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Our Take: Creating more digitally engaged nurses and digital nurse leadership is integral to optimizing the benefits of digital technologies and solutions in nursing practice. Digital health technologies and solutions have become an essential part of healthcare delivery and is widely debated to be the future of healthcare. Nursing is not left out with opportunities to explore the potential of utilizing technology or digital health solutions. The accelerated pace of adoption of disruptive digital health innovations demands that nurses remain at the forefront of digital innovations in patient care. Different countries all over the world are taking deliberate steps to elevate nursing leadership in the digital sphere. In its policy agenda the U.S. cannot be left behind. Key Takeaways: Despite the many benefits of digital health innovations in nursing practice, nurses have been reluctant to adopt technology because of inadequate support, complicated systems, and technological lapses. As noted in one study “nurses provide about 80% of care and are described as a link between patients and processes.” The top nursing challenges are nurse retention (61%), nurse recruitment (59%), nurse engagement (35%), and nurse leadership development (33%) per the 2017 Health Leaders Media Nursing Excellence Survey. Lack of nurse leadership poses a major challenge to nurse engagement with digital technology. The Problem: Globally, there was a massive increase in nurse shortages and poor retention that worsened during the COVID-19 pandemic because of theincreased health risk and inadequate support. In a 2017 survey, respondents ranked nurse retention as the top nursing challenge, followed by nurse engagement and nurse leadership development. Interestingly, the response from the survey revealed that engagement and leadership development drive nurse retention more than money. Digital health technologies and solutions have become increasingly adopted and integrated in healthcare with promises of transforming healthcare by reducing workloads, making processes simpler, and improving access and patients’ experience. It has benefits for improving nurse retention and overall performance with features that allow flexible scheduling and improved communication. Despite the many benefits of digital health innovations in nursing practice, nurses have been reluctant to adopt technology because of inadequate support, complicated systems, and technological lapses. Nurses' concerns about technological lapses and outdated systems have validity because the resulting disruption of work processes endangers patients’ lives. The Backdrop: Digital technologies like wearables, telehealth, remote patient monitoring, and scheduling apps have become integral to healthcare service delivery and are projected to remain part of the future of healthcare. Nurses who are at the forefront of implementing these technologies have experienced difficulties in adapting to this new normal. A major constraint contributing to poor nurse engagement with digital technologies is inadequate support caused by gaps in nurse leadership in digital health innovation. . While nurses are not averse to digital engagement, encouraging their active engagement in the technology development and implementation is fundamental for improved performance of these innovations. In addition, this appears to be an area in need of greater research focus. For example, as noted in “Artificial Intelligence in Healthcare: Implications for the Job Design of Healthcare Professionals”, most of the studies around AI and job design noted “the implications for job design …for doctors and patients but only seldomly for 1) nurses, 2) managers and 3) organizations” which the authors found “surprising as nurses provide about 80% of care and are described as a link between patients and processes.” In addition, while in many cases AI assistants are designed to help reduce workload, as the aforementioned study notes, “with the advent of digitalization and novel technologies, doctors and nurses must process much more information about patients and scientific publications, thereby both increasing and decreasing their job demands. Keeping up with such medical information, which is doubling every 5 years, is an example of an increased job demand.” Implications: The accelerated digitalization of health services and systems has expanded healthcare leadership responsibilities to developing and managing digital health. Nurses’ participation in implementing digital transformation projects at an early stage makes them central to digital healthcare leadership. As a result, empowering and enabling nurses to engage with digital tools is crucial for several reasons. When nurses are involved in the design of digital solutions, it helps in factoring complexities and peculiarities of different sector needs. For instance, community nurses might face more hurdles to using technology, especially if the systems are outdated or in instances where communities lack access to basic technological infrastructures or poor internet connectivity. Furthermore, technologies that are not fit for purpose pose a major barrier to nurses’ engagement with technology. Nurse leadership in the digital health space could lead to useful feedback on improvements in technologies and systems that would better serve the nurses and improve patients’ outcome. Moreover, enhanced communication between caregivers and caregivers and patients is another benefit. As noted above, nurses provide the majority of patient care and are an integral part of any design changes in the process of care for patients. Nurse leaders speak a language that other nurses understand and they are also better placed to address the concerns that they might have. For instance, concerns about reduced interactions with patients caused by uptake in technology can be addressed by flagging areas in which technology saves time or provides useful data for improved patient interactions. Implemented correctly, digital health solutions have the potential of alleviating many of the administrative demands of the nursing profession, however, nurse leaders need to be at the helm for sustainability and for better buy-in and adoption. Related Reading: Nurses 2.0 - The digital transformation of nursing Leadership in Digital Health Services: Protocol for a Concept Analysis How the nursing profession should adapt for a digital future Digital engagement in nursing: the benefits and barriers Artificial intelligence in health-care: implications for the job design of healthcare professionals

The Driver: Sidekick Health recently raised $55 million in series B funding led by London-based Venture Capital firm Novator Ventures, with additional participation from Wellington Partners, Asabys Partners, Frumtak Ventures, and a US-based partner that has yet to be revealed. Sidekick Health is an Iceland-based digital care platform focused on managing chronic diseases. Sidekick develops personalized digital therapeutics to encourage lifestyle and chronic disease management in a game-like format. During the COVID pandemic, Sidekick collaborated with the Icelandic government by providing remote triaging, remote monitoring, and management of COVID infections. The funds from the Series B funding will be used to develop additional treatments, further expand the platform to other countries, strengthen existing partnerships, and create new partnerships with stakeholders in the healthcare industry. Key Takeaways: 90% of the nation’s $4.1 trillion in healthcare expenditures are for people with chronic and mental health conditions according to the CDC. Nearly half (approximately 45%, or 133 million) of all Americans suffer from at least one chronic disease, and the number is growing. The DTx platform has helped 40,000+ patients globally at this stage, with its products currently available in six languages. A recent Frontiers in Public Health article found digital interventions can effectively improve the management of pain, fatigue, stress, and increase overall health-related quality of life. The Story: The Iceland-based startup Sidekick Health was founded by CEO and Co-founder Dr. Tryggvi Thorgeirsson and Dr. Saemundur Oddsson in 2014. The two doctors worked for years treating patients with lifestyle-related illnesses. They noticed that 68% of all deaths were related to lifestyle-related illnesses. This led them to pursue innovative ways to prevent chronic illnesses as well develop treatments for those already suffering from the diseases. The solution they came up with was to create a platform that combines behavioral economics with games, and make it scalable across multiple therapeutic areas. The product they created became the digital therapeutic platform called Sidekick. Sidekick’s go-to-market model is business-to-business (B2B) meaning it is designed to work with health insurance and pharmaceutical companies. Currently, Sidekick has partnerships with U.S-based health insurer Anthem to provide “digital first” care programs and pharmaceutical companies Bayer and Pfizer to develop a combination therapy using molecular drugs and digital therapy. With the funds from the fundraising round “Sidekick plans to double [the size of its] team from 120 to 240 team members across our four office locations.” The Differentiators: One thing that sets Sidekick apart from many of its competitors is its “integrated combination therapeutics consisting of a molecular drug and a digital therapeutic.” As noted in a recent TechCrunch article Sidekick’s approach used “digital therapeutics plus pills…that is designed to support healthcare outcomes by applying personalized behavioral lifestyle nudges, alongside clinical treatments like drugs, to augment, extend and support patient care for a range of chronic diseases and conditions”. As pointed out by Fierce Healthcare, “the digital platform features the Sidekick Health app for the patient, a care portal for HCPs to remotely monitor patients with communication and support, and what the company calls the DTx studio, where a team of doctors, nurses, physiotherapists and clinical experts create the portfolio of therapeutics.” In addition, “Sidekick works closely with pharmas …in creating auxiliary DTx programs to complement traditional drug treatments. There is also a strong connection with patient advocacy organizations to ensure the recommended treatment follows those groups’ guidelines. The application itself is free to use, however members will need a code for specialized features such as the Rheumatoid Arthritis program. Sidekick develops programs for a number of lifestyle diseases such as diabetes, ulcerative colitis, and smoking cessation. According to the company they “are building toward a portfolio of over 40 medical-grade digital therapeutics by 2026, and currently have 18 in Research & Development, with a total of 14 commercial partnerships secured so far”. They also have collaborations with other companies to bring new treatments and programs to their platform. The Big Picture: Sidekick Health’s solution shows that there is potential for digital health solutions to extend the life of traditional therapies as well as create new, innovative, efficient therapies that can enable more people to access personalized DTx and lifestyle management programs. The Sidekick platform will add to the growing number of DTx resources, expanding the reach of digital health. Insurance providers can work together with Sidekick to create other app-based therapies targeting chronic diseases. Since Sidekick will also be working with pharma companies, they will be able to create combination therapeutics as a way to increase adherence and effectiveness of treatments. The Sidekick app aims to improve the efficiency of digital therapeutics by adding a game-like element to health management which effectiveness has been proven and can be less costly to develop than traditional pharmaceuticals. The success of Sidekick’s solution is dependent on evidence-based evaluation on the effectiveness of these treatments. Research has been shown to support the idea that digital lifestyle programs can improve individual health outcomes. If evidence shows that Sidekick’s digital programs are effective, then more countries may adopt this type of treatment. Sidekick Health grabs $55M for digital-first care programs ; Digital therapeutics firm Sidekick lands $55M in Series B round, Health and Economic Costs of Chronic Diseases; An Empirical Study of Chronic Diseases in the United States: A Visual Analytics Approach to Public Health, Sidekick’s Feasibility Study Shows Encouraging Results for Breast Cancer Patients

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

The Driver: Clipboard Health recently raised $30 million in Series C funding led by Sequoia Capital with participation from Caffeinated Capital, Initialized Capital, Michael Seibel of Y Combinator; Tony Xu, co-founder of DoorDash; and Emmett Shear, CEO of Twitch. This latest funding round brings the total funds raised to more than $90 million. Clipboard is an app-based marketplace company whose goal is to serve as a solution to the labor shortage at healthcare facilities around the country. Their marketplace provides nurses and certified nursing assistants (CNAs) the opportunity to find work wherever they go through their application. This platform is as much for hospitals and nursing homes as it is for healthcare workers. Clipboard Health will be using the recently earned funding to hire new workers in all areas, including sales and marketing, and to double the size of its engineering team. Key Takeaways: Since March 2020, the number of people working at U.S. hospitals declined by more than 2%, according to data from the U.S. Bureau of Labor Statistics, while emergency department wait times increased. A recent analysis of workforce data by Premier found that staffing shortages cost hospitals $24 billion during the pandemic. 3 in 10 healthcare workers considered leaving their profession and 6 of 10 remarked that pandemic-related stress hurt their mental health according to a 2021 Kaiser Family Foundation study. Clipboard Health’s application allows for healthcare workers to find flexible shifts and for hospitals to find skilled healthcare workers. The Story: Founder and CEO, Wei Deng, started Clipboard Health in 2016 with a mission to revolutionize the market for healthcare talent by leading the way in reliability, affordability, and ease of use for facilities and healthcare professionals. For years, the healthcare profession faced a severe shortage of workers leading to facilities having to outsource their employees. The shortage of staff was made more apparent during the Pandemic when many hospitals were at full capacity and the number of people working in hospitals declined by over 2% in part due to COVID illnesses and disputes over safety protocols. Clipboard Health is an ideal solution to provide those facilities the ability to find qualified workers in less time. This easy-to-use application is organized so that healthcare facilities can post available shifts and qualified healthcare workers can find and register for those shifts. According to TechCrunch, “Clipboard, is an online marketplace that pairs nurses, nursing assistants and other healthcare professionals with facilities in need of staffing. Using the platform, facilities can post shifts they need to fill and healthcare workers can book these shifts, managing their schedules via Clipboard’s mobile app.” Clipboard is easy to access and like any smartphone app, providers and healthcare workers can find this application in the app store for Apple devices and the play store for Google devices. The Differentiators: Clipboard differs from similar companies like Trusted health which created a platform for nurses to find contract positions and ShiftMed which allows healthcare workers to find available shifts through the app with next-day pay. Clipboard is unique in that it does not require healthcare workers to apply for a contract or long-term position at a particular facility. The healthcare worker can choose shifts anywhere in their area using only their mobile device. The feature of Clipboard that particularly stands out is the instant pay after the shift ends. Healthcare workers are typically paid weekly, bi-weekly, or the next day when working as employees or contractors, however, Clipboard allows healthcare workers to get paid much faster than traditional methods. In addition, Clipboard prides itself on providing flexibility to its consumers to reduce worker burnout and creating a healthcare marketplace of talented workers for facilities. The Big Picture: Clipboard Health’s solution of an online marketplace for healthcare providers has the potential to become a model for helping alleviate the workforce shortage in healthcare by making it easier to advertise and fill available positions. Clipboard’s app approach can benefit hospitals, nursing homes, nurses, CNAs as well as the patients they serve. The company’s solution allows hospitals and nursing homes to be more efficient in recruiting and filling vacant positions by increasing access to talented healthcare professionals quickly and easily. Providing nurses and CNAs with access to numerous opportunities in their local geographic area and on their own time can help reduce stress on the healthcare worker and benefit the patient by having caregivers who are engage, satisfied and rapidly rewarded financially for their efforts. In addition, as noted in numerous studies, less burnout and greater job satisfaction with their jobs translates into higher quality, more attentive care for patients. Over time this becomes a virtuous circle, the more providers that Clipboard works with, the more opportunity for the workers and the better results. However, maintaining these levels of success and ensuring Clipboard’s solution is effective will likely mean the company will need to expand its network of providers andservices geographically and diversify the number and types of shifts offered. Moreover, one additional challenge Clipboard may face is the robust competition within healthcare for talent between providers, travel nursing companies and other types of contractors. For example, while Clipboards model is differentiated, there are several companies such as NurseDash, CareRev, NomadHealth, and ConnectRN that have similar models that could pose strong competition if Clipboard’s model does not further differentiate itself. For Clipboard to stay competitive, it may need to extend its list of service offerings to other healthcare professions such as medical assistants, physician assistants, and physicians themselves if it is to succeed long-term. Clipboard Health, which matches health workers with facilities, raises $80M; Clipboard Health, an online hiring platform, snags $80M to expand into more cities; Healthcare staffing startup Clipboard Health raises $80M across two rounds and more digital health fundings

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

The Driver: Evernow recently raised $28.5 million in a Series A funding led by NEA, with participation from 8VC, Refactor Capital and Coelius Capital, plus angel investors, among them Color CEO Othman Laraki, and Carla Harris. The San Francisco based company built its platform focusing on women’s health and more specifically those who suffer from adverse symptoms of perimenopause. The company claims its using its clinically-validated health intakes to fill gaps in care for menopausal women while being inclusive to women from all backgrounds especially in underserved communities. The new funding will be used for expanding the team, building community, and leveraging the company's data and research to focus on product development. Key Takeaways: There are an estimated 1.3 million women entering into menopause every year in the United States. This equals to over “$2,100 per woman per year” in added costs on the healthcare system and overall economy. Black women, in particular, have reported longer-lasting and more severe menopause symptoms than other racial groups for years. A subscription includes unlimited access to the startup’s medical team and the delivery of hormone therapies estradiol or paroxetine, supplemented with progesterone when needed. Although funding has increased for women’s health start-ups overall, it still remains a relatively small portion of the digital health investments. The Story: Menopause is defined as as the end of a woman’s menstrual cycle and is diagnosed after a woman has gone 12 months without a menstrual period. Perimenopause is defined as the process of Menopause beginning which most women start in their 40's and is evidenced by skipped cycles and period irregularities. Alicia Jackson, founder and current CEO of Evernow stated that the company’s goal is to “build a new way of delivering healthcare based on science, innovation, and women’s lived experience with menopause”. Established in 2019, Evernow’s goal is to serve as a link between women who are or are about to reach menopause and a team of specialists who can advise and prescribe to them. Evernow aim to provide a resource for the approximately 1.3 million women just beginning the process and entering the perimenopausal phase, a process that spans 10-20 years of their life, produces symptoms for 85% of patients, and yet where there are very few viable options for treatment and management. Studies have shown that women who experience menopause are more likely to be at higher risks for cardiovascular disease, stroke and osteoporosis. As noted by the Office of Women’s Health at the U.S. Depatrtment of Health and Human Services, low levels of estrogen and other changes related to aging (like gaining weight) are indications of these conditions making it crucial in addressing the symtpoms of those who are most at risk. For example, in a survey of 100,000 women experiencing menopause who filled out Evernow’s intake form, 75% of perimenopausal women reported experiencing fatigue and low energy, weight changes, sleep disruption and brain fog. Almost two-thirds of women (60%) reported anxiety or depression, night sweats, hot flashes and joint or muscular pain. The Differentiators: While there are many healthcare companies targeting women’s issues, sometimes referred to as “Femtech”, their efforts generally focus on sectors catering to women under 40 such as pregnancy and fertility, but far fewer focus on the issues of women undergoing the three phases of menopause (Perimenopause, Menopause, and Late Menopause). Evernow is focusing on menopausal issues and trying to make access to education and the necessary treatments to manage the symptoms of this phase of a woman’s life more effective and discreet. For example, although there are a number of tools to address either the physical or the behavioral aspects of menopause, Evernow provides both hormone therapy, like the estradiol patch or pill, and paroxetine as well as an SSRI that can be used to treat night sweats and hot flashes. In addition, when users sign up for the service, they're matched with a clinician who helps build their treatment plan based on the patient's health history and their medications are unobtrusively delivered to their homes. The user is alsl given access to a library of resources and guides aimed at educating not-only women currently experiencing menopause, but also the millions of perimenopausal women who are transitioning into the menopause phase. According to the company, treatment data is based on its studies of more than 100,000 women experiencing perimenopause and menopause symptoms since its founding in 2019. Also, the company is backed by influential female celebrities such as Gwyneth Paltrow, Drew Barrymore and Cameron Diaz who are known for their activism on women’s health and rights. According to CEO Jackson, “women going through the healthcare system understand where the gaps are in a way that I don’t think men do.” Members pay between $75 and $129 per month for the services which are seemingly cheaper than that of similar companies such as Parsley Health, which offer their subscriptions for approximately $175 per month (however, Parsley does offer out-of-network reimbursement up to 70%). Evernow accepts Health Savings Account (HSA) and Flexible Spending Account (FSA) since they are not in network with any insurance providers. The Big Picture: Investors spent $1.023 billion on U.S. women’s health technology startups in 2020, up from $625 million in 2019, according to Crunchbase data. Investment in this space has steadily risen since 2017, with total funding of $2.9 billion since 2016. As the industry shifts its focus to an older generation of women, it is evident how neglected they were. According to the company, while over 55 million women publicly and secretly experience menopausal symptoms, over 75% of those who seek help seldom get it. This appears to be due in part to a lack of attention from the healthcare industry. For example, according to an article by Fortune, of the millions invested in technology for women’s health over the past decade, only 5% has gone to menopause management. Consequently, as the numbers increase for women who are approaching perimenopausal age, there needs to be more talk and concern surrounding this health issue and the health disparities that accompany treatment. In addition, many of the issues associated with menopause such as cardiovascular disease and stroke often disproportionately affect women of color, so addressing the issues and concerns of underserved communities should be a priority in disease prevention and management. Evernow, and companies like it, are actively taking the steps to address the concerns of millions of women by offering its 24/7 communication services with their clinicians as well as guaranteeing improved conditions for night sweats, and hot flashes among much more in under 3 months. Treatments like this which increase the convenience and accessibility care for menopausal women can improve the quality of life as well as reduce the risk of other health complications that would further burden an already distressed health care system. Clearly many women can directly benefit from utilizing such a platform and it would give them a greater degree of control over their health. Gwyneth Paltrow, Cameron Diaz-backed Evernow raises $28.5, It’s Time to Prioritize Menopause: Our Investment in Evernow (Note: authors are employees of NEA, lead investor in the company)

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

The Driver: The AI-programed Dental care company VideaHealth recently raised $20 million in Series A funding led by Spark Capital with participation from Zetta Venture Partners and Pillar VC. This latest funding round brings the total funds raised by VideaHealth to $26.4 million. VideaHealth’s software helps detect dental pathologies that the dentist may miss. They hope to make this type of AI a standard part of dental care by assisting dentists in their clinical diagnosis and ensuring quality dental care for their patients. We beleive that over time AI-based dental tools like VideaHealth can be used to extend care to many currently lacking care through the use or dental hygienists or other professionals under the supervision of a dentist using their platform thereby eliminating or reducing the number of people lacking access (our theory not currently a strategy of Videa’s to our knowledge). This would impact reduce the chances of developing poor dental health and pathologies. Key Takeaways: Oral conditions affected 3.9 billion people and “$244.4 billion of the expenditures occurred in high-income regions” per the Global Burden of Disease study. The populations most prone to oral diseases are also the most vulnerable: the poor, the very young, the elderly, those with disabilities, and those with comorbidities. VideaHealth AI software works like a second pair of eyes to help dentists diagnose oral diseases and works to help do diagnostics and practice management. Currently, dentists miss up to 50% of oral pathologies in dental diagnostic imaging. The Story: The founder and CEO, Florian Hillen, founded VideaHealth in 2018 with a mission to improve patient health using artificial intelligence. Videa is harnessing the power of AI to make dentistry more transparent to dentists, insurance providers, and patients. The company was founded to overcome the high rate of missed diagnoses in the dental industry. A study published in 2011 by Dr. Ida Kondori, then at Xavier University, found that 43% of clinical diagnoses submitted by dentists were incorrect. That means that almost half of the patients were not receiving an accurate diagnosis. Similarly, Kondori and colleagues found that “General dentists misdiagnosed 45.9%, oral and maxillofacial surgeons 42.8%, endodontists 42.2%, and periodontists 41.2% of the time”. Hillen and partners recognized these high misdiagnoses rates and subsequently developed a tool to combat this. To accomplish this, the AI program is trained on data from millions of patient records from images that have been previously reviewed and labeled by dental experts. By analyzing these records, the program can identify and measure clinical indicators on x-rays to provide an accurate diagnosis. Although the company is for-profit, most of the money generated comes from venture capital investments. The Differentiators: Videa is one of the early companies aiming to apply artificial intelligence to the problem of dental diagnosis and aims to reduce the percentage of dentists misdiagnosing patients by utilizing AI dental software. Videa is different from other dental services like Quip which is involved in the design and delivery of oral care products and Pearl Inc which provides AI analysis which attempts to either support or refute a diagnosis (as opposed to capture a potentially missing diagnosis or improper treatment). Videa's solution is unique because it’s a digital resource used by dentists to improve diagnosis accuracy when seeing patients. With the proper usage and development, their software may be able to improve overall oral health outcomes. This is extremely important as noted in a recent article in BMC Human Resources for Health “the combined worldwide direct and indirect costs estimated [for oral health conditions are] near $442 billion USD annually and “the populations most prone to these diseases are also the most vulnerable: the poor, the very young, the elderly, those with disabilities, and those with comorbidities.” The Big Picture: Videa’s dental tool AI is one of what is expected to be many digital health tools that could play a role in oral health. Moreover, we expect the recognition of good oral health to gain prominence as a prerequisite to strong physical and mental health. Those lacking in good oral health often cannot eat certain foods that help their diets which in turn contributes to other health issues. In addition, missing teeth or poor gums, can also contribute to poor self-image which can contribute to social isolation leading to other behavioral health issues. As noted in “Improving Access to Oral Health Care for Vulnerable and Underserved Population”, “access to oral health care is essential to promoting and maintaining overall health and well-being, yet only half of the population visits a dentist each year…the consequences of these disparities in access to oral health care can lead to a number of conditions including malnutrition, childhood speech problems, infections, diabetes, heart disease, and premature births.” In addition, as noted above, the cost of poor oral care in the U.S can be associated with almost $500B in disease. The Global Burden of Disease study reported that oral conditions affected 3.9 billion people. [Tooth decay] and periodontal disease are the most prevalent oral diseases globally and that “$244.4 billion of the expenditures occurred in high-income regions including North America, Western Europe and Asia-Pacific”. Tools like VideaHealth can not only make practitioners more effective it can also potentially broaden the delivery of care by improving e the efficiency of dental providers in making an accurate prognosis. In areas where providers are scarce this could help address the social determinants of health associated with oral care by reducing the number of people who will not have access to Videa’s platform. Accuracy of dentists in the clinical diagnosis of oral lesions, VideaHealth raises $20M for AI-enabled dental care

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: 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?

The Driver: Season Health recently raised $34 million in a series A funding led by Andreessen Horowitz and joined by LRV Health, Company Ventures, Toyin Ajayi, (CEO of Cityblock), along with the founders of Shef, Instacart and MasterClass executives. The company which emerged out of stealth mode earlier this year, developed a platform where it pitched itself as a “digital food pharmacy” where it offers personalized nutrition to patients based on their health needs and has it delivered to their homes. The HIPAA-compliant platform also pairs patients with dietitians where disease management can be discussed based on patients’ preferences of food. Currently, Season Health is available in 7 states and the new funding will be used to build its business development and operations teams, and to support integration and partnerships with food retailers. Key Takeaways: Diabetes cost the U.S. $327B according to a study entitled “Economic Costs of Diabetes in the U.S. in 2017” by the American Diabetes Association Season Health’s dietitians develop meal plans aimed at helping patients manage chronic conditions, such as diabetes and kidney issues A 2010 study found that antioxidant rich diets contributed to improved cell function in heart and blood vessels but only when the antioxidants came from diet (not supplements) The company claims its programs enable better health outcomes for patients and reduce the cost of care for insurers The Story: CEO Josh Hix, co-founded Season’s Health in 2019 in Austin, Texas along with Mustafa Shabib, his co-founder and CTO. Hix was the former CEO of consumer meal kit and delivery business, Plated, and stated that his initial idea on starting this new company stemmed from his belief that “Unhealthy diets are a core reason for nearly 85% of U.S. healthcare costs”. The company is among a number of startups focused on a "food as medicine" approach to better support the management of chronic disease. Under programs like Season’s, given clients receive a more nutrient rich, higher quality, more tailored meal they believe patients receive better health outcomes and lower total healthcare costs. With over 50 employees now, Season also claims to work with leading health systems to support providers in writing evidence-based food prescriptions across a spectrum of clinical conditions and socioeconomic statuses. Currently, Season operates on a self-pay model; patients pay $75 per month as a subscription fee, which includes access to a dedicated registered dietitian, personalized meal recommendations, and concierge ordering. The Differentiators: One of the main differentiators is the tailored nutrition-based meals based on disease status or a desire to improve one’s health. While other meal delivery platforms such as Hello Fresh and Home chef deliver meals, Season Health has dietitians that prepare meals based on individual chronic disease management versus those just based on taste or dietary preference. Along with dietitians, the company also works alongside doctors and nutritionists to meet the proper requirements to help improve disease outcomes. While Season Health competes with companies like Soda Health, Soda’s programs provide debit cards to purchase healthy food and medications as well as transportation and it is not focused on meal planning or matching meals to medical conditions. Along those lines, tailoring meals could be important as according to the Center for Disease Control (CDC), nearly half of adults in the United States (about 47% or 116 million) have Hypertension and almost 11% (34 million) suffer from diabetes. With platforms such as Season Health, the goal is to adjust meal planning and realign it with healthcare with a focus on the nutritional content of meals to reduce disease prevalence and improve outcomes. Season Health and programs like it could potentially help underserved communities reduce the healthcare burden given the higher incidence of chronic disease and the large number of food deserts in those communities. The company is working to have its service covered by most health insurance providers, which would not only provide a reliable source of revenue but would also be beneficial for patients by broadening its reach to those who cannot afford it as a self-pay product. Season is currently working with Geisinger, CommonSpirit Health, and kidney-focused telehealth provider Cricket Health, (which recently merged with Fresenius Health Partners and InterWell Health). They are said to be partnering with Season in order to reach even more patients. The company claims that their focus will be on diabetes and kidney disease while working its way to eventually expand into cancer, and maternity and heart health. The Big Picture: Season Health’s mission is to bring the benefits of food as medicine and improve the lives of millions of people who are struggling with nutrition sensitive conditions. By creating a platform that offers cost effective food all while managing health conditions, Season is combining the convenience of home delivery with better health. Season Health is taking the first step in trying to properly manage health conditions by treating nutrition as the medication for its patients. Given prevention and wellness is generally a better, less expensive way to treat chronic conditions than treating disease after the fact, Season Health may be on the right path to having meaningful impact and ROI in treating disease. Moreover, with the current prevalence of food deserts in underserved communities they may make it possible to address health outcomes on a broad scale as patients adopt a healthier lifestyle. We believe Julie Yoo of Andreessen Horowitz was right on point in a statement accompanying the fundraising when she noted that while “we can readily shop and receive advice for better dietary choices from our doctors, dieticians, health coaches, and even the NYTimes Cooking app...translating that advice into actual healthy food showing up on our dining tables is still a disjunct, highly manual, and costly process." Season Health raises $34 million in Series A funding, Food-as-medicine startup Season Health nabs $34M backed by Andreessen Horowitz, Cityblock's Toyin Ajayi

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