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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

Femtech Shatters Glass Ceiling Over Addressing Unique Needs of Women Our Take: Despite the fact that women now make up a majority of the U.S. workforce and U.S. population, healthcare that caters to their needs, often called Femtech remains in its infancy. With leading medical groups endorsing telemedicine to bolster healthcare for women’s lives, (reproductive health, post-partum, lactation assistance, post-menopausal, etc.) women’s access to resources has begun to expand and could be the next hyper-growth market in digital health. Description: According to Pitchbook, “Femtech'' refers to the range of health software and tech-enabled products that cater to female biological needs and attempts to highlight the historical and systemic exclusion of women’s health needs in the healthcare industry. These services range from general women’s health diagnostic tests to screening for disease management and fertility solutions. With the growing need for more digital solutions and telemedicine options during the COVID crisis, this industry has become a key asset in the healthcare realm. Moreover, according to an article by Frost & Sullivan, driven by the rise in female purchasing power and the increasing (though still lagging) numbers of influential women in healthcare, Femtech has the potential to be a $25 billion business by 2025 by addressing women’s healthcare needs that often go unmet. For example, according to a 2017 women’s health survey from the Kaiser Family Foundation (KFF), many women, particularly low-income women, delay or forgo necessary healthcare. According to the report, this is primarily due to issues in obtaining transportation or childcare, underscoring the potential benefit telemedicine could have for females in low-income, urban populations. The unmet healthcare needs of low-income women along with the fact that over 4 in 10 babies born in the U.S. are covered by Medicaid has led Congress to look for high-quality, low-cost, patient-centered solutions such as digital tools for prenatal care and post-birth support. For example, in September Congress introduced the Maximizing Outcomes for Moms through Medicaid and Enhancement of Services Act (MOMMIES), which focused specifically on improving the health of women covered by Medicaid. Similarly, there has been an increase in the roll-out of virtual care options, tackling postpartum depression screenings, lactation assistance, contraception consultations, sexually transmitted infection (STI) care, and various other pivotal women’s health issues. With the additional funding and support of telehealth and virtual care programs through the passage of the CARES Act, struggles with out-of-pocket costs and lack of coverage have diminished in many states, creating better access to care for women. Implications: With the constant innovations created for women in the Femtech industry and the increase in telehealth platforms, women are continuously gaining improved access to healthcare resources. This has been especially important in increasing accessibility and decreasing emergency room (ER) visits for Black and Hispanic women who have previously had the highest rates of ER visits among both racial groups. Some researchers speculate that increased telehealth visits for women of color may help reduce providers’ biases due to the standardization in policies and procedures for these visits. As the pandemic presses on, it is likely that services for all women will continue to expand allowing more personalized and tailored treatment going forward particularly if states expand Medicaid to help broaden coverage. However, the road to more access and tailored care will not be without bumps, particularly in the areas of privacy and data security. As the recent settlement agreement between the Federal Trade Commission (FTC) and Flo Health demonstrates, providers will have to take adequate precautions to protect the privacy of women using these apps. Despite this, the future for women’s health continues to look bright, even beyond the pandemic, as access to resources continues to expand and providers focus on addressing the unique needs of women patients. Telemedicine in Sexual and Reproductive Health, KFF, Exploring Telehealth: The Next frontier for Women’s Health, Femtech Expected to Break New Grounds (last article subscription only) Sidecar Health’s Low-cost, Cash-pay Health Insurance Service Now Valued at $1 Billion Event: TechCrunch recently reported that L.A. based Sidecar Health had raised $125 million in additional funding bringing its new valuation to over $1 billion. Unlike traditional healthcare insurance where providers are paid via a third party, like the government or managed care company, Sidebar members pay for care directly with a Sidebar card (like a debit card). Sidebar uses the card to pay for clinician care, prescriptions and consultations directly, eliminating the paperwork in exchange for discounts.This gives patients the ability to pay directly for care at steep discounts, often at the same prices they would be charged under traditional insurance plans. They are growing in popularity, and are projected to end the year with 30,000 members. Description: Sidecar issues its users a debit card to pay for necessary services. The balance comes from the company’s claims accounts eliminating the need for practitioners and providers to collect co-pays, track deductibles, file claims or adjudicate any disputes.The typical Sidecar Health member pays a $240 monthly premium for a plan Sidecar which argues offers more flexibility for millions of uninsured US adults. The plans are designed to allow customers to shop around to find the best providers using pricing information available on their app and pay directly for care. The app provides live geotagged information on the pricing of medical services, procedures, and pharmaceuticals and allows users to shop where they can get the best deal. While Sidecar members currently skew younger than average MCO populations, the average age of the company’s members is 33 years old with an annual income of between $45,000 and $75,000 annually. The company is hoping to broaden its membership beyond the uninsured to government-funded and employer-sponsored plans as well. Implications: The future of health care financing and coverage in the United States is nebulous. As a result there is room for tremendous innovation. The appeal of Sidecar Health is its simple, direct payment structure that eliminates a significant amount of friction and inefficiencies. Not only could this create a large opportunity for Sidecar and others like them seeking to reduce the burden of administrative paperwork on the industry, success of the model could spur other insurers to adapt their models to expand their reach (ex: entry level direct pay plans). In addition, the technological appeal of getting healthcare insurance through an app and debit card with limited paperwork like Sidecar has intuitive appeal for a Millennial customer base, those tech-savvy young people who are generally healthy and may view health insurance as a burdensome responsibility. Over time we would see models shifting in a similar direction as this simplifies administrative interactions, provides immediate price transparency and increases choice. LA-based Sidecar Health’s Low-Cost, Cash-Pay Health Insurance Service Is Now Valued at $1 Billion Women, Critical Care Physicians Report Highest Level of Burnout Event: On January 26th, Healthcare IT News reported that female critical care physicians report the highest level of burnout due to working long hours, engaging in administrative tasks, increasing computerization of practice, and insufficient compensation according to the Medscape National Physician Burnout & Suicide Report 2021. The article also highlighted a number of comparisons of physician stress, burnout and psychological well-being both pre and post-Pandemic. Description: Medscape surveys 12,000 physicians across 29 specialties between August 30th and November 5th, 2020. While in general providers noted that the stress of treating COVID patients did not substantially increase burnout, it did exacerbate already existing issues. For purposes of the study burnout was described as long-term, unresolved job-related stress that leads to exhaustion, cynicism, detachment, and a lack of a sense of personal accomplishment. Along those lines, only about half of physicians reported that they were happy with their work life in 2020, down from over two-thirds prior to the pandemic. In addition, nearly three-quarters of physicians aged 25-54 and two-thirds of physicians between 55-73 reported that burnout has strained personal relationships with friends and family. As noted by Medscape senior director Leslie Kane, “the incidence of burnout and depression among physicians has been a concern for years and the pandemic only made a bad situation worse”. She went on to note that burnout was most severe for female physicians who have faced the brunt of at-home schooling and other disruptions. For example, over half of female physicians said they were burned out, compared to just over one-third of men. Implications: Even before the onset of the COVID pandemic, the incidence of burnout and depression among physicians was on the rise. Medscapes Ms. Kane noted that post-pandemic, healthcare organizations and the medical community have an opportunity to rethink how best to support physicians in order to see reductions in burnout, depression, and suicide rates moving forward. While physicians cited exercise, talking with family members or close friends, isolation, and sleep as popular methods of dealing with stress currently, more needs to be done. Among suggested solutions were increased compensation, easier and more intuitive EHR workflows, technologies that reduce the administrative burden and returning clinicians to a greater focus on patient care. Women, Critical Care Physicians Report Highest Level of Burnout & Medscape National Physician Burnout and Suicide Report 2021 Compliance with ONC and CMS Rules Could Offer Growth Opportunity Event: Healthcare IT News reported that new ONC rules on hospital price transparency from the Centers for Medicare & Medicaid Services (CMS) which took effect January 1st, and new rules around information blocking and patient access from the Office of the National Coordinator for Health Information Technology (ONC) taking effect in April could actually provide growth opportunities for providers. Description: Based on a recent report from Deloitte, the article noted that the new rules are anticipated to drive improved care coordination and quality of care because consumers and clinicians will now have easier access to information for diagnosis and treatment decisions. The article also surmised that this could create a more consumer-centered care market, increasing competition among providers . The Deloitte report also advocated using these regulatory programs as part of their broader competitive, financial and and digital strategies. Executives surveyed in the report recognized this and expressed plans to boost consumer participation in care, with 70% saying they plan to develop new online scheduling capabilities, 53% new cost estimation apps, and 53% new payment financing options. Implications: Health systems should prepare for a changing ecosystem as a result of these new rules. Deloitte noted several actions as a result of the new rules including: 1) that plans should include market analyses to help drive strategic decisions; 2) developing new consumer engagement strategies and product designs; 3) learning how to work with new technology platforms; 4) developing new platforms for tracking and monitoring consumer inquiries; and, 5) finding more innovative collaborations with payer organizations. The researchers also found that measures to comply with price transparency can be leveraged to increase trust between consumers and providers. While clearly there is potential to benefit the population health goals that the new rules from ONC and CMS target, compliance with these rules presents an opportunity to engage their patient populations more deeply. Compliance with ONC and CMS Rules Could Offer Growth Opportunity Eli Raises $1.5 Million (USD) in Seed Funding to Develop At-Home Hormone Monitoring Tech Event: An article in BetaKit (a publication covering Canadian startup news and tech innovation) reported that Eli Science Inc., a fertility app, has raised a $1.5 million (USD) seed round to target the historically underserved women’s healthtech market. Eli has a saliva-based daily hormone tracking technology whose goal is to give women a no-compromise option to own their fertility and contraception decisions. According to the company, Eli aims to provide a non-invasive, hormone-free alternative to traditional contraception and fertility monitoring options through its personal hormone monitoring device and accompanying mobile app. Description: Eli gives women their hormone information to let them take control of their health. It can act as a guide for couples seeking to conceive and a contraceptive alternative to other more invasive or hormone-based options. To measure their hormones, users place the Eli cartridge in their mouth to give a saliva sample. They then remove it and place it inside Eli’s portable measuring device, which records daily hormone fluctuations. This data is then given to the startup’s learning algorithm-powered mobile app for interpretation. The app then gives users tailored information, including their hormonal profile and precise fertile days. The data is configured into an app to provide personalized insights. With this information, users know their precise fertile and non-fertile days. For couples who want to conceive, this data increases their chances significantly. For women who want a safe contraceptive method that’s hormone-free and non-invasive, Eli finally brings a no-compromise option. The proprietary consumables are recharged with a subscription. This unique approach was designed to engage users and provide increased effectiveness. Implications: The lack of data in women's health has led to it being poorly understood and addressed and the pandemic is amplifying those widespread unmet needs. Eli's technology has been engineered to overcome this and tackle major unmet needs at all stages of women’s lives. In addition, Eli can help eliminate the unwanted side effects of hormonal birth control including side-effects and headaches. Eli joins a burgeoning market for so-called “Femtech” products and fertility apps such as Clue Ovia, Glow, Natural Cycles, and Flo. Research indicates that 1 in 6 couples in North America experience difficulties in conceiving. Moreover as Millennials put off forming families and having children, more couples are trying to conceive in their early 30s rather than their 20s, leading to a decrease in the chances of conception. By monitoring hormones and selecting the most fertile days, Eli will help older couples maximize their efforts to conceive at a time comfortable for them. Eli Raises $1.9 Million CAD in Seed Funding to Develop At-Home Hormone Monitoring Tech Telehealth Fraud: Tampa Pharmacy Owner Faces 10 Years for $931M Conspiracy Event: A recent article in Healthcare IT News reported that four people and one company have pleaded guilty in a telemedicine pharmacy healthcare-fraud conspiracy that allegedly lasted for years. Description: Tampa-based pharmacy owner Larry Everett Smith conspired with several individuals and telemedicine marketing companies (HealthRight and Sterling-Knight) to defraud pharmacy benefit managers into paying for fraudulent prescriptions. The group was charged with a conspiracy to defraud pharmacy benefit managers out of $174,202,105 by submitting $931,356,936 in fraudulent prescriptions. From 2015 to 2018, the scheme solicited insurance coverage and prescription information from consumers across the country. After soliciting patient information, marketing companies obtained approvals through contracted telemedicine prescribers, then sold the costly prescriptions to pharmacies in exchange for kickbacks. A press release from the Justice Department states that doctors approved the prescriptions without knowing that the defendants were massively marking up the prices of invalidly prescribed drugs. All of these drugs were then billed to private insurance carriers. All defendants have plead guilty and will have to pay restitution and face prison time of up to 10 years. Implications: As highlighted in the article telehealth fraud is a significant threat to consumers, providers and government and commercial insurance programs' integrity. The dramatic rate of increase in telemedicine usage has exponentially multiplied the opportunities for hackers to steal patient data (either directly from consumers themselves or indirectly through provider and payer systems). As a result the entire healthcare system needs to be on the lookout for social engineering schemes which enable ransomware and other forms of targeting digital tools. Even though consumers think that they are dealing with trustworthy entities such as pharmacies or doctor's offices, unscrupulous actors can easily obtain sensitive information that enables billing fraud. With the mass adoption of telehealth technology, payers and providers in particular have to ensure a more significant focus on cybersecurity through such means as improving endpoint controls, patching critical security tools, security audits and identity and access controls. (Please see our 9/22/20 blog post covering the following two articles, “Targeted Cyberattacks on Telehealth Vendors Skyrocketed Along with Adoption & Report Finds & Fewer than Half of Healthcare Institutions Met National Cybersecurity Standards Last Year”, Link Here ). Telehealth Fraud: Tampa Pharmacy Owner Faces 10 Years for $931M Conspiracy

The Driver: In late March Crossover Health raised $168M in a Series D round to expand it’s employer-based primary care model, including a recently announced agreement to expand its partnership to build primary care clinics for Amazon workers. According to the company the funds will be used to expand their data intensive “Connected System of Health” across the U.S. and to build out centers for the Amazon partnership. The Entrepreneurial Insights: Founders must be willing to take a step even if they can’t see a clear outcome...you can’t sit around and wait for inspiration, the inspiration comes from putting the work in You must have a clear vision and build towards that. Healthcare is very difficult and it will outlast you. You can’t be impatient and think everything will turn in two years, there are too many twists in the road. We realized from day one that our model had to work outside the [existing] system. We knew we didn’t want to be fee-for-service and we were going to go all in on that. Today’s world is focused on instant fixes, you must have a long-term vision, don’t get distracted by what is cheap, convenient or easy. Outlast the noise, outlast the rumor and have enough conviction to stay with it...you can affect lives. The Story: Founded in 2010, Crossover Health provides an integrated care model primarily for self-funded employers including Apple, LinkedIn, Comcast, Amazon and others. Crossover’s model which began with on-site clinics and now includes virtual care, behavioral health, health coaching and patient navigation which the company refers to as Primary Health. The company has approximately 400K lives under management served by 48 in-person health centers in 11 states. In addition, the company delivers care virtually in all 50 states. In July 2020 Crossover announced a partnership with Amazon to build clinics for Amazon employees, near fulfillment and operations centers and the partnership has since been expanded to a total of 20 clinics. The company claims to save their clients approximately 15% on average by emphasizing coordinated primary care. Unlike other models where patients just have a single primary care physician (PCP) , Crossover patients are assigned to a dedicated collaborative care team which has the ability to share patient data. Crossover patients can choose on-site or virtual care and can connect with care providers via synchronous or asynchronous options which according to Crossover CEO Scott Shreeve allows them to build deeper relationships with their patients whereby they “leverage technology to extend the capabilities of the care team to augment the clinician/patient relationship, not displace it.” Along those lines Crossover uses an in-house data analytics platform to which Crossover can access a patient’s medical history, recommend evidence based treatments for high risk patients or those with high cost chronic conditions. The Differentiator(s): Crossover employs all of it’s physicians. Physician compensation is composed of salary plus outcome based incentives in order to keep the clinicians’ interests aligned with those of its employer clients. According to CEO Shreeve, employing physicians, creating coordinated care teams and even the physical design of the clinic facilities is part of a top down effort to “have that relationship with the patient” and use it as a competitive differentiator. Shreeve added that each patient care team can manage a “maximum of 10,000 patient lives to maintain a consistent quality of care”. Unlike many other models, Crossover also gets paid by employers on a subscription basis per employee per month (PMPM) or on a per population basis which improves employee access, the depth of the relationship with care teams, removes the transactional nature of the visit and helps lower costs. As noted by CEO Shreeve, “you can’t control costs unless you control healthcare delivery”. The Big Picture: Despite the tremendous increase in the use of telehealth during COVID the quality, convenience and level of customer service surrounding the transaction did not noticeably change. However, providers like Crossover which focus on creating and maintaining a relationship with the patient, where the patient is at the center of the relationship have the potential to improve the level of customer engagement and satisfaction with care and by doing so improve outcomes and lower costs. For far too long, healthcare has lagged behind most other consumer facing industries in the quality and convenience of its relationship with consumers, often making the location of care or the clinician the focus of attention at the center as opposed to the patient. Moreover, by failing to create this relationship physicians have likely failed to leverage their talents to the fullest. For example, according to the Accenture Digital Health Consumer Survey 2020, when asked “which of the following would motivate you to take a more active role in managing your health”, more respondents answered “a trusted healthcare professional who works closely with me to manage my wellness” (55%). In addition, as empowered by more convenient and more accurate technology consumers are increasingly taking charge of their own care. As such they are more willing to share their health data and embrace virtual tools to help them accomplish their goals. For example, According to the 2019 Global Health Care Consumer Survey, almost 60% of respondents are willing to share health data with their doctor to help provide better care, while 44% of respondents would be willing to use an at home test to identify a health risk and 47% of respondents would be willing to use an app to track changes in their vital signs. All of these imply that provider organization and individual clinicians are increasingly going to have more personalized and more strategic relationships with patients through vendors such as Crossover who can build relationships and leverage technology to improve care. The Brainchild of an ER Doctor, Crossover Health Focuses on Data and Preventative Care; Digital-Backed Care Provider Crossover Health Hauls in $168M Series D

What Did We Learn Implementing...Conversational AI in Healthcare? Event: (10/7) On October 7th, an article was published in Medium regarding Inception Health’s efforts and insight into implementing conversational AI in healthcare. Although the healthcare field may seem ideal for the implementation of AI tools and resources, they encountered several barriers that would present some difficulty in the process. Description: Inception Health (created by the Froedtert & the Medical College of Wisconsin) partners with innovative companies to solve key health care problems, develop new ideas, and scale solutions across their network and beyond. As a result, the organization sought out conversational AI because it seemed to have everything needed to have a positive impact on healthcare practice. Conversational AI is designed to teach computers to answer questions and help guide a person based on prompts. In healthcare, it can enable an enhanced and personalized patient experience and scale data access, transparency, and health literacy. While there are several tools available, the article mentions the challenges that would come with the implementation of this AI tool. This includes the biases associated with using data generated by current healthcare systems and legal restrictions that impact the ability to create these tools. As a result, the authors opted to use open source solutions to help build conversational AI agents (including Parl AI and BERT). Implications: The use of conversational AI has many components and designs that can be used by researchers to improve healthcare disparities, but the legal restrictions and biases have limited the development of medical AI to a few research projects and a few AI startups. While there continues to be a large amount of data generated by healthcare providers, most of it cannot be used for training algorithms and are severely restricted by data privacy and security regulations. While several solutions have been proposed such as developing an open-source healthcare chatbot dataset or using desensitized data to create “fake” patients with realistic health conditions for training algorithms, the data is still difficult to retrieve and additional processes are in place that create barriers. As a result of these issues, deployment of conversational AI in healthcare is not as effective as it could be and it remains behind other industries with similar amounts of data at its disposal. What Did We Learn Implementing GPT-2 and BERT for Conversational AI in Healthcare? Therapy Startup Coa Raises $3M to Launch World's First Gym for Mental Health Event: (10/14) On October 14th, Coa, a platform that offers therapy-led classes and one-on-one therapy, announced it had closed a $3 million seed round of funding. Since March 2020, demand for its workplace curriculum has grown 900% according to the company’s press release. To date, more than 3,500 people have joined Coa's waitlist for the studio launch. Coa aims to build a home for therapy, emotional fitness classes, and a sense of community. Background: Coa offers several services, giving communities a "gym" for mental health. These include emotional fitness classes to teach patients how to treat their mind like a muscle and increase resilience to deal with stress and anxiety. Users can also fill out a short questionnaire to be matched with therapists for one-on-one sessions. Coa also has the ability to partner with employers to provide employees with deep-dive sessions to develop mental health and emotional fitness skills, Q&A sessions about managing anxiety in the workplace, and workshops that follow a "learn, exercise, breakout, discuss" framework built on Coa founder Dr. Emilty Anhalt's research into the 7 Traits of Emotional Fitness. Implications: Coa's educational and emotional fitness services can help users in group or one-on-one environments in the comfort of their own home (and can even influence users to pursue careers in therapy). By partnering with employers, Coa is building an emotional safety net for employees with their companies and giving them additional resources during this difficult time. Once the pandemic is over, Coa can continue to maximize company’s and individuals' emotional well-being through regular classes, workshops, and one-on-one sessions. Therapy Startup Coa Raises $3M to Launch World's First Gym for Mental Health Oliver Wyman Executive says “Men and Women View Leadership Differently, Propelling the Gender Gap in Healthcare” Event: (10/15) A recent article in Mobihealthnews examined the continuous underrepresentation of women in leadership positions within the healthcare sector, despite years of initiatives. The article was a summary of the women in the workplace event at the HLTH VRTL conference. Description: Healthcare has a gender parity issue in terms of leadership positions with women making up only about 24% of executives of Fortune 500 healthcare companies, approximately 37% of hospital executives, and only 14% of digital health deals (defined as closed by female-led startups). Experts have noted that when companies attempt to address gender inequality without meaningful improvement there is usually something unexamined going on beneath the surface. According to many of these experts, the challenge for some women is the inconsistency at a leadership level of what a leader looks and acts like. Research indicates that the definition of leadership skills were often a function of which gender someone was speaking about. For example when leaders were asked about the top 3 leadership traits for both men and women they agreed that the most important leadership trait was confidence. Answers differed sharply on the 2nd and 3rd traits with “direct” and “decisive” cited for males, while “empowering teams” and “being collaborative” were cited for females. This inconsistency in leadership expectations sends a mixed message and makes it difficult for women to understand and demonstrate the appropriate skill sets to advance. Implications: As a result of this dichotomy, while there have been a wave of programs and initiatives at boosting women in leadership roles the results have been mixed at best. This signals that commonly implemented initiatives are not aligned with what experts think are most effective ways to close the gap. Among steps organizations can take are to directly and clearly address and eliminate the differing expectations for men and women in leadership roles. In addition, aspiring women leaders should be paired with sponsors (as opposed to mentors), who use their own political capital and credibility to advocate on these aspiring leader’s behalf. Oliver Wyman Executive says “Men and Women View Leadership Differently, Propelling the Gender Gap in Healthcare” Twentyeight Health Raises $5.1M to Scale Affordable Telemedicine Solution for Women’s Sexual and Reproductive Care Event: (10/15) TechCrunch recently profiled Twentyeight Health, a health tech company expanding access to women's sexual and reproductive healthcare for those on Medicaid or uninsured, which closed $5.1 million in seed funding last week. Background: Twentyeight Health was formed to bring contraceptive care to a population that historically hasn’t had as good access to “quality, dignified and convenient care”. To ensure it is catering to underserved communities the company works with Bottomless Closet, a workforce entry program for women as well as 8 colleges in the City University of New York (CUNY) system where 70% of the students come from families making less than $30K in annual income. The Company’s services are available in FL, MD, NY, NJ, NC and PA and it is the only telemedicine company focused on contraception services to accept Medicaid. Implications: Women who are on Medicaid, who are underinsured or without health insurance often struggle to find access to reproductive health services, and these struggles have only increased with COVID-19 pandemic limiting access to in-person appointments. Where seeking the right sexual health treatment may be overwhelming for women, Twentyeight Health makes this easier. As the company notes, low income women are 3x more likely than average to have an unintended pregnancy and nearly ⅓ of physicians nationwide aren’t accepting Medicaid. Services like Twentyeight health and others are demonstrating the efficacy of using digital tools to bring broader, more convenient and more inclusive access to care to under-resourced populations. Twentyeight Health Raises $5.1M to Scale Affordable Telemedicine Solution for Women’s Sexual and Reproductive Care Spain’s Savana Medica Raises $15 Million to Bring to the US its AI Toolkit Turning Clinical Notes Into Care Insights Event: (10/15) On October 15th, Spain’s Savana Medica announced that it had raised $15 million to bring its AI based technology from Europe to the U.S. Telehealth market. Savana has a machine learning-based service that turns clinical notes into structured patient information for pharmacists and physicians. Description: According to the company, Savana is already working with the world’s largest pharmaceutical companies and more than 100 healthcare facilities. The company states it has already processed some 400 million electronic medical records (EMRs) in English, Spanish, German and French. According to Savana Chief Executive Jorge Tello, one of the company’s main value propositions is its focus on security, where “information remains controlled by the hospital, with privacy guaranteed by the de-identification of patient data before [they] process it”. Implications: As the COVID pandemic has demonstrated, having up-to-date actionable information is crucial to treating patients as effectively as possible. Given The company’s mission is to “predict...disease at the patient level” and “discovering new ways of providing medical knowledge in almost real time could provide crucial minutes in the treatment of certain diseases and could be especially valuable during public health crises like the current pandemic. The integration of technology like Savana’s into US hospitals could ease the burden on healthcare providers, and speed response times. Spain’s Savana Medica raises $15 million to bring to the US its AI toolkit turning clinical notes into care insights Lifelight and Karantis360 Partner to Deliver Social Care Remote Patient Monitoring Event: (10/16) A recent article in MobiHealth News noted that UK companies Lifelight and Karantis360 had formed a partnership to enable safer independent living for older and vulnerable individuals by delivering a remote picture of their wellbeing. The Karantis360 solution will run on the IBM Cloud and use IBM AI and analytics coupled with a network of smart sensors to identify and learn an individual’s typical behavior. Description: According to the companies, their solution allows regular behavior and vital sign readings to be taken in homes and other outpatient care settings safely, and has optimized clinician’s workflow.The combined solution allows for timely interventions and clinical actions based on real-time physiological data. Lifelight allows the contactless measurement of vital signs by using a standard smartphone or tablet and will detect tiny changes in facial skin color which may indicate a deviation in heart rate, blood pressure, respiration, or oxygen levels. If changes appear in relation to an individual’s daily routine or vital sign readings, automated alerts will be sent to the care provider and family members. Implications: The continuing need to physically distance has increased the demand for virtual care tools like the one described by the partnership. While telehealth visits are increasingly replacing many in-person visits some conditions still require physical observations. A digital tool with sensors and remote monitoring capabilities reduces the need for certain in-person visits, while improving patient care and supporting clinical decision-making. As such the combined solution can help support earlier patient discharges and prevent readmissions in real-time without the need or cost of additional hardware. These types of apps reinforce the role of IoT devices in healthcare in the move to value-based care via lower cost, higher quality, and patient friendly solutions. Lifelight and Karantis360 Partner to Deliver Social Care Remote Patient Monitoring

Access to Telemedicine Is Hardest for Those Who Need It Most Event: (9/3) A recent article in WIRED magazine noted the practical and technological issues that many older Americans, particularly Black and Latinx Americans have in accessing and using digital health technologies. Description: While virtual care exploded during the COVID crisis, accounting for as much as 44% of Medicare visits at one point, studies indicate that as much as 41% of Medicare recipients don’t have an internet-capable computer or smartphone at home, with elderly Black and Latinx people the least likely to have access compared to whites. Another study in JAMA noted that approximately 13M elderly adults have trouble accessing telemedicine services, and approximately ½ of those people may not be capable of having a telephone call with a physician due to problems with hearing, communications, dementia, or eyesight, including 71% of elderly Latinx people and 60% of elderly Black people. Implications: Although growth in virtual and telemedicine visits has exploded during the COVID pandemic, the increase in the digital delivery of healthcare services exposes and magnifies the disparities in care and access for the underserved, and is especially acute for the elderly in those groups. Providers and payers must look at methods of bridging the “digital divide” when expanding use of virtual care/remote access. They must pay attention to visual and non-visual cues to ensure understanding and incorporate other accommodations (such as automatic captioning and amplification) for elderly Black and Latinx populations. Access to Telemedicine Is Hardest for Those Who Need It Most Telehealth grew wildly popular amid Covid-19. Now visits are plunging, forcing providers to recalibrate (subscription required) Event: (9/1) In a September 1st article, STAT News looked at the nationwide slowing of telehealth visits and, noting that although telemedicine visits are higher than pre-pandemic levels the downturn is causing providers to adjust offerings based on patient preferences and needs. Description: As telemedicine visits have decreased from 69% of total encounters in April to just 21% of total encounters in July, providers are trying to figure out at what level the ultimate balance between in-person and virtual visits will stabilize and how visits will break down across service lines. For example, the University of Pittsburgh Medical Center launched a program to determine when patients should be seen remotely or in-person. They have found that while telemedicine visits have declined about 60% from April, most mental health visits are continuing to occur virtually while specialists are seeing more patients return to their offices. Implications: Following the pandemic providers are going to have to adjust the level of virtual visits by investigating what mix of virtual and in-person visits best suits their patient population. They need to determine what mix of the two will be most cost-efficient and profitable for them. In addition, the leveling off of virtual visits may create challenges for large telemedicine companies that are planning to expand based on the initial surge in demand and easing in the regulatory environment. This is due to the uncertainties about whether they will be able to sustain those numbers as patients return to in-person visits and what will happen with an unpredictable regulatory landscape. Deloitte survey shows consumers are more engaged with their health through technology Event: (8/26) A recent article in Healthcare Finance highlighted that two Deloitte surveys (the Deloitte 2020 Survey of US Health Care Consumers and The Health Care Consumer Response to COVID-19 Survey) show consumers are more engaged with their health through technology as a result of the COVID-19 pandemic. Description: Consumers are actively engaging in their health care, which has allowed them to discuss cost information, track health conditions, access and use their medical record data, disagree with their doctors about treatment and cost, and engage in healthy/preventative behavior. The Deloitte COVID-19 consumer survey found among consumers who had virtual doctor visits 80% would choose to have another virtual visit, provided the positive patient-physician experience which was defined as one where the healthcare provider was accessible and willing to listen. Implications: While consumers are more open to virtual visits since COVID Deloitte’s survey found consumers still want to have a personalized physician-patient relationship with a provider who listens, shows they care, takes their time, and communicates with them. The enhanced use of technology has also exacerbated health disparities, especially along racial lines. As a result organizations need to extend access to care deeper into the communities they serve addressing both clinical issues as well as issues around the social determinants of health (SDOH). Deloitte survey shows consumers are more engaged with their health through technology Carewell Secures $5M For Caregiver Advocacy, Home Health E-commerce Site Event: (9/2) Carewell, a North Carolina startup recently closed $5 million in seed funding to expand its e-commerce and home health advocacy site for home health products. Description: Carewell was started to support and educate families caring for loved ones, particularly those who are doing so for the first time. The online shopping platform consists of vetted product recommendations as well as a subscription service for caregivers who consistently need products and resources. Additionally, the company is looking to expand and create new categories of products that will continue to serve its customers. Implications: The demand for at-home care for seniors has exploded during the pandemic, with Carewell seeing revenue doubling and nearly 40,000 unique customers making purchases since February. With a disproportionate percentage of COVID deaths attributable to skilled nursing homes and senior living facilities, alternatives to institutionalized care and services which enable them are likely to see growing demand and interest. Carewell Secures $5M For Caregiver Advocacy, Home Health E-commerce Site Using technology to self-manage diabetes results in healthy lifestyle choices Event: (8/28) The University of Texas Health Science Center at San Antonio conducted a study to monitor how adults living with Type 2 diabetes use current healthcare technology to self-monitor their lifestyles and current health behaviors. Research found that allowing participants to track their behaviors, led to them making healthier lifestyle choices to manage their diabetes. Description: Using self-monitoring technology allows participants to understand the importance of making healthier lifestyle choices and helps to make sense of why certain decisions must be made to control blood glucose levels. A separate study conducted by Omada and Evidation Health also showed a reduction in participants’ A1C levels for those who used these digital chronic care management tools (please see 2nd link below). Implications: Being able to self-manage diabetes via healthcare technology platforms can lower A1C levels, reduce diabetes complications, improve quality of life, and lower medical experiences. Programs like Omada and Evidation Health allow people to improve quantitative and qualitative measures while monitoring their diabetes and making healthier lifestyle choices on their own. Using technology to self-manage diabetes results in healthy lifestyle choices Patients using Omada's diabetes management tool see reduction in A1c levels, according to research How 5G Can Enable Life-Saving Technology Event: (8/27) A recent article in CES Tech updated the progress on 5 companies selected into the latest cohort of Verizon’s 5G First Responder Lab, launched in partnership with Responder Corp. in 2019. The 5G First Responder Labs goal is to empower first responders by delivering the life-saving capabilities they need to serve their communities. The 5 companies accepted to this round using Verizon's 5G Wideband network are Biotricity, Rave Mobile Safety, DispatchHealth, Vuzix, and Visionable. Description: Biotricity is offering a patient-monitoring platform that allows medical professionals to remotely identify potential urgent alerts. Vuzix, whose Blade Edge smart glasses were a CES 2019 Innovation Award honoree, is creating augmented reality smart glasses to connect on-site first responders with experts to receive real-time feedback. Visionable’s collaboration platform will virtually connect medical professionals to provide follow-up care to patients remotely. Implications: As the world faces the COVID-19 pandemic, the spotlight is on health care-related technologies. As 5G technology continues to develop and get rolled-out it will enable greater use of more innovative and powerful virtual and remote care technologies closer to the site of care. This will improve emergency care, broaden access specialists, and enhance care in rural and underserved communities. How 5G Can Enable Life-Saving Technology

Event: Canvas Medical, a San Francisco-based AI-powered electronic medical records startup, recently raised $17M in Series A funding. The round was co-led by Inspired Capital and IA Ventures with additional participation from existing investor Upfront Ventures. The company plans to use the funds to build new partnerships with insurers, to grow its business among virtual first clinics and, to meet regulatory goals to allow it to receive federal incentive payments. Description: Canvas is an EMR startup targeting small to mid-size PCPs ranging from sole practitioners to practices with up to 50 clinicians. According to the company, they offer a fully integrated platform that can run all of the administrative tasks of physician practices as well as reduce the amount of time doctors spend entering patient data, diagnoses, and tests into EMRs. For example, according to the San Francisco Business Journal, Canvas has eliminated the need for doctors to click through multiple menus when entering data. Instead, Canvas’ machine learning and statistical modeling software organizes and classifies the information in real-time so that all clinicians need to do is type the information onto a blank page. This allows clinicians to focus on the work of caring for patients and less on entering data into an EMR which has shown to be a major drain on physician productivity and contributor to physician burnout (please see “U.S. Clinicians Spend 50% More Time in EHR than those in other Countries” in the 12/22/20 edition of the HSB blog, link here). According to Canvas Medical CEO Andrew Hines, their product can make doctors 30% more productive in the first month of use and help reduce the amount of time spent on charting by 1-2 hours per day (clinicians typically spend 2 hours in the EMR for each hour of direct patient-facing time according to a study in the Annals of Internal Medicine, ). In addition to time and cost savings, the Canvas Medical EMR is designed to better align practices with value-based care models, where payments are tied to outcomes instead of volume. This allows practices to better track and attribute outcomes to the measurements required by insurers under these contracts. Implication: While the move over the last several years to greater use of EMRs had helped providers and payers collect and generally exchange larger volumes of data, it has come at the cost of a dramatic increase in demands on clinicians. As noted, the average physician now spends over two hours in an EMR for each hour of patient care and an additional 1-2 hours of so-called “pajama time” entering records after hours to catch up on record keeping. Solutions like Canvas Medical’s can not only help reduce stress on overworked physicians but also improve coding and the quality of patient care. In addition, given their solution was designed and built to capture and supply both providers and payers with the data needed to measure and attribute care under value-based models, they will facilitate the movement of more physicians to risk-sharing models. Moreover, by eliminating the need for physicians to click through multiple screens to find the appropriate field to input data, less data is likely to end up in unstructured free text fields reducing miscategorization or missing data which should improve the data integrity and data completeness of clinical files. Medical Records Startup Raises $17M to Grow Partnerships with Insurers and Double Workforce & EHR Startup Canvas Medical Raises $17M and Partners with Insurance Heavyweight Anthem

Adopt Basic Tools to Fix Disparities While Digital Divide Persists “Our Take'': While certain barriers to access telehealth technologies were acknowledged and are slowly being addressed during the pandemic (ex: ‘broadband access’, ‘reimbursement’, and ‘licensure’) the ‘digital divide still limits the utilization of digital technologies so the industry must look at deploying basic tools in the near term to address the divide. Although telehealth has been around for quite some time, it was not until the advent of COVID that it gained significant traction with consumers and doctors, seeing an increase in utilization of 154% compared to 2019. Despite the relative ease of deployment, convenience, and ability to limit patients’ exposure to the virus in physical facilities, there are still several patient populations that are not being reached. As a result, providers, payers, and policy officials need to continue to prioritize initiatives to make healthtech more accessible to poor, rural, and other underresourced communities. While issues such as reimbursement and licensure had been temporarily solved, permanent fixes may take time and as such, we need to look at adopting basic tools near-term to address health disparities. Description: Prior to the pandemic there were a limited number of services CMS approved for reimbursement delivered via telehealth. However, with the onset of COVID and the declaration of a public health emergency (PHE) both CMS and State regulators waived enforcement of restrictions or added reimbursement for a significant number of procedures including originating site requirements and originating place of service requirements. As a result of the eased restrictions, providers and payers reported dramatic increases in demand in the wake of limits on access to physical facilities. For example, Blue Cross and Blue Shield of Massachusetts reported that claims for telehealth visits skyrocketed 190-fold during the pandemic, from 200 prior to onset to 38,000 at peak. Healthcare Dive reported that before the PHE was declared in March, only 15,000 traditional Medicare beneficiaries used a Medicare telehealth service each week, but between the middle of March and the middle of October, more than a third of fee-for-service Medicare recipients had used virtual care according to CMS. Nevertheless, although there has been a substantial pickup in usage, one of the most challenging hurdles to overcome with telehealth adoption is the digital barrier. Even with regulations being eased for existing telehealth services, and additional support being provided for digital tools, there remains a large population of underresourced communities that didn’t have access to smartphones, broadband, or which are simply not digitally literate. As noted in “Assessing Telemedicine Unreadiness Among Older Adults in the United States During the COVID-19 Pandemic”, digital barriers are responsible for poor adoption of telehealth among older adults, racial/ethnic minority population, rural population with low socioeconomic status, and those with limited English proficiency. Similarly, a recent Kaiser Family Foundation poll found that only 7 in 10 adults 65 and older (68%) report having a computer, smartphone, or tablet with internet access versus virtually all younger adults. Moreover, while 18% of older American adults need chronic management, only 55%-60% of them own a smartphone or have access to broadband. Some of the barriers noted in a recent study by the School of Public Health at the University of Maryland are: 1) the cost of implementation; 2) patients’ inability or difficulty to view their medical record online; 3) the ability to electronically transmit medical information to a third party; 4) the ability to request an amendment to change/update their medical record, request refills for prescriptions online; 5) being able to schedule appointments online; 6) capability to pay bills online; 7) mechanisms to submit patient-generated data; and 8) a means to communicate via secure messaging with providers. The study also found lower overall adoption of telehealth was due to lack of training of both patients and health care providers in the use of healthcare information technology systems. Implications: Over the last year, telehealth use has skyrocketed. Barriers such as reimbursement have been identified and at least temporarily rescinded thus facilitating increased access of patients to the digital healthcare system. However, there are steps that still need to be taken to close the gap in healthcare disparities. According to a recent article in the NEJM, a number of additional steps are needed including: 1) developing solutions to mitigate barriers to digital literacy and resources needed for engagement in video-visits; 2) removing health system-created barriers to accessing video visits; and, 3) advocating policies and infrastructure that facilitate equitable telemedicine access. Along those lines, providers such as UCSF General Internal Medicine Primary Care Practice and San Francisco General Hospital academic practices have started an outreach program for all patients 65 years old and older. Under the program, staff members contact patients with scheduled visits by phone and walk them through setting up video platform application and practice connecting to the video. While, introductions such as this step-by-step guide are useful in enabling patients to access digital tools, access to broadband to close the digital divide needs to be addressed. It is not just the rural parts of the country that experience inaccessibility to broadband, certain groups or parts of even major cities still don’t have access to wifi or smartphones. As noted in a recent JAMA article, “Assessment of Disparities in Digital Access Among Medicare Beneficiaries and Implications for Telemedicine”, over 40% of Medicare beneficiaries lacked access to a computer with high-speed internet access at home, and a similar amount lacked a smartphone with a wireless data plan. In order to make it available, healthcare institutions, providers and government must work together. An option could be stakeholders partnering together and providing hotspots every few miles so people can access it, Another option might be providing various broadband internet options at subsidized rates of low-cost to encourage communities to adapt to digitalization. While increasing broadband access is a necessary step and will likely take time, there are other immediate steps that the healthcare system can take to improve access. One strategy deployed by NYC Health+Hospitals Corporation during the pandemic was to make available city-wide telephone hotlines that connected providers for same-day-appointments with patients for opioid addiction treatment, leading to continued access and increased access for a lifesaving medication-assisted treatment. However, for actions such as this to work, telephone call appointments and even check ins need to be reimbursed at the more commensurate rate with video-visits. Despite certain security and privacy concerns, a strong argument can be made that, particularly in underserved areas and for lower income populations, audio-only telephone visits and even the ability to provide asynchronous communication would broaden access, is more convenient and has lower technological and locational barriers than audio-visual calls. While CMS began providing reimbursement for audio-only telephone services in March, and they have been broadly used during the pandemic, the American Medical Association, along with other physician groups, urged CMS to continue allowing the audio-only services in recent comments on proposed rule changes, and to make the change permanent which we would agree with. No doubt there are challenges to implementing strategies to mitigate disparities, and though there have been temporary fixes, knowing telehealth is here to stay, measures in favor of broadening access to digital services and enhancing convenience need to be made permanent. Addressing Equity in Telemedicine for Chronic Disease Management During the Covid-19 Pandemic; COVID-19 Reveals Telehealth Barriers, Solutions; Are There Health Disparities in COVID-19 Telehealth Access, Use? At the Height of Digital Wellness, Are We Missing the Human Touch? Event: On January 14th, an article in MedCityNews highlighted that human interaction must remain an instrumental part of the healthcare experience. The article noted that if we are not careful about how we implement the move towards digital care healthcare risks losing empathy. Although the COVID-19 pandemic rapidly accelerated the healthcare industry toward digitization, human touch, and face-to-face interactions remain necessary and risk becoming “a thing of the past,” if we are not careful. While many providers have turned to digital communication and data management, e-visits, and telehealth to continue serving patients in a time of lockdowns and social-distancing mandates, going forward in a post-pandemic world will require a delicate balance. Description: Touch and human interaction are vital to learning secret information about the body, reliably guiding providers a problem's root cause (often referred to as the “laying on of hands” by the physician). Multiple studies have championed the power of touch and empathy in medicine showing that: 1) compassion can reduce pain after surgery; 2) improve survival rates; and, 3) boost the immune system. Additional studies have demonstrated that patients have significantly better outcomes when their physicians score high on empathy, as it increases both patient satisfaction and compliance, while the simple act of holding a patient's hand can be beneficial as human touch can lower cortisol levels caused by stress. While firms are scrambling to provide more efficient and higher quality care by streamlining delivery systems via secure, accessible and reliable technologies, healthcare industry participants are struggling to find the right role for doctor-patient interaction. Although providers, payers, and patients are beginning to embrace digital innovation, the article highlights that human touch continues to be fundamental to one's health experience as it forges personal connections, decodes human emotion, and promotes trust and healing. Implications: Health technology has become extremely advanced and intuitive but cannot replace human interaction because patients will always value and seek human touch. This is because: 1) they remain wary of AI and other nuanced technology, preferring to seek care from other human beings rather than computers; 2) have emotional needs when dealing with potentially life-altering diagnoses and unforeseen outcomes, that are best delivered by a living, breathing, and feeling individual; and, 3) believe that physical examinations are reassuring and restorative. While there is no single solution that can help preserve touch in health care, as we move towards digitization at a rapid pace, it is crucial to pay attention to the positive aspects of technology. For example, technology allows providers to reach more patients, reduces administrative burden, and expands access to treatment both through efficiency and remote care. Even though technology can often place a barrier between patient and provider, providers must explore the new avenues that technology can be applied to enhance empathy and build rapport. Although medicine will never progress without technology, human interaction remains an integral part of the healthcare experience and it should not be left in the past as it remains unique in its power to comfort, heal, diagnose and treat patients. At the Height of Digital Wellness, Are We Missing the Human Touch? What Is the Healthcare Cost of Racial Health Disparities, Inequity? Event: On January 13th, Patient EngagementHIT reported that the social determinants of health in Texas have resulted in $2.7 billion in excess medical spending, and another $5 billion in lost productivity. That represents a 60 percent increase in excess medical spending and 72 percent in lost productivity due to health disparities since 2016. The article noted how healthcare costs could have been avoided during COVID if racial health disparities had been more adequately addressed prior to the pandemic. Description: In Texas, Black and Hispanic children are more likely to grow up in neighborhoods of poverty and their families are more likely to lack health insurance, causing large disparities in health status, disease prevalence, and premature death. According to Episcopal Health Foundation, Texas is incurring $2.7 billion in excess medical care spending annually as well as $5 billion in lost productivity. In addition, this lack of care leads to 452,000 life years lost due to premature deaths valued at $22.6 billion. It is likely that these figures will increase by 22% as the Texas population grows and becomes more diverse, increasing racial healthcare disparities. According to the article, if Black and Hispanic populations in Texas were hospitalized for COVID at the same rates as non-Hispanic Whites, there would have been 24,000 fewer COVID hospitalizations in Texas through September 2020. The article adds that if Black and Hispanic populations had the same mortality rates as their non-Hispanic counterparts, there would have been 5,000 fewer deaths as of the end of September 2020, reducing the death toll by 30%. These outcomes are largely attributed to institutional inequality and the fact that Black and Hispanics are more likely to work frontline or essential workers and are at a higher risk for severe illness should they contract coronavirus due to pre-existing chronic illness as well as lack of health insurance. Implications: If the issue with racial healthcare disparities and higher costs persists, Texas may see up to $3.4 billion in excess medical spending, $6.1 billion in lost productivity, and 551,000 life years lost. Although Texas is being highlighted, racial healthcare disparities occur all over the world and need to be addressed. The global pandemic has laid bare healthcare disparities that are claiming the lives of many minorities due to lack of access and availability of healthcare resources. The study highlights Medicaid expansion as a gateway to closing racial health disparities exposed by COVID, which could help increase patient access to care through telemedicine. However, policymakers still need to focus on key factors such as housing access and quality, food security, air quality, educational attainment, employment, and institutional racism as part of their efforts to close gaps in care due to race. If stakeholders do not make these factors priorities, this will continue to be an issue and many more lives will be claimed as a result. What Is the Healthcare Cost of Racial Health Disparities, Inequity? Doctor on Demand Partners with Texas Health Plan for Virtual Primary Care HMO Event: A recent article in Healthcare Dive noted that Community Health Choice, a Texas-based health insurance not-for-profit organization, is partnering with telehealth vendor Doctor on Demand to set up an HMO plan for virtual primary care. The plan is launching on the Texas ACA marketplace and will offer patients a primary care physician and virtual visits with urgent care and behavioral health. Description: Community Health Choice has significant Medicaid offerings in Texas, a state that has not expanded Medicare eligibility under the ACA. Deemed the “Virtual Bronze” plan, this HMO plan is targeting uninsured people who are not eligible for Medicaid, filling a gap in coverage for more than 760,000 residents who are also ineligible for premium subsidies. This new partnership is consistent with the other steps Doctor on Demand has taken to capitalize on demand for virtual health services during the pandemic. It became the first telehealth vendor to enter the Medicare Part B market in May, and entered into a contract with the state of Massachusetts to provide free virtual visits for people who are on Medicaid or uninsured during the pandemic in April. Implications: As noted by Doctor on Demand’s head of growth and strategy David Deane, during the pandemic, patients have been deferring non-urgent care and preventive care, delaying appointments or missing annual check-ups as they seek to avoid potential exposure to COVID in healthcare facilities. Through virtual primary care plans such as this, patients can experience the “environment of having a primary care physician” without having to expose themselves to potential harm while maintaining routine and preventive care. In addition, by providing less expensive access to primary care, virtual primary care can provide an underutilized service to an underserved population. The pandemic has opened up space in the primary care market for telehealth services to fill. Other states can expect to see plans similar to this one from Community Health Choice and Doctor on Demand popping up on marketplaces soon. Doctor on Demand Partners with Texas Health Plan for Virtual Primary Care HMO Trustworthy AI Has the Ability to Transform Healthcare Event: On January 12th, an article in Mobihealthnews reported that a problem remains among clinicians, staff, and patients with trusting recommendations derived from artificial intelligence (AI) since they cannot see or understand what the software is doing or how the model performs calculations on the data and arrives at its conclusions. The article highlighted that according to Pat Baird,senior regulatory specialist at Philips, AI needs to build trust on three levels: 1) technical trust; 2) regulatory trust; and 3) human trust.. Description: According to Mr. Baird, technical trust asks if the algorithm does what it is designed to do, regulatory trust determines if the software stands up to different agencies' [and user] expectations and requirements, and, human (interaction) trust faces the user and decides whether or not people will like it and trust it. All of these levels are important, but success is dependent on who the stakeholder is and who the user is. All applications have to be customized to fit the needs of the users. Another way to build trust in AI aside from the three levels of trust is to make the applications better by improving the data, such as making data interoperable and linkable. Implications: Creating trust in AI has the power to transform healthcare for clinicians and patients alike. It can help free up clinicians by facilitating care and enabling computers to recommend protocols for clinicians to follow. The article highlights that part of the human-interaction trust comes from considering the differences among user populations. Often, there is an underrepresentation of intended populations due to incomplete data for which AI technology should be trained to provide unbiased outcomes. Careful attention must be given to drive positive outcomes. Using data to program technology will allow for fluidity and technological opportunities to transform healthcare delivery for many patients. Moreover, it is imperative to understand clinician preferences with regard to using artificial intelligence applications because clinicians want to know and understand how and if it will work for them and their patients. Importantly, clinicians also want to ensure they will get paid for using AI as well as ensure they won’t be held liable for decisions made or strongly influenced by AI enabled products. Trustworthy AI has the Ability to Transform Healthcare Aspen RxHealth Raises $23M Series B Funding Round Led by Bessemer Venture Partners Event: Aspen RxHealth, a Tampa-based platform that connects pharmacists with patients in need of enhanced medication services, has raised $23 million. Aspen RxHealth matches clinical pharmacists with patients based on social and clinical factors. This enriches the patient-pharmacist experience and helps them achieve better medication compliance while reducing costs. Description: Aspen RxHealth matches its community of 5,000 pharmacists to patients using algorithms based on specific demographics and clinical attributes. This allows pharmacists to focus on meeting the needs of their patients while Aspen RxHealth manages the administrative tasks related to delivery of care. AspenRxHealth's services include medication therapy management, quality measure initiatives, medication reconciliation, high-value segments (HIV, cancer, specialty drugs), and more. With an easy-to-use clinical workflow and user experience, the Aspen RxHealth application simplifies the task of documenting patient encounters. Accessible from a mobile phone or tablet, the application is powered by an advanced clinical decision support engine which identifies the most relevant patient care interventions. Implications: Aspen RxHealth will help improve the efficiency, quality, cost, and convenience of care. First, Aspen RxHealth helps pharmacists and doctors apply and channel their expertise most efficiently. As the market has seen a continuous oversupply of pharmacists, Aspen RxHealth helps realign pharmacists, instead of overburdened doctors, to effectively help patients. As a result, doctors can use that time and energy to help other patients in need. Second, Aspen RxHealth can improve the quality of care by utilizing the expertise of trained and passionate pharmacists. Pharmacists will be able to advise patients on medicine complications, side effects, combinations, and substitutes. Lastly, Aspen RxHealth is easy to use and convenient for patients. The platform matches patients to pharmacists based on their location and social and clinical factors. With an easy-to-use clinical workflow and crisp user experience, the Aspen RxHealth application simplifies the otherwise arduous task of documenting patient encounters for doctors and makes communication easier for patients. During the pandemic, this user-friendly platform allows patients to easily communicate with pharmacists in the comfort of their own home. Aspen RxHealth Raises $23M Series B Funding Round Led by Bessemer Venture Partners

Biden’s Public Option Brings Americans One Step Closer to Fixing the System Event: Among President-elect Biden’s stated legislative goals is to improve healthcare access by lowering the Medicare eligibility age from 65 to 60 years old and allowing those below age 65 to buy-in to Medicare via a “public option”. Under Biden’s plan, eligible participants between the ages of 60-65 could maintain their existing source of coverage or purchase Medicare via the public option. While it is impossible to analyze this portion of the plan in isolation (and we will include additional analysis in later posts), we believe the Medicare public option is a net positive for healthcare access and would generally improve the quality and lower the cost of care in the U.S. Description: Under the proposal, Biden plans to create a public health insurance option which would let individuals purchase Medicare coverage. As noted by the Committee for a Responsible Federal Budget (CFRB), since “Medicare rates are generally lower than private insurance, the public option could be cheaper than alternatives in many cases…[and] competition from the public option could reduce the cost of private insurance as well”. Biden’s proposal would make coverage available to those who lack coverage, those with Employer sponsored insurance, those who get coverage through the current ACA exchanges and in states where Medicaid was not expanded. It is estimated that under the plan approximately 15-20 million uninsured Americans would gain coverage. Biden’s proposal would pay for coverage by increasing the amount of ACA premium subsidies and financing them by increasing the top marginal tax rate (to 39.6% from its current 37%), increasing tax rates for those making over $1M per year on capital gains (to 39.6% from the current 20%) and estate taxes (via the addition of a stepped up cost basis). While many insurers oppose the plan fearing that pressure from the public option could significantly shift coverage, according to Avalere only about “13.4M individuals currently enrolled in employer sponsored insurance [ESI]”, or approximately 9% of the total ESI market (and likely less-as discussed in implications) would buy in to the public option. Biden’s plan should not be confused with a nationalized or single-payer healthcare system, as: 1) It doesn’t require that everyone be enrolled in a single government insurance plan, 2) it does not contain limits on provider payment rates, 3) it does not eliminate the Medicaid eligibility gap, and, 4) it does not allow those in households eligible for ESI to take advantage of Federal insurance subsidies. Despite the fact that many would argue that his plan would be the beginning of a move in that direction, given the lack of traction gained by Senator’s Sanders and Warren during this election cycle, we see this as highly unlikely for the foreseeable future. Implications: The current U.S. healthcare system is unsustainable for well known reasons of cost, quality, inefficiency and equity. While Biden’s public option will create some near term shifts in sources of coverage for payers and providers, it would provide coverage for many Americans without healthcare insurance or struggling to pay premiums, and we expect over time will actually benefit providers and payers. For example, as cited earlier, Avalere estimates that 13.4M would shift from ESI to Biden’s public option, realistically any public option will have to be bid out to the commercial insurance companies in the same way Medicare Advantage is currently run. Although some have surmised that employers may chose to drop employees to let them buy into a public option plan or that large segments will drop employer coverage to buy into Medicare, we note similar arguments were made with ACA exchange plans and never materialized (and could run afoul of discrimination laws). Moreover, given that Medicare Advantage is one of the most successful government programs ever and now accounts for almost 40% of Medicare enrollees up from 25% in 2011 we expect payers to benefit from additional application of analytics and further economies of scale in treating this cohort. In addition, despite the fact there is some dispute about MA margins, given that over 50% of MA market share is concentrated among three of the public managed care programs that would argue in favor of its profitability and attractiveness. Although Biden's plan will increase the national deficit by $800 billion in ten years according to the CRFB, additional improvements in coverage could bring additional benefits of lower costs and improved outcomes much like were seen in the early years of the ACA. Primary Care: Estimating Democratic Candidates’ Health Plans; Comparing Health Insurance Reform Options; Measuring the Scope of Presidential Candidates’ Coverage Proposals Pre-Symptomatic Detection of COVID-19 From Smartwatch Data Event: A study shows consumer smartwatches data can be used for the pre-symptomatic detection of COVID-19. The study analyzed physiological activity data from 32 individuals infected with COVID-19, identified from a cohort of nearly 5,300 participants, and found 81% had alterations in heart rate, number of daily steps, or time asleep. Using retrospective smartwatch data, it was shown 63% of the COVID-19 cases could have been detected before symptom onset in real-time via a two-tiered warning system based on the occurrence of extreme elevations in resting heart rate relative to the individual baseline. Description: This cohort study investigated whether smartwatches could be used to detect COVID-19 at an early, pre-symptomatic stage. Smartwatches included Fitbits, Apple watch, Garmin devices, and others. The parameters evaluated were abnormal resting heart rate (RHR), heart rate-to-steps ratio, sleep and activity alterations, heart rate signals and other symptoms. These were evaluated for association with COVID-19 and to establish an approach for the early detection of early COVID-19 onset in real-time. The study found that all the above parameters were altered by COIVD-19. Elevated heart rates occur before disease and provide utility as a general signal of respiratory illness. CuSum an online detection method with the ability to detect altered physiology in advance of symptoms, was developed to detect early stages of COVID-19 illness in advance of symptoms using a smartwatch. Implications: As the findings suggested, activity tracking and health monitoring via consumer wearable devices can be used for large-scale, real-time detection of respiratory infections, including COVID, often pre-symptomatically. With the second surge of COVID-19 currently hitting the US, the use of smartwatches could help substantially improve widespread testing detection. In addition, the application of wearable devices to virus detection has ample potential to mitigate the spread of the pandemic as well as addressing respiratory illness overall. It allows self-monitoring, the early detection of symptoms and the ability to place suspected virus carriers in protective protocols without having to expose themselves or others to additional sources of infection. Pre-Symptomatic Detection of COVID-19 From Smartwatch Data Flow Depression Headset to Tackle UK’s ‘Lockdown Loneliness’ Event: A recent article in Mobihealthnews examined the positive health outcomes resulting from the new rollout of the Flow headset and therapy app treatment. Individuals in the UK and EU have been using it to tackle depression and ‘lockdown loneliness.’ Recent user analysis shows that 81% of patients using the Flow headset and therapy app reported feeling better after just three weeks. Description: The Flow depression headset aims to alleviate the burden of loneliness caused by lockdown by improving accessibility to treatment delivered to patients within 48 hours. Patients who use Flow and the behavioral therapy app wear a brain stimulation headset that improves areas known to impact depression, emotion regulation and sleep quality while increasing social support with the app. The therapy program provides an interactive chatbot therapist and a constant companion that offers personalized behavioral therapy in areas proven to reduce symptoms of depression. A study in Plos One indicated that loneliness is a significant public health issue with 70% of people with depression feeling isolated and with worse quality sleep due to the pandemic. Implications: The COVID-19 pandemic has resulted in lockdown measures limiting social contact, which adversely affected mental health outcomes. Providing patients with access to therapeutic applications such as Flow will help tackle common conditions like depression and improve emotion regulation, sleep quality, and increase social support. Rates of loneliness during the initial phase of the lockdown were high, and findings have shown that supportive interventions can reduce loneliness that leads to depression and other mental health symptoms. Flow appears to be a promising solution for patients and clinicians because it's tailored to individual needs; it is controlled in real-time and can monitor a patient's condition and progression of treatment thus far. Flow Depression Headset to Tackle UK’s ‘Lockdown Loneliness’ AliveCor Gets FDA Nod for Suite of Cardiac Focused AI Algorithms Event: On November 23rd, Mobihealthnews reported that AliveCor received FDA clearance for a new suite of algorithms called Kardia AI V2 that interpret ECG data to detect cardiovascular illness. The company also recently announced a $65 million Series E funding round to support its research. Description: The algorithms are designed to capture sinus rhythms with premature ventricular contractions, supraventricular ectopy, and with wide QRS. They work using AliveCor’s KardiaMobile and KardiaMobile 6L devices, which are at-home consumer health management devices that can take 30-second electrocardiograms (ECGs) and are linked to a smartphone app. AliveCor stated the new algorithms will reduce the number of unclassified readings and have improved sensitivity and specificity relative to the company’s atrial fibrillation and other algorithms. There will also be new visualization features on the app, once these algorithms are implemented that will allow users to see their heartbeat average, PVC identification (extra heartbeats that disrupt your regular heart rhythm causing your heart to feel like its fluttering) and tachogram (for detecting heart rate variability analysts). Implications: FDA clearance allows AliveCor to move forward with product development using their new AI technology and implement it in their current devices. Heart disease is the leading cause of death in the United States, according to the CDC. Tech companies have taken the opportunity to participate in the fight against heart disease using innovative new approaches the medical community would otherwise not implement on its own. The marketing for AliveCor’s new algorithm suggests it can improve cardiac care and telehealth services by bringing advanced preventive measures into the home thus lowering costs and improving quality. AliveCor Gets FDA Nod for Suite of Cardiac Focused AI Algorithms Smartwatches Could Monitor Coronavirus Vaccine Safety Event: On November 19th, Lifewire reported that the U.S. Centers for Disease Control (CDC) plans to use smart watches to monitor the safety of coronavirus vaccines if they are distributed in the U.S. Using V-SAFE, a smartphone based health checker researchers will be able to check in on vaccine recipients for health problems. Although this is an efficient way of monitoring patients, adherence to privacy and HIPAA regulations may be an issue as well as long-term patient compliance. Description: With the roll out of the COVID-19 vaccine, health officials are concerned about the safety and how they will monitor the vaccine recipients. Although the results of two vaccine trials are expected to be more than 90% effective, health officials want to continue to monitor the safety of these patients along with millions of others who will receive the vaccine in the upcoming months. The CDC plans to have those who are vaccinated use V-SAFE, a smartphone based health checker that will use phone numbers from the registration process to send text messages and web surveys from the CDC to check in with recipients for any health problems resulting from the disease. Daily texts and emails will be sent within the first week followed by weekly messages thereafter for the following six weeks. Some privacy advocates have also raised concerns regarding the security of the data generated by the smartwatches in this program due to the lack of some safeguards found in contact tracing solutions. According to data privacy and protection advisor, while medical data is usually regulated under HIPAA, since participants will be using commercially available devices for this project, HIPAA may not be applicable. In addition, healthcare officials have raised questions about getting people to participate long term without feeling coerced into wearing the device in order to receive the vaccine. Implications: While imperfect, the continued monitoring of patients via smartwatch after receiving the vaccine can aid in tracking adverse effects that may not become apparent during clinical trials. With the device, experts have the ability to see side effects or adverse events and can quickly in real-time or near-real time decide if it is a true safety concern. When needed they can make vaccine recommendations for improvements. Although data privacy could be an issue, many experts feel this can be addressed as long as patients are fully consented and informed about the distribution of the data and how it is being shared. Perhaps of greater concern is the tendency for individuals to stop wearing their smartwatches after a period of time. As such, healthcare professionals need to reiterate the importance of consistently wearing the watch so patients can see how it will benefit their well-being and the wellbeing of others in such studies. Smartwatches Could Monitor Coronavirus Vaccine Safety

The Driver: Adyn, a Seattle startup, raised a $2.5 million seed round co-led by Lux Capital and M13. Adyn plans to use the funds to launch its birth control optimization test later this year. It has already sparked demand and has a waiting list for users. The Takeaways: Adyn’s at-home kit measures hormone baseline levels and assesses genetic risk for two of the most serious birth control side-effects: depression & blood clots Women’s health is often understudied, resulting in medically unexplained symptoms according to a report in Cogent Psychology. Women are more commonly misdiagnosed than men due to the medical research gap per the Association of Health Care Journalists. The Story: Adyn’s co-founder, Dr. Elizabeth Russo came up with the idea when she encountered side-effects of changing her birth control medication and “was thrown into suicidal ideation”. Given her background as a Ph.D. in genetics and genomics, Ruzzo was able to recognize this was due to the change in medication. However, as a result of the experience, she became dedicated to defining how gender gaps in research can lead to differences in disease and drug response particularly with birth control medications. For example, the company notes that over 50% of women try four or more birth control medications before finding one that works for them. Following her experience, Ruzzo launched a platform to address health disparities in women’s health while improving health literacy for her clients. Adyn’s mission is to close the medical research gap in women’s reproductive health. The Differentiator(s): While there are platforms that offer birth control without a doctor’s prescription, Adyn is attempting to change healthcare diagnostics and delivery through its telemedicine platform by using precision medicine to better match patients with accurate birth control prescriptions that attempts to minimize side effects. For example, while there are over 200 birth control contraceptives on the market they are generally prescribed for specific patients without any kind genomic testing for side effects, etc. (not to be confused with side effects and efficacy testing during the approval process) . Since the 1960s, birth control users have generally gone through a process of trial and error with multiple birth control prescriptions before finding one that works for them. For example, according to an article in Business Insider the “average time spent on contraceptive counseling is 12.9 minutes” and both patients and providers have become accustomed to this unscientific method when it comes to finding the best birth control. Due to gender and racial gaps in medical research, the pill selection process remains shrouded in mystery and frustration resulting in a broad range of reported side effects. These can range from weight gain to blood clots to depression when the patient and provider’s actual goal would be to have birth control be side effect free. Adyn’s telemedicine platform is equipped with specialized birth control specialists who aid in the pill selection process after testing and reviewing a patient's history. Adyn’s optimized at-home test collects information about an individual’s hormone level (through multiple readings) and genetic risk (via a single reading). These results are then explained to the patient, providing them access to their own biological data to help them make the decision in a comprehensive manner. Adyn is aiming to improve both the diagnostic approach and delivery of birth control contraceptives, and Adyn expects to offer reproductive healthcare recommendations (family planning, fertility, birth control) through their trained specialists. The Big Picture: For the past 30 years, women have generally been using an opaque process when choosing their birth control and certainly not one as scientific as many would expect given the wide range and severity of potential side effects. By closely monitoring and pairing birth control users with contraceptives that have minimal side effects, women's daily life and reproductive health should be improved. Through feedback and surveys with their patients, Adyn will also have the opportunity to investigate other reproductive problems such as polycystic ovary syndrome (PCOS) is a hormonal disorder common among women of reproductive age than can cause infrequent or prolonged menstrual as well as other menstrual irregularities. Lastly, by rejecting the outdated ‘trial and error’ method for birth control selection, Adyn can help demonstrate the quality and effectiveness benefits of personalized medicine and genomics on a broad scale which is likely to shape healthcare delivery well into the future. Precision Medicine Company Adyn Raises $2.5M Seed Funding for Personalized Birth Control

Telehealth Patient Satisfaction Surges During Pandemic but Barriers to Access Persist, J.D. Power Finds Event: (10/1) On October 1st, J.D. Power released its 2020 U.S. Telehealth Satisfaction Study noting that while “public awareness with Telehealth is higher due to ...COVID-19, the barriers for the consumer to engage with the technology has been a consistent theme” in their research. Description: The survey of approximately 4,200 healthcare consumers who have used telehealth services within the last 12 months, was conducted from June-July 2020. The survey measures consumer satisfaction based on 4 factors (in order of importance): customer service, consultation, enrollment and billing/payment. Among the key finding of the study were: 1) overall customer satisfaction scores for telehealth were among the highest of all healthcare, 2) barriers to access still exist with 52% of telehealth users stating they had encountered at least one barrier that made it difficult to use telehealth: with the most common complaints being services were too limited (24%), technology requirements were confusing (17%), or there was lack of awareness around cost (15%). Researchers found that many of those who were less satisfied with telehealth had lower self-reported health, lower wellness levels, and an overall lower health status Implications: While overall telehealth patient satisfaction scores have risen, both technical and access barriers remain (with technical audio issues being the most frequently reported problem). Driven to telehealth largely by the COVID pandemic with 46% of respondents indicating safety as the main driver for utilization, providers and payers now need to address how to make the technology even easier and more accessible. It is especially important for those in under resourced communities which may have technological limitations as well as for seniors who may struggle with the technology due to physiological issues (hearing or vision loss, etc). Telehealth Patient Satisfaction Surges During Pandemic but Barriers to Access Persist, J.D. Power Finds Avalere Analysis Shows Home Care Services Reduce Medicare Spending Event: (10/2) Healthcare consulting firm Avalere recently released an analysis that showed Medicare Fee-for-Service (FFS) patients getting home-based care services experienced a reduction in Medicare spending compared to patients who did not receive home based care and actually saw an increase in spending. Specifically Avalere determined the average Medicare FFS change in per-beneficiary-per-month (PBPM) was a decrease of about 5% for those with home care versus an increase of approximately 16% for those without home care.The study also found the spending difference was higher among Medicare beneficiaries with functional limitations and multiple chronic conditions. Description: Avalere conducted a retrospective study to analyze the comprehensive effect of home care interventions on Medicare spending. The Avalere retrospective study conducted from 2009 through 2018, compared 31,000 Medicare beneficiaries with home care services between 2012 and 2017 and those without home care services. This suggests a lower spend over time with home care services. Similarly, condition-specific subpopulation PBPM spending was low for home care services. The conditions compared were Diabetes with Chronic complications (-$227 vs +$324), chronic heart failure (-$175 vs +$432), and chronic obstructive pulmonary disease (-$155 vs +$410). Implications: The analysis recommends home care services as an efficient means to manage frail beneficiaries with chronic conditions against a difficult experience of a significant decline in their health and high-cost healthcare services. Homecare can save Medicare money by preventing unnecessary emergency department visits, hospitalizations, and readmissions. While additional research is mandated to concretely determine which home care services are causally linked to lower spending, the analysis shows a correlation between the delivery of home care services and reduced spending over time. Avalere Analysis Shows Home Care Services Reduce Medicare Spending Startup Aimed at Helping Patients Understand Doctor’s Orders Abridge Launches Event: (10/6) On October 6th, a new startup called Abridge was launched fueled by $15 million in funding. Abridge is an app that uses machine learning to record a patient's doctor's visit and then turns that recording into a patient focused transcript that simplifies details of their symptoms, conditions, procedures and medications.The app is designed to increase patient understanding of their diagnosis and adherence to their treatment plan. Description: Patient adherence has long been a problem in healthcare with the CDC noting that 20% of new prescriptions are never filled and over 50% of prescriptions are taken incorrectly. According to the CDC this lack of adherence is a combination of intentional factors such as inability to pay and unintentional factors such as a patients lack of understanding of how to use the medication. Abridge was built on the basis that everyone needs an easy way to remember and understand the details of their care. The new platform aims to help patients follow their provider’s advice and educate patients about their health, by recording the doctor’s visits and translating the conversation into an understandable transcript. Implications: With access to digital tools like Abridge, patients will be more comfortable and confident at their medical appointments and it will allow them to understand and question unfamiliar terms that may interfere with diagnosis and treatment. As a result patients will be better able to understand provider instructions and gain more insight into their plan of care. With Abridge’s automated speech-recognition technology at their disposal, patients will be able to take a more active role as an engaged consumer in their own care. This approach should lead to increased medication adherence and improved health behaviors both of which should contribute to higher quality outcomes at lower costs. Startup Aimed at Helping Patients Understand Doctor’s Orders Abridge Launches COVID-19 and Psychological Distress-Changes in Internet Searches for Mental Health Issues in New York During the Pandemic Event: (10/5) The Journal of the American Medical Association (JAMA) recently published a research letter looking at trends in internet searches for mental health issues in NY during the COVID pandemic. In order to better understand the pandemic’s impact on mental health the authors used Google Trends data to examine internet search histories for people living in NY state for the terms “suicide”, “anxiety”, “panic attack”, “insomnia” and, “depression” during the period from 3/22/20 (when NY state entered a COVID lockdown) through 5/14/20 (when portions of the state began a phased reopening). Description: To better understand the mental health concerns and the impact the pandemic had on mental health the authors used trends in search data as a proxy for increase or decrease in disease. According to the authors searches for anxiety significantly increased following the lockdown and remained on average 18% higher than expected prior to lockdown for a period of three weeks. Searches for the term panic attacks rose dramatically (56%) in the first week following closures and remained at elevated levels for five weeks. Similarly searches for the term insomnia rose 21% than historical data would predict during the lockdown and remained at those higher levels throughout the lockdown. Somewhat surprisingly, searches for the terms suicide and depression didn’t exhibit a significant increase from pre-COVID patterns, with the authors theorizing that this might be due to the impact of a feeling of solidarity with others facing the same situation. Implications: The study lends credence to the idea of using digital tools/data like internet search terms/trends in social media to get real time indications of changes in the mental health of a population. This type of data could be very useful both in tracking the longitudinal health of certain geographic populations as well as tracking the emotional health of a population in response to specific traumatizing natural or man made events (storms, fires, terrorism, etc.). By giving public health officials a more rapid view into changes in mental health, data like the above may empower a more proactive response from public health officials. This could, theoretically lessen the impact of such incidents on a population's mental health and thus lower the cost of care. COVID-19 and Psychological Distress—Changes in Internet Searches for Mental Health Issues in New York During the Pandemic Healthtech Startup Your.MD Raises €25m from FTSE 100 company Event: (10/05) European startup newsletter, Sifted recently ran an article that London-based healthtech startup Your.MD has raised €25m (~$29.5M USD) in fresh funds from Reckitt Benckiser (“RB”) to roll out its "health hubs" concept. Your.MD has developed a self-care app, Healthily, that helps users learn, assess, navigate, improve, and track specific behaviors that lead to better health. Description: Your.MD is using artificial intelligence to help users make better decisions around health. Unlike some others however, it does not make a diagnosis. Rather Your.MD is using AI to help users check their symptoms and advises users on what they should do next, whether it be talking to a doctor, ordering tests and medications, or finding a specialist. The company also views the app as a way to help lessen the strain on the healthcare system. The app provides a symptom mapper that shows users how their symptoms compare to others around the world. According to the company, it has seen a 350% increase in the number of users over the last 12 months, from 6m users from January to August 2019 to 26m the same period this year with part of the increase attributable to Your.MD’s COVID-19 symptom mapper, which had more than 4M visits. Implications: Firms like Your.MD which allow users to measure and monitor their own health help patients save time from unnecessary doctor consultations and empowers them to stay engaged and responsible in the management of their own health. In addition, Your.MD’s partnership with RB shows the strength of working with strategic investors, such as RB, which owns several over the counter brands such as Strepsils (similar to Cepacol), Gaviscon and Nurofen (Ibuprofen) which have broad consumer reach. As healthcare becomes more retail oriented this will become increasingly important. Healthtech startup Your.MD raises €25m from FTSE 100 company AdventHealth Adds to Long-Term Tele-ICU Partnership with Advanced ICU Care Event: (10/6) A recent article from PR Newswire noted that AdventHealth, a healthcare system based in Florida, rolled out its tele-ICU care services. This is an extension of its existing partnership with Advanced ICU Care, as it joins other AdventHealth hospitals that have telehealth-enabled ICUs. The partnership involves remote inpatient telemetry monitoring in addition to virtual ICU services. Description: AdventHealth Lake Wales, is a 160-bed acute care facility that strongly believes in whole person health as well as quality care. In 2014, AdventHealth created a partnership with Advanced ICU care, which is one the nation’s leading provider of high-acuity telemedicine. This partnership provides tele-ICU services that support frontline critical teams in the ICU. Tele-ICU services consist of an off-site command center in which a critical care team made up of intensivists and critical care nurses are connected with patients in distant ICUs to exchange health information through real-time audio, visual, and electronic devices. Implications: The new tele-ICU installation will move AdventHealth Lake Wales towards achieving the AdventHealth three-tiered care goal for critical care which includes lowering mortality rates, supporting bedside providers and improving data capture to support best practice compliance. In addition, tele-ICUs can also help to support immediate and ongoing acute care needs. Given the influx of patients in need of critical care during the ongoing pandemic combined with the need to keep providers and caretakers out of harm's way, telehealth can play a vital role in delivering needed care safely. AdventHealth Adds to Long-Term Tele-ICU Partnership with Advanced ICU Care

Healthcare Must-Have, Cultural Competency To Empower SDOH Our Take: Expanding access to digital tools with technology that incorporates cultural competencies and targets a diverse racial and ethnic population is an essential step toward ameliorating disparities. The ethnic community needs platforms that enhance the patient-physician connection by connecting patients with culturally competent medical professionals in ways that incorporate cultural, physical, and mental needs, allowing for decreased disparities and improved health outcomes for people of all backgrounds. Otherwise, as noted in a recent study in the Journal of the American Medical Informatics Association (JAMIA), innovations in health care policies and technologies risk reproducing and exacerbating existing inequalities caused by systemic racism making it less likely that members of racial and ethnic minority groups can benefit from advances in digital health. Description: The COVID pandemic has laid bare the heightened concerns about inequities in healthcare access, particularly with respect to patients' race and ethnicity. In addition, by 2050, studies indicate that 50% of the U.S. population will be of non-European origins. With studies showing that African Americans and Latinos experience 30% to 40% poorer health outcomes than White Americans because they do not get the health and medical care they need, providers need to incorporate culturally competent care. Moreover, research shows this poor care for the underserved is because of fear, access to quality healthcare, distrust of doctors, and often dismissed symptoms and pains.The hurdles to gaining healthcare access have been persistent throughout the past years. Despite significant research and efforts to improve access on many fronts, people of color still experience decreased access and treatment to care compared to their White counterparts. Importantly, the research also shows a difference in the way people of color access, experience, and receive healthcare compared to their White counterparts. For example, according to a study in the Journal of Cultural Diversity, rebuilding the African American community's trust needs to be at the forefront of healthcare’s diversity efforts since they feel they will be used as test subjects, in part reflecting the legacy of the infamous “Tuskegee experiment”. The study also notes that many African Americans feel that the actual act of receiving health care is a degrading and humiliating experience attributing some of these problems to insults, lack of communication, and low quality of care. Insults may also include some form of gestures or comments that may be demeaning. For example, in a recent post in the Harvard Health blog a physician noted how a patient reported that during an emergency room visit for a painful medical condition. doctors had treated her like “she was trying to play them, like I was just trying to get pain meds out of them” simply because she was black. The article went on to note there was nothing in the patient chart to indicate any pain-medication seeking behavior, had never had any issues with substance abuse and eventually had to go elsewhere to get an appropriate diagnosis and care. Another study conducted by the Perelman School of Medicine at the University of Pennsylvania addressed the correlation between patient experience scores, race, and health systems' need to address implicit racial biases in medical settings. The study found that patients who saw physicians of their own race or ethnicity were more likely to rate their physicians higher on patient experience surveys than those who saw physicians of different races or ethnicities. The relationship also shows a higher occurrence of participation by the patients with their own health care needs. For health outcomes to be improved, mistrust of the healthcare system for minority racial and ethnic groups needs to be addressed by improving cultural competence amongst healthcare providers. In addition, the shortage of minorities working in the healthcare system needs to change in order to adequately represent solutions to the most salient issues of the minority population. With limited minority health care professionals at all levels, the diversity of the healthcare system will continue to be non-representative of the population which it’s serving, limiting its effectiveness. Implications: The combination of historical and modern-day experiences has created mistrust of the health care system by many minority groups. The minority community has to be educated about promotion and prevention related to health and health care issues. If there is a continued distrust of the healthcare system, racial and ethnic groups will continue to experience increased disease complications, increased health costs, and poor health care management and outcomes. Health care must be re-directed to raise awareness by health care groups and communities so they .can mobilize and change these complex issues that remain in society today. Efforts on the part of the government, businesses, health care providers, and the general community will play critical roles in getting this accomplished. A study conducted by Rumi Chunara analyzed health records for 140,184 patients who sought care either in person or through telemedicine. An inference was made that Black patients using telemedicine were more likely to receive a suspected diagnosis of COVID and subsequently test positive as compared to White patients, suggesting that Black patients, “may be sicker when seeking care through telemedicine compared to White patients.” Evidence from the study showed that Black patients were less likely to receive a suspected COVID diagnosis overall than White patients suggesting that more equitable care occurs over telemedicine. This is an exact result of interactions normalizing between clinicians and patients virtually and decreasing biases in healthcare. Chunara also indicates that including diverse perspectives in a "participatory design" process and incorporating "cultural and linguistic adaptations can inform the redesign of telemedicine tools and platforms that cater to racial and ethnic populations. HealthcareITNews noted a study that used the Mount Sinai De-Identified COVID database to promote research showing that Black and Latinx patients were less likely than White patients to use telehealth services because they did not have access to a usual source of care, such as a primary care physician. Additionally, disparities in digital access, digital literacy, telehealth awareness, issues of cost and coverage, and mistrust of digital appointments were all potential barriers to using telehealth. In order to reduce disparities, public awareness should be given to racial and ethnic differences present in minority groups. Moreover, formal and informal policies and interactions that are rooted in inequality, discrimination, oppression and exclusion among patients and clinicians need to be addressed in the future. A recent paper found that there were eleven educational strategies which could be employed to teach and train about cultural competency and disparities. We believe some of the most interesting were: 1) immersion experiences; 2) discussion groups; 3) simulations; 4) reflections; case-based learnings (CBL); and, 5) assessments. These methods could prove quite useful for healthcare organizations that rely heavily on patient experience scores for assessing physicians as these directly impact PressGaney scores and reimbursement. Moreover, providers and educators need to invest in the re-education of providers and revamp the medical school curriculum so new providers can be culturally competent and care for patients of any race or ethnicity. In addition, a number of innovative new technological platforms like Mahmee, Spora Health, Hued, Health in Her HUE, and Therapy for Black Girls give access to minorities at their convenience to boost health outcomes for people of color. Mahmee is a secure management platform connecting payers, providers, and patients to comprehensive prenatal and postpartum healthcare from anywhere. Spora Health is a culture-centered healthcare provider that provides telemedicine services to people of color in order to navigate a healthier lifestyle. Hued, Health in Her Hue, and Therapy for Black Girls facilitates a compatible, matched physician-patient connection amongst minority communities and culturally diverse clinicians to improve the disproportionate health outcomes for people of color. By increasing cultural competence and access to minority clinicians within the current healthcare system, racial and ethnic minorities will engage the system early and have better health outcomes with lower costs, thereby improving performance. Racism and Discrimination in Health Care: Providers and Patients & Study: NYC Black and Latino Patients Less Likely than White Patients to Use Telehealth During Pandemic 2020 Revealed How Poorly Prepared the US Was for COVID-19--and Future Pandemics Event: A recent article in JAMA Forum noted that not only were the effects of the COVID pandemic on the United States unexpected, the COVID pandemic exposed how poorly the U.S. was prepared for this-and potentially future pandemics. The author noted a number of steps that can be taken going forward to ensure that the U.S. is more prepared for the next pandemic. Description: When the COVID pandemic reached the United States in January of 2020 with a man who had returned from Wuhan China four days earlier, no one could have been prepared for what followed. While the U.S. CDC began screening international travelers, in late February the first cases not related to international travel were confirmed. By the end of the year, the US had over 20 million COVID cases and 346,000 deaths. While the pandemic decimated the economy, with over 15 million fewer people on the payrolls in June than had existed in February, female workers were impacted disproportionately. According to the U.S. Bureau of Labor Statistics, over 5 million women lost their jobs and 2.1 million have left the workforce entirely given they were the primary caregivers in the home and the closure of in-person schooling had left them without childcare. In addition, while the development and emergency use authorization of a COVID vaccine occurred with record speed, the distribution and administration of vaccines has been haphazard at best. Drawing on state and local government’s role in the preservation of public health the prior administration gave them authority to devise distribution plans. However, between the the Federal government not providing state and local governments additional resources to handle distribution and the impact of the economic crisis on states finances, states were poorly positioned to take on this added responsibility. Implications: While there were significant missteps that led to a lack of preparedness for the pandemic, and there is more than enough blame to go around, certain actions should be taken to increase preparedness for a future pandemic. First, while the global health position on the National Security Council had been eliminated under the prior administration and has been reestablished under the current one, this consistent pattern of brinksmanship needs to be avoided and the position made permanent. In addition, the Federal government needs to rethink the stockpiling of supplies and their deployment as well as develop strategies for providing surge capacities of medical personnel and facilities in preparation for another pandemic. Moreover, advance preparations need to be in place to determine which populations would be most vulnerable to a new threat and plan how best to distribute resources to protect them. Finally, authorities need to devise better communication and education strategies to encourage people to embrace and undertake actions for the common good (ex: mask wearing, social distancing) in the event of a future pandemic. 2020 Revealed How Poorly the US Was Prepared for COVID-19—and Future Pandemics At Home Health Testing Kits Everlywell and Luciera Health Raise Money Event: Recently TechCrunch and the San Francisco Business Journal reported that at-home health testing kit companies Everlywell and Lucira Health have raised $75 million and $115 million, respectively. In addition to a home collection kit for COVID (which both have developed) Everlywell has developed a test for thyroid issues, allergies and food sensitivities. Lucira, which was the first to receive authorization as the first at-home COVID self-test is also developing a combination COVID and flu test kit. Description: Everlywell and Lucira are two examples of the increased acceptance and innovation in the at-home diagnostics and therapeutics space. Everlywell’s SARS-CoV-2 test, allows individuals to check infection without having to visit an in-person test site. After the individual collects and ships their sample, they receive secure digital results within 24-72 hours. A telehealth consult is available to guide users through the next steps. The kit rt-PCR test has received an EUA from the FDA, and meets their benchmarks for accuracy. Although the cost for the test is a steep $109, the test cost can be reimbursed with healthcare insurance or if the user is HSA & FSA eligible. Lucira has developed an at-home testing kit that allows individuals to self collect their nasal swab samples and receive their results within 30 minute without shipping it out. Although the test has been authorized by the FDA, it has not rolled out for sale yet. Lucira estimates the test will cost around $50. The testing platform that produces centralized-laboratory-accurate molecular testing in a single-use, consumer-friendly test kit is powered by two AA batteries. The company's initial focus is within respiratory diseases, starting with COVID and influenza A and B virus indications. In a Community Testing Study, where the Lucira test was compared to a FDA authorized SARS-CoV-2 test, Lucira achieved a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA). The results are easy to read with a simple light up display. Implications: Whether the at home testing kit delivers results within 30 minutes or within 24-72 hours, these solutions give individuals the ability to get tested and remain in their own homes. By contrast, in-person testing can have long wait lines and often require long commutes which can interfere with time working or caring for loved ones. In addition, as noted, in person-testing requires patients to expose themselves to more risk and potential danger. At home testing kits can be done anywhere, anytime and more safely. This results in improved access for people who don’t have time to make appointments or commute to the nearest clinic. While at home testing kits are currently more expensive than on-site testing, this could be addressed by insurers and regulators thereby broadening availability and access. Moreover, at home testing and therapeutics could easily become a way to address healthcare disparities by reducing commuting and waiting times for testing at clinics and increasing access to testing for those in under resourced communities. COVID-19 test kit developer Lucira Health files for a $115 million IPO & Everlywell Raises $75M from HealthQuest Capital following its recent $175M Series D Round HCAP Partners Announces New Investment in 83bar Event: 83bar, an Austin, TX-based leader in patient journey management for both clinical trials and commercial clients across pharma, medical device, and diagnostic industries, has raised an undisclosed amount. 83bar provides a cost-effective patient activation platform to find and retain qualified individuals for clinical trials and commercial clients. The company locates patients on behalf of its clients, evaluates them using online screeners, and activates patients who are then ready to act with medical providers. Description: 83bar is used to help identify patients for clinical trials. It locates patients on behalf of its clients, evaluates them using online screeners, and connects appropriate patients with medical providers. The distributed Patient Education Specialists call center provides personalized, rapid-response education, screening, and qualification for prospective patients. Its end-to-end data capture platform provides full campaign reporting, analytics, insights, forecasting, and optimization in a proprietary database of over one million patients that can be specifically targeted for future trials. Patients used in test trials are then compensated for their efforts. As of December 2020, the platform successfully scheduled 130,000 appointments, facilitated 6.8 million communications, and captured 840,000 completed surveys. Implications: Clinical trials are necessary to develop drugs and learn more about the safety and efficacy of drugs. With over 48% of trial missing enrollment targets and almost half of patients dropping out of trials before its completion 83bar can capitalize on it’s unique investment and infrastructure to expand its clientele to help medical providers and patients to discover more about drugs under development. For example, clinical trials can help discover the long-term effectiveness of drugs for deadly illnesses like COVID vaccine, however these drugs must be developed as quickly and cost effectively as possible. In addition, once discovered drug dosages and safety profiles need to be adjusted/tested (ex: such as the effectiveness COVID vaccines for children) by administering the vaccine. Firms enabling digital clinical trials such as 83bar can help speed development and improve efficacy. HCAP Partners Announces New Investment in 83bar Washington State Taps Key Stakeholders for Help with COVID-19 Vaccine Rollout Event: On January 18th, Medium reported that Governor Jay Inslee of Washington State announced a new statewide vaccine distribution and administration plan to increase the number of Washington state residents receiving the COVID vaccination. Through a partnership with key stakeholders, the state will work to reach the state’s daily vaccination goal of 45,000. Description: With the Coronavirus growing, the need for COVID vaccination distribution has become even more pressing. As a result, Washington state created a new statewide public-private partnership, the Washington State Vaccine Command and Coordination Center, to boost vaccine distribution efforts. Under the plan, each stakeholder is expected to focus on different areas of vaccine distribution including logistics coordination, allocation strategies, infrastructure support and development, and cross-organizational and agency operational communications. Among the stakeholders Kaiser Permanente will be responsible for planning expertise for mass vaccination clinics and the distribution of vaccine to healthcare providers; Starbucks will be responsible for operational efficiency, scalable modeling, and human centered design expertise; Microsoft will be responsible for technology expertise and support; SeaMar will be responsible for representing historically underserved communities; and Costco will be responsible for vaccine delivery. Implications: The involvement of these companies in this private-public partnership will both aid the state in reaching their goal and hopefully grab the attention of skeptical residents who need reassurance that they will be receiving a safe and thoroughly tested vaccine. However, despite the involvement of these companies in the plan's potential success, several changes to both distribution phases and state infrastructure are still necessary. This includes: 1) An update to vaccine distribution phases to include those 65 and older, aligning with new federal guidelines from the CDC and increasing accessibility to high risk populations, 2) Mandating providers administering vaccines to administer 95% of vaccine allocations within a week of receipt and reporting vaccine data to the state within 24 hours of administration, 3) The DOH will coordinate volunteer vaccinators to support vaccine administration, connect with all vaccine administrators across the state to assess where additional assistance is needed to meet the new requirements, and establish high vaccination sites to prepare for future vaccine allocations. Once these changes are achieved, and with the expertise and efforts of the companies involved, Washington State’s vaccination goals and resident’s access will be improved. This will give them a greater chance that their goal will be met, bringing Washingtonians’ that much closer to effectively combating the COVID virus. Washington State Taps Starbucks, Costco for Help With COVID-19 Vaccine Rollout & Inslee Announces State Plan for Widespread Vaccine Distribution and Administration Tech Partners Unveil Life Science Data Platform Event: Healthcare IT News reported that Microsoft, the Broad Institute of MIT and Alphabet’s Verily subsidiary had formed a partnership that supports new life science data platform – the Terra platform designed to work across different types of biomedical information. Terra simplifies a range of processes allowing researchers to analyze and share data they have generated. Description: Terra platform is a secure, scalable, open-source platform for biomedical researchers to access data, run analysis tools, and collaborate. The platform is a new strategic partnership with the goal of accelerating the pace of potential biomedical innovations. This aims at the potential benefits of collecting previously unimaginable amounts of biomedical data combined with the huge challenge of identifying how to organize and manage those same stockpiles. According to the partners, while more biomedical data (ex: genomics, imaging, biomarkers, EMR data, etc.) are being generated and digitized than ever before “making use of these important datasets remains difficult for researchers who face huge, siloed data estates, disparate tools and fragmented systems''. The goal of the partnership is to bring together technology experts, science researchers, and data scientists to combat challenges and boost Terra’s overall vision for health and life sciences. Implications: The companies aim to create a seamless and secure workflow to quicken the delivery of data and insights between research and clinical domains. With such companies partnering together and developing digitals tools such as these it will speed up biomedical research and lower cost across healthcare and life sciences. The partnership combines multimodal data, secure analytics, and scalable cloud computing to improve insight and evidence generation to ultimately impact more patients’ lives. According to Stephen Gillett, chief operating officer at Verily, all three organizations share the goals of “improving patient care, driving innovation in biomedical research and lowering costs across life sciences”. Tech Partners Unveil Life Science Data Platform

Slipping Away: Does the Employer-Sponsored Health Care System Have an Expiration Date? Event: On November 3rd, Benefits Pro released an article stating that the employer-sponsored health care system may come to an end if employers don’t move more quickly to improve the system. According to former Florida Governor Jeb Bush’ “for those who believe in markets, choice and patient responsibility haven’t been offering creative 21st-century suggestions...there has been very little discussion about alternatives” to expanding Medicare. Description: The article noted that unless the Employer-sponsored insurance (ESI) industry can deliver on much needed reforms, its day’s might be numbered. It added, that “while there is still time to step in with solutions that ease the pain”, by some estimates, “if the health care system can’t be righted within the next five years, we’ll be looking at a full government takeover”. It is also clear that existing healthcare industry participants are resisting change and that the current system is “riddled with throwing technology on top of broken processes” instead of fixing “the process and then [applying] the technology”. As a result many are looking to big names like Amazon (and its Haven health care venture), Google, Apple, and Microsoft to bring health care costs under control and improve outcomes. Implications: ”Our country is creeping--in some cases jogging and even sprinting--toward a government dominated healthcare system” as pointed out by former Florida Governor Jeb Bush, but employer resistance to innovation and true improvement risks crippling the system. While COVID has laid bare the shortcomings of the system it has also dramatically accelerated the pace of change. Taking advantage of this opportunity now is especially important as Millennials, the largest generation in history who are expected to make up 75% of the workforce by 2025, are starting to get to the point where they interact with the healthcare system and demand more. Smart employers can take advantage of the opportunity to design a curated, more modern ESI healthcare plan or risk a permanent move toward a government-run healthcare system. Slipping Away: Does the Employer-Sponsored Health Care System Have an Expiration Date? Amazon Teams up with 2 Ohio Health Organizations on Telemedicine Offering Event: On November 2nd, The Daily Record reported that two Ohio healthcare companies have partnered with Amazon to offer telemedicine services with free prescription drugs to Amazon’s customers. This partnership serves as another significant strategic investment in Amazon’s quest to infiltrate the healthcare space to create better health options and outcomes for consumers. Description: Since the early 2000’s, Amazon has worked diligently to enter the pharmaceutical market, investing in companies such as Drug.com with plans of expansion. In June 2018, the company successfully did so with its $1B acquisition of PillPack, a pharmaceutical company with licenses in 49 states that would help to accelerate expansion in the market. The companies partnership with Healthcare Advisory Network, a healthcare consulting firm in Centerville, Ohio and BasiCare Plus, a national prescription and telemedicine program in Wooster, Ohio came together over the past two years to offer employer groups, colleges, and associations telehealth services. The partnership with Amazon was inspired by many patients opting to use telehealth services due to COVID-19 concerns instead of going to a doctor’s office for non-urgent medical issues. The organization also offers coverage with no copays or deductibles through telemedicine service MDLive for up to nine family members starting at $65 for a three-month subscription. Additionally, the program provides discounts on medications at more than 65,000 pharmacies. For patients to obtain these services, it is as easy as going on Amazon’s website and searching BasiCare Plus. Implications: This partnership has extended Amazon’s penetration of the pharmaceutical market, increasing its leverage over other retail giants as they seek to gain a footing in the healthcare industry. The partnership also gives the businesses the opportunity to provide inexpensive health care to people who lack coverage and allows patients to avoid copays and deductibles when visiting a doctor, urgent care or emergency room for non emergency issues. Given the company’s extensive distribution network, Amazon can use this leverage to disrupt everything from the pharmaceutical supply chain to Medicare drug benefit management. Its continued move deeper into the healthcare realm will either drive changes in healthcare delivery or force the existing retail giants to become more competitive. Amazon Teams up with 2 Ohio Health Organizations on Telemedicine Offering MIT Researchers’ AI Model Detects COVID-19 by Listening to Coughs Event: On November 4th, an article in Mobihealthnews reported that MIT researchers developed an AI tool that can listen to a person’s cough and determine if they have COVID-19, whether or not they are symptomatic. The research, first published in IEEE Open Journal of Engineering, reported that for asymptomatic positive cases, the tool performed at 100% accuracy. Description: To build the artificial intelligence tool, researchers solicited more than 70,000 audio recordings of individuals coughing, with an average of three coughs per subject in addition to accompanying information about a subject’s condition through an online website. Researchers trained and validated a convolutional neural network-based model using the cough recordings and an equal number of randomly selected COVID-19 negative samples. This was done by listening for specific acoustic biomarkers related to muscular degradation, vocal chord changes, sentiment or mood changes, and changes in the lungs or respiratory tract. The new artificial intelligence tool yielded 97.1% overall accuracy, 98.5% sensitivity, and 94.2% specificity. Implications: MIT envisions its new AI tool as a low-cost COVID-19 pre-screener that can be deployed in settings where comprehensive diagnostic testing is unavailable or cannot scale for entire populations. According to the research, “this noninvasive, free, real-time prescreening tool may prove to have a great potential to complement current efforts to contain the disease in low-infected areas, as well as mitigate the impact in highly infected areas, where unconscious asymptomatics may [unknowingly] spread the virus.” The same MIT team has been developing vocal biomarkers for use in diagnosing respiratory conditions and Alzheimer’s disease, suggesting that there may be some other higher level biomarkers that can be used to diagnose diseases thought to be unrelated. MIT Researchers' AI model Detects COVID-19 by Listening to Coughs Curve Health Raises $6M Seed Round Event: On October 29th, Citybizlist reported that Curve Health which delivers connected senior care via a platform that combines telemedicine, smart billing, health information exchange, and predictive analytics had raised a $6M seed round. Description: Curve Health advances connected senior care by enabling physicians to remotely care for patients in skilled nursing facilities (SNFs), in the home, in ambulances or wherever they may be. Curve Health combines telemedicine, a health information exchange, predictive analytics, and smart billing into a single platform, resulting in higher quality care and significant return on investment. In addition this ensures a virtually seamless patient experience. Curve Health, which is built on, and expands, the Call9 platform, not only facilitates telemedicine but creates a true virtual hospital-level care experience for patients and providers. By bringing the hospital to the patient, Curve is able to improve outcomes, reduce unnecessary hospitalizations and improve bottom lines. Implications: Patient transfers from SNFs to EDs can be stressful and traumatic for patients and expensive for providers, Curve is built on a platform that has been demonstrated to markedly reduce transfers to ED’s thereby improving patient experience while simultaneously cutting the risk of infection. In addition, by using telemedicine, Curve allows seniors to age-in-place longer enjoying the comfort of their own home. By reducing transfers and hospitalizations, services such as Curve can redirect high cost institutional care to a more appropriate setting and significantly reduce patient cost while improving care. Curve Health Raises $6M Seed Round Patients Shirked Diagnostic Testing, In-person Preventive Care Amid Telehealth Boom this Spring Event: In a recent article Healthcare Dive reported that during the Covid-19 pandemic while numerous patients opted for telehealth visits there were also substantial drops in diagnostic procedures and preventive elective care. Description: While telehealth boomed during the pandemic, there are certain services that providers are not able to deliver virtually including routine diagnostic procedures used to detect major health conditions before they progress. Overall, healthcare utilization dropped 23% in March and 52% in April. Mammograms and colonoscopies dropped more than 65% in March/April compared to last year; musculoskeletal surgery, cataract surgery, and MRIs all dropped by 45% or more; chronic conditions including blood sugar tests fell 50%, chemotherapy dropped 4%, and, vaccination for children under 2 years dropped by 22%. Comparatively, telemedicine visits jumped 4,000% compared to the year prior, but only replaced about 40% of the drop in in-person visits. Implications: Delaying diagnostic procedures poses a danger to high-risk patients since early signs of serious diseases may get missed leading to potential adverse outcomes. The pandemic has caused fear and anxiety among patients surrounding in-person visits unless they are absolutely necessary. However, providers and payers can use improved communication and a more collaborative environment to engage patients and ensure they get the necessary tests and treatments. Telemedicine can factor in by scheduling screening appointments to connect with patients and build confidence that will get them back to the facility for necessary testing and procedures. Not only would this benefit patients, but increases in diagnostic and elective services would help replace revenues lost during the pandemic and have positive financial implications on providers as well. Patients Shirked Diagnostic Testing, In-person Preventive Care Amid Telehealth Boom this Spring