wearable electroencephalogram (EEG) device that can predict epileptic seizures up to an hour before the onset. The system is based on machine learning algorithms for analyzing EEG signals. Description: The device, Epiness, uses machine learning algorithms to analyze brain activity and detect potential seizures. It then sends a warning to the smartphone connected to the device. Sufficient warnings could give patients time to prepare for an onset seizure by taking medication. Those who don’t respond well enough to anti-epileptic drugs would have a chance to remove themselves from seizure-related injuries e.g driving. The algorithm has tested 97% accurate. Implications: Epiness would not only prompt patients to take appropriate medicine in advance to control their seizures, but it would also prevent seizure-related injuries that can occur during activities such as driving. This device is giving patients control of what is typically an unpredicted traumatic event. Warned patients can prepare for the onset event and care for themselves in a safe environment. Seizure prediction device can send mobile alerts Six Things to Know About Telehealth Medical Malpractice Concerns Event: (9/30) On September 29th, Bloomberg Law published an article entitled “Uptick in telehealth reveals Medical Malpractice Concerns”, addressing the issues that have arisen due to the increase in telemedicine platform usage. The article highlighted that telehealth platforms create a higher risk for data breaches and more challenges for clinicians when examining patients via digital health rather than in-person and thus must be sure to protect themselves when embracing digital health. Description: With the surge in telehealth use during the COVID-19 pandemic, The Department of Health and Human Services has temporarily relaxed regulations under the Health Insurance Portability and Accountability Act. This allows physicians to communicate with patients on various video-conferencing platforms. This raises concerns with the malpractice risks associated with virtual care since providers are now at a higher risk for data breaches of their patient’s health information. With the inability to examine the patient in-office, misdiagnosis is possible as well as improper prescription of the patient’s medication. Providers may be held liable for breaching the standard of care if patients experience any harm during “visits”, due to negligent act or omission, miscommunication, misdiagnosis, software malfunction or other technological risks. Implications: As a result of the rise in concern, physicians are urged to become acclimated to malpractice risks to avoid civil or criminal liability, which could ultimately lead to revocation of their license, suspension of the physician’s practice of medicine, monetary penalties, or imprisonment. The Bloomberg Law article suggests best practice for providers, which includes: 1) educating patients regarding their telehealth visit and providing informed consent that details potential risks and security measures, 2) the importance of documenting virtual visits and maintaining proper patient records to ensure confidentiality and standards of care are met, 3) becoming familiar with state laws associated with telemedicine. By following these guidelines, physicians can safely continue to use telehealth platforms and patients’ health needs can be addressed in the safest manner. Uptick in Telehealth Reveals Medical Malpractice Concerns

Patients Report Scrolling on Social Media, Exercising and Drinking During Virtual Doctor Appointments Event: On October 28th, an article in Mobihealthnews reported that patients admit to often being distracted during virtual doctor appointments, with as many as 24% reporting multitasking during the visit. The article noted that new research from DrFirst showed the most common distractions were surfing the web, checking emails, or texting. Description: Virtual doctors’ appointments have given patients the ability to consult with healthcare providers at their convenience. DrFirst surveyed 1,000 consumers nationally ages 18 and up in June of 2020. Of those surveyed, 73% of men and 39% of women said they had been distracted during a telehealth visit, and more than 24% of respondents admitted they had been distracted by things such as watching TV (24%), checking social media (21%), eating (21%), playing video games (10%), working out (18%) and even drinking (9%), The survey asked patients how telehealth can be improved, and responses indicated there could be higher-quality video, texting doctors before the appointment with any questions, the option to see their personal physician for telehealth visits and more user-friendly technology. Implications: While research from Massachusetts General Hospital suggests that “virtual visits are just as effective as in-person visits.” Empirical survey research like the above challenge that assumption, especially when it indicates that patients are distracted and not fully engaged with their healthcare providers. In addition, although telehealth usage has increased dramatically with 22% of consumers indicating they have had a virtual visit in 2020 (up from 8% in 2019) and 80% of physicians reporting they have had a virtual visit in 2020 (up from 22% in 2019) quantity and quality are not the same. Although telehealth has made dramatice strides in 2020, when patients are multitasking and inattentive, they are less proactive about their health, potentially leading to lower quality care and poorer health outcomes. Patients Report Scrolling on Social Media, Exercising and Drinking During Virtual Doctor Appointments FBI, HHS Warn of "Increased and Imminent' Cyber Threat to Hospitals Event: On October 29th, Healthcare IT News reported that the FBI and HHS had issued a joint alert warning of ‘increased and imminent’ cyber threat aimed at healthcare providers and public health agencies via ransomware. The warning suggested hospitals, practices and public health organizations take "timely and reasonable precautions to protect their networks from these threats" – which they said include targeting with Trickbot malware, "often leading to ransomware attacks, data theft, and the disruption of healthcare services. Description: The alert sent by the Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the U.S.Department of Health and Human Services (HHS) state that malicious cyber actors indicated their desire to infect systems with Ryuk ransomware (responsible for 75% of attacks) at more than 400 healthcare facilities for financial gain thus, suggesting timely and reasonable precautions to be taken against these threats. The illegal cyber activities include credential harvesting, mail exfiltration, crypto mining, point-of-sale data exfiltration, and the deployment of Ryuk ransomware. The agencies advise patching operating software, changing passwords regularly, multifactorial authentication, disabling remote desktop assistance, and configuration check to prevent issues. These attacks have recently affected hospitals in upstate New York causing system failures. UNC1878 has disrupted hospitals throughout the U.S. with ransomware, forcing them to divert patients to other healthcare providers as the hospital networks go offline. Implications: With Ransomware attacks on the healthcare system not only threaten the security of the institution in terms of medical data, but it will prolong patients' wait time to receive critical care as a result of hospital networks being taken offline. This could be especially troublesome with COVID cases on the rise. While these threats are still ongoing, hospitals and healthcare organizations need to take up precautionary recommendations suggested by CISA, FBI, and HHS in a timely manner and secure their systems. The warning also noted that the perpetrators were often demanding ransom payments both to preserve the data that had been compromised and a second ransom to decrypt it. Attacks such as these demonstrate the continued increase in risk of health data as a cyber target as well as the need for vigilance against multiple types of threats going forward. FBI, HHS warn of 'Increased and Imminent' Cyber Threat to Hospitals Fitbit CEO Hints at Company's Telemedicine Plans Event: A recent article in TechSpot reviewed an interview Fitbit CEO James Park gave to the Wall Street Journal where he discussed Fitbit’s strategy in wearables and telemedicine as it pursues its merger with Google, noting that Fitbit’s premium health and fitness service already has over 500K users worldwide. The article noted that although the company has experienced some hardship it has managed to remain among the top five wearable makers worldwide and hopes to have a more significant impact on healthcare with the addition of new software and services. Description: One of the first developers of wearable technology, Fitbit has generally been focused around health and fitness, agreeing in 2019 to be bought by Google (the purchase still needs regulatory approvals). While Fitbit had expected demand for its devices to decline during COVID lockdowns, the company has noticed that business is doing better than expected and users remain connected to their devices and software services. In addition, earlier in 2020 Fitbit released results of a study with the Stanford Medicine Healthcare Innovations Lab and Scripps Research Translational Institute that validated an algorithm Fitibit had developed for the successful detection of COVID prior to the onset of symptoms. The company is doing additional research and is expected to seek regulatory approval for the device. Implications: Upon completion of its merger with Google, Fitbit will have a solid and loyal user base combined with a generous balance sheet to continue to pursue innovations within health and fitness. In addition, aligned under the Google umbrella along with its other consumer brands such as Nest, and YouTube, Fitbit has the potential to leverage its consumer reputation along with its future parents to tap into the growth of telemedicine. However, given several data privacy miscues by Google, Fitbit will have to provide solid reassurances about data privacy in order to convince consumers to invest in tools like a connected thermometer and an otoscope with confidence. Fitbit CEO Hints at Company's Telemedicine Plans & Fitbit CEO Reveals the Company's Plan to Conquer Fitness Wearables and Telemedicine Nutrium App, which links Dietitians and Patients, Raises $4.9M Led by Indico Capital Event: In a recent article, Tech Crunch noted that Nutrium, a digital health startup which links dieticians and patients via an app had raised $4.9m. According to the article Nutrium now offers professional nutrition software to 80,000 nutrition professionals and 800,000 patients in more than 40 countries. Description: Nutrium gives patients integrated nutrition counseling which combines professional advice, continuous monitoring, nutritional analysis, meal planning and access to commercial products all in one place. This app brings together nutritionists, patients, products and wellness data to enable healthier and happier lives. With this investment round, Nutrium plans to double the team size in the next 24 months in order to focus on platform development and expand global sales in markets like Spain, France, Italy, the U.S. and the U.K., where the company already has a strong customer base. Implications: A healthy diet throughout life supports normal growth, development and aging, helps to maintain a healthy body weight, promotes healthy pregnancy outcomes and reduces the risk of chronic disease leading to overall health and well-being. This app, and others like it, which give the user critical tools for a healthy diet could be an essential part of maintaining a healthy lifestyle. In addition, poor diet and nutrition levels, particularly earlier in life have been linked to slower educational and emotional development in children which can often plague them later in life. Apps such as Nutrium, which expand access to easy and convenient nutritional counseling can help increase healthy lifestyles, particularly in underserved communities. Nutrium App, which links Dietitians and Patients, Raises $4.9M Led by Indico Capital Fitness Wearable Whoop Joins the Unicorn Club with $1.2B Valuation Event: MobiHealth News reports that the fitness wearable Whoop announced a $1.2 billion valuation following its $100 million in Series E Funding. Unlike many other fitness wearables, Whoop is available via a subscription service and measures sleep performance and heart rate variability, which is part of the information used to calculate a proprietary active recovery score called the Whoop recovery score. Description: The WHOOP Strap 3.0 collects 24/7 physiological data including sleep, fitness and recovery to provide the most accurate and granular understanding of your body. That data is then sent to a corresponding app, which can give users insights about their training and recovery. WHOOP Strap 3.0 also comes along with personalized coaching. The app will provide users with sleep recommendations and can measure the stress someone has over a 24-hour period. It's lightweight, waterproof, and features the new and improved 5-day battery life and bluetooth low energy connect. Implications: Wearable device tech companies are growing, from Apple Watch, to Fitbit, to Amazon to now Whoop. Whoop uses its data to provide personalized coaching on sleep and stress as well as the amount of sleep and recovery a body needs from certain activities. Exercise technology which incorporates body feedback can be used not only to improve athletic performance but also to monitor and react to certain disease states. As a result, this will likely accelerate the pace of change in the traditional patient-doctor relationship due to the influence medical wearables have given their ability to automate processes, expedite diagnosis and treatment and allow people to monitor their own health. Fitness Wearable Whoop Joins the Unicorn Club with $1.2B Valuation Cross-border Collaborations Lead to Data Sharing Efforts During COVID-19 Event: A recent article in Mobihealthnews highlighted lessons learned from panelists who attended the World Health Summit, centered around the importance of global collaboration and data sharing during a pandemic. Among the conclusions noted was that in taking on a pandemic, “global collaboration and data sharing are key”. The panel also highlighted the importance of digital technology as the world tries to understand, manage, and overcome the impacts of the disease. Description: The World Health Summit was held virtually October 25th-27th, with this year’s topic naturally being current knowledge about Coronavirus,new strategies in the worldwide fight against pandemics and the role of Europe and the WHO in global health. During the presentations, panelists noted, “in a pandemic there is no sense in having solutions which apply only within our national borders. You have to have solutions that work around the world because people are moving all the time." The panel also pointed out how digital solutions have become seamlessly crucial as the world continues to overcome COVID-19. Including the new European Union (EU) interoperability gateway system, which connects contact tracing and warning apps amongst participating EU countries. The system would notify a person of the possible risk of infection if they were around someone who was infected, regardless of their location [if participating]. While COVID is the Summit’s current focus, the article noted that participants were also joining forces to look ahead at pandemics of the future, including the UK’s Trinity Challenge. Implications: The Summit clearly highlighted that “digital collaboration underpins the coordinated systematic approach we need to strengthen health systems and our healthcare.” However, panelists remained mindful of the need for data security, with the article pointing out that while the applications for digital are increasing, protecting patient privacy should still be front and center. Participants also concluded that although collaborating globally and accelerating interoperability, has the potential to improve response to future disasters, “the use of data and analytics in global public health, particularly the use of non-health data is not as good as it needs to be and varies across countries”. This clearly indicates the potential for strides to be made in all countries on the issue of social determinants of health data and solutions. Cross-border Collaborations Lead to Data Sharing Efforts During COVID-19

Event: Ginger, a San Francisco based mental health startup, recently raised $100M in a series E round. Ginger partners with companies to provide its users a personalized plan through a platform equipped with evidence-based therapy sessions and psychiatry services; a self-care library offering over 120 stress management activities; and behavioral coaches available 24/7. As reported by Fierce Healthcare, since 2020 many investors have backed digital mental health startups, with the number of employees utilizing these mental health services increasing by 66% during the COVID pandemic. Founded in 2011 and spun-out from MIT Media Lab, Ginger has raised over $236M backed by investors from Kaiser Permanente Ventures, Cigna Ventures, Bessemer Venture Partners, Advance Venture Partners, Khosla Ventures, Health Velocity Capital, City Light Capital and WP Global Partners. This is the second time in that last 8 months that Ginger has raised capital raising $50M in August of 2020. Description: Ginger provides an on-demand system that brings together behavioral health coaches, therapists, and psychiatrists, to deliver personalized care platform for the delivery of mental healthcare. Ginger’s approach combines high-quality human care with science and augmented intelligence offering conversational interfaces and behavioral pattern recognition for the treatment of stress, depression, and issues with work or relationships. Ginger offers its mental health and wellness platform to over 200 companies, across 40 countries, connecting over millions of employers, employees and payers with their services. Additionally, BusinessWire notes that Ginger offers their services to 30 integrated health systems and health plans. According to the company, “70% of members see an improvement in depression symptoms within 10–14 weeks of care” and using peer-reviewed assessments, Ginger promises a return on investment of 4.2 times. The company also stated that since last year, Ginger has tripled in revenue, “tripled its employee base and expanded its team of behavioral health coaches, clinicians, engineers, and operational leaders.” Ginger CEO Russ Glass noted that the company intends to use the funds to “continue expanding access to value-based mental healthcare through additional partnerships with multinational employers and health plans” and “to extend its reach to support underserved populations through new government payer relationships and collaborations with non-profit organizations”, among other things. Implication: Ginger offers its services to over 10 million people, yet demand remains as “high as 3x pre-pandemic levels”. As more people are working from home, isolated and stressed, the need for on-demand telebehavioral health services is on the rise. For example, a 2020 survey by Vyond suggested 45% of employees who are isolated at home want education in mental health strategies from their employers…” Specifically, the need for integrated and virtual mental health care is evident, as many clinics are shifting to virtual care or an omnichannel model that combines many care delivery models (in-person, virtual, etc.). Nevertheless, according to the World Innovation Summit for Health (WISH) despite the fact that about one in five people are affected by mental health issues and an estimated one in twenty disabled by mental health issues, getting people into care remains a barrier. As a result, Gingers evidence-based platform and others like it, which are reasonably priced (typically under $500 per year) provide an opportunity to address mental health issues in a convenient, stigma free way from the privacy of their homes. Moreover, by allowing people to track their progress and personalize when and how they receive care can empower Ginger users to take command of an issue that many may have felt were beyond their control.. Ginger Banks Another $100M to Ramp up Partnerships with Health Plans, Government Payers; Ginger Announces $100 Million Series E Financing from Blackstone to Bring Value-Based Mental Healthcare to Millions of Employees and Health Plan Members

AI Products Must Incorporate These Elements to Optimize Healthcare Our Take: To fully realize the potential of AI in healthcare, policymakers must prioritize strategies to help providers ensure data access, improve interdisciplinary education and establish a rigorous oversight regime for implementing AI. Without establishing a framework for the implementation of AI, it is unlikely to achieve its full potential to transform healthcare. Description: With dramatic advancements in massively parallel processing, data storage and compute power AI is increasingly being applied to solve issues that have bedeviled healthcare for years. AI tools are being applied to diagnostic, monitoring, administrative, and surgical uses, among others. According to the Association for the Advancement of Medical Instrumentation (AAMI), AI is considered to be “one of the most promising digital health tools” in the words of former Food and Drug Administration (FDA) Commissioner Scott Gottlieb. The AAMI also notes that 77% of organizations either already leverage AI to support clinical decision-making or are likely to, and 66% are using AI to extract meaning from big data. Providers are interested in AI and recognize its huge potential but face obstacles to implementing AI tools. The most fundamental issue for AI integration faced by the healthcare system is a lack of uniform access to high-quality, representative data. The usefulness of AI hinges entirely on the quality of the data it’s working. In addition, as noted by the AAMI data concerns also center on patient privacy, the expenses of data collection, and the challenge of interoperability between different provider databases. This is particularly true for electronic health record systems, as patient data are often incomplete or split into multiple databases. AI requires deep and complete data sets to train and run models which requires data that is comprehensive and in a compatible format with any existing data sets. As a result, policymakers need to establish and expand high-quality data access mechanisms beyond the recent interoperability standards that were introduced. According to a report from the US Government Accountability Office (GAO) and the National Academy of Medicine (NAM), one way to achieve this is to create a data commons, which is a cloud-based data sharing platform that allows participants to access, edit, share, and store data in one digital space. According to the report, increasing high-quality data access and transparency can help developers eliminate bias in data by ensuring data are representative at larger scales. Without such data access mechanisms, AI tools could be vulnerable to bias from skewed data, which can impact the manner in which decisions are made as well as the quality of such decisions which could have negative consequences for health equity. In addition, policymakers must address the level of education and practical experience healthcare professionals have in developing AI models and applying their conclusions. Among other things the GAO/NAM report suggests broadening interdisciplinary education to help providers use AI effectively. For example, the report recommends not only changing the curriculum in medical and nursing schools to include AI content, but also establishing new research grants to encourage participation in interdisciplinary projects that utilize AI. It highlights a model program offered at the Department of Veteran’s Affairs for postdoctoral fellows to gain experience working on AI and big data initiatives. Interdisciplinary education for providers such as that outlined would enable providers to better understand and critically evaluate recommendations from AI tools and empower them to make more informed decisions. Finally, policymakers must create standardized regulatory oversight to ensure the safety and efficacy of AI models as well as any recommended treatment protocols. Among other recommendations, regulators have proposed an evolutionary approach to the regulation of adaptive AI to encourage the consistent monitoring and improvement of tools throughout their life cycle. This includes the review and audit of both the inputs used to train and develop the models as well as the auditing of any model recommendations. One suggestion for the GAO/NAM report is that a multi-stakeholder party collaborate with policymakers to focus on AI tools the FDA does not oversee, like the Medical Device Regulators Forum, a trans-governmental regulatory organization that covers medical devices the FDA does not. Implications: While the potential applications and benefit to the healthcare industry that AI presents is clearly recognized, policymakers, regulators, practitioners and data scientists that develop these tools must all collaborate in applying the practices mentioned to address data access, education, and oversight. At a minimum neglecting to do so would leave potential advancements in care unrealized or delayed. Failure to do so would also potentially lead to the application of poorly trained models that could produce inappropriate or even dangerous treatment recommendations. Moreover, such models could produce biased or inaccurate results leading to a lack of trust in the models thus hurting their adoption. Establishing consistent and flexible frameworks for the regulation of AI will also be key as adaptive AI could drive changes in treatment protocols as models become more precise and prediction algorithms improve with experience. Coordinating these efforts, not just simply pursuing them, will be a demanding task. Once AI technology is adopted by larger, resource rich providers its benefits and usefulness should become even more broadly apparent, spurring a virtuous cycle of broader adoption and efficacy. Artificial Intelligence in Health Care & Getting Smarter: The Promise and Potential of Artificial Intelligence in Healthcare As the FDA Clears a Flood of AI Tools, Missing Data Raise Troubling Questions on Safety and Fairness Event: A recent article published in STAT+ newsletter highlighted existing gaps in the FDA’s regulatory and standards approval process. STAT+ examined data reported in hundreds of pages of documents filed with the FDA over the last six years by companies that ultimately gained the approval of products that rely on AI. The examination found inconsistent standardized frameworks to assure safety, efficacy, and fairness when it came to FDA approvals. Also, there was a lack of information on whether AI products improved care or triggered unintended consequences such as an increase in incorrect diagnoses, unnecessary treatment, or racial disparities. The FDA has sought to refine and clarify its regulatory approach by releasing several guidance documents and establishing a new digital health unit to deploy regulatory standards for developing and managing such tools. Description: FDA clearance is necessary when determining whether a product is safe to deploy in healthcare facilities or assist clinicians in deciding various patient health outcomes. However, most AI products submitted to the FDA are not required to file and be approved under a premarket approval (PMA) the most stringent of the device marketing applications, but instead are reviewed through the FDA’s 510(k) pathways. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent) to one or more similar legally marketed devices (predicates). The submitter of a 510(k) must make and provide evidence to support their substantial equivalency claims. As a result, AI product manufacturers are not required to systematically document how the AI was developed or whether its performance was validated on an independent dataset. This is a crucial component to ensuring whether the product will work on a wide range of patients relative to diverse characteristics such as age, sex, gender, race, and ethnicity. However, machine learning (ML) systems are designed to help find hidden patterns in data that may improve care, a fundamental difference from the drugs and traditional devices the FDA is accustomed to viewing. STAT+ found that of the 161 products cleared by the FDA between 2012 and 2020, only 73 disclosed the amount of patient data used to validate their devices' performance, only 7 reported the racial makeup of their study populations, and only 13 provided a gender breakdown. Moreover, there is often a noticeable gap in demographic data, for example in breast imaging. The inconsistencies with FDA standards have led clinicians to question whether the tools will be useful and equitable to the patients it intends to serve. Recognizing this inconsistency, the agency has proposed a new action plan for increased regulation and how AI tools will be monitored. Their new action plan proposes to create a process for reviewing planned alterations or updates to a product before they are made so that the agency can allow companies to iterate their products in ways the agency finds safe and useful. The agency is also exploring ways to alter its regulatory frameworks to use more real-world performance data. Also, since much of the submitted documentation for tools does not assess the demographic of their training datasets, STAT+ recommends manufacturers be transparent about their reference datasets at submission so that people know the constraints of the AI instrument. Implications: The FDA has received an influx of demands from political and business leaders to speedily approve products financed with millions of dollars in private investment. The pressure is likely to grow as rapid software innovations and computing power increases, making it faster and easier to encode algorithms into medical products. Although regulations are a vital component in standardizing AI products, potential risks should be identified early before becoming rooted in healthcare delivery. For future AI products to be successful and utilized in healthcare facilities and clinicians, inconsistencies in datasets have to be addressed. Diverse and unbiased patient cohorts are clearly necessary and will allow for less biased data and remove clinical variables that lead to AI devices' mistakes. In addition, incorporating a diverse population of patients in AI technologies will provide transparency and confidence in the products, especially for clinicians where such technology can often be opaque. Experts argue that the FDA must treat AI more like a human by asking questions like how and where it was trained and how the AI product will react when exposed to complicated situations in the real world. Moreover, attention should be given by the FDA to executives who are initiating discussions with the agency to ensure study designs are inclusive. Details such as the ethnicities and races of training data upon which the machines were trained should be routinely exposed and scrutinized by the FDA. Currently there is often an underrepresentation of certain populations, generally people of color, which is required for these systems to provide unbiased outcomes.The lack of evidence or standardized regulation has put the burden on hospitals to determine that the AI the tools cleared by the FDA actually perform as indicated because AI tools developed based on unrepresentative data may not be accurate for the variety of populations whose care many hospitals are charged with. As the FDA Clears a Flood of AI Tools, Missing Data Raise Troubling Questions on Safety and Fairness (subscription required) Folx Health Raises $25 Million for Virtual Clinical Offerings and Care for the LGBTQIA+ Community Event: Folx Health, a Boston-based startup that offers virtual care and prescriptions for hormone replacement therapy and sexual health, has raised $25 million in new funding. Folx Health was designed for the queer and transgender community. It provides access to a network of queer and trans clinicians with a tailored focus on clinical offerings that are often marginalized in traditional health settings. Description: Folx Health is a primary care practice with in-person and virtual options for the LGBTQIA+ (lesbian, gay, bisexual, pansexual, transgender, genderqueer, queer, intersexed, agender, asexual and ally) community. The company announced the availability of its hormone replacement therapy for testosterone or estrogen with monthly plans starting at $59 a month. It will also begin releasing its sexual health and wellness offerings starting with erectile dysfunction (ED) treatment, soon to be followed by at-home sexually transmitted infection (STI) testing and treatment and pre-exposure prophylaxis (PReP), all customized for the specifics of queer and trans bodies. The services will include unlimited on-demand clinical support with at-home lab testing (for most plans) and home-delivered medications (costs may vary based on medication). The company’s services are now available in California, Connecticut, Delaware, Florida, Illinois, Massachusetts, North Carolina, New York, Texas, Virginia and Washington. The company is also launching a Folx Library, which will serve as a content hub and resource for Queer and Trans health, written by Folx clinicians and its broader community. Implications: As 2% of the population identify as transgender and 10% to 20% of the population identify as part of the LGBTQIA+ community, there is a large market opportunity to digitally cater to this community. Although the community has been historically under-served in the healthcare market, the pandemic further limited the community. The LGBTQIA+ community requires not only physical needs like hormone replacement therapy as well as sexual health and wellness services, but also community resources and a safe space with other members of the LGBTQIA+ community. Since Folx Health was founded at the peak of the pandemic (Spring 2020), it has helped the LGBTQIA+ community access their online and home-delivered needs. In addition to Folx Health, there are a growing number of digital health companies tackling health issues for the LGBTQIA+ community. Queerly Health is an online marketplace where LGBTQIA+ people can connect with vetted and trained providers, telehealth tools and concierge health. Violet Services is a mental healthcare startup run by and for the LGBTQIA+ community, and Plume is a digital health service focused exclusively on the transgender community and has expanded into employee benefits. Folx Health Raises $25 Million for Virtual Clinical Offerings and Care for the LGBTQIA+ Community FDA Urged to Review Accuracy of Pulse Oximeters for People of Color Event: On January 28th, the American Hospital Association reported that three senators are urging the FDA to examine the accuracy of pulse oximeters of minority patients due to recent studies that have concluded that the devices are providing inaccurate measures due to the color of their skin. In an era where providing quality care has become essential in healthcare, it is imperative that this issue is addressed immediately to ensure positive health outcomes, reduce health disparities, and exhibit equality. Description: As COVID has continued to surge through hospitals, many patients have been given pulse oximeters, a tool that monitors blood oxygen levels. Due to the ongoing impact of the virus and its disproportionate consequences on minorities, their use of pulse oximeters has significantly increased. According to the letter sent to the U.S. Food and Drug Administration (FDA) by Senators Elizabeth Warren, Cory Booker, and Ron Wyden, studies suggest that these devices are biased against patients with “darkly pigmented” skin. They are less accurate in Black patients with undetected low levels of oxygen in their blood compared to White patients and as a result, black patients are at a higher risk for hypoxemia. With the increased purchase of oximeters in retail pharmacies, usage in emergency departments and outpatient testing centers, it is important that these devices maintain the highest level of accuracy. Although these three senators have only recently shed light on this issue, the medical community has long acknowledged that there may be racial bias in these devices. According to a 2005 publication, three pulse oximeter brands were tested on 11 black participants and 10 white participants. All three assigned higher pulse oxygen saturation (SpO2) levels to the Black individual, notably finding the effect of skin pigment on inaccuracy in the pulse oximeters increased linearly as SpO2 levels decreased. This means a patient was actually more ill than the pulse oximeter reflected and placed the patient in jeopardy, clearly a serious failing and concern. Implications: With the history of healthy disparities, trauma, and distrust amongst minorities, specifically African Americans, within the healthcare system, it is important that the issue with the pulse oximeters be swiftly addressed. The senators have tasked the FDA with reviewing this issue and providing answers to some of the following questions: 1) Has the FDA reviewed data on the inaccuracy due to skin color of pulse oximeters, including those used in professional and at-home settings? If so, what has the FDA concluded, and what is the clinical significance of this inaccuracy? 2) For current pulse oximeters being used clinically and over-the-counter, before the product received FDA clearance or approval, did the FDA collect data on the accuracy of the product among subgroups for example, by sex, age, race, and ethnicity? 3) Has the FDA been monitoring these devices to ensure they are being marketed appropriately under the Federal Food, Drug, and Cosmetic Act (FDCA)? 4) To what degree are different cleared or approved pulse oximeters efficacious across racial and ethnic groups? Is one group consistently producing more accurate measures? Is one group consistently producing less accurate measures? 5) Does the FDA plan to adjust accuracy requirements of future pulse oximeters seeking clearance or approval to ensure they are accurate on all patients regardless of skin color? 6) Is there evidence that other infrared medical devices that interact with a patient’s skin pigment, such as vein visualization devices or thermometers, also vary in efficacy by the patient’s race and ethnicity? Accountability is key as the pandemic continues to significantly impact communities of color and the accuracy of these devices can mean the difference between life or death for many of these individuals. Their right to quality care should not be infringed upon due to a medical device’s bias towards their darkly pigmented skin. FDA Urged to Review Accuracy of Pulse Oximeters for People of Color & FDA Urged to Review Blood Monitoring Device’s Accuracy for Patients of Color Biden Administration Awards $231M to Increase US Production of At-Home, OTC COVID-19 Test Event: The U.S. Department of Defense, under the Biden administration, awarded $231.8 million to Australia's Ellume to expand U.S. production of a rapid at-home test for COVID. The contract is a part of the Biden Administration’s pandemic response effort that includes the purchase of 8.5 million antigen tests for nationwide distribution. According to Ellume their rollout strategy for the COVID home test includes retail commercialization and partnerships with other public and private institutions. Description: Throughout his presidential campaign President Biden pledged to act rapidly and decisively with regard to pandemic response. As a result, President Biden is following through on a campaign pledge to scale up testing capacity and invest in advanced technologies such as at-home and rapid tests. This is part of his team’s unified national strategy to reduce the spread of the Coronavirus. In addition, President Biden issued an executive order to establish a national pandemic testing board to coordinate federal efforts to expand test availability and use. Ellume's product is the first over-the-counter self-test for COVID to receive FDA emergency use authorization. The test was developed with a $30 million contract from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) initiative. The Ellume test is an antigen test and can be performed in about 15 minutes using a nasal swab specimen from adults and children as young as 2 years old and is authorized for people with our without symptoms. While the FDA has acknowledged that antigen tests can be less sensitive and less specific than lab run tests, Ellume’s test correctly identified the presence of a virus (or lack of it) with over 95% accuracy in people with symptoms and over 90% accuracy in people without symptoms. Implications: The convenience of an over the counter kit gives the general public the ability to test themselves and receive their results within minutes. The availability of such tests through initiatives undertaken by the Biden administration will build confidence in controlling the pandemic and in testing to understand the spread of the virus. The widespread availability of testing can also help control the spread of the virus in rural and underresourced communities where testing facilities and access to testing may be limited. In addition, testing solutions such as this will give people better information about their own exposure to the virus and enable them to be more cautious about exposing themselves to others as well as taking required precautions when they have symptoms. Tests like these which are provided with a smartphone application that walks users through specific instructions about how to perform the test and receive their results should make the process user-friendly, easy to use and help eliminate the current backlog in testing. Biden Administration Awards $231M to Increase US Production of At-home, OTC COVID-19 Test