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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: Osmind recently raised $40 million in Series B funding round led by DFJ Growth, with additional participation from Susa Ventures, General Catalyst, Future Ventures, Tiger Global, Pear VC, and angels Lachy Groom, Brent Saunders, Helena Goodman, and Ariel Katz. The US-based startup is a technology platform for breakthrough mental health treatment and research. Osmind is an electronic health record designed exclusively for doctors and researchers who use and study ketamine, other psychedelics, and Transcranial Magnetic Stimulation for treatment-resistant depression. The platform supports clinicians treating individuals with serious and refractory mental health conditions, such as severe depression, suicidality, PTSD, substance use disorders, anxiety, and OCD, among other conditions. The funds generated from the fundraising round will be used to continue developing and scaling its EHR, carry out research with additional partners, and expand the staff. Key Takeaways: Mental Illnesses are common in the U.S with nearly 1 in 5 U.S adults living with a mental illness (52.9 million in 2020) according to the National Institute of Mental Health. According to one study the national burden of treatment-resistant depression (TRD) is $29–$48 billion annually and assumes that 12%–20% among all patients with depression have TRD. Spending on mental health treatment and services reached $225 billion in 2019, according to an Open Minds Market Intelligence Report. In 2020 an estimated 21.0 million (8.4%) adults in the United States had at least one major depressive episode. according to the National Institute of Mental Health. The Story: The U.S-based startup Osmind was founded by CEO and Co-founder Lucia Huang and COO and Co-founder Jimmy Qian in 2020. Their mission is to empower clinicians and researchers to develop innovative mental health treatments for patients who have not responded to other therapeutic treatments for depression. Prior to founding Osmind, the 2 co-founders led successful businesses in biotechnology and health tech respectively. Lucia Huang led business and operations at Verge Genomics which used AI for central nervous system diseases like ALS and Parkinson’s. Qian was a medical research fellow at the Stanford University School of Medicine and a researcher in digital health, mental health, and health policy. The two co-founders came together to make an EHR platform for mental health clinicians to manage their patients’ records. The Osmind software will be sold to researchers, psychiatrists, and other specialties as the latest innovation in EHR. The Differentiators: Osmind’s software is unique in that it has a number of features that are noton other mental health EHR platforms. For example, since Osmind was built by psychiatrists it includes ketamine infusion and therapy templates, interventional psych templates, synchronized vital sign monitoring, and many more. In addition, while Ketamine has been administered previously, after its recent approval many clinicians are looking at other ways to administer it safely. As noted in an article in the Journal of Psychoactive Drugs, “we believe ketamine can benefit patients with a wide variety of diagnoses when administered with psychotherapy and using its psychedelic properties without need for intravenous (IV) access. Its proven safety over decades of use makes it ideal for office and supervised at-home use.“ In addition to having templates for Ketamine and other psychedelics, Lucia Huang notes, “we automate a lot of patient-reported outcomes and other sorts of data tracking on patients which is really important for this patient population because providers don’t want to fly blind between visits. They want to know how patients are doing so they can adjust their care plan accordingly”. Osmind attempts to be a broad package that simplifies mental health treatment workflow and enhances the patient experience. The website also allows clinicians to book a free demo for their own practice before buying the product. According to Lucia Huang, co-founder, “Existing tooling is just not serving providers well and it’s causing them to burn out.” In addition to those noted above, Osmind has several other noteworthy features including streamlined charting workflows, secure patient engagement, and automated outcomes tracking. As mental health research and treatments advance, so should the medical systems that clinicians use. These updates to the EHR system aim to provide users and patients with a better experience by incorporating the tracking of patient health outcomes. The Big Picture: Osmind’s solution hhighlights for us the fact that technology currently being used to house patients’ medical records is outdated, and are more focused on physical health. As such refinements are needed to customize them for the demands of behavioral healthcare. This solution is meant to increase clinician efficiency and the availability of patient records through the use of AI and the application of new non-traditional treatments. For the Osmind platform to succeed, clinicians and researchers need to adopt and implement this system starting with psychiatric clinics. The best way to prove its effectiveness is to use Osmind in everyday practices. Gathering data and feedback from clinicians is a good indicator of how well the platform works. Earlier this year Osmind collaborated with Stanford University School of Medicine physicians and scientists to publish the biggest real-world data study on ketamine infusion therapy in the Journal of Affective Disorders. If Osmind receives positive evaluations and release data studies such as this, then the implementation of this EHR is almost guaranteed. Osmind raises $40M for emerging mental health treatment EHR and more digital health fundings; Osmind banks $40M to scale up EHR for mental health providers with a focus on psychedelic, ketamine therapies; Osmind raises $40 million to expand electronic records for mental health

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

Our Take: The increased use and availability of digital health during COVID has begun to address some of the structural racism in healthcare improving satisfaction and broadening access to healthcare delivery. Ultimately, this may be a first step towards eliminating the patient divide and unconscious biases that currently exist. Nevertheless, structural racism in healthcare remains and has impacted the quality of care provided and the health outcomes of patients amongst diverse populations. However, exposing structurally embedded racist ideologies or unconscious bias will be a task of its own. Culturally competent care and diversity training will improve the quality and access to healthcare facilities. The use of telehealth has become an integral part of healthcare for many during this pandemic as its delivery methods cater to the needs and comfort of patients. Key Takeaways: A 2018 study found that Black patients had higher incidence rates of hospital-onset MRSA infection than White patients (6.21 per 100,000 vs. 2.94 per 100,000) One study found that black patients were significantly less likely than white patients to receive analgesics for extremity fractures in the emergency room (57% vs. 74%), despite having similar self-reports of pain A recent study in the journal Cultural Infectious Disease Reports found higher rates of infection and death during COVID-19 were seen in racial/ethnically diverse groups Black, Hispanic, American Indian/Alaska Native, and Native Hawaiian/Pacific Islander patients were reported to receive worse care than White patients for 35–40% of quality measures evaluated according to the 2018 National Healthcare Quality and Disparities Report The Problem: Recognizing how structural racism has played a significant role in the quality of care that is being provided to patients brings to light certain challenges racially diverse groups face. The hesitation of racially diverse groups in approaching healthcare providers is often associated with fear of being stereotyped. Unfortunately, unconscious bias among healthcare professionals still exists which can impact the attitude and tone that they use when speaking to patients of color. For example, there is still a high percentage of medical professionals that believe there are fundamental biological and innate differences that exist between Black patients and White patients when assessing pain or possible treatments. Century-old beliefs in physiological differences amongst racial groups when observing pain tolerance and management have only added to the structural inequities and poor health outcomes of diverse groups. For example, according to Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between Blacks and Whites, "For example, in a retrospective study entitled "Ethnicity and analgesic practice"the study found that Black patients were significantly less likely than white patients to receive analgesics for extremity fractures in the emergency room (57% vs. 74%), despite having similar self-reports of pain." Similarly, “Racial/Ethnic Inequities in Healthcare-associated Infections Under the Shadow of Structural Racism: Narrative Review and Call to Action” found that “the downstream consequences of structural racism have manifested throughout the COVID-19 pandemic, with Black, Native Americans, and Hispanic populations experiencing disproportionately higher rates of infection and death compared to White Americans.” Unfortunately, two years into this pandemic very few changes have been seen, however, the use of telemedicine has been quite helpful. Certain telehealth platforms provide patients with the option of audio, video, or audio-video calls with translators/interpreters that could be incorporated into the session if necessary. The Backdrop: Structural racism has played an integral part in the structuring of our healthcare systems starting from the conception of public healthcare facilities. Construction plans would include racially segregated sections that would be both unequal in standard and funding. For example, in 1946 the federal government enacted the Hospital Survey and Construction Act, commonly known as the Hill-Burton Act, to provide for the construction of public hospitals and long-term care facilities. Although the act mandated that healthcare facilities be made available to all without consideration of race, it allowed states to construct racially separate and unequal facilities. In addition, federal programs such as the Medical Assistance for the Aged program (also known as Kerr-Mills), which provided health care to the poor, “were underfunded and few states participated, especially states with large populations of Black Americans.” In addition, although these facilities were available would not be easy for many people of color to access other support services like insurance, health benefits, or paid sick leave were often not granted for workers that were not White. According to “Structural Racism in Historical and Modern US Health Care Policy”, “the National Labor Relations Act of 1935 expanded union rights for workers, which resulted in higher wages and benefits such as health insurance for those represented by unions. However, the act did not apply to the service, domestic, and agricultural industries, and it allowed unions to discriminate against racial and ethnic minority workers employed in other industries such as manufacturing.” Inconsistencies in the law such as this kept diverse groups struggling for adequate income and insurance coverage and it made healthcare inaccessible for many. In fact, it was not until the creation of Medicare and Medicaid programs in the 1960s that the first steps towards addressing the hardships of racial/ethnic minority populations were actively taken. However, the enactment of these social programs shaped an uneven, structurally racist system that did not look to provide long-term benefits to people of all colors. The federal government provided a free range of options for states to design eligibility requirements often making it difficult for diverse and minority populations to qualify for coverage. The financial strain, inadequate facilities, and limited resources made accessing care difficult and set up an unfortunate structurally racist and inequitable healthcare system. The implementation of the Affordable Care Act during the Obama Administration continued to target the inequities within healthcare and hoped to improve the accessibility and quality of care provided. However, while there are multiple avenues through which one can acquire coverage, the level of deductibles and out-of-pocket expenses required by even the most inexpensive plans can quickly add up for those of limited financial means resulting in financial and mental strain. In addition, due to the lack of higher education access and opportunities for people of color, there is a lack of racially diverse groups in the healthcare professions. This lack of diversity has only added to the structural issues and racially strained environments where unconscious bias still clouds the judgment and treatment provided to minority populations. For example, as noted in the study “Structural Racism In Historical and Modern US Health Care Policy”, “compared with White patients, racial and ethnic minority patients are less likely to receive evidence-based cardiovascular care, kidney transplants when indicated, age-appropriate diagnostic screening for breast and colon cancer, timely treatment related to cancer and stroke, appropriate mental health treatment, and adequate treatment when presenting suffering from pain.” As a recent article in JAMA noted, “systemic racism is both pervasive and understudied in medical care”, our healthcare environment and future healthcare professionals need to understand and incorporate culturally competent practices that would eradicate structurally racist practices. Due to COVID-19 telehealth platforms have begun to bridge this divide and have helped increase positive communication and patient satisfaction. For example, telehealth had enabled scheduling flexibility, available translators/interpreters, and a broader range of appointment options (audio, visual, or audio-visual) to cater to underserved patient needs. Implications: The importance of combatting structural racism and inequities that exist within our healthcare system has become a primary goal to ensure equitable treatment of diverse populations going forward. The use of telehealth and digital platforms has shown positive patient satisfaction and overall health outcomes in racial and ethnic minority populations. The incorporation of cultural competence training increased diversity training in healthcare delivery, broader community assessments, as well as continued input in the form of evaluations from both patients and staff, will provide greater insight into the issues as they arise. While telehealth provides flexibility and multiple features that could help ease patient experience, there are many individuals who are either not comfortable technologically nor technologically advanced and thus may continue to face greater difficulty. New policies that will aim to modify and lift licensing restrictions for telehealth services will also provide a broader, more diverse network of healthcare professionals for patients to consult. According to the Federation of State Medical Boards, approximately nineteen states and territories have implemented long-term interstate telemedicine waivers as of February 2022. However, despite an easing of licensing restrictions and discounts on telehealth services one concern that remains is how to overcome the issue of Internet and broadband access in communities that do not currently have it and where it may take time for them to get it. While significant funding has been dedicated to the development of broadband for such communities, that will take time. In the interim many have proposed the development of Internet hubs that offer free Wi-Fi to aid the adoption of digital health services for underserved communities. No matter how the issue of broadband access is conquered, as noted in a recent issue of JAMA Network, “only when outcomes are culturally sensitive and meaningful when minority communities are able to collaborate with research and researchers, and when studies point out not just the existence of but also the amelioration strategies for care inequities will we start to navigate our way through this most complex of ecosystems to achieve more optimal, beneficial, compassionate, culturally sensitive, and equitable …care for all.” Related Readings: Structural Racism In Historical And Modern US Health Care Policy Racial/Ethnic Inequities in Healthcare-associated Infections Under the Shadow of Structural Racism: Narrative Review and Call to Action Racial and ethnic differences in self-reported telehealth use during the COVID-19 pandemic: a secondary analysis of a US survey of internet users from late March U.S. States and Territories Modifying Requirements for Telehealth in Response to COVID-19

Our Take: While moving data to the cloud is becoming increasingly common for healthcare organizations as they look to handle the massive volumes of digitized data, data security concerns remain paramount. By choosing the right data storage healthcare solution, organizations can provide better patient health outcomes by controlling how data is accessed (clinician and researcher use) as well as achieving HIPAA compliance and security. Public clouds, on-premise private clouds, and hybrid clouds come with their own set of advantages and disadvantages and should be chosen based on the healthcare organization’s needs and values for managing data growth. However, the security of cloud installations seems to be a common concern that needs to be addressed no matter what type of deployment. Key Takeaways: A single patient generates approximately 80MB of data in just EMR and imaging data each year according to the New England Journal of Medicine. Using clouds as data storage has helped healthcare organizations to adopt new technologies that transform and support their model of patient-centered care. The global healthcare data storage market is expected to grow at a CAGR of over 16% between 2019-2026, reaching over $8B by 2026. According to the Flexera State of the Cloud Report, security was the largest concern for enterprises working with the cloud with 85% of respondents expressing concern, a rise of 4% from the prior year. The Problem: While healthcare data has increasingly been digitized and moved online, the dramatic rise in the use of telehealth and other online services drove an exponential increase in healthcare data as well as a need to easily access and consolidate all data in one place. For example, according to the New England Journal of Medicine, a single patient generates approximately 80MB of data in just EMR and imaging data each year. As a result, industry research firm Researchandmarkets estimates that the global healthcare data storage market will grow at a CAGR of over 16% from 2019 to 2026, reaching over $8B by 2026. This has given rise to an increase in the exploration of cloud storage by healthcare organizations to increase access while simultaneously reducing costs. According to the National Institute of Standards and Technology (NIST), “the cloud” is “a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.” As noted in “Security Concerns of Cloud-Based Healthcare Systems” cloud has become a popular option in healthcare “mainly due to reduced cost and increased performance in terms of reliability, scalability, and flexibility.” Cloud computing deployments can be further divided into three types, public cloud (where a user can access and use the cloud through the public Internet), private cloud or on-premise (which runs on an organization's one infrastructure and security), and hybrid cloud (which is a combination of public and on-premise). Each type has its own storage options, security considerations, and risks for accessibility and control of patient data for healthcare organizations. In general, as noted in “Securing Services in Networked Cloud Infrastructures” there are a number of security considerations for all types of cloud computing. For example, security and privacy challenges arise when there are multiple tenants with different policies and requirements using the cloud infrastructure. When sensitive data belonging to enterprises and individuals are stored and used by services in the cloud, it poses security as well as privacy issues. 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.” Costs, maintenance, scalability, flexibility, and control are also important factors that healthcare organizations must evaluate when deciding which cloud storage option to deploy. While the following is not exhaustive some of the advantages and disadvantages of each method are listed below: Public cloud: Advantages: Leverages shared infrastructure, relatively easy to scale and provision, reduction or elimination of maintenance as 3rd party provider responsible for infrastructure. Disadvantages: Potential security concerns, third party provider will secure the cloud itself but the user must secure the network and applications Users will need to decide on security protocol (ex: encryption) for data in transit or at rest. Private cloud: Advantages: Stores that organization’s data and resides only on their equipment so the organization has direct control and responsibility for security. Disadvantages: Generally higher operating costs and slower scalability when more resources are required to accommodate growth. The organization is required to handle all updating and patching of software. Hybrid cloud: Advantages: Allows organizations to store highly sensitive data on the private portion of the cloud and less sensitive data on the public portion of the cloud. Allows organizations to take advantage or the rapid scalability of the public portion of the cloud. Disadvantages: More complex and time-consuming process to set up than compared to the public cloud as the cloud service provider has the obligation to ensure only authorized users access the private cloud portion while allowing outside users to access the public cloud. Potential for interoperability issues between data stored on public and private clouds. Requires the assistance of third-party services to deploy. While there are several delivery models for cloud computing, Software as a Service (SaaS), Platforms as a Service (PaaS), and Infrastructure as a Service (IaaS), the remainder of this Our Take will focus on Infrastructure as Service models as we think they are currently most relevant. The Backdrop: Healthcare data comes in a variety of types and formats including Electronic Health Records (EHRs), patient registries, claims data, health surveys, Picture Archiving and Communication Systems (PACS), as well as clinical and research data. Using clouds as data storage has helped healthcare organizations to adopt new technologies that transform and support their model of patient-centered care. This is crucial not only for advancing data utilization but improving healthcare outcomes for patients through such mechanisms as population health and predictive analytics. For example, since public cloud infrastructure is easy to scale and empowers geographically dispersed clinicians and researchers to simultaneously work on large data sets it can aid in knowledge transfer and innovation. For example, pharmaceutical companies can use large datasets, patient registries and even create digital twins (allowing virtual copies of patients’ physiological profiles) to explore the potential of drug candidates worldwide for drug development. As noted in “Security Concerns of Cloud-Based Healthcare Systems”, the public cloud is considered more cost-efficient as it is “pay-as-you-go…it allows users of cloud to purchase the computing resources according to their necessities and requirements without [having] to invest a large amount of cost in purchasing the IT infrastructure.” In addition, given the security concerns associated with public cloud, private cloud data storage is often a popular option amongst healthcare organizations, as it provides more control over data and lets organizations design in whatever customized level of security features it desires to meet regulations such as HIPPA, GDPR, CCPA, etc. According to Xtelligent Healthcare Media, the private cloud is believed to be a more secure option since “on-premise EHR systems must ensure IT professionals are on staff to maintain and oversee hardware and software… [and] must maintain security safeguards and manage all controls.” There is also the benefit of protecting against downtime risks such as outages that can occur in the public cloud. Hybrid cloud storage is viewed as offering the best of both architectures with its public cloud portion typically used for less sensitive web-based services as well as data backup and recovery protocols. According to O’Reilly’s “The Cloud in 2021” report, the top cloud service providers to the healthcare industry are Amazon Web Services, Microsoft Azure, Google Cloud, and other. Implications: Cloud storage and other technologies have dramatic potential to improve the quality, accessibility, and timeliness of healthcare data but healthcare continues to lag behind most other industries, ranking 7th out of 12 industries in cloud usage according to O’Reilly’s “The Cloud in 2021 Report”. Given the importance of data security and privacy in healthcare, this will likely not occur until healthcare overcomes the challenges of security, latency, and manpower. For example, according to the Flexera State of the Cloud Report, security was the largest concern for enterprises working with the cloud with 85% of respondents expressing concern, a rise of 4% from the prior year. Interestingly, while great advances have been made in cloud security, it has consistently remained a concern for healthcare executives. Moreover, the recent increase in healthcare data breaches, with a total of over 700 reported in 2021 (up 11% from 2020) has only reinforced and highlighted these concerns. While each organization will have to determine which cloud model would be best for them, there are several steps that healthcare organizations in particular should take to secure IT assets as they move to the cloud. As highlighted in “Security Concerns of Cloud-Based Heatlhcare Systems” the most important issue with the public and hybrid cloud is multi-tenancy “The most important security issue involved in cloud computing is the presence of third–party because the healthcare organizations have no command of their medical data dispensation and management.” Healthcare organizations must work with Cloud Service Providers (CSP) and their counsel to ensure they are aware of “what level of security is being enforced by the service provider, what potentials risks exists and what compromises can take place on the cloud infrastructure must be between the healthcare organizations and service provider” (including the right to audit). Importantly, healthcare organizations should note that using a HIPAA compliant CSP is essential and that under HIPPA Business Associates are responsible for ensuring that their software and systems are in compliance with HIPAA. In addition, healthcare organizations should ensure that they have strong access and identity management controls in place. This includes the use of two-factor authentication as well as ------- As noted in “Cloud Computing Security Challenges and Threats” it is important that access controls cover “all stages of the user access life cycle, from initial registration of new users to removal of the last registration of users who do not need access to the latest information systems and services.” Moreover, these groups should ensure that they are using encryption both for data at rest and data in transit. Healthcare organizations considering moving to the cloud need to ensure they have a history of strong auditing and enforcement procedures in place, which include honest assessments of how often they are auditing their systems, consequences for violations, and remedial steps taken when defects or lax enforcement of procedures have been uncovered. Finally, those considering moving to the cloud may want to consider the use of offshore cloud vendors, as data stored outside the U.S. may not be subject to the same level of protection as that stored in the U.S., and should a breach occur with an offshore vendor, HHS’ Office for Civil Rights (OCR) or State Attorney’s General may have limited power to take action. Related Reading: Choosing Between Healthcare Public Cloud, Private Cloud Guidance on HIPAA & Cloud Computing | HHS.gov Security Concerns of Cloud-Based Healthcare Systems: A Perspective of Moving from Single-Cloud to a Multi-cloud Infrastructure Cloud Computing Security Challenges and Threats

Our Take: While the Pandemic forced the adoption of virtual physical therapy and the waiver of certain restrictions, the lessons learned from that experience have created an opportunity to broaden the use of these offerings to improve the quality and efficiency of care for patients. The management and availability of consultations for physical therapies as well as sports-related injuries through telehealth platforms during COVID-19 have aided in discovering quick, effective, accurate, and quality diagnoses and delivery of care. As we begin to move to an endemic phase of the Pandemic, the use of certain technologies deployed during COVID such as telemedicine robots that feature a virtual neurologist could be broadened to not only help to assess athletes’ injuries on-site but extend care to underserved areas. Key Takeaways: A number of research studies have demonstrated that “the accuracy of telehealth tools to determine pain, swelling, range of motion, strength, balance, and gait has been found to be valid, reliable, and feasible.” As noted in one study, in more than 20K public and private secondary schools in the U.S. 34% of schools had no access to athletic training services or physical therapists, and almost ½ had part-time coverage only. While prior to COVID, telehealth for physical therapy (or telePT/virtual PT) had been widely used in many foreign countries, “utilization and reimbursement in the United States remained mostly limited to different government agencies such as the U.S. Army and Indian Health Service. In northern Canada, approximately 80% of pediatric patients are evaluated through telehealth services. The Problem: During COVID the use of physical therapy was difficult due to the social distancing measures enacted during the pandemic and the associated limited access to physical care facilities. As noted in “The Role of Virtual Physical Therapy in a Post-Pandemic World: Pearls, Pitfalls, Challenges, and Adaptations”, while telehealth for physical therapy (or virtual /telePT) had been widely used in many foreign countries, “utilization and reimbursement in the United States remained mostly limited to different government agencies such as the U.S. Army and Indian Health Service.” However, as result, many institutions rapidly shifted in order to determine how to deliver physical therapy via telehealth platforms to reduce the risk of infection through physical contact. In order to facilitate this, in April of 2020, the Centers for Medicare and Medicaid Services (CMS) waived certain regulations thereby allowing providers of physical therapy services via telehealth to offer and collect a bill for the telehealth services that had been provided. In addition, many states eased or waived certain state licensure requirements making the provision of physical therapy services across state lines easier. Nevertheless, even with these changes being implemented there were concerns that patients would forego the necessary follow-up care or implement exercises improperly leading to complications or sub-standard efficacy of procedures. As a result to make sure similar, high-quality care was delivered via telehealth as in the study noted above it was important to ensure “prior to performing telehealth physical therapy visits, clinicians were required to complete all training material to ensure comfortability and confidence.” The Backdrop: As noted earlier, prior to COVID the use of telePT was fairly limited and there were concerns about the accuracy of certain measurements given that prior to COVID these were often done in a physician's or physical therapist's office. For example prior to the assignment of exercises or a program clinicians would have patients go through a series of exercises to determine their range of motion, strength, balance, etc. In addition, as noted in “The Role of Virtual Physical Therapy in a Post-Pandemic World”, “The main challenge associated with telehealth physical therapy for the clinician is the inability to use one’s hands or provide tactile cues during the evaluation and treatment.” Depending on the level of technological sophistication of the client or their ability to access broadband technology there may be technological hurdles on the part of patients as well. While “telehealth physical therapy requires a different set of skills that involve no physical contact and highlight therapists’ use of strong “subjective” questioning, a sound understanding of kinematics and movement patterns, and a systematic process to problem-solve” over time a number of training programs have been developed to aid in the successful application of telePT. In addition, a number of research studies have demonstrated that “the accuracy of telehealth tools to determine pain, swelling, range of motion, strength, balance, and gait has been found to be valid, reliable, and feasible. Also, prior studies have shown there is a high agreement between in-person measurements and virtual evaluation of a range of motion measurements and assessment of function for the shoulder, elbow, hip, and knee.” Nevertheless, the issues of technological competency and access remain. For certain age groups or those who may not be as adept at technology, providers need to ensure adequate user training is put in place to ensure the success of telePT encounters. Clinicians will need to realize that due to technological limitations there may be clients where delivery of telePT is not possible. For example, as Wired Magazine pointed out in “Access to Telemedicine is Hardest for Those Who Need it Most” 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. 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. Implications: While certain technological and access limitations continue to exist and should be addressed as rapidly as possible, telePT services have proven to be effective and high quality and should be expanded. For example, according to “The Role of Virtual Physical Therapy in a Post-Pandemic World” provision of telePT provided patients with “quicker access to care, similar patient satisfaction, and increased geographical outreach compared to in-person care.” The study noted that patients were able to get quicker access to telePT with the ability to get an appointment in approximately 3 days vs. approximately 7 days for in-person care. Assuming workarounds or fixes are found to overcome the technical hurdles noted above, this could be a strong option for individuals looking to age in place or in senior care centers where seniors may have limited mobility or who may no longer be living with family or are unable to successfully complete exercises without direction. Not only would this provide appropriate rehabilitation or maintenance of muscle tone, but it would also help with aspects of social isolation. Moreover, expansion of telePT services could help speed recovery and reduce reinjury for communities where the time and lack of transportation make these services more “expensive”. For example, several studies have found that travel and wait times for appointments can eat up anywhere from ½ an hour to 2 hours, making them prohibitively expensive for those on hourly salaries. By contrast, with telePT travel and wait, time would be eliminated improving the quality of care, reducing potential reinjury and the need for expensive follow-up or corrective treatment. Not only does such care reduce the chance of reinjury, studies indicate that such rehabilitative therapy has persistent and lasting effects. For example, according to “Overview of Telehealth and Its Application to Cardiopulmonary Physical Therapy”, results were encouraging based on improvements in function following 30 one-hour VE [virtual-environment based] treatment sessions [and] most improvements persisted well after physical therapy services were discontinued.” Related Reading: The Role of Virtual Physical Therapy in a Post-Pandemic World: Pearls, Pitfalls, Challenges, and Adaptations Evaluation of Pragmatic Telehealth Physical Therapy Implementation During the COVID-19 Pandemic Overview of Telehealth and Its Application to Cardiopulmonary Physical Therapy A Systematic Review of Telehealth and Sport-Related Concussion: Baseline Testing, Diagnosis, and Management

Our Take: Digital health apps have been up and coming in recent years. As technology continues to advance, the apps are becoming more streamline and user friendly. The rise of new digital tools could potentially improve patient treatment and outcomes while easily connecting patients to their healthcare providers at their fingertips. However, major concerns circulating digital apps revolve around security, privacy, and usability. In particular, “Despite some recent initiatives, there is still no specific regulation procedure, accreditation system, or standards to help the development of the apps, mitigate risks, or guarantee quality.” Consequently, both in the U.S. and internationally, the struggle to incorporate the accelerating pace of growth of health apps into healthcare systems while ensuring its efficacy continues to pose a risk. As both the industry and regulations mature, these applications need to give users confidence that these apps can be used without exposing their PHI (personal health information) and with the peace of mind that the health information they gain is both accurate and reliable. Key Takeaways: According to the IQVIA Digital Health Trends report, there are now over 350K health-related mobile apps, and almost 90K were created in 2020 alone. The FDA updated its guidance on Device Software Functions and Mobile Medical Applications in September 2019. According to the guidelines, the FDA would not enforce laws for software that assists patients in self-management of their condition without proposing specific therapies and automating simple tasks for healthcare practitioners. Operationalization of digital health apps are not entirely understood and require adjustments in order to provide the best form of functionality. Information quality, interface usability, digital divide, and physician burnout are among several factors that need to be addressed for the future of mobile health apps Problem: The ongoing challenge of the health care system to integrate digital health apps will be limited until standards can be established for their safety and effectiveness. While the markets and technology are moving at a rapid pace, policies and efforts around regulation move extremely slowly and have generally lagged behind advancement. Nevertheless, despite the fact that regulatory regimes still lag behind the pace of development, factors like efficacy, quality, safety and data privacy still need to be assessed so that users can fully enjoy the benefits of these health apps. As noted in “Standards for Mobile Health–Related Apps: Systematic Review and Development of a Guide”, “this is a problem not only for the safety of end users (i.e., patients and health care professionals) but also for professional developers”. For example, developers need to understand the current and future direction of regulatory regimes so that product roadmaps and any required adjustments can be made in order to provide the best form of functionality. In the U.S while policy is lagging innovation, it does seem to be at least moving in the right direction. In September 2019, the FDA amended its guidelines on Device Software Functions and Mobile Medical Applications. The guideline material suggested that the FDA will not enforce regulations for software that “assist patients in self-management of their ailment without recommending particular therapies and automating simple activities for healthcare practitioners.” Furthermore, the FDA stressed that software regulations are function-specific and apply across platforms. As a result, references to "mobile application" in the guideline have been replaced with "software function." In addition, in March of 2020, the FDA launched a Digital Health Innovation Action Plan, an initiative aimed at streamlining device approvals by concentrating on developers and processes. Under the plan, the FDA divides device software functions into two categories: 1) Software as a Medical Device (SaMD) and 2) Software in a Medical Device (SiMD). SaMD means that software itself is the device and according to the FDA it “ranges from software that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes to Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer.” By contrast SiMD is software that is a component of another medical device that aids in its operation in some way. For example, “if the software in question helps in any way to run a medical device, it is SiMD. Software that powers the mechanics of a medical device or processes the information that is produced by a medical device is obviously considered SiMD as is software that controls the device remotely.” The FDA has created a definition that centers around the primary way to read or see the results, noting that “if you cannot use the medical device without this software, it is SMID.” The Backdrop: According to industry estimates, 325,000 healthcare apps were accessible on smartphones in 2017, equating to an estimated 3.7 billion mobile health app downloads by smartphone users globally that year. The foundation of digital health apps is to provide a convenient and efficient method for patients to not only take control of their health but have immediate access to their health information all stored in one place. Despite this, as noted in “Standards for Mobile Health–Related Apps: Systematic Review and Development of a Guide”, “the exponential growth in mHealth solutions has occurred with almost no control or regulation of any kind. Despite some recent initiatives, there is still no specific regulation procedure, accreditation system, orstandards to help the development of the apps, mitigate risks, or guarantee quality.” This impedes both innovation and confidence in development, for as the study goes on to point out “progress depends not only on what each research group is doing but also on developing general standards and improving certification procedures.” Moreover, because “very few of the health apps available have undergone a thorough validation process, the end result is a lack of confidence among health professionals. Internationally “Belgium and Germany [appear to have] come the furthest in operationalizing and implementing their market access and reimbursement approval framework for medical apps (excluding apps that do not fulfill criteria for medical devices)” according to a recent article in NPJ Digital Medicine. “While in many other countries, initiatives to replace multiple local and fragmented initiatives with little impact with national frameworks are ongoing” in the U.S. regulation of medical apps is fragmented due to jurisdictional issues. In the U. S. a "regulated medical device" is one that meets the definition of a device under section 201(h) of The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress in 1938 that helped establish the legal framework within which FDA operates. Under the act a product has to have been cleared or authorized by the FDA via a review of a premarket submission or otherwise categorized by the FDA. One example of how this is applied to digital health apps and emerging technology occurred back in September of 2017 when the FDA approved Pear Therapeutics De Novo request, allowing the company to market reSET for the treatment of patients with substance use disorder (SUD). This marked the first time the FDA had approved what are known as digital therapeutics, which are one type of health app and are defined by the Digital Therapeutics Alliance as devices which “deliver evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes of claims to improve clinical outcomes in a disease. Despite this, challenges around thorough vetting and testing of digital health apps remain. As noted in the NPJ Digital Medicine article there is “a demand for ‘someone’ to provide a quality stamp on the apps that fulfill basic medical and privacy criteria, that is, to provide a labeling of apps that denote which ones have achieved standards or endorsement of some type”. In addition, there is a “broad, international convergence in terms of requirements in the areas of transparency, health content, interoperability, and privacy and security” for such apps. Implications: As the delivery of healthcare information continues to digitize, a number of concerns remain around the development, efficacy, data privacy and security of digital health apps. First and foremost, as noted in “Health app policy: international comparison of nine countries’ approaches” “apps currently provide alarmingly low levels of information to consumers about data use” dramatically undermining user confidence and trust. In addition, Transparency regarding ‘how the app achieves its decisions’ (suggested by [International Standards Organization] ISO) is similarly critical but needs to be better operationalized in all countries, not least in relation to the increasing incorporation of AI-based algorithms in apps,” contributing to hesitation to embrace the conclusions of the apps and concern among both patients and clinicians that they are dealing with a black-box. To combat these issues the authors of “Standards for Mobile Health–Related Apps: Systematic Review and Development of a Guide” have come up with 8 criteria which should serve to create solid guidelines until a broader regulatory framework is in place. These include: 1) Usability (i.e., the app must be adapted to the targeted population), 2) Privacy (i.e., compliance with the law and treatment of users’ data), 3) Security (i.e., data protection, authorization mechanisms, and detection of vulnerability) 4) Appropriateness and Suitability (i.e., the benefits and advantages for the end users are explained), 5) Transparency and Content (i.e., scientific evidence and sources information), 6) Safety (i.e., the potentiality of risk to end users), 7) Technical Support and Updates (i.e., there is a policy about the maintenance of the app post launch), 8) Technology (i.e., the app works smoothly and does not fail abruptly). Finally, app developers and product teams should remember medical terminology used in the apps may be hard to understand or grasp by certain patients, so it should be adjusted so that it is accessible to all. In addition, while some individuals may be more technologically savvy than others, those who are older or not familiar with using smartphones may not be able to understand how to use health apps at its optimal level. This ties very closely with concerns around the so-called “digital divide” and how that digital divide may turn into a social determinant of health as these apps gain popularity. This could occur where patients with low health literacy or who are unable to access or afford technologies such as smartphones or tablets will be unable to experience or benefit from them. And lastly, physician burnout may be intensified by the load of digital health apps and having to learn how to utilize them. So, it may be a burden for some physicians to adapt to new technologies and transition to a more digitized form of communication. Related Readings: Health app policy: international comparison of nine countries' approaches | npj Digital Medicine Beyond validation: getting health apps into clinical practice | npj Digital Medicine Standards for Mobile Health–Related Apps: Systematic Review and Development of a Guide SaMD vs SiMD: What's the Difference?

Our Take: While digital health/telehealth platforms during COVID-19 have been a favorable mode of receiving care for many, it can be considered a social determinant of health for individuals that have limited internet access. During the initial wave of COVID-19, inadequate housing, financial insecurities, and employment status continued to negatively impact racial and ethnically diverse populations. However, our reliance on digital platforms in all aspects of our lives has exacerbated socioeconomic factors that impact an individual’s ability to acquire adequate internet access and therfore limit their ability to avail themselves of health and wellness checks via telehealth or virtual appointments. Key Takeaways: Approximately 37% of Americans who have smartphones do not have high-speed internet connection within their homes. Approximately 63% of Americans that reside in tribal or rural areas lack sufficient broadband connection in their homes. Less than 1% of the funding from the Federal Communications Commission (FCC) is spent on expanding broadband connections for tribal or accompanying rural areas. The likelihood of experiencing poor health outcomes increases within households that do not have a broadband connection and internet access. The Problem: As the COVID pandemic put the world into lockdown our main source of communication relied heavily on internet access and technological devices to interact and engage with our peers, fulfill work commitments and as in-person health care facilities shut down, there was a shift to digital platforms and/or the phone.However, the lack of high-speed internet access or the difficulty of accessing broadband connections at all within underserved communities was rarely taken into account. Underserved communities already have a preponderance of racial and ethnically diverse populations that struggle to receive quality healthcare, as a result moving healthcare online only compounded the problem where inaccessibility to internet connectivity and lack of broadband were already issues. In addition, of those who had internet access via smartphones many were constrained by limited data plans or data rates which were quickly throttled down beyond a certain usage point. Thus, what many viewed as the great equalizer was in fact adding another barrier to care. The Backdrop: While prior to the COVID pandemic electronic health records (EHR) and patient portals had become common mobile health applications that were broadly used, the lack of internet access or patient mobile usage demonstrated a significant gap in access amongst elderly groups and individuals who had resided in poor, rural, and tribal areas. According to “Digital inclusion as a social determinant of health,” “nearly 30% of older adults and 30% of those earning less than $30,000 own a smartphone and many low-income households share devices, raising both access and privacy issues.” In addition, elderly populations often need assistance to develop the technical fluency to do even the most basic things such as create emails and profiles to access patient portals. Moreover, barriers to understanding the technical or medical jargon can intimidate patients leading to inadvertent or unwanted logoffs from systems. However, expanding broadband access generally and the improvement of health via digitally inclusive platforms relies heavily on governmental funding to promote broadband connection within neighborhoods that currently lack access. For example, although the Federal Communications Commission (FCC) Lifeline program subsidizes the costs of smartphone devices and internet services, the qualification process varies per state and a lack of consumer awareness appears to be to blame for the limited success to date of the program. Similarly, the Pandemic has also demonstrated that lack of access to broadband connection impacts not just healthcare but also the ability of individuals to find work from home or attend virtual school. For example, a study by the The Economic Policy Institute found that only 20% of African American populations and 16% of Hispanic/LatinX populations were able to work remotely due to connectivity issued. Moreover, a report entitled “Digital Disenfranchisement and COVID-19: Broadband Internet Access as a Social Determinant of Health”, found that “In Washington State, for example, some districts reported 50% or more students and families do not have access to the internet at home (Equity in Education Coalition, 2020)”. Internet service providers (ISPs) are not the only onesto blame for the inconsistent or poor provision of broadband service that exists in many urban low-income and rural neighborhoods. It is the Federal government that regulates the delivery of internet as a regulated resource and they are taking too much of a hands off approach to this regulation. Perhaps the provision of internet should in fact be a regulated monopoly or duopoly like electric power or land-line phone service. Currently, the Federal government continues to try a nuanced approach by providing $7.171 billion to reimburse schools and libraries for providing free broadband service in the recent American Rescue Plan Act and $65 billion to expand broadband, create more low-cost broadband service options, and subsidize the cost of service for low-income households in the recent Bipartisan Infrastructure Deal. This is likely not enough. Implications: While moving healthcare delivery online has been shown to be a benefit to many in underserved communities in terms of convenience, reduced travel time, decreased time away from work and lower costs, this is only true for those who have consistent broadband access. Otherwise, the move to telehealth and other digital tools actually ends up exacerbating or worsening disparities that already exist. As a result, policymakers, providers, and payers need to consider this when integrating digital services into systems and care planning. For example, as noted in the AMA 2021 Telehealth Survey Report “The digital divide remains the No. 1 barrier to telehealth access for patients. Limited patient access to technology, limited digital literacy in patient mix, and limited patient access to broadband internet were the top three barriers cited by physicians.” In addition, a majority of physicians in the survey “said they use audio-only modalities to offer telehealth services” which would be one way to overcome some of the issues noted above, according to a recent survey conducted by the American Medical Association. In addition, all of the parties noted above need to realize that once the public health emergency (PHE) is declared over a number of crucial supports for many patients will cease and many deficiencies in the system will reappear. Language barriers, lack of digital literacy, unaffordability of internet access plans or continued lack of coverage post-COVID will all remain problems. For example, a 2020 JAMA study noted 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. As a result, clinicians need to make sure that when attempting to use these tools patients have the technology to access them, the capability to use them and the wherewithal to get the maximum benefit from them, otherwise they need to sit down and take corrective action so that proper care can be delivered. Related Readings: Internet Access as a Social Determinant of Health Digital Disenfranchisement and COVID-19: Broadband Internet Access as a Social Determinant of Health Digital inclusion as a social determinant of health Telehealth and the digital divide as a social determinant of health during the COVID-19 pandemic

Our Take: As the adult population continues to increase in size, age-related discrimination, biases, beliefs, and stereotypes are becoming more prevalent. Ageism has been shown to have adverse effects on one’s health outcomes and influences the psychological, physiological, and behavioral health of the older population. Additionally, such ageist beliefs can promote negligent behavior by staff and lead to the further development of chronic diseases. However, the inclusion of geriatric-related clinical coursework can promote a change in how future healthcare professionals interact with and provide care to such populations. While the use of telehealth services has increased positive responses from elderly populations limited digital/technical knowledge has halted further success. Key Takeaways: Approximately 89% of elderly adults from previous studies have experienced some form of ageist behavior or discrimination. Older individuals are less likely to be selected as organ transplant recipients in comparison to younger individuals. Elderly populations are likely to visit their healthcare providers annually an average of 12 times. Older adults with negative perceptions about ageing demonstrated poorer functional health, recovered from disease more slowly and had shorter average life spans.” The Problem: While older populations are regular consumers of medical services, they are more likely to face harsher treatment, poor attitudes, and poor bedside manner by staff. Oftentimes, healthcare professionals present will bypass the elderly patients and speak directly with their families showing a lack of regard for their input and undermining their decisions. For example, in the study “Physical Therapists’ Nonverbal Communication Predicts Geriatric Patients Health Outcomes” a series of videotaped interactions focused on capturing indifferent behaviors by physical therapists resulted in a negative “short- and long-term cognitive physical health outcomes for the patient”. Additionally, despite the growing need for geriatric physicians many medical students or residents entering the field find it to be frustrating and less rewarding. However, they fail to understand that the need to investigate and research sensory and cognitive impairments within elderly populations is an important aspect of formulating treatment options for future generations when they reach this stage. The Backdrop: Ageism in healthcare, while often not recognized, has been a long-standing issue in the proper treatment, communication and experiences of elderly patients. These negative views within the healthcare system are often influenced by clinician’s initial exposure to hospitalized elderly patients more so than in community-dwellings. For example, medical trainees’ exposure to geriatric patients within a healthcare facility led to misconceptions that stereotype them as frail, disoriented, or incurable solely due to age. In addition, as housing seniors in institutional settings has become more common and worker shortages have become more severe, the level of training and sophistication in serving the needs of the elderly has also declined. This has led to a lack recognition and ability to effectively treat and deal with geriatric-related conditions. As stated in the “Geriatrics Workforce by the Numbers,” “with this population growth, the demand for Geriatricians is expected to increase 45% by the year 2025, yet [the] emerging number of Geriatricians in America actually decreased from 10,270 in 200 to 8502 in 2010”. Furthermore, the lack of training and educational curriculums in the health workforce has led providers to apply age-based, group characteristics to most geriatric patients regardless of their individual health status.” Thus, treatment may be delivered regardless of health status. For example, according to an Ageism Survey conducted by Dr. Erdman Palmore, approximately 43% of elderly individuals between the ages of 60 – 93 stated their healthcare provider would associate their ailments as a direct factor of their age, with 9 percent of participants stating that they had been denied the opportunity to receive medical treatment due to their age.” This was particularly evident in treatment guidelines established during the recent COVID pandemic, where many elderly individuals that were turned away from care and had been placed in a stereotypical age-related illness category despite their health status. Older adults were more often looked at in terms of the mortality rates as tables which were considered “normal” regardless of the state of the disease, comorbid conditions and overall physical health. According to “Ageism and COVID-19: what does our society’s response say about us?” in the United States a Ventilator Allocation Guideline has been put in place “whereby ‘age may be considered as a tie-breaking criterion”. Additionally, the creation of the ‘Vulnerable Person Registry’ has aided in supporting elderly populations to keep them socially engaged and provide the necessary resources needed during these tough times, the name itself is ageist. However, in terms of telehealth, the adoption of consult services with video-conferencing and post-discharge maintenance has been shown to have positive health outcomes among the limited number of individuals that actively use them. Implications: While elderly populations are not as familiar with technology or digital platforms it is not an impossible task to help them obtain technological literacy in order to use and get the maximum impact from digital tools. For example, when New York Presbyterian-Weill Cornell Emergency Department incorporated a geriatric emergency medicine, over 1, 000 patients were evaluated with most noted they had “high levels of satisfaction after receiving care,” This demonstrates that not only do elderly patients defy the stereotypes but also, they are capable and in fact eager to learn more about technological platforms/advancements available via digital platforms. However, many times digital tools do not incorporate the appropriate methods to train seniors how to make maximum use of the technology. Consequently, innovators, providers and payors should make sure to include this in all phases of their products using customer journey mapping to ensure products are available to seniors along all levels of the health continuum. In addition, as noted in Ageism as a Risk Factor in Chronic Disease, “older adults with negative perceptions about ageing demonstrated poorer functional health, recovered from disease more slowly and had shorter average life spans” Hence, as they note, given the burden of chronic disease in the aging population, better understanding and addressing ageism is a promising and largely unexplored strategy for decreasing morbidity and mortality in the United States. Related Readings: Not for Doctors Only: Ageism in Healthcare A New Interprofessional Community-Service Learning Program, HATS (Health Ambassador Teams for Seniors) to Improve Older Adults Attitudes about Telehealth and Functionality Ageism as a Risk Factor for Chronic Disease Older adults and technology: in telehealth, they may not be who you think they are Ageism and COVID-19: what does our society’s response say about us? Chapter 13 Ageism in the Health Care System: Providers, Patients, and Systems