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The Driver: Healthie a company building the infrastructure for next-gen digital health companies for virtual care recently raised $16 million in series A funding. The funding round was led by Velvet Sea Ventures with participation from Greymatter Capital, Watershed, Builders VC, and a customer syndicate. Healthie offers a digital infrastructure for next-generation digital health companies that offer virtual first care. The co-founders of Healthie are focusing on providing customers with a template that allows them to customize their care needs and allows companies to provide virtual engagements. Healthie’s CEO Cavan Klinisky stated that the funds raised in this funding round will be used to develop their software platform further. Key Takeaways: Healthie’s clients which include Crossover Health, Plume, and Wellinks have raised around $700 million in VC funds per Business Insider. According to a report from the University of Southern California Sol Price School of Public Policy, 35 million people in the country lack basic healthcare access due to cost and lack of accessibility. According to the Office of the Assistant Secretary for Planning and Evaluation, since the beginning of the pandemic, close to 22% of Americans use telehealth services. Currently, more than 2,000 organizations use Healthie’s services, and the company stores upward of 1.3 million patient records. The Story: Healthie was founded in 2016 by co-founders Cavan Klinsky and Erica Jain. The idea behind Healthie started with cofounder Erica Jain after she witnessed her parents struggle with weight loss but lack access to a comprehensive care team. Her solution to this issue was to create an all-in-one health platform that other companies can utilize for their healthcare business. The platform includes a client portal, electronic records, scheduling, wellness programs, billing options, telehealth and webinars, and cloud-based EHR. As noted by the company, historically these solutions were delivered as separate tools that companies were forced to integrate or build in-house, which is timely and expensive. There are 5 different subscription plans that Healthie offers providers for their healthcare startup. The Starter plan is free and allows for 10 active clients along with the features mentioned above. The other subscription plans are paid annually, but subscription rates are listed per member per month. Subscription prices range from $45/month to $135+/month. The Differentiators: The Covid-19 pandemic has changed the way that people expect to receive healthcare services and Healthie is taking the initiative by supporting the evolving landscape of healthcare. This platform differs from its competitors in that Healthie is not just an electronic medical record but a broad offering where its users can manage patient data, arrange schedules, pay bills, and allow for virtual telehealth visits. Healthie aims to make it possible for anyone to start their own healthcare company by managing administrative and operational functions at cheaper rates than their competitors. Although there are companies such as Athenahealth and Epic that are used for their EMR, Healthie is aimed more broadly than offering just a medical or billing-driven application. The Healthie platform prides itself on its ease of use and affordability for whoever wants to use it. The Big Picture: The co-founders of Healthie recognize the need for advancement and engagement within the healthcare industry. Their proposed solution is aimed to make the startup process for healthcare providers as smooth as possible by taking care of the tedious aspects of running a business. For providers, this means updated electronic databases, telehealth services, billing software, and analytic tools to track how their business is performing. The patients benefit from this as well because they can access virtual appointments and webinars, participate in wellness programs, and access it all easily from a mobile device. While the solution is not the first of its kind, it definitely is an improvement in terms of accessibility, efficiency, and cost-effectiveness for newer startups. While, as noted by the founders, healthcare systems are capable of creating their own electronic health record system, the adoption of the platform has been successful, because their goal sits at the center of provider and customer interaction, housing the business, operational, financial, and health information for customers as the “underlying infrastructure for next-generation virtual care.” Healthie lands $16.5M to build the Stripe for virtual patient care, This startup helps healthcare providers offer better virtual care. Check out the 18-slide pitch deck Healthie used to raise $16 million (subscription required).

Overview: Since we have written approximately 75 Our Takes in the last two plus years we thought it might be helpful to take some of the summer to look at “Lessons Learned” from our posts. As such, this summer we will be looking at our lessons learned on the broad range of digital health on topics we’ve written about including Artificial Intelligence; RPM and Virtual Care; Value-Based Care, and Mental Health (among others). This week we look at healthcare data interoperability and exchange of electronic medical records with a focus on how new digital tools can change current practices, empowering patients and providers alike. The Backdrop: With increased utilization of digital and mobile health tools comes a deluge of data to collect and analyze. As digitization brings increases in the availability and applications of data many patients and providers alike are reporting increased support for such data sharing and demanding better interoperability measures that make their healthcare more efficient and effective. For example, a survey conducted by the Pew Charitable Trusts found that approximately 40% of survey participants reported COVID made them more likely to support data-sharing enabling efforts among healthcare providers and to allow the download of one’s electronic health records (EHR) to their mobile apps. Additionally, between the passage of the HITECH Act in 2009 and 2015, EHR adoption grew from 12% to 72% for hospitals and 22% to 54% for ambulances according to the Office of the National Coordinator for Health Information Technology as government incentives helped drive adoption. More medical data is being generated than ever and there is a need to modernize data processing and sharing to meet this growing demand. However, the inefficiency due to a lack of data interoperability between medical organizations is adding significant additional costs that the industry must bear both financial and non-financial. In terms of financial costs, according to an “Administrative simplification: How to save a quarter-trillion dollars in US healthcare” by McKinsey & Co it may be possible to save over $250 billion annually in healthcare spending by reducing and eliminating wasteful practices with over $100B of that coming from improvements in technology platforms like a centralized, automated claims clearinghouse for insurers. In terms of non-financial benefits, the COVID pandemic was one of the first widespread pushes toward interoperability and data sharing on a national scale and international scale for public health, highlighting the importance of open data standards in collecting and analyzing such a large volume of data rapidly. Panelists at the 2020 World Health Summit concluded that global collaboration and data interoperability has the potential to vastly improve responses to similar events in the future, and sharing health data is necessary to coordinate an effective counter to any public health emergency. However, in an increasingly digitized world, data, privacy, and security cannot be neglected and in fact, must be prioritized. Moreover, not only is it extremely important to preserve patients’ privacy, payers, providers, and others in the healthcare ecosystem must follow both the letter and spirit of the law if they are to maintain patients’ trust. Lessons Learned: What have been some of the “lessons learned” on contemporary issues surrounding health information exchange from our earlier Our Takes? There continues to be a need for digital tools to be developed with an emphasis on interoperability for healthcare payers and providers to standardize practices given the flawed and disconnected nature of healthcare data and the inability to share data easily. According to the Office of the National Coordinator for Health Information Technology (ONC), one of the core issues regarding interoperability is that interoperability is more than just implementing a standard or being able to have two systems exchange data with each other. Healthcare is plagued by the fact that there is no single system of record for interactions with the system and even no single way to identify patients (ex: a national patient identifier). Often data can be lost between systems or very difficult to exchange between systems. For example, while claims data is predominantly financial, clinical systems have to deal with structured data (ex: coding for diagnosis and testing), unstructured data (ex: physician notes in free text fields), and fields involving different storage mediums and signal processing (ex: blood tests, EKGs, etc.). There are now over 350K health-related mobile apps, with almost 90K created in 2020 alone, greatly expanding the amount and types of data available and further driving the need for data access and interoperability. Eliminating Interoperability Hurdles in Digital Health Requires More Than FHIR-The HSB Blog 10/4/21 Promoting data interoperability has the potential to significantly reduce healthcare disparities and empower patients to take control of their own health data. As noted at the Workgroup for Electronic Data Interchange event, studies have shown that minority patients routinely receive inferior care because they may be bouncing between hospitals and clinics and also have higher rates of chronic illnesses like diabetes and hypertension, which research indicates can be better addressed by digital technologies. Having access to digital technology can empower consumers to make better-informed decisions about their health, provide new options for facilitating prevention, and manage chronic conditions outside of traditional healthcare settings. A report by the U.S. Government Accountability Office and the National Academy of Medicine states that increasing high-quality data access and transparency can help developers eliminate bias in data by ensuring the data is representative at larger scales. Without such data access mechanisms, AI tools could be vulnerable to bias from skewed data, which can impact the manner by which decisions are made as well as the quality of these decisions. This would have negative consequences for health equity. Does AI Always Optimize Healthcare? You Need Data Access, Education & Oversight -The HSB Blog 2/8/21 Enhancing Telemedicine Can Close The Infant and Maternal Mortality Gap-The HSB Blog 3/8/21 The creation of digital healthcare platforms to address data interoperability and increase operational efficiency can help healthcare providers exchange data seamlessly and lower costs moving forward. As noted in a 2020 Forbes article healthcare data interoperability solutions can provide the foundation for additional healthcare applications and solutions to be built on. Given the lack of standardization in workflows and custom technology building platforms for software engineers will reduce the cost of custom solutions and support more healthcare innovation. Opportunities for integrating platforms in healthcare, include improving the transferability of patient data to support care coordination, reducing the administrative costs associated with paying for care to reduce overbilling and improving cost accounting to support the transition from fee-for-service to value-based care. It is estimated that $191 billion to $286 billion, or 5% to 8% of total US costs could be saved if interventions to reduce waste were implemented and were successful according to a recent study in Health Affairs, Platforms In Healthcare-Part 1. Platforms Explained-The HSB Blog 11/29/21 Platforms in Healthcare Pt. 3-Healthcare Specific Challenges & Opportunities-The HSB Blog 12/13/21 Data security must remain a top priority as healthcare becomes increasingly digitized both for protection and to ensure access by appropriate parties. All parties need to ensure they have comprehensive policies, procedures, and audits in place to protect patient data, and comply with HIPAA both in terms of the rule of the law and its intent. For example, research done by ONC on individuals’ perceptions of data privacy and security shows approximately two-thirds of respondents remain concerned about unauthorized viewing when data is shared by providers. This will become an even bigger concern as the volume of data grows. One study estimates the global healthcare data storage market is expected to grow at a compound annual growth rate of over 16% between 2019-2026 and will reach over $8B by 2026. Although moving data to the cloud will help increase availability and decrease costs it could pose additional security risks. A 2016 article published by the Institute of Electrical and Electronics Engineers, found additional security and privacy issues when sensitive data belonging to enterprises and individuals are stored and used by services in the cloud. In addition, there are also significant security issues arising out of malware attacks in the cloud which have access to both data and services of many users and also the ability to propagate to many systems over the cloud infrastructure. Many consumer-facing apps have found themselves in the news for exposing user information or undisclosed third-party data sharing, the dramatic increase in the use of mobile health apps during the pandemic has only heightened the security risks according to an article from Business Wire. Despite Advances, Data Security Still The Key To Cloud Adoption in Healthcare-The HSB Blog 3/28/22 Eliminating Interoperability Hurdles in Digital Health Requires More Than FHIR-The HSB Blog 10/4/21Telehealth Could Magnify Inequity For Those Who Lack Access-The HSB Blog 2/16/21 Final Thoughts: COVID dramatically accelerated the use and application of digital and mobile health and with the large volume of data generated and collected by medical providers, the problem of system interoperability and data sharing remains an issue. While recent regulations have put a focus on encouraging interoperability of data and electronic medical records, and the creation of new digital platforms has created ways to speed the development of such systems, healthcare data remains incredibly disconnected and siloed. Alongside this explosive growth in patient data that will increase our ability to improve care and forecast outcomes, comes concerns surrounding data security and privacy which will need to be prioritized. Improving data sharing and interoperability will allow digital and mobile health solutions to fulfill their potential to create new ecosystems that can improve operational efficiency, promote interconnectivity between providers and patients and help tackle historic health disparities. Moreover, this would give patients a greater say and the ability to get involved in and manage their own care which could have meaningful benefits in terms of costs and quality.

The Driver: Medallion recently raised $35 million in Series C funding led by Sequoia Capital who were joined by repeat investors Optum Ventures, Spark Capital, Elad Gil, and Daniel Gross. Also joining this round were Mario Schlosser CEO of Oscar Health, Iyah Romm CEO of Cityblock Health, and Will Gaybrick Chief Product Officer of Stripe. Medallion promises to help healthcare institutions become more streamlined and updated on the administrative level so patient care is improved, patient throughput increases and productivity of administrative staff becomes more efficient Key Takeaways: Healthcare administrative expenses (which include billing, patient enrollment, and insurance claims) are said to represent anywhere from 15-25 percent of the total nation's healthcare spending. Administrative spending also includes other “insurance-related activities” such as licensing healthcare workers (doctors and nurses), background checks on healthcare staff and signing up with different insurers (enrollment/empanelment). The U.S. spends significantly more than other nations on administrative costs, spending twice as much as Canada on administrative costs. Medallion claims to have cut over 250,000 hours (of bureaucratic headaches) since its inception due to the streamlining of the extensive administrative process which can instead be spent on provider care. The Story: Derek Lo, CEO of Medallion founded the company after talking with Zachariah Reitano co-founder and CEO of Ro and discussing how difficult and antiquated the medical licensing, credentialing and certification process was. Following the discussion, he quickly came up with the template to create a process for making this one cohesive unit. His goal was to help healthcare professionals and healthcare organizations by providing operational support to alleviate the arduous administrative process many healthcare organizations face to have doctors credentialed, licensed, and background checks completed. As noted by Medallion CEO Derek Lo to Forbes, “the average time to get to contract with a health insurer or hospital is usually six months at the fastest and can take up to 2 years.” Medallion works on payer empanelment which is when a clinician (ex: doctor or therapist) requests to be a part of a health insurance network in order to accept patients from their networks and be reimbursed by their plans. This process can be very arduous and requires the collection of data from the provider to the insurance company including such things as Drug Enforcement Agency (DEA) and/or Controlled Dangerous Substances certification, provider credentialing criteria (which often differ by payer), etc. Medallion works to decrease the time the empanelment process takes so providers become registered in-network and can start seeing patients faster. Medallion has increased its customer base from 25 at startup to close to 100. Medallion also manages license updates in all 50 states and provides reminders when a provider's license needs to be renewed. They lessen the time it takes to get licensure approved and complete for all provider types from NPs, MDs, RNs, PAsS, LCSWs and RDss, and many more. Payer empanelment under Medallion is more smooth and efficient, they submit the request to the insurance company and make sure the detailed information and files that are required are updated and ready to send. They also make sure the verification process from the insurance company is followed and done correctly as these often vary between companies. This process allows for providers to focus on clinical needs. The Differentiator Medallion is focused on providing and streamlining back-office support to providers in many areas of administration where they deal with inefficient and non-standardized procedures that vary by the state board and the insurance company that often have their own unique set of requirements. This can take significant time and effort to ensure that clinicians are registered, licensed, and credentialed properly and then properly enrolled in health insurance company's networks to make sure that a provider is paid. Medallion bases its costs on the number of medical doctors in a healthcare organization. According to the company they have doubled revenue since November 2021 and now have over 200 customers. Medallion’s goal is to take the burden off its customer base of group practices, health systems, and other health care facilities by doing all administrative work. Systems by Medallion and others can help fill the gap while regulators move toward uniform, standardized benchmarks so providers can fill out a single application and undergo a single process. In addition, by serving virtual primary care practices as well as telehealth and remote patient monitoring (RPM) platforms Medallion is helping ensure that both large and small health care organizations delivering care digitally will be able to meet rapidly the current demands of an ever-growing customer patient base. The Big Picture: There is clearly a need for an answer to the problem of the unnecessary spending in both money and time in administrative or back office spending on healthcare in the U.S. For example, according to the Healthcare Value Hub of Altarum, almost 19% of Medicare Advantage Plan spending and over 12% of Employer-Based Healthcare spending is due to administrative costs. In addition, as noted earlier, the licensing and credentialing process can often take 3-6 months thus slowing the addition of new providers to networks and ultimately leading to fewer people getting the care they need. While some states such as Maryland have programs in place such as all-payer rate setting that helps lower administrative costs, other steps are necessary to reduce the burden. For example, as noted by Altarum, “Standardizing licensure reporting requirements for quality and safety programs and minimum criteria will promote greater uniformity and lower compliance expenses.” Given that efforts like this have been contemplated for many years, tools like Medallion’s can help providers accomplish many of the same things while long-awaited regulatory change takes place. Obviously were that to occur, Medallion and others would have to further differentiate themselves. Healthcare Automation Startup Medallion Raises $35 Million To Go On The Offensive; Credentialing platform Medallion raises $35M and more digital health fundings; This Founder Raised $30 Million To Cut Through The Red Tape Every Health Startup Hates

The Driver: August Health raised $15 million in a Series A funding round led by Matrix Partners and returning investor General Catalyst with participation from Dan Baty, the founder of Columbia Pacific, and Arine Whitman, founder of Formation Capital. August Health’s goal is to apply technology to improve the quality of care for seniors in senior living and has designed a SaaS software system to help digitize patient records. The company feels this will help improve both the care for residents and operations as most senior living communities still rely on paper recordkeeping systems. Key Takeaways: A study by the CDC found that less than 20% of residential care communities use electronic health records (EHRs) leaving over 80% of residential care communities, essentially still relying on paper record keeping. According to a survey by Senior Housing News, 56% of workers in nursing homes and assisted living settings reported feeling burned out at work as a result of the continued response to the Pandemic. Of the senior living communities using record-keeping technology, most were deploying legacy technology typically designed for an adjacent industry according to August Health. Senior care facilities, because of issues with paper-based record keeping, often have trouble tracking things as simple as (for example) how many falls have occurred in their facility. The Story: August Health was founded in 2003 by Co-founders Erez Cohen, Dr. Justin Dr. Schram, and Michael Watts. The co-founders all have prior experience as entrepreneurs with their own companies. Cohen previously founded the company Mapsense which was later acquired by Apple and Dr. Schram was a medical director at Landmark Health which provides home-based medical care to individuals with multiple chronic conditions. During his time at Landmark health, Dr. Schram noticed that most senior living facilities were still using paper-based record-keeping systems. This was not only time-consuming but made finding specific documents difficult especially in an emergency situation. According to Cohen, he and Dr. Schram started visiting communities where Dr. Schram previously had patients and saw an opportunity to support administrators and caregivers by building software that would automate busywork, simplify compliance, and streamline community services. As noted in a recent article in TechCrunch, the two found that “people working at senior care residences often struggle with time-consuming paperwork, including move-in packets, face sheets, emergency binders, medication administration records, and service plans.” As a result, information is not updated across the facility, and having a single “source of truth” is difficult. This has led to the creation of August’s two main products which it currently markets, 1) a move-in-only product that deals with the patient intake process and the move-in-packets described above, and 2) an end-to-end Assisted Living software platform that allows for easier access to resident documents when they need it. Both products are billed on a per active resident per month basis. The Differentiators: August Health's software platform modernizes the functionality of senior living communities by digitizing their resident's records and care coordination. The platform allows for easier tracking of analytics, an online portal for tracking forms, updating information, and compliance tools with built-in reminders to fix outdated information. This solution not only makes accessing resident information easier but also takes stress off the staff members by automating many administrative functions. August Health attempts to differentiate itself by allowing customers to tailor their software to ease of use allowing staff members and residents to find the documentation they need. Moreover, August Health has comprehensive features that allow their platform to integrate everything from resident move-ins to medication management, emergency packets, progress notes and alert charting to a family portal for viewing patient care and billing matter. The Big Picture: August Health’s SaaS platform is very practical for older individuals, incorporating all their needs into one software. This software modernizes senior living facilities by switching the paper records to a digital format, making it easier for providers and staff to keep tabs on their residents. This has become increasingly more important as more patients are being transitioned to post-acute care, and more rapidly. As one study noted “what’s [care that’s] come out of the hospital now was always treated in the hospital years ago, to a large extent. People are coming out quicker. They’re coming out sicker.” In addition, for the residents themselves and for family members, August’s software gives them access to their own records, telehealth appointments, and assistance moving in and out of the facility. As a result, the platform helps improve access, efficiency, communication, and the quality of care for those within the community. For example, in an emergency situation, a staff member can easily pull up a resident's record to see if they have allergies to certain medications without the hassle of going through reams of paper. Moreover by automating records and giving family members and caregivers access (with permission) will free up the time of facility staff who will no longer have to find the information on the paper records. Given the ability to establish a single source of truth and ensure consistent care August’s software has the potential to help significantly improve outcomes and reduce costs. August Health digitizes senior living communities for better care; $18 million tech startup eyes creating efficiencies specifically for assisted living; Over 50% of Assisted Living, Nursing Home Workers Report Burnout; 24% Say They Had Covid-19

Overview: Given we have written approximately 75 Our Takes over the last two years we thought it might be helpful over the course of the summer to look at “Lessons Learned” from our posts. As such, this summer we will be looking at our lessons learned on the broad range of digital health on topics we’ve written about including Artificial Intelligence; RPM and Virtual Care; Value-Based Care, and Mental Health (among others). This week we look at Social Determinants of Health (SDOH) and chronic conditions with a focus on how digital health can make a difference. The Backdrop: Chronic Health conditions are one of the leading causes of death and illness worldwide. According to the CDC, approximately 85% of adults over 55 have at least one chronic health condition, and 60% have at least two chronic conditions. As we age, naturally we are increasingly prone to falling ill and are more susceptible to chronic illness resulting in increased spending on healthcare treatments. Chronic conditions can have major impacts on healthcare, patient livelihood, employee productivity, mental health outcomes, and much more. Chronic illnesses like diabetes and obesity could lead to absenteeism and missed work days over long periods of time causing economic strain on employers. Unfortunately, due to uneven distribution of care among certain socio-economic, and geographic groups, certain racial and ethnic groups are at higher risk for certain chronic conditions. However, recent advances in digital health may enable chronic conditions to be dealt with early in the patients' journey by deploying tools that empower patients to monitor and act on or change certain behaviors thereby impacting health conditions. For example, remote patient monitoring (RPM) technology has become increasingly popular and is being used to help treat patients with heart conditions, high blood pressure, cancer, and respiratory diseases. During the Pandemic, digital tools like telehealth measures allowed clinicians to continue to monitor and track patients who were either unable or unwilling to come into the office. Wearable devices such as smart watches or smart apps can aid in monitoring chronic conditions such as hypertension and provide patients with useful and actionable information about their personal health indicators without ever having to leave the comfort of their homes. These technologies can be particularly helpful with certain chronic conditions like cardiovascular disease, where lifestyle modification and self-management can be critical to improving outcomes. These are some of the very many ways in which chronic health conditions can be mitigated by digital health. What follows below are our insights, we hope you enjoy them. Lessons Learned: That said, what were some of the “lessons learned” on chronic health from some of our prior Our Take’s? While digital tools can help the elderly remain independent and age in place, close attention has to be paid to the technology gap and specific, age-appropriate training is required. For example, according to AARP’s “Home and Community Preference Survey” conducted in 2021, “77 percent of adults 50 and older want to remain in their homes for the long term — a number that has been consistent for more than a decade.” In addition, according to a recent article in Mobi entitled “Seniors aren't tech-averse. We're just not designing for their needs.”. The article noted, “Digital health companies that design user-friendly services or products for the elderly could mitigate adverse health-related outcomes and worsened chronic conditions linked to usage barriers by addressing the age-related barriers. These technologies can be particularly helpful with certain chronic conditions like cardiovascular disease, where lifestyle modification and self-management of chronic conditions are critical to improving outcomes. Age Related Barriers to Digital Health Remain-The HSB Blog 5/24/22 https://www.healthcarebullpen.com/single-post/age-related-barriers-to-digital-health-remain The Digital Divide and Broadband Access Must Be Addressed to Make Broad-Based RPM a Reality. A 2020 study in the Journal of the American Medical Informatics Association found that “areas with limited broadband access also had higher rates of chronic diseases such as obesity and diabetes, resulting in a double burden where those with the lowest connectivity have the highest need”. Data from the National Telecommunications and Information Administration indicate that only 12% of those with an annual household income of $25,000 or less used the internet to communicate with their healthcare provider compared to 40% of those making $100,000 or more in 2019. Hispanic, American Native/Alaska Native, and African Americans had the lowest rate of internet use for health-related activities, trailing White and Asian Americans. Biden’s Plan to End Cancer Won’t Succeed Without Social Infrastructure-The HSB Blog 6/7/21 https://www.healthcarebullpen.com/single-post/biden-s-plan-to-end-cancer-won-t-succeed-without-social-infrastructure-the-hsb-blog-6-7-21 Telehealth Could Magnify Inequity For Those Who Lack Access-The HSB Blog 2/16/21 https://www.healthcarebullpen.com/single-post/telehealth-could-magnify-inequity-for-those-who-lack-access-the-hsb-blog-2-16-21 Digital Tools Could Significantly Increase Engagement, Utilization, and Compliance A 2019 JAMA article found, that chronic health conditions lower employees’ productivity and increase the number of missed workdays. Employee absenteeism caused by high blood pressure, diabetes, smoking, physical inactivity, and obesity, incur an annual cost for employers of $36.4 billion. A study by NCQA found that “telehealth facilitates access to healthcare for individuals who might otherwise skip or avoid important services. It also allows care delivery more quickly and efficiently in lower-cost settings. [The report] also found evidence that telehealth can help reduce more costly urgent and emergency department (ED) care, as well as the use of costly and often overused services such as imaging.” Digital Wellness Programs Could Be Key to Engagement and Utilization-The HSB Blog 10/18/21 https://www.healthcarebullpen.com/single-post/digital-wellness-programs-could-be-key-to-engagement-and-utilization-the-hsb-blog-10-18-21 Are Patient Satisfaction and Outcomes Better with Telehealth?-The HSB Blog 3/29/21 https://www.healthcarebullpen.com/single-post/are-patient-satisfaction-and-outcomes-better-with-telehealth-the-hsb-blog-3-29-21 Healthtech Could Meaningfully Address Disparities in Health for the Underserved (assuming broadband access is addressed). For example, data from the CDC indicates that “integrating community health workers (CHW) into the healthcare system [who are often empowered by digital technology] will reduce the burden placed on strained resources and overworked clinicians. It will also help improve health outcomes when used for addressing chronic health conditions [many of which disproportionately impact people of color and are preventable]. In 2021 HealthcareITNews reported, “studies have shown that minority patients routinely receive inferior care because they may be bouncing between hospitals and clinics and also have higher rates of chronic illnesses like diabetes and hypertension, which research indicates can be better addressed by digital technologies.” A 2021 article in the Central European Journal of Medicine entitled, the “Role of new digital technologies and telemedicine in pulmonary rehabilitation” noted that “the continuous monitoring for chronic respiratory conditions can produce the expected efficacy needed for the lower occurrence of systemic side effects and effectively determine the appropriate number of doses for inhalation therapy." Community Health Workers Will Reduce Disparities & Improve Outcomes-The HSB Blog 4/19/21 https://www.healthcarebullpen.com/single-post/community-health-workers-will-reduce-disparities-improve-outcomes-the-hsb-blog-4-19-21 Enhancing Telemedicine Can Close The Infant and Maternal Mortality Gap-The HSB Blog 3/8/21 https://www.healthcarebullpen.com/single-post/enhancing-telemedicine-can-close-the-infant-and-maternal-mortality-gap-the-hsb-blog-3-8-21 Digital Tools Can Improve Efficiency & Effectiveness of Respiratory Therapy-The HSB Blog 6/7/22 https://www.healthcarebullpen.com/single-post/digital-tools-can-improve-efficiency-effectiveness-of-respiratory-therapy-the-hsb-blog-6-7-22 Final Thoughts: Given all the dramatic change we’ve seen in the past 2 years, in large part as a result of COVID and the near-instantaneous embrace of digital care, our lessons learned focus on these factors: chronic care is moving from discrete, point-in-time monitoring to real-time continuous monitoring but is not yet there, at a minimum the pandemic has demonstrated that digital tools will serve as a significant adjunct to in-person care for many underserved communities and may in fact open new avenues for access; providers and payers must pay attention to and design plans to deal with technological issues, cultural barriers and issues around health literacy; remote-patient monitoring, virtual care, and even hospital-at-home models should be designed by disease state and therapeutic category, not one size fits all.

OurTake: With investment in the public and private sphere into programs such as the Affordable Care Act, Medicare/Medicaid, and the adoption of services such as Folx Health’s or Plume’s digital care offerings, the lesbian, gay, bisexual, transgender, queer and others (LGBTQ+) community is being empowered with the healthcare tools they need for healthy lives that begin to address historic disparities in healthcare access and outcomes. LGBTQ+ insurance coverage and healthcare discrimination are two significant issues faced by this community which have seen major improvements over the past several years (although this may come under threat with the recent Supreme Court decision overturning Roe v. Wade). Many legislative and court victories have established or upheld a variety of new benefits and protections over the past two decades. Although many of these disparities still persist and more effort will be required from public and private stakeholders to properly deal with these issues, cultural attitudes towards the LGBTQ+ community appear to be changing and broad awareness and support of celebrations such as Pride Month seem to indicate a more promising future. Key Takeaways: 8% of the general population identify as LGBTQ+ according to U.S. Census data. About 20% of LGB and transgender adults respectively lack insurance coverage vs. 12% of the general population according to Jurnal of Public Health Management and Practice Almost 32% of lesbian, gay, or bisexual individuals and 38% of transgender individuals have been diagnosed with a depressive disorder compared to only 16% of the general population according to a New York State Department of Health study. 16% of all LGBTQ+ adults reported experiencing healthcare discrimination according to a 2019 study published in the Health Services Research journal. The Problem: The LGBTQ+ community has long been neglected with regard to the availability of culturally competent healthcare. Struggles persist in achieving widespread coverage sensitive to the unique needs of this group delivered in a non-threatening and non-discriminatory manner. For example, data from an article published in the journal of Public Health Management and Practice indicates that LGBTQ+ suffer from greater health insurance coverage issues than the general population, with 17% of LGBTQ+ adults lacking any kind of coverage compared with 12% of the general population. This disparity is even more apparent among LGBTQ+ adults of color and transgender adults at 23% and 22% without coverage, respectively. Additionally, the prevalence afforded states’ rights in the U.S. policy-making on a national level is disjointed allowing many states to make their own laws that have led to more than half of all U.S. states having no protections for LGBTQ+ inclusive insurance policies. Many more are left with inadequate protections against discrimination based on sexual orientation, gender identity, or both according to a national map of LGBTQ+ healthcare laws and policies by the Movement Advancement Project. Access to insurance coverage and sexual or identity-based discrimination are undoubtedly the paramount concerns that the LGBTQ+ community faces in trying to ensure they receive proper health care and efforts must be taken to address this. Increased investment in health insurance programs such as the Affordable Care Act, Medicare, or other digital health tools from the private sector has made large strides in helping to address coverage issues. Moreover, new legislation must be passed guaranteeing protections to this already vulnerable community that has faced a long history of oppression and inadequate care. The Backdrop: At least 20 million American adults self-identified as LGBTQ+ in 2021, representing nearly 8% of the general population according to U.S. Census data. These numbers have seen considerable increases as more people have gained the confidence to come out publicly as American society has become more accepting of LGBTQ+ individuals, and policies guaranteeing their civil rights have been codified into law. However, many challenges still remain for this community. The overall state of LGBTQ+ health and availability of healthcare in America is still very poor compared to the general population. For example, a 2020 survey conducted by the NYS Department of Health found that nearly 31.7% of lesbian, gay, or bisexual individuals and 37.8% of transgender individuals have been diagnosed with a depressive disorder compared to only 16% of the general population. The study also reported that these same individuals also noted dramatically higher rates of self-reported mental illness, with the study finding that these same individuals reported rates of self-reported mental illness that were almost double the rate of the general population (24%). Additionally, LGBTQ+ youth are well documented to have higher rates of substance abuse than do heterosexual youth, and the LGBTQ+ community has long been targeted by tobacco industry advertising and marketing, with higher rates of tobacco usage as well in comparison to their cisgender, heterosexual peers. There is a clear need for quality and affordable healthcare among the LGBTQ+ community that necessitates further attention and investment in order to address these disparities. Interpersonal discrimination is something that any LGBTQ+ adult will know well, and this problem remains ever-present even while seeking healthcare. 18% of LGBTQ+ adults reported having avoided healthcare due to anticipation of discrimination, along with 22% of transgender adults, while 16% of all LGBTQ+ adults reported actually experiencing discrimination in their healthcare visits according to a 2019 study by the Health Services Research journal. Nevertheless, changing societal attitudes toward LGBTQ+ individuals and recent legislation guaranteeing certain civil rights to these individuals have led to a brighter outlook for the future. A larger part of America is arguably more accepting of LGBTQ+ individuals than ever, and significant resources are being devoted to ensuring continued improvement in the quality of their care from both the public and private sectors. Investment into government-led health insurance programs like the Affordable Care Act and Medicare has indeed led to the expansion of health insurance benefits to cover thousands more of LGBTQ+ Americans. Given recent court rulings relating to qualifying for these programs as well as the Federal recognition of gay marriage, many protections are now codified into law marking significant headway being made in combating discrimination in healthcare. Implications: Recent research into the impacts that increased public and private investment has had on LGBTQ+ healthcare coverage and health outcomes is promising. Affordable Care Act enrollment has been successful in reducing the number of uninsured LGBTQ+individuals. For example, the uninsured rate for LGBTQ+ individuals declined from 34% for low- and middle-income LGBTQ+ adults in 2013 to 26% in 2014 in just the first year of ACA adoption, according to Health Affairs. Similarly, large reductions were seen in states that chose to expand Medicaid coverage, along with substantial improvements in healthcare access. Affordable health insurance options such as these allow the most vulnerable to secure the coverage they need. Guaranteed protection in these public insurance policies can help LGBTQ+ families get the same full family coverage that heterosexual couples are eligible for, including explicit protections on the basis of gender identity and sex stereotypes according to Section 1557 of the Patient Protection and Affordable Care Act. The Office for Civil Rights at the Department of Health and Human Services has also committed itself to investigating and resolve complaints of discrimination regarding LGBTQ+ health care in line with the Biden administration’s commitment to ensuring LGBTQ+ patients can access health care services without fear of discrimination. The private sector is also heavily involved in helping to address these historic disparities, primarily through the deployment of digital technologies and funding of startups dedicated to addressing the needs of the LGBTQ+ community, healthtech has focused on making healthcare more accessible and ensuring it is delivered in a more culturally competent way. For example, Folx Health, a startup offering virtual care to LGBTQ+ patients, received more than $25 million in Series A financing in February 2021 allowing them to expand access to their tools so that employers can now offer services such as virtual primary care and telehealth. In addition, Folx offers hormone replacement therapy for transgender employees, and PrEP which helps fight against the risk of HIV transmitted through sex. Including such services in an employee health plan is a significant step forward for normalizing the inclusion of LGBTQ+ health benefits in employer-sponsored health insurance plans. There are many more companies that offer similar services and could be of immense help to LGBTQ+ individuals in need of accessible and affordable care. Plume, offers a service transgender people can access directly from their phones that allows them to connect with experienced healthcare providers to get hormone replacement therapy services, if medically appropriate, from the comfort of their homes. By reducing the stigma associated with LGBTQ+ specific health issues and making these benefits available through employer-sponsored benefit plans, companies like Folx and Plume will help make this a benefit for all plans. As such, expanding health insurance benefits to include the previously marginalized LGBTQ+ community can go a long way toward addressing LGBTQ+ health disparities, improving mental health, fighting discrimination in healthcare, and improving the attitudes of some caregivers. Related Reading: Sexual Orientation and Gender Identity: Demographics and Health Indicators Discrimination in the United States: Experiences of lesbian, gay, bisexual, transgender, and queer Americans Implications of the COVID-19 Pandemic on LGBTQ Communities Lesbian, Gay, And Bisexual Adults Report Continued Problems Affording Care Despite Coverage Gains Healthcare Laws and Policies Folx Health launches employer offering for LGBTQIA+ care

The Driver: Bicycle Health, a virtual addiction medicine clinic, raised 50 million dollars in a Series B funding round led by InterAlpen Partners with participation from current investors Questa Capital, City Light Capital, Cressey Ventures, and existing investors. It will invest the new funding in additional staffing, improving its virtual health clinic, building business partnerships, and research to investigate the efficacy of its treatment model. Key Takeaways: According to the CDC, Opioid abuse increased by 30% from the pandemic's beginning to April 2021. The most abused type of opioid was a synthetic opioid. Examples include fentanyl and U47700 (a high-powered synthetic opioid). According to the 2019 National Survey on Drug Use and Health (NSDUH), almost 10 million people misused prescription pain relievers and approximately 750,000 people used heroin. Young adults between the age of 18 and 25 are most likely to be at risk for opioid abuse according to Risk Factors for Opioid Misuse, Addiction, and Overdose from the U.S. Department of Labor. The Story: CEO and founder Ankit Gupta established Bicycle Health, an addiction medicine clinic in 2017, to combat the rise in opioid abuse along with the increase in opioid-related deaths. In response to the rise in depression, anxiety, and mental health illnesses during the pandemic, Bicycle Health expanded its services to a virtual platform. Bicycle Health provides opioid use disorder treatment and medication-assisted treatment services through telemedicine. It provides access to medical specialists and other resources customized to meet patients’ unique needs remotely. Virtual access to medical specialists is significant because almost half of the country does not have a medical doctor specializing in opioid abuse. It also works with in-network health insurance carriers such as Aetna, Anthem, Blue Cross/Blue Shield, Medicare, and United Healthcare. Bicycle Health operates in 25 states and its platform has doctors and health care experts that provide confidential, credible, and customized healthcare plans to meet patients’ needs. Patients can schedule appointments via phone or telehealth and get same-day prescription refills if needed. Beyond providing opioid care, Bicycle Health also provides referrals to primary care providers when needed for those who require one. The Differentiator: Bicycle Health services focus on providing meticulous care to patients that are tagged incurable. It provides affordable, specialized, and customized medical care for opioid abuse patients when they are ready to embark on the journey of becoming opioid-free. The cost of Bicycle health’s full-length program is comparable to competitors like Eleanor Health (which provides comprehensive mental health and substance use disorder care in clinics, virtually, and in patients’ homes) and Ophelia (which offers medication and support for quitting opioids). According to the company, Bicycle Health’s services for patients whose insurance does not cover their monthly cost is approximately $200. This monthly charge covers the cost of all the resources and doctor's visits except for the prescription costs. Another unique benefit of its virtual addiction clinic is that patients have a say in how and when they get treated. Also, the virtual platform addresses privacy concerns and eliminates patients’ fears of being noticed or judged for seeking treatment. The Big Picture: The stigma or perceived stigma of receiving treatment for opioid abuse could prevent patients from getting the help they need. Access to addiction treatment or medicine virtually is a welcome development that could avert the rise in opioid-related deaths among all age groups. Bicycle Health is helping to demystify the treatment of opioid addiction. Companies that help remove the taint of treating substance addiction like Bicycle and others are illustrating that opioid addiction is a medical issue that requires medical treatment and attention, just like other diseases. Moreover, by specializing and focusing on the needs of those with substance use disorder, these companies are demonstrating that there are distinct needs of these patients that necessitate special skills that providers must bring to bear in recovery. By creating nurturing, non-judgmental environments, Bicycle Health is empowering and supporting patients to seek treatment and helping them succeed in overcoming their addiction. Bicycle Health raises $50M for virtual opioid use disorder treatment; Risk Factors for Opioid Misuse, Addiction, and Overdose; Synthetic Opioid Overdose Data

OurTake: The dramatic rise in the incidence and treatment of behavioral health issues with digital tools during COVID has created an opportunity that begs the question of how to better utilize these tools to impact populations going forward. Understanding the implications of these digital interventions will allow public health professionals to better assess when and where these tools could be most effectively deployed going forward, particularly in underserved areas. While research indicates promising early results, this is still a relatively new development only two-plus years removed from the beginning of the pandemic, and longitudinal research is needed to accurately interpret results and findings. Researchers and health professionals are looking for solutions. Key Takeaways: According to findings by “Mental Health America” approximately 20% of American adults or about 50 million people suffer from a mental illness. In a 2021 PubMed review of 735 studies there was an increase in positive health behaviors by about 33% after the uptick in telehealth appointments instead of in-person care. Mental illness has a prevalence rate of about 14% and accounts for 7% of the overall global burden of disease according to Current Psychiatry Reports. The pandemic generally precipitated a broad-based increase in mental illnesses such as anxiety and depression often driven by social isolation and fear (both of COVID itself and of its impacts). The Problem: Mental illness is a global public health concern but as with many health issues, there is no uniform response to it. Each country has its own cultural views of behavioral health, as well as its own approach to addressing and mitigating some of the impacts mental health issues have on its society. According to the study “Global burden of disease and the impact of mental and addictive disorders” by Current Psychiatry Reports, mental illness has a prevalence rate of about 14% of the population globally and accounts for 7% of the overall disease burden worldwide. With the rise in social isolation, ongoing changes in societies and economics due to the pandemic as well as the continued looming threat of COVID itself, conditions emanating from the pandemic such as increased anxiety, depression, and substance abuse will likely continue to increase over time. In addition, the pandemic created a worldwide increase in demand for mental health services as people struggled with new or exacerbated issues triggered by the pandemic itself. In addition, one of the biggest struggles for the behavioral health industry during the pandemic was the transition period for clinicians themselves as they learned to move from predominantly in-person services to ones that were almost exclusively via telehealth. The industry changed dramatically almost overnight. In addition, given the impact of the pandemic on caregivers themselves (sickness, caring for loved ones, etc.) there was a strain on the availability of practitioners and supply of services creating issues of access to care for many Americans. Given the almost instant elimination of in-person care, telebehavioral health became a lifeline all over the world as people sought to deal with existing issues and the new strain of a once-in-a-lifetime pandemic. This was particularly important for those receiving their care with the aid of some type of coverage assistance (ex: CHIP, Medicaid, etc.) as many of them could not have afforded or accessed their services without that support. Background: To evaluate the impact of telemental health it is helpful to first set the context by understanding the overall state of behavioral health in the country. As noted earlier, according to Mental Health America, 19.86% or approximately 50 million American adults suffer from a mental illness. According to the National Alliance on Mental Illness the most prevalent conditions are anxiety (impacting 19% of U.S. adults), depression (8%), post-traumatic stress disorder and dual diagnosis (both 4%), and bipolar disorder (3%). Moreover, over half of adults with mental illness do not seek out treatment, with current estimates of that population at approximately 27 million Americans. Sadly, almost 25% of U.S. adults report an unmet need for treatment of mental illness and this number has remained fairly consistent for over a decade. That said, digital health technologies appear to hold great promise for the treatment of behavioral health issues and have the potential to help close the gap to access given their ability to be widely used and broadly distributed in underserved communities at a relatively low cost (assuming broadband access is not a problem). For example, in terms of efficacy, a 2021 study entitled, “Effect of Engagement with Digital interventions on Mental Health Outcomes” which analyzed 35 studies, covering a total of approximately 4,500 participants whose conditions were assessed over a period of 3 to 14 weeks (from baseline to post-intervention assessment). The study looked at three online databases that utilized digital tools to interact with patients via smartphone, tablet, and computer. The authors found that those who interacted with digital tools in the studies showed improvements in a variety of different mental health disorders including anxiety, depression, psychological distress, and various other mental health outcomes. The study demonstrated statistically significant improvements and concluded that not a single one proved to be ineffective. All of this leads us to conclude that the application of telemental health has demonstrated positive outcomes and has additional potential in the treatment of mental illness. Implications: Implementing digital health technologies can be a daunting task when it comes to behavioral health. For example, while the increase in the delivery of telebehavioral health has dramatically lowered the rate of cancellations and no-shows for providers, the ability to access care at home has created certain privacy issues such as accessing care in multigenerational homes (ex: when discussing topics such as sex, and gender issues) and patients’ abilities to discuss concerns without fears of being overheard (ex: relationship issues with parents or partners or even domestic abuse). However, despite these tradeoffs, academic methods do allow us to determine whether or not digital tools can effectively assist in the treatment of mental health for populations. For example, according to a recent article in MobiHealthNews, “Data science provides quantitative information on current health statuses and its near-term implications”. These data points, in addition to a person’s usage of the digital intervention method, provide key insights into health behaviors. Continuous feedback loops between health behaviors and data can allow public health professionals to gain a better understanding of mental health illnesses as well as how it is trending. Along those lines, the rise in mental illness during the Pandemic sparked a significant increase in the development and deployment of digital tools for mental health illnesses. In a recent article by “Frontier in Digital Health”, an Australian longitudinal survey of 1370 participants showed that about 70% of the participants reported at least one positive effect of digital methodologies for treatment. Recent research on interventions like Mind Spot treatment courses were shown to have a reduction of adverse health symptoms of about 50%. These courses were sustained over a course of a minimum of three months and utilized telehealth calls for clinicians to meet with patients. Telemental Health has been shown to make strides in the health of populations and has been consistently shown to reduce and mitigate adverse health effects, however, it should be noted that more research still needs to be done over longer treatment periods to assess and measure the true longitudinal effects of treatment. Related Reading: Effect of Engagement With Digital Interventions on Mental Health Outcomes: A Systematic Review and Meta-Analysis How Digital Technology Mediated the Effects of the COVID-19 Pandemic on Mental Health: The Good, the Bad, and the Indifferent User characteristics and outcomes from a national digital mental health service: an observational study of registrants of the Australian MindSpot Clinic Contributed: The biggest merger in digital health should be between behavioral and data sciences

Our Take: Understanding the uniqueness of the U.S. healthcare sector is crucial for digital health investors and innovators in order to better navigate and position themselves for success. The U.S. healthcare sector is complex and unique, especially in terms of the culture around privacy and confidentiality. While there is an abundance of healthcare data, unlike many markets where tech companies have had success, it is not as easy to access or as readily interoperable among market participants. As a result, replicating measures that have proven successful in other industries (ex: finance, retail, etc.) does not guarantee success. Consequently, those looking to enter the healthcare market need to understand the culture, requirements, barriers and gaps that could mean the difference between success and failure. Key Takeaways: In 2020, U.S. spending on healthcare grew by 9.7%, reaching $4.1 trillion or $12,530 per person. The U.S ranks 30th out of 39 countries in the world for life expectancy, despite having the highest per capita cost in all industrialized nations. Readmitting Medicare patients costs the US about $26 billion annually and $17 million of the costs are from avoidable readmissions. Attempts by big tech companies like Google (Google Health), Microsoft (Health Vault), and Apple (Health Habit project) to disrupt the healthcare space have been largely unsuccessful. The Problem: The US healthcare system is highly inefficient, with costs now approaching almost 20% of U.S. GDP, a level well above most other countries, and yet the U.S. has the worst health outcomes compared to almost all other developed countries. Not only are costs high but due to the fragmented nature of the system, access to routine and preventive care is poor for many who have minimal or no insurance coverage. Perversely, this can be a key driver of costs as many treatable conditions go without care and become high-cost chronic conditions. Despite numerous attempts to find solutions and many interventions towards fixing the system, problems persist because of certain core issues within the U.S. system. These issues include a large majority of citizens getting health insurance from their employer, reimbursement that is tied primarily to the volume of procedures instead of the value of healthcare spending, and the lack of a broad national safety net system for consistent care. Perhaps most importantly for tech companies looking to fix what they see as an inefficient system, data is not well organized, is not easily shared among constituents or even patients and their providers and at times may even not clearly be associated with an individual patient. As a result, the management and analysis of this crucial component, which the tech sector has relied upon in the past to disrupt other industries, may not be as readily mined for value in healthcare. Thus, attempts by the tech sector to replicate the disruptions they have achieved in other industries based upon their dominance of data have proved challenging because the health sector is a unique and specialized industry that requires significant domain knowledge and expertise. The Backdrop: One issue that makes healthcare difficult for tech innovators is the need to achieve the goals of the so-called “triple aim” of healthcare reform simultaneously. This Triple Aim, which seeks to improve the health of a population, improve the healthcare experience of patients and reduce per capita cost can in some ways be thought of as asking innovators to squeeze a balloon without causing a bulge in any one side. In addition, despite many attempts, many big tech companies like Google and Amazon have recorded repeated setbacks in the healthcare industry despite deep pockets and technological expertise. Several industry experts have attributed this to two factors: 1) downplaying the impact of the payment and reimbursement models, and, 2) trying to resolve tough health sector issues without enough buy-in from health sector players. While the tech industry alone won’t be able to resolve all the challenges in the health sector, given its ability to leverage data and drive innovation it has great potential. Consequently, by developing a better understanding of the restrictions drivers, and other uniqueaspects to healthcare will be crucial to their success going forward. Some of these include: Regulatory drivers and restrictions: The health sector has legal and regulatory frameworks for collecting, analyzing, and using data that limit and regulate the health data usage and sharing. Some such frameworks include the HIPAA/HITECH and oversight of Institutional Review Boards (IRBs) for clinical trials. Lack of awareness and compliance with these regulatory restrictions can lead to delays, fines and even prohibitions from doing business with certain government entities. In addition, digital innovators have to ensure subcontractors are in compliance with many of these laws and regulations, as they can become vicariously liable (for example under HIPAA). In addition, even advertising healthcare products can prove cumbersome as regulations which ban deceptive and misleading marketing practices can take on special meaning in the advertisement of certain healthcare products or services. Understanding financial drivers of performance and the impact of government policies, agenda and programs on the healthcare system requires participants to stay abreast of areas that the government policies and programs impact the industry and how to better align digital health companies’ strategy, products and services design. The source of market power: The healthcare sector has many players with competing interests and agendas. These players yield and deploy enormous resources to influence public policy that can help or delay the efforts of innovators and they must understand and incorporate this into their strategy and marketing plans. The peculiar nature of the health data ecosystem: Compared to data generated from other markets, health data is quite complex, and difficult to access and analyze. This in itself can hamper tech Co’s ability to increase efficiencies. Context matters: The usability, cultural sensitivity and simplicity of digital health interventions matter. Payment and healthcare costs: The system of payment and reimbursement in the healthcare sector is complex and payment mostly comes from third parties and not the actual end consumer. So even where an innovation would reduce inefficiencies or reduce cost in the long-term, insurers who actually pay for the services might be hesitant to adopt or pay for it because of the need to incur immediate cost or the aggregate cost over the total patient pool. Implications: The healthcare sector is a unique industry with several requirements that healthcare innovators need to understand as they attempt to innovate to improve efficiency and performance. Unlike other sectors where startups have more leeway in utilizing collected data, the regulation of data privacy and security in healthcare is more heavily regulated than other industries. Many digital health startups have failed not because of lack of ingenuity but due to an inability to comply with laws and regulations that are peculiar to the health sector and the failure to design these processes into their product from the start. Consequently, investments in digital health interventions for the healthcare sector require careful consideration of its impact on cost, without jeopardizing transparency and patient privacy. Equally important is the functionality and user-friendliness of interventions to both the healthcare providers and patients without downplaying safety considerations. Mistakes in digital health intervention design or implementation are too costly. While it should go without saying, unlike a mistake in a financial or retail app which could have serious consequences, mistakes in healthcare related apps could lead to outcomes like permanent injuries or even death. As a result, therein lies the greatest potential for innovation, as new products or services that can indeed factor the needs of both providers and patients can have life and cost-saving implications. Identifying the decision-makers’ pain points and partnerships with the right stakeholders could help health tech innovators to unlock hidden opportunities and improve the effectiveness of digital healthcare interventions. The possibilities of tech and digital innovations in the healthcare sector are endless but require a different approach that reflects the complicated and fragmented nature of U.S. healthcare. However, if approached with care and respect, the possibilities are endless. Related Reading: The Business of Healthcare and the Economics of Healthcare: Shall Ever the Twain Meet? Regina E. Herzlinger, Why Innovation in Health Care is so Hard Big Tech & Retail Disruptors Continue to Run Into Same Challenges in Healthcare-The HSB Blog 3/22/21 Lessons Learned: Big Tech Stumbles in Healthcare Again, Google Health Closing-The HSB Blog 8/30/21

The Driver: Legacy, also known as Give Legacy, recently raised $25 million in a Series B funding round led by Bain Capital Ventures with participation from FirstMark Capital, Section 32, TQ Ventures, and Valor Equity Partners. The company plans to use the new funding to expand its team, and scale its offerings beyond sperm testing, freezing and fertility supportprovide as well as launch the Legacy lab that will provide same-day, at-home service to customers. Key Takeaways: According to Cleveland Clinic, infertility affects one in every six couples who are trying to conceive. The average in vitro fertilization (IVF) patient goes through two cycles, which can cost between $40K-$60K in total for treatment including procedures and medications, according to SingleCare. In the United States, about 10% of all males attempting to conceive suffer from infertility. According to Johns Hopkins Medicine problems with male sperm can include: immature or abnormally shaped sperm, sperm that are unable to swim or insufficient or non-existent sperm production. The Story: Legacy is a fe rtility startup that was founded back in 2018 by CEO and founder Khaled Kteily, a member of the American Society for Reproductive Medicine and the Canadian Fertility & Andrology Society. His goal was to make the experience of dealing with infertility more humane by eliminating the pain points by increasing access to sperm analysis, DNA fragmentation, and sperm freezing. According to the American Society of Andrology, sperm counts have decreased by over 50% globally in the past 40 years, creating a significant challenge for those looking to start a family. Kteily and the Legacy team are working to change the narrative of nfertilety and empower men to take ownership of their role in the family planning process. Legacy offers three different packages ranging from $195 for a one-time semen analysis all the way to $3,995 for 3 semen analyses, 2 DNA fragmentation analysis, lifetime cryogenic storage, and 3 free telehealth calls with their fertility nurses. According to the company, Legacy’s services are covered for approximately 8M lives through partnerships with all of the leading fertility benefits providers and an additional 12M lives through insurance contracts in California, New York, and New Jersey with insurers like Aetna, Cigna, and UnitedHealthcare. Legacy is also in partnership with organizations like the Navy SEALs and Memorial Sloan Kettering. The Differentiators: One of the main differentiators is that, unlike most fertility clinics, Legacy focuses strictly on male fertility in reproductive services and is working towards providing comprehensive male fertility services. Some notable competitors in the reproductive industry are direct-to-consumer virtual care company Ro, hybrid fertility company Kindbody, and fertility testing startup Proov. One particularly attractive thing about Legacy’s service is that customers can use the sperm testing kit and schedule for pickup from the comfort and privacy of their home. Once the company receives and analyzes the sample, the company generates a report from the analysis highlighting lifestyle recommendations. Following the analysis, patients have the option to set up a telehealth appointment with Legacy physicians to discuss the results. Legacy also plans to launch Legacy Labs, which will provide same-day, at-home service to customers, helping the company to offer some of the most comprehensive solutions in the fertility field. The Big Picture: While fertility issues are often seen as a woman’s issue and female fertility startups have raised significant venture funding, male fertility issues need to be addressed as well.. The United States is the only country that investigates the egg-producing partner first when a family is facing infertility. Male fertility complications are easier and cheaper to diagnose and treat with something as simple as lifestyle changes. Legacy, through its digital clinic, is working towards improving access to fertility testing, sperm storage and male fertility information for those who are planning to start a family. This solution provides a virtual option that enables people from across the United States to access fertility resources tailored for the male populace. The unique male-centered approach to treating infertility could change how providers engage in family planning. If successful, Legacy could improve access to fertility options and reduce infertility rates among men. Moreover, a solution such as Legacy’s could help reduce healthcare costs for couples seeking fertility treatments. Attempting to conceive can be a difficult and emotionally taxing process for both parties involved. By reducing stress and eliminating administrative hurdles Legacy can help make the process simpler and easier. As noted by CEO Kteily, “our goal is to eliminate the pain points involved, make the experience human rather than clinical, and help everyone create the families they want when they want.” Male fertility startup Legacy raises $25M to expand offerings, Legacy Raises $25M in Series B Funding with Plans to Go Hybrid and Invest in Growth

Our Take: The continuous monitoring of chronic respiratory conditions with digital tools allows patients to better understand conditions and assist clinicians in monitoring effective dosages and treatments for illnesses. Digital health technology allows patients to utilize tools such as smartphone applications, remote patient monitoring, digital inhalers, and self-education tools to combat an increasing litany of health conditions and has been shown to be an effective treatment for disease. In addition, with projected temperature increases due to climate change and ever-changing atmospheric and weather conditions adding pollutants and irritants to the atmosphere, respiratory illnesses are expected to increase in incidence in the future. Key Takeaways: It is estimated that over 300 million people worldwide suffer from asthma, 64 million with COPD & 30% of the European population suffer with Allergic Rhinitis. With increased hazardous climate conditions, COPD is predicted to become one of the leading causes of death worldwide by 2030. Evidence indicates that digital inhalers enhance medication management and guide clinical care in patients with asthma or COPD. Continuous monitoring for chronic respiratory conditions can produce the expected efficacy needed and effectively determine the appropriate number of doses for inhalation therapy. The Problem: As noted in “Climate Change and Respiratory Health” accelerating climate change poses a particular threat to people living with chronic disease, including respiratory issues like asthma, chronic obstructive pulmonary disease (COPD), allergies, emphysema, and lung cancer. While nations work to reduce greenhouse gasses by 80 percent by 2050 in order to curb many of these health consequences, some effects are inevitable and persons living with respiratory disease and their caretakers will need to adapt to a changing climate.” While more recently the world has begun to focus on issues of Environmental, Social, and Governance (ESG), one often overlooked issue is that the state of the worlds respiratory health is directly related to many of the current changes the world’s population is going through. As pointed out in “Climate Change and Respiratory Health” as the world’s climate worsens & summers become hotter and drier, there is an increase in the pollution of the atmosphere, in the unpredictability of extreme weather conditions, in wildfire incidences, of allergies per season, and diseases spread by weather related vectors become more prominent. The risk to human health is increasing with the change in climate. For example, a study by the World Health Organization (WHO) in 2018 concluded that chronic respiratory disease accounted for about 7% of all deaths during the year. These chronic conditions are not only an issue for patients and communities but they are an added stressor on the healthcare system. It is estimated that over 300 million people worldwide suffer from asthma, of which of 10-15% suffer from uncontrolled asthma. Allergic Rhinitis affects up to 30% of the European population & 64 million people suffer from COPD according to the Journal Allergy. They also note it is predicted that COPD will become the leading cause of death worldwide by 2030 and that these percentages are either set to stay the same or rise with the increases in global temperatures brought on by climate change. The Backdrop: While respiratory health solutions such as inhalers and spirometers have been available for some time, digital health offers updated formats of these devices and others including home respiratory monitoring devices, and digital inhalers that facilitate continuous monitoring of one’s own respiratory conditions. For example, according to a 2018 research study in the Journal Allergy, mHealth tools for chronic respiratory diseases were able to measure the functionalities of 112 different applications. The applications’ functions included self-monitoring, personalized feedback, and patient education on conditions such as asthma, COPD, rhinitis, and rhinosinusitis. In addition, as a recent article in Medical Informatics noted, predictive AI algorithms for remote monitoring interventions may have the potential to improve current chronic condition management strategies. Moreover, as noted in a recent article in Pulmonary Therapy, other forms of research involve the use of digital inhalers for asthma and COPD. These are inhalers that monitor the time and date of dosing, thus promoting collaborative care between clinicians and patients. This will provide a more in depth understanding of inhaler use. Digital devices record the inspiratory flow with inhaler use and can guide proper inhaler technique which is likely to be a clinically useful lung function measure. For example, companies like NuvoAir use a Bluetooth enabled spirometer that remotely monitors lung function,a sensor that attaches to asthma and COPD inhalers, and an integration with Fitbit devices. This data is tracked through remote monitor systems that detect changes in the way you cough during the night. Implications: As noted earlier both COPD and asthma are common diseases worldwide and currently affect over 300M people. Both diseases require inhalation therapy methods in order to effectively monitor conditions. As noted in “Role of new digital technologies and telemedicine in pulmonary rehabilitation” the continuous monitoring for chronic respiratory conditions can produce the expected efficacy needed for the lower occurrence of systemic side effects and effectively determine the appropriate number of doses for inhalation therapy.” In addition, as the aforementioned article from the Journal of Medical Informatics noted, the effectiveness of remote Bluetooth monitoring for chronic conditions demonstrated that “impact studies [show ]some evidence of improvement in process and outcome measures [as well as the fact] that remote monitoring interventions may have the potential to improve current chronic condition management strategies.” Moreover, the use of smart phone applications like the Propeller Health from ResMed which includes digital inhalers for asthma and COPD have proven effective in research and been well received in the market. For example, as noted in the previously referenced article in Pulmonary Therapy, “evidence indicates that digital inhalers enhance medication management and guide clinical care in patients with asthma or COPD, with benefits of increased medication adherence having the potential to improve clinical outcomes”. Similarly, a recent TechCrunch article entitled “Inspired by founder's childhood asthma, NuvoAir raises $12m to tackle respiratory illnesses” reported that digital health technology companies like NuvoAir determined that with the correct amount of funding poured into research for respiratory diseases, data could better inform people with ongoing respiratory illnesses about their conditions and help them manage their health more efficiently. Using devices like these, clinicians are able to more precisely monitor dosing, titrate dosing based on weather conditions and irritants and even monitor patient responses to dosages, all of which would help move treatment from point-in-time therapy towards more effective, adaptive and efficient continuous monitoring. Related Reading: Inspired by founder's childhood asthma, NuvoAir raises $12m to tackle respiratory illnesses. Predictive performance and impact of algorithms in remote monitoring of chronic conditions: A systematic review and meta-analysis Digital Inhalers for Asthma or Chronic Obstructive Pulmonary Disease: A Scientific Perspective Role of new digital technologies and telemedicine in pulmonary rehabilitation Mobile health tools for the management of chronic respiratory diseases

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