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Our Take: Given the dramatic rise in connected medical devices (the so-called “Internet of Things”) and remote care, especially since the COVID pandemic, increases in digital health have exposed heightened risks in medical device information security. Consequently, investments in healthcare cybersecurity need to be focused more significantly on medical devices. Accompanying the growing demand for data analytics, remote patient monitoring, and remote diagnostics is a notable rise in threats and risks posed by unsecured medical devices. Medical devices require connection to both external and internal networks, exposing them to unauthorized access and many forms of malicious attacks that lead to device failure. ​​Key Takeaways: There are over 500K different types of medical devices and growing according to Deloitte’s report, “Medtech and the Internet of Medical Things”. Connected medical devices using the public Internet are more vulnerable to unauthorized access and data breaches if not properly protected. Many legacy medical devices are used and have hard-coded administrative login information and are infrequently provided software updates More recently, there are regulation guidelines in the US and the EU for medical device manufacturers to provide security design of medical devices. The Problem: Medical devices, such as heart monitors and lab equipment, collect and store sensitive data in healthcare organization systems vulnerable to hacking. Cybersecurity risks such as exposure to hacking open up healthcare organizations to legal and regulatory consequences from breach of data privacy and could potentially expose patients to harm. For instance, unauthorized access to medical devices could lead to the modification of Bluetooth-enabled insulin pumps and defibrillators, both of which could result in severe harm to patients. Notwithstanding the gravity of cybersecurity risk, it is challenging to manage because of the many legacy systems within the healthcare system that still have security vulnerabilities, some of which are so old that they are built on unsecure protocols such as Telnet which uses unencrypted logins and thus are less secure (more modern protocols such as SSH use encrypted logins and are thus more secure). For example, when users login to devices using Telnet, the user’s login information, including authentication data can get picked up through wireless sniffers or so-called man-in-the-middle attacks (where an attacker listens in to gain access to your data or injects malicious code into the stream to gain access to sensitive data and systems). As a result, connecting legacy medical devices to the public Internet increases its vulnerability to cybersecurity risks. According to security research using Shodan, a search engine that allows users to search devices linked to the Internet, case studies show that glucose monitors, fetal monitors, and PACS accessible on the public Internet are particularly vulnerable to numerous security threats. The Backdrop: According to research from MarketsandMarkets, the connected medical devices market segment that helps to diagnose, monitor, and treat patients is expected to rise from $14.9 billion in 2017 to $52.2 billion by 2022. The increased adoption of connected medical devices is driven by increased amounts of care moving outside of hospitals and doctors’ offices, a shift towards data-driven value-based care, and increased demand for remote patient monitoring devices, wearable technology, and at-home diagnostics which can improve the quality of care while lowering costs. There are currently over 500,000 different types of medical devices. These include: 1) wearable external medical devices (skin patches, insulin pumps, and blood glucose monitors), 2) implanted medical devices (pacemakers and implantable cardioverter-defibrillator devices), and 3) stationary medical devices (home monitoring devices, connected imaging devices, and scanning machines). These types of devices can be connected to health systems in different ways and can transfer health data to healthcare systems both internally and externally. Increasingly as devices become more sophisticated and patients connect to hospitals and providers with an increasing number of devices, connected medical devices dramatically increase the number of vulnerabilities/endpoints for providers and increase the risk of cybersecurity issues. In 2016, the FDA released guidance recommending timely software updates to patch security vulnerabilities and documentation for security assessments of existing and new products. However, currently in the US, medical device manufacturers have no legal obligation to address cybersecurity risks, either before or after releasing the medical device into the market. By contrast, in May 2017, European Union instituted Regulation 2017/745 on Medical Devices (MDR) that went into effect this year that provided specific cybersecurity guidelines for medical devices. Among other things, the rule created the position of "Person Responsible for Regulatory Compliance" (PRRC) and increased certain requirements for post-market surveillance activities. This is particularly important as a large number of medical devices run on legacy software that is no longer supported. For example, according to a study by VDC reports, there are approximately 1 billion medical devices worldwide that continue to run on unsupported software. Implications: Investment in infrastructure and the traditional security paradigm needs expansion and adaptations to include security vulnerability assessment for medical devices. In particular, prior to the Pandemic, many healthcare providers’ security frameworks were designed on the concept of the “walled garden” when firewalls and other intrusion protection devices were instituted to keep malicious parties off the providers’ network which was conceptually behind several layers of security. However, the pandemic flipped that model on its head as many of the providers’ employees, patients, and contractors were now operating outside of an organization’s physical facilities to keep exposure to a minimum which effectively placed them beyond most institutions’ “walled garden”. Instead, this exposed many institutions to a world where clinicians and patients were now accessing an organization’s network remotely, thereby opening up holes in that organization’s security and exposing it to many more threat vectors. In addition, while next-generation medical devices may be more secure and regulated through new security guidelines, many legacy systems remain vulnerable. These legacy systems require collaboration between the purchaser and manufacturer to implement appropriate security design as security updates may not have been implemented for some time or done on a haphazard basis. Connected medical devices and sensors hold the potential for improving operational efficiency for providers and outcomes for patients. However, as device manufacturers look to make legacy devices more secure they also face the dilemma of destabilizing devices on the market as well as exposing themselves to (or potentially admitting liability for) devices already on the market. This may account for device manufacturers' hesitancy to install new patches on stable legacy systems, notwithstanding the risk of potential device issues and interruption in workflows. While balancing risk and productivity is a challenge for healthcare technology management teams, incorporating medical devices in existing security design for risk mitigation should be prioritized. To this end, the actionable steps recommended by the National Institute of Standards and Technology (NIST) and security researchers for implementing better security practices for medical devices are worth considering. These include: Identifying vulnerable connected medical devices and processes that can lead to unauthorized access and device failure. Incorporating security testing and design before choosing a specific product and/or vendor. Protecting existing medical devices by updating the firmware (software that contains operational instructions for hardware devices) and limiting administrative privileges, when possible with support from the vendor. This is necessary to mitigate against potential risks for device issues and workflow interruption caused by software updates. Reporting and monitoring systems are needed to develop audit trails for detecting unauthorized access and configuration changes. Having reporting and monitoring systems is needed for implementing appropriate security compliance for medical devices. Conducting internal and external security audits to allow thorough vulnerability assessments. Audits should include medical devices as a focus requiring collaboration with medical device specialists and researchers. Related Reading: Mayo Clinic's Strategies for Securing Medical Devices It's Insanely Easy to Hack Hospital Equipment Report: Hospitals are Flooded with Vulnerable IoT Devices Medtech and the Internet of Medical Things

The Driver: Oshi Health, a digital gastrointestinal care startup, recently raised $23M in Series A funding from corporate investors including Flare Capital Partners, Bessemer Venture Partners, Frist Cressey Ventures, CVS Health Ventures, and Takeda Digital Ventures. In addition to the institutional investors, individual investors who joined the round included Jonathan Bush, founder and CEO of Zus Health, (and cofounder of Athenahealth), and Russell Glass, CEO of Headspace Health. The funding has been mapped out for expanding Oshi Health’s digital care platform. Key Takeaways: According to Vivante Health, $136B per year is spent on GI conditions in the US, that is more than heart disease ($113B), trauma ($103B), or mental health ($99B). 90% of Oshi Health members gain control over GI symptoms within 10 weeks. Direct costs for IBS alone are as high as $10 billion and indirect costs can total almost $20 billion. 1 in 5 people who suffer from diagnosed GI conditions also suffer from undiagnosed chronic symptoms. The Story: CEO and founder Sam Holliday dealt with GI while observing his mother and sister’s ordeal when managing their own IBS care. Holliday’s experience watching his family deal with the difficulties of managing IBS without clinical assistance prompted his interest in companies like Virta Health that use food as medicine for treating diabetes. Holliday saw the contrast between his family’s experience and Virta’s approach of supporting people in reversing the impact of diabetes on their daily lives. Holliday was fascinated with Virta’s holistic approach of care that prioritized the user's experience while saving cost and providing easy access to virtual care that leveraged technology and was data-driven. The possibilities that Virta’s virtual model presented for GI spurred the idea of creating Oshi Health. Oshi Health’s encompassing platform supports patients by granting them access to GI specialists, prescriptions, and lab work from the comforts of their homes. Oshi Health provides comprehensive and patient-focused care to patients with GI conditions such as Irritable Bowel Syndrome (IBS), Crohn’s disease, Inflammatory Bowel Disease (IBD), and Gastroesophageal Reflux Disease (GERD). Oshi Health works is by connecting patients with an Oshi Health clinician that assesses symptoms and orders lab tests and diagnostics if needed. Following which the patient has an option of speaking to either a registered dietitian or GI-specialized psychologists that will help in forming a customized plan as many of these conditions often involve a mental health component as well. The customized plan attempts to capture the patient’s needs regarding anxiety, nutrition, or stress. The Oshi Health service extends beyond testing and planning by providing stand-by health coaches and care teams to support patients and help them stay on track. Oshi Health’s platform also offers an app designed to help patients take action and stay organized through their GI care journey. With the app, patients can record their symptoms, quality of life measurements, and other factors known to impact their diet, sleep, or exercise. The app also features useful educational materials and recipes to help patients learn more about their condition. Oshi Health is currently available in 3 states and works through individual and employer-based health plans. Holliday hopes to use the series A funding to expand Oshi Health and expand coverage throughout the U.S. The Differentiators: About 1 in 5 people suffer from diagnosed GI conditions and many more suffer from chronic undiagnosed symptoms. “GI conditions are really stigmatized”. says Holliday. Integrated GI care is a missing piece of the healthcare infrastructure. There’s a huge group of people who don’t have anywhere to go to access care that’s proven to work.” By using this virtual-first model and increasing access to care at a lower cost for patients, Oshi Health is attempting to revolutionize GI care. Oshi Health plans to use a community of IBD patients for disease research, personalized insights, and a new digital therapeutic. Oshi Health is one of the first companies to address GI disorders and is easily accessible for patients through a virtual approach. It is the only virtual platform exclusively for GI patients. Being virtual helps patients receive treatment from the convenience of their home, saving them time and hassle of commuting for GI treatment which can involve extensive and costly testing. Patients are in control of their care and have access to a team of medical professionals at their fingertips The Big Picture: Oshi Health’s commitment to making GI care accessible, convenient, and affordable is more likely to lower the costs of treatments such as cognitive-behavioral therapy, colonoscopies, X-rays, sonograms, and more in healthcare centers. Oshi Health helps avoid preventable and expensive ER visits as well as unnecessary colonoscopies and endoscopies. By incorporating access to psychologists in the membership plan rather than requiring it to be paid out of pocket it allows patients to access the services of mental health professionals. Patients can schedule appointments within 3 days and there is always support between visits with care plan implementation. By incorporating both physical and mental health Oshi Health is attempting to treat not just the symptoms but the causes as well, helping to lower the costs versus receiving in-person which can lower the incidence of GI conditions and increase the quality of care they receive. Billions of dollars are saved annually on avoidable treatments and expenses because these patients are receiving the treatment they need rather than physicians ordering expensive tests without knowing the root cause of their problems. Due to the comprehensiveness of the virtual-first care model, physicians, dieticians, health coaches, care coordinators, psychologists are all involved in the patient's journey. Under traditional models, generally, patients with GI issues see just a gastroenterologist. By contrast, in Oshi’s model, a holistic team is involved every step of the way that is customized for each patient’s lifestyle that creates a personalized care plan for their lifestyle. Oshi Health Targets Costly GI Conditions with Virtual Care, Raises $23M; Healthtech Leader of the Month: Sam Holliday, CEO, Oshi Health

Our Take: Digital health organizations' data-driven and personalized approach to employee wellness programs design will improve employee engagement by shifting more control of health management to employees. Digital health and technology products like wellness software, smartphones, apps, and virtual services, have provided organizations and businesses with enormous support in improving employees’ health and well-being. The COVID-19 pandemic has shifted the fragmented approach of traditional wellness programs by introducing centralized and personalized digital health solutions in managing work stress and physical and mental health. Digitized solutions are particularly significant because the COVID-19 pandemic made remote working the new norm with accompanying spikes in work stress and mental health-related issues. However, the impact of wellness programs on saving cost, regardless of its form, traditional or digitized, remains unclear. Key Takeaways: According to the CDC, “work stress is the leading workplace health problem and a major occupational health risk, ranking above physical inactivity and obesity.” 82% of large firms and 53% of small employers in the United States offered a wellness program, amounting to an $8 billion industry. 80% of health care costs borne by employers are a result of preventable health conditions. According to a 2020 Aetna International survey, employees believe technological innovations and digital tools could further help them to improve their health. The Problem: Chronic health conditions lower employees’ productivity and increase the number of missed workdays. For employee absenteeism caused by high blood pressure, diabetes, smoking, physical inactivity, and obesity, employers incur an annual cost of $36.4 billion. Consequently, strategic and successful companies establish wellness programs to reduce health-related absenteeism, increase employee productivity and mitigate costs. While most businesses have embraced wellness programs as an essential component of their recruitment and retention strategy, a number of factors have limited employee engagement levels. According to a Harvard Business Review article entitled, “Why People Do - and Don’t - Participate in Wellness Programs” in a survey of 465 full-time employees in companies with established wellness programs, a lack of information and privacy concerns were the most prevalent reasons for nonparticipation in wellness programs. Employees are less likely to engage if they feel that the wellness program is intrusive or a channel for monitoring their health. Improved employee involvement in the wellness program decision-making is crucial for its effectiveness because driving lifestyle changes require individual interest and commitment. With the COVID-19 pandemic, employers faced a different dynamic for employee wellness management, with most employees working from home. Studies and surveys reported high rates of burnout, mental distress, and increased substance use rates for employees working remotely; essential workers faced an even higher risk. ​​The Backdrop: There are a number of issues that should be evaluated when looking at the role and efficacy of employee wellness programs. First, the early case for workplace wellness programs hinged on their ability to help employers manage employee health costs by reducing absenteeism, enhancing productivity, and reducing the overall cost of care. Driven by research that demonstrated many of the unhealthy lifestyle behaviors linked to reduced productivity are modifiable by behavior changes, wellness programs' claim of providing solutions that enhance workers' productivity gained in popularity. However, evidence that clearly shows that wellness programs reduce costs was limited. For example, a 2018 report published in the Journal of the American Medical Association (JAMA) stated that while 82% of large firms and 53% of small employers in the United States offered a wellness program, the report found no significant difference in the control and treatment groups when considering the impact of healthcare spending and utilization. Secondly, enticing employees to take part in employee wellness programs has long been an issue, with rates of engagement generally staying at low levels. This is due in part to the fact that some employees consider workplace wellness programs to be intrusive and would prefer to manage their wellness from the comfort of their homes. Interestingly, many organizations are less supportive when employees opt out of formalized wellness created by the organization and often choose not to support or reimburse more personalized options that employees might pursue (ex: purchasing equipment for exercise at home priced comparably to gym memberships). While there are clear issues with monitoring usage and correlating effectiveness, well-designed self-management programs might be cheaper and more impactful for certain employees than taking advantage of a company's wellness benefits. Finally, there is the issue of an employer's ability to reach the family decision-maker when it comes to wellness programs. For example, in the case of married employees when companies employ the male spouse, it is typically the female member of the household that makes the decision whether or not to engage in wellness programs. For example, a study by the Optum unit of United Healthcare women's uptake in workplace wellness programs was prompted more by physical appearance while 40% of the men engaged because they were prompted by their family. Furthermore, the study observed that mailers to the homes of employees that targeted female spouses had the potential of increasing the uptake rate of the male employees. As a result, many believe digital wellness programs have the potential to vastly alter employee engagement with easier usage, greater customization, and improved ability to target users. All of which could lead to improved utilization. Implications: Digital health applications for employee wellness have the potential to dramatically improve deidentified data collection, enhance workflow, increase productivity, and reduce the financial costs of employee health risks. The digital health wellness programs have filled a gap by providing one-stop solutions for employees that eliminate the hurdle of navigating numerous unrelated solutions offered by many traditional wellness programs. Even companies traditionally thought of as non-technology companies have become involved in digitized wellness program innovations. For instance, Peloton, an exercise equipment company, developed a corporate wellness program providing employees with subsidized access to its digital fitness membership. Similarly, Blue Shield of California saw an increased uptake in employees' engagement with its personalized digital wellness program. The organization reported that at the beginning of the pandemic, there was a significant increase in the organization’s employee engagement and a tenfold increase after the initial outbreak. Another sweet spot is that digitized wellness programs collate and analyze data to provide personalized solutions that motivate employees’ engagement resulting in higher levels of success. For example, ongoing data collection allows providers to tailor solutions to changes in employees' lifestyles or health conditions. This can be particularly important in the area of mental health. As was broadly reported, during COVID-19 lockdown, there was a spike in the rate of anxiety, depression, and substance abuse as a result of many factors related to the pandemic. When this was combined with the shortage of mental health practitioners in the U.S, digitized solutions for mental health became an effective and expedient way to narrow this gap. Companies including Modern Health, Lyra, and Ginger all have mental health applications targeted at the employer wellness space. Nevertheless, there remains the issue of effectiveness and return on investment. As noted in “Effect of a Workplace Wellness Program on Employee Health and Economic Outcomes”, when the authors looked at the impact of workplace wellness programs in the retail industry, they found no significant differences in clinical measures of health, health care spending, and utilization. Making wellness programs more effective requires a different approach that focuses on creating a personalized experience, informed outreach, and providing individualized incentives for improved engagement. Digitized wellness programs that focus on designing solutions that reduce cost while leveraging its unique approach of improving employee engagement through customized and centralized solutions for employees have the potential to drive this change. Related Readings: The Impact of Digital Health Interventions on Health-Related Outcomes in the Workplace: A Systematic Review Effect of a Workplace Wellness Program on Employee Health and Economic Outcomes The Digital Health Dilemma: Is Technology Keeping Workers Healthy or Making them Ill? Digital Wellness Programs with Key Elements may be the Answer

The Driver: Cured, a healthcare digital marketing and customer relationship management (CRM) platform, has raised $10 million in its Series A funding round. The round was led by DNA Capital and joined by CU Healthcare Innovation Fund, UCHealth, High Alpha, Waterline Ventures, Matchstick Ventures, and Headwater Ventures. Upon closure of the round DNA Capital partner Partha Mishra, will join Cured’s Board of Directors. Proceeds of the funding will be deployed in accelerating the advancement of the Digital Marketing and Insights platform, and the continued growth of Cured’s team of healthcare and customer experience experts. Key Takeaways: Cured’s clients have sent over 35 million interactions through the company’s solutions. According to Pew Research, 80% of Internet users have searched on health-related topics online yet less than one-third typically use patient portals. Cured is a pioneer of deploying machine learning models to contextualize outputs, which are then applied to a health system setting. According to the company, Cured has a 45% appointment scheduling rate, significantly above the industry average. The Story: Cured was founded in May of 2018 by CEO Andrew Sawyer, Ashmer Aslam, and Ro Narayan; former employees of Epic Systems and SalesForce. During their time in other roles, the founders noticed that healthcare organizations were consistently under-utilizing CRM, other marketing automation tools, and similar cloud-based platforms relative to how productively they were being used in other industries (ex: retail, financial services). Unlike other industries, the healthcare industry sends digital communication to patients as an exception instead of a norm. To address this gap, the founders defined an initial roadmap of numerous solutions they envisaged on a platform, which eventually became the minimum viable product of Cured Health. Since its launch Cured has partnered with leading health systems, healthcare services, and digital health organizations to transform their growth and experience strategies through technology. Cured provides a range of services to consumers that include driving consumers to preventative services, creating awareness of healthcare options suitable to their situation, and providing guidance to foster adherence and engagement. Cured enables leading healthcare organizations to engage patients as customers by enhancing user experience. With an established customer base of several top 50 health system and healthcare services organizations, Cured solutions enhance interaction with patients, partner relationships management, patient outreach relevance, and patient access experience and efficacy. These created interactions using data from EMRs and other sources, improve healthcare behaviors and patients' connections on more accessible and convenient platforms. The Differentiators: Health systems have a lot of structured clinical and industry-specific data, yet data exchanges are complex and resource-intensive. Cured has developed prescriptive data schemas for more efficient management, storage, and mobilization of data. It is one of the first companies to introduce personalized templates, communication channels, and CRM technology to connect with healthcare organizations. Cured is a pioneer of deploying machine learning models that are tailored to an individual’s healthcare based on where they are in their unique healthcare journey which the company believes can markedly improve engagement and loyalty. The data which provides context around when and where a patient is in their care drives communications and marketing strategy that allows health systems to gain insights on consumers’ behaviors and make predictions on their responses to future communications. According to Bill Altorfer, a principal at Cured, “we deploy machine learning models to better understand your first-party data…[which] allows you to not only gain significant insights into your consumers’ behaviors but also predicts how they will respond to your future communications and allow you to message those who are the most likely to take the action you desire”. Along these lines, detailed analytics helps healthcare organizations in understanding the ROI and performance of their marketing engagements. This unique approach of making data personalized and relevant for consumers helps differentiate Cured from its CRM competitors whose output is often limited to compiling customer data with limited analytics. Applying insights from modeling to identify gaps in health service utilization and more timely delivery of healthcare services to patients helps improve utilization and outcomes. Cured’s latest innovation in healthcare marketing allows healthcare organizations to use over 70 “curations” or pre-built templates of patient journeys with tailored content to create campaigns for customer experiences and custom content to deliver engagement points across different channels. Curations are Cured’s portfolio of 70+ interactions and corresponding care pathways, personalized with content relevant to healthcare consumers at specific points as patients. From care communications and front door inquiry responses to lifecycle and retention communications and growth and awareness campaigns, Curations tie all digital interactions together under one platform. Compared to other regular marketing templates, Curations is tailored specifically for healthcare organizations. As noted by Altorfer, “Curations are powered by standard first-party data [models] used by the vast majority of healthcare organizations and can be personalized to every consumer at every stage of the consumer lifecycle.” The Big Picture: As healthcare becomes increasingly digitalized, patients are becoming more proactive and informed consumers of their role in their own health care and Cured's technology can help them gain proactive insights into their consumer’s behavior. As providers and consumers become more data-driven, CRM systems like Cured make more data available for both parties to be partners in care, something that has historically been lacking. As Ashmer Aslam CTO of Cured put it, “you should view your provider as a trusted advisor and I don’t think any of us feel that way. If the health system is not being proactive, then there is no reason for me to choose your health system over any other.” Despite major advancements in marketing technology, data gathering, and the analytics that accompany it (ex: customer engagement, click-through rates, etc.) many of these advancements have not been deployed in healthcare. According to Ashmer, “all these things that exist in other industries just need to be translated into healthcare speak.” In addition, healthcare has long had lower rates of digital engagement than other industries, in part due to privacy issues but also due to poor user experience and design. For example, EMR portals are typically underused with the ONC reporting in 2018 that less than 60% of patients were offered online access to their records, and only one-third of patients routinely using portals to access them. Tools like Cured’s can not only help track portal utilization and awareness but strategically help encourage utilization. In addition, improving marketing analytics has impacts beyond just provider economics. Health systems investment in improving patient engagement with healthcare services and information can improve patients and health system outcomes in terms of tangible metrics such as medication adherence, disease prevention, and chronic care thereby lowering costs and improving care. Cured Raises $10M Series A; Launches Next Generation Healthcare Digital Marketing & CRM Solutions; CEO Spotlight Andrew Sawyer of Cured; Sneak Peek: Curations -70+ Pre-built Patient Journeys to Attract, Engage, and Retain Healthcare Consumers

The Driver: In early September, Invitae, a medical genetics company, acquired Ciitizen for approximately $325M with a deal consisting of almost $125M in cash and approximately 7M shares of Invitae common stock. Ciitizen, a patient-centric tech company, offers a global platform for digitally collecting, organizing, storing, and sharing patient medical records digitally. By leveraging Ciitizen’s existing technologies, Invitae's acquisition broadens ts plans of combining results from genetic tests globally into a single, easy-to-use service to make genetic information accessible to everyone. Key Takeaways: Invitae will acquire Ciitizen for $325 million $125M in cash and 7M shares of common stock based on the average closing price before the agreement date. Ciitizen had raised a total of $20M in two rounds of funding prior to the acquisition. Most states do not require hospitals to retain patients’ records beyond 7-10 years. Invitae has raised more than $1.4B in 2021 and this is its 13th acquisition in five years. The Story: Ciitizen was established in 2017 after the founder, Anil Sethi, lost his sister to metastatic cancer. While battling to save his sister’s life, Anil consulted over 23 different specialists across 17 institutions, and none of them had access to her complete medical history with life-saving data. When Sethi attempted to access his sister’s medical records, the clinical data were disorganized and not even digitized (ex: PDFs that had been scanned in). This experience with the difficulty accessing useful information inspired him to leave his job as a Director of Records with Apple to set up Ciitizen. “It’s tragic that in the most advanced healthcare system, because of a lack of connectivity, standards and even personal access, there’s no way for patients to fully arm themselves against cancer and other serious conditions,” Sethi said. The Ciitizen platform is designed to transfer the control of health data to patients by collating patients' medical records in a convenient and easily accessible manner. Following registration with Ciitizen, a patient can request health records after providing a photo ID and details of the healthcare providers. Over the next 2-4 weeks from the requested date, Ciitizen then acquires the patient's medical records, provides a personalized disease summary generated from the health data, and gives the patient access to use or share as they choose; empowering them to take charge of their own medical care. Invitae’s acquisition of the Ciitizen platform will grant its users access to all their clinical and genomic information in a centralized location and streamline the process of collecting and organizing health data. While Ciitizen's services are completely free to the consumer, revenue comes from connecting pharmaceutical companies and advocacy groups with health data, contingent upon obtaining patients’ explicit consent. In addition to Ciitizen, there are a number of other companies attempting to give patients improved access to their records including PicnicHealth, Medicalchain, and OneRecord. PicnicHealth is also a digital medical records system where you sign up, fill out some forms about your medical history and doctors’ information, then the PicnicHealth team will retrieve your records and store them in one area. You can access your records anywhere you have internet access. It costs $300 to enroll and then a $39 monthly subscription. You can even choose to de-identify your records and submit them for research. If a patient chooses this option, they will not have to pay any enrollment or subscription fees. Medicalchain a U.K.-based company has a very similar process, however, Medicalchain will place health records on a blockchain and use “medtokens” as a form of currency. “Patients will use the tokens to pay doctors for telemedicine consultations, and these doctors can then exchange them for fiat currency, or use them to pay their own or their family members' doctors.” Finally, Becker’s describes OneRecord as a digital platform used to access and share healthcare data through an app. The Differentiators: Patients diagnosed with terminal diseases often end up consulting multiple different specialists across the country in desperate search of a cure. In the absence of easy and convenient access to their complete medical history, generally including genetic testing results, previous treatment, and medical treatment, the health provider could miss out on vital life-saving information. Ciitizen enables patients to exercise their right to access complete health records by using its technology to obtain patient records from different health providers and translating the data into a comprehensive and understandable summary. Ciitizen’s technology provides an easier, more convenient, and timely alternative for patients to access their complete medical records. Accessing complete medical records promptly increases the chances of survival, especially for patients with advanced diseases like cancer. Furthermore, Ciitizen uniqueness lies in its patient-centric orientation that ensures that patients' control who gains access to their health data. Ciitizen can only grant third parties access to a patient's health record after obtaining express consent. The Big Picture: When patients' have a convenient and timely means of accessing their complete medical history, it makes finding doctors easier and expands affordable and life-saving treatment options. For healthcare providers, accessing a patient's complete health history enhances continuity of care and reduces data entry errors and omissions. Consequently, adopting technological solutions like Ciitizens' platform could reduce or eliminate medical errors costing approximately $20 billion annually. The NIH estimates that there are as many as 7,000 rare diseases and an estimated 20-30M Americans living with a rare disease. Furthermore, the synthesized data created from collating patients' medical history will improve the biopharma industry’s ability to collect and analyze research potentially creating improving treatments and moving personalized medicine forward. In addition, collection and analysis of research of this type will generally improve medical research and efforts to advance medical knowledge and clinical care. Moreover, services like Ciitizens that can centralize a patients' complete medical history can improve a practitioner’s ability to view a patient holistically hopefully resulting in improved diagnosis, treatment, and outcomes. Invitae Acquires Ciitizen for $325M to Strengthen its Patient-Consented Health Data Platform; Invitae to Buy Health Records Startup Ciitizen for $325M

Our Take: While FHIR may help improve many of healthcare’s data interoperability problems, it will not solve all of them. Getting the full value of new data sources created by the digitization of healthcare and making it interoperable requires not only looking at what is currently available and supported by the HL7 standard but what may not be as well. Healthcare payers and providers will have to be compliant with the interoperability rules but need to think holistically about their own organization and how to create a flexible technology architecture, in addition to what is provided by HL7 to ensure an organization’s specific data requirements are met. As data interactions will vary dramatically as new digital tools are incorporated into current workflows, stakeholders need to consider the best ways to use and incorporate these into the future of care, when implementing a data standard and planning for interoperability. ​​Key Takeaways: According to the Pew Charitable Trusts, “approximately 40% of survey respondents said COVID made them more likely to support efforts that enable data-sharing among a patient’s providers and let people download their personal data from EHRs to apps.” Between 2009 (when HITECH Act passed) and 2015 basic EHR adoption went from 12% to 72% for hospitals and from 22% to 54% for ambulatory EHRs. Research done by ONC on individual’s perceptions of data privacy and security shows approximately two-thirds of respondents remain concerned about unauthorized viewing when data is shared by providers. 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, driving the need for data access and interoperability. The Problem: For years healthcare has been plagued by underinvestment in technology and systems that were dominated by records kept on paper and exchanged by fax. In 2009 the U.S. Congress passed the HITECH Act hoping to spur investment in technology to digitize paper-based hospital records. The HITECH Act incented hospitals and physicians to adopt electronic medical record systems (EMRs) by giving them reimbursement payments and other benefits for using EHRs which met certain standards. One of the goals of the HITECH Act was to improve the efficiency and accuracy of healthcare records while improving the exchange and portability of records. However, while the HITECH Act did successfully move the vast majority of hospitals and physician practices onto EMRs and other electronic record-keeping systems, by and large data remained largely interoperable, trapped in silos behind the walls of individual institutions, and often not shareable between EMR vendors or interoperable between systems. To help overcome these issues in 2016, the U.S. Congress passed the 21st Century Cures Act which addressed the issues of interoperability, information blocking, and patient access to records. As required to implement the 21st Century Cures Act, in March of 2020, the ONC published the information blocking rule that took effect in April of 2021. While the ONC Final Rule created a number of legal requirements for interoperability, we feel healthcare is at a critical point where it is more important to explore the true functional requirements for interoperability. One of the core issues regarding interoperability is that interoperability is more than just implementing a standard or being able to have two systems exchange data with each other. It is beyond the technical challenges of integrating multiple vendors with different compliance needs. In addition, healthcare is also plagued by the fact that there is no single system of record for interactions with the system and even no single way to identify patients (ex: a national patient identifier). For example, interactions with hospitals and physicians are governed by clinical data generally stored in an EHR detailing clinician interactions, medications, prescriptions, lab tests, imaging, and other diagnostics. By contrast, claims data is used by payers (healthcare insurance companies) to track and pay for providers used, charges billed and discounts to those charges and prescriptions filled.In addition, there is often a third system that is used to track and reconcile financial transactions with patients, payers, and providers. Often data can be lost between systems or very difficult to exchange between systems. For example, while claims data is predominantly financial, clinical systems have to deal with structured data (ex: coding for diagnosis and testing), unstructured data (ex: physician notes in free text fields), and fields involving different storage mediums and signal processing (ex: blood tests, EKGs, etc.). While much improved from earlier in the decade, these issues remain at the heart of poor communication between providers, payers, and patients and, often in inefficient coordination of care. The Backdrop: As noted on its website, “founded in 1987, Health Level Seven International (HL7) is a not-for-profit, standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery, and evaluation of health services.HL7”s mission is to provide standards that empower global health data interoperability.” In addition, the Office of the National Coordinator for Health Information Technology (ONC) also provides national guidance in the US regarding data standards and expectations for improving data interoperability. The ONC and HL7, among other organizations, have worked to establish the Fast Healthcare Interoperability Resources (FHIR) standard for how to structure and format health data to provide guidance to improve the implementation of health IT solutions. According to “A Brief History of FHIA and Its Impact on Connectivity”, “FHIR seeks to be the next-generation foundation by which electronic health records (EHRs), digital health applications, and consumers use and exchange structured healthcare data.”The FHIR standard helps developers and clinicians develop software to access and exchange data by using a shared structured format for making an Application Programming Interface (API). APIs themselves are a standard for how to exchange and access data that requires multiple parties to understand how the API works, such as what variables are available for programs that interact with the API to be able to perform operations for creating, reading, updating, and deleting data. An API can be thought of as a series of doors that can provide access for different software applications, and the standard is like a map that provides the route for how to find a specific door, and an API key is a key that allows you access to the door that you were granted access to. By using APIs HL7 is seeking to bring healthcare applications and systems closer to more typical consumer-driven applications which are plug and play between systems. According to HHS the goal of the interoperability rule is to “support a patient’s access and control of their electronic health information [and by using APIs] patients will be empowered to more securely and easily obtain their electronic health information from their provider’s medical record for free’” As Donald Rucker, National Coordinator for Health Information Technology at ONC stated when the Final Rule was announced, “delivering interoperability actually gives patients the ability to manage their healthcare the same way they manage their finances, travel and every other component of their lives. Implications: Digital health has the potential to radically change the process and efficiency by which healthcare is delivered, however, one of the biggest challenges faced by these products is an inability to interact with, extract and exchange patient data within or among existing systems. Having standards, such as FHIR, create an opportunity to simplify the development and implementation of products that leverage health data as it moves into the digital age. This is particularly important as digital health products, which can improve the ability to monitor and thus intervene with patients such as wearables and other remote patient monitoring and virtual tools, generate significant amounts of data that needs to be exchanged, analyzed, and acted upon in real-time to have maximum impact. In addition, FHIR was developed with current clinical processes and workflows in mind; this means while it may help solve the issues and data requirements of workflows and care protocols of today, it will not future-proof the organization in the creation of the healthcare delivery system of tomorrow. Healthcare delivery systems must develop a roadmap for integration with systems that generate health data, and real-world evidence for treatment research that will be used in the future. Moreover, having an interoperability standard does not solve healthcare’s data issues outside of interoperability, such as data completeness, data integrity, managing structured and unstructured data, and data security. As healthcare slowly begins to shift data to the cloud, development and implementation times will be dramatically reduced but this will shift the burden to chief information officers (CIOs) and Chief Medical Information Officers (CMIOs) to ensure they are deploying the right architecture designed for new data models as well as the different types of data to be stored, processed, and analyzed in care going forward. While FHIR is a major step forward in easing the exchange of healthcare data, it is important to consider how FHIR does and does not fit the data requirements of your organization. Other solutions that have compatibility with FHIR API standards and have additional features and support for other forms of health data may or may not be more appropriate. As pointed out in “A Brief History of FHIR and Its Impact on Connectivity” “nothing has fundamentally changed about how EHRs implement and use standards with FHIR. Real disruptors may use FHIR, but the real change in value and hence disruption is going to come [as it addresses] ‘what problems does FHIR not solve." Related Reading: Shared Nationwide Interoperability Roadmap: The Journey to Better Health and Care | HealthIT.gov There's an API for That | Journal Of AHIMA FHIR: What's Great, What Isn't So Good, and What It's Not Built to Do A Survey Of Health Information Exchange Organizations In Advance Of A Nationwide Connectivity Framework

The Driver: 9am.health launched a virtual diabetes platform with $3.7M seed funding from investors, including Founders Fund, Define Ventures, Speedinvest, and iSeed ventures. The digital platform provides a holistic virtual package for diabetes care that is personalized, affordable, and convenient. The company aims to alleviate the financial burden for over 34 million diabetes patients in the U.S. who pay close to $10,000 ($8,400-$9,600) for their care, by providing safe and accessible virtual diabetes care and treatment plans. With a digital diabetes market projected to grow by 18.8% through 2027, 9am.health plans to use the seed funding to capture part of the market by investing in growth, virtual screening ability, and expanding the range of medications offered on the platform. Key Takeaways: The average medical expenditure for people with diabetes in the U.S. is approximately $16,000 (of which 57% is attributed to diabetes). The digital diabetes market was valued at $13 billion in 2020 and is projected to grow by 18.8% through 2027. 98% of Americans that live with diabetes also have comorbidities and approximately 88M Americans have prediabetes, defined as higher than normal blood sugar levels but not high enough to be Type 2 diabetes. Indirect costs of diabetes include: $3.3B for increased absenteeism from work, $26.9B from reduced productivity while at work. The Story: Frank Westermann and Anton Kittelberger, the founders of 9am.health, bonded as Type 1 diabetes patients, and in April 2021 created 9am.health targeted at those with the highest risk of developing Type 1 diabetes, pre-diabetes and those with Type 2 diabetes. Their vision is to provide people living with prediabetes and Type 2 diabetes better access to diabetes care. They began with a goal of creating a virtual diabetes clinic with affordable medications, personalized care plans, and at-home lab tests monthly. From their own experience, the founders saw the challenges in access to diabetes care faced by prediabetes and Type 2 diabetes patients. This led them to develop a virtual clinic providing personalized diabetes care while eliminating the hassles patients face in managing diabetes every day. The virtual clinic provides a holistic care package that eliminates doctor waiting time by providing online prescriptions, at-home lab tests, personal medical care, and medication delivery, all from the comfort of the patient’s home. After subscribing patients fill out a brief medical questionnaire, they are connected to a licensed medical provider that prescribes the appropriate medications. A team of licensed providers, pharmacists, diabetes care, and education specialists are available on-demand on patients' schedules. Also, the virtual clinic platform equally provides care for conditions like hypertension or high cholesterol in recognition of the comorbidities that diabetic patients often face. While 9am.health doesn’t currently support insulin prescriptions, they have plans to include them in the future. The service is currently available in 33 states with subscriptions starting at $25 a month for a package including the first medication prescription, home delivery, and support from the care team via chat. Additional charges accrue for each added medication starting from $5 per month, and at-home testing for A1C or lipid screening, including delivery and lab analysis, is available for $15 or more per month. The Differentiators: Even with insurance, the average person living with diabetes spends about “$16,750 per year on medical expenses and has approximately 2.3 times higher the costs than if they didn’t have the disease.” Patients subscribed to 9am.health spend from $25 per month to get a holistic package including online prescription shipping and unlimited personal medical care. 9am.health’s uniqueness lies in its provision of “a digital front door for entire diabetes care,” that is personalized to meet the patients’ needs. As co-founder Westermann, explained to TechCrunch 9am.health wants "to tear down the barriers and make care as easy as possible and managing diabetes part of life”. Furthermore, the service captures other comorbidities like high blood pressure, high cholesterol, and mental health issues associated with 98% of Americans with diabetes. The Big Picture: 9 am. health’s commitment to making diabetic care accessible, more convenient, and affordable is more likely to lower the costs of other treatments such as kidney dialysis, insulin testing, and routine check-ups in healthcare facilities. It also addresses social determinants of health gaps that prevent patients from accessing diabetes care in an easy and convenient fashion. By addressing the barriers associated with accessing diabetes in-person care, the number of people that receive diabetes care could be increased over time thus helping to lower the overall diabetes rate in the U.S. Furthermore, the holistic service provided by 9am.health could potentially reduce the over-utilization of the ED by helping to reduce delayed care or non-adoption of preventive care measures leading to improved adherence, better outcomes, and lower costs. In addition to the direct costs of the disease itself, the American Diabetes Association estimates that the indirect costs of diabetes include: $3.3B for increased absenteeism from work and $26.9B for reduced productivity while at work. Solutions like 9 am.health and others should help dramatically reduce this. As healthcare increasingly moves towards greater self-care, empowering patients to exercise more control over healthcare decisions and management, retail, consumer-friendly solutions like 9 am.health will change the nature of care delivery. 9am.health Launches Virtual Diabetes Clinic, Raises $3.7M, Virtual Clinic 9 am.health Launches with $3.7M to Address Prediabetes, Type 2 Diabetes, 9am.health Launches with $3.7M to Tackle Virtual Diabetes Care

Our Take: With the increased momentum towards reopening the economy, vaccine passports will become important in the United States (U.S) even if they are not mandatory. Vaccine passports, which serve as official proof of vaccination are now required by several countries for traveling and accessing social and recreational spaces. In the U.S, mandating vaccine passports has been rife with debates with several states either banning its usage outright or partially allowing private businesses to choose to mandate vaccination. Notwithstanding the general push back against vaccine passports, ease and convenience considerations could incentivize an increased COVID vaccine uptake. Key Takeaways: The U.S. lacks a national framework for vaccine passports so digital vaccination credentials are largely led by state and private initiatives but have been hamperd by personal rights, privacy and equity concerns. While no state has mandated the use of vaccine passports, 7 cities require that customers must undergo vaccine checks through a digital vaccine verification system before entering businesses. Your chances of dying from a confirmed case [of COVID] roughly double with every five to eight years of age Twenty states have banned vaccine passports either through executive orders or legislation. The Problem: American culture is deeply rooted in individual liberties and states rights. Any attempts perceived to depart or infringe on the right to choose or personal freedom are resisted as illustrated by protests against mask mandates in a number of cities and states. Vaccine passports pose a big challenge as it requires the extraction of possibly private data and more importantly vaccination. Requiring vaccine passports to gain entrance into restaurants or sports venues could be interpreted as compelling Americans to get vaccinated and a subtle enabler of discriminatory practices. Furthermore, the legal basis for such requirements is currently working its way through the courts, and the extent to which the vaccine protects the vaccinated against current and new variants is a matter of constant scientific testing. In addition to the debates around civil liberties, the debate around vaccine passports centers around three issues: 1) the ability to use vaccine passports as de facto tracking devices, 2) the basic legality of vaccine passports, and, 3) potential inequities raised or made more severe requiring vaccine passports. An argument can be made that requiring vaccine passports would expose those who don’t have them to being tracked and potentially prosecuted for participating in events that require passports. In addition, there are concerns about possible exploitation or fraudulent use of data in the absence of regulations and guidelines. For example, immigrant rights activists worry that tracking features could be used to monitor the movements of undocumented immigrants and potentially expose them to arrest or even deportation. In addition, the very legality of government organizations, businesses, and employers to require vaccine passports is being questioned by civil libertarians and those politically opposed to such mandates. While numerous legal opinions have taken the position that businesses can lawfully mandate employees to get the COVID vaccine, provided exemptions are made for legitimate medical or religious grounds, this is actively being challenged in the courts. Similarly, school mandates that do not offer exemptions or testing as an alternative are being challenged (six states do not offer exemptions on personal or religious grounds). Legal clarity on this issue is expected to take some time as this issue winds its way through the courts. As we go to publication, the U.S. Court of Appeals for the Second Circuit blocked the imposition of the New York City school vaccine mandate for teachers and other professionals. According to Reuters, the court “granted a temporary injunction to a small group of public school teachers and paraprofessionals who are challenging the mandate, which does not allow for weekly testing as an alternative.” Conversely, the Federal court and the Court of Appeal for the Seventh Circuit ruled that Indiana University’s COVID mandate requiring students to get vaccinated was lawful. In terms of potential inequities created by a vaccine passport requirement, several studies show that blacks and Latin Americans were almost 50% less likely to receive the COVID vaccine compared to their white counterparts. While some may choose not to get vaccinated for a variety of reasons, substantial research exists that underresourced minority communities lack access to the vaccine compared to other non-minority communities. Hence, vaccine passports may potentially exacerbate existing inequities of the COVID pandemic by punishing people who are willing to get vaccinated but unable to access the vaccines. Moreover, some have argued that the so-called “digital divide” could further alienate Americans that lack access to either broadband internet or smartphones. While this argument holds less weight with respect to smartphone access than broadband (approximately 90% of people have smartphones, compared to lower percentages for broadband), this could still be an issue for those who may have limited data plans or are not as technologically sophisticated in the use of their phones (potentially making paper vaccine passports an option might address this issue). The Backdrop: Although vaccine passports seem novel they actually date back as early as the 1800s where proof of immunization was required for smallpox. For the COVID pandemic, several nations have adopted a similar measure in the form of pass systems or vaccine mandates before people can get into indoor events. While France recorded a drop in Coronavirus infection a month after implementing vaccine passports, England recently reneged on immediate plans of adopting vaccine passports while keeping it as a likely option. Italy and Israel are implementing a green pass system with Israel achieving an impressively fast vaccine roll-out. In the United States, President Biden has put forth a 6-point agenda with the goal of creating an unprecedented path to vaccine mandates especially for businesses with 100 or more employees by announcing a vaccine or test mandate. President Biden’s mandate coupled with the FDA’s full approval of the Pfizer COVID vaccine likely puts vaccine mandates on a stronger legal footing and eliminates a roadblock to vaccination for some Americans, likely leading to an increase in the number of vaccinated Americans. This is because, prior to the FDA’s full approval of the Pfizer vaccine, many individuals had used this as a rationale for not getting the vaccine and several states had used the fact that vaccines had only been approved under the FDA’s Emergency Use Authorization authority as the basis for banning businesses and employers from imposing vaccine mandates. While no state currently compels mandatory vaccine checks, cities like New York and San Francisco have vaccine verification systems for vaccine checks. The California experience could make a case for vaccine passports in the U.S given the significant increase in COVID vaccine uptake and decrease in COVID deaths following implementation. When people refer to “vaccine passports” they are referring to turning proof of vaccination into some kind of electronic credential, typically via an app that is stored on a smartphone or other electronic devices. While no standard currently exists several tech companies like Clear and IBM have provided a convenient way for individual citizens to digitize their vaccination credentials through their apps. Implications: While requiring or even mandating digital health certificates or vaccine passports raises valid privacy and equity concerns by default broad-based usage could increase vaccine uptake. They could also be useful for building a public health infrastructure that allows for proactive tracking of the diseases and other potential public health emergencies. While the court battle over the legality of vaccines will likely not play out for some time, if businesses, employers, and government bodies require them for various forms of access while allowing a non-vaccine alternative like testing, the ease of use and convenience is likely to increase the popularity of these digital authorization methods at least at the margin. In addition, if the government and private businesses look to proactively and transparently address privacy and equity concerns by establishing standard guidelines for the collection, processing, and sharing of collected data, additional resistance can be overcome. For this to succeed, it is equally important that mechanisms are developed to ensure that the certifications are shown to be unbiased, reliable, and accurate. Along these lines, with proper support from concerned parties, one could envision something like a public-private partnership that seeks to broaden access to the vaccine and even devices to show evidence of a passport to underserved groups. Given the Coronavirus and its variants are likely to be with us for the foreseeable future, businesses, employers and other large organizations will look to protect their members and give them the greatest sense of protection and security. This is particularly true for those catering to customers in an older demographic for as noted in a recent New York Magazine article, “your chances of dying from a confirmed case [of COVID] roughly double with every five to eight years of age”. Moreover, some organizations will likely look to protect as many of their stakeholders and customers by requiring the unvaccinated to observe disease precautions such as social distancing and/or smaller gathering sizes (such as when restaurants limit dining party sizes). Here too, ease of access and the desire of individuals to return to pre-COVID norms are likely to increase vaccination rates. In such situations, businesses such as restaurants, bars, sports, and entertainment venues have a legitimate economic interest in maximizing capacity and are likely to allocate greater space to vaccinated patrons (a position we view as likely to be held up so long as it acts with some balance and doesn’t discriminate). The new wave of COVID cases has impacted mostly the unvaccinated so the market focus will likely demonstrate that a vaccine passport could provide the needed nudge to keep more people safe in the interest of public health. Related Reading: Digital Health Passes in the Age of COVID-19 Are “Vaccine Passports” Lawful and Ethical? “Vaccine Passport” Certification — Policy and Ethical Considerations Covid Passports: How Do They Work Around the World Vaccine Passports: Are They Legal—or Even a Good Idea? Vaccine Mandates Are Lawful, Effective, and Based on Rock-Solid Science State Efforts to Ban or Enforce COVID-19 Vaccine Mandates and Passports

The Driver: This week, Caresyntax raised an additional $30M in Series C funding for its digital surgery platform that brings AI into operating rooms to assess and improve care by providing surgeons with their performance assessments rates and helping them reduce fatal surgical complications. This funding, which Bloomberg reports “was an extension of the company’s Series C round in April” brings Caresyntax’s total raised to over $130M. Investors include BlackRock Inc., specialty insurer ProAssurance Corp, Harmonix, Relyens Group, and IPF Partners. Investors from Caresyntax’s fundraising in April include Optum Ventures, Intel Capital, and Lauxera Capital Partners. Key Takeaways: Caresyntax has a database of over 10M cases and 50,000 surgeons that it uses to support its proprietary software and AI-based insights Operating rooms generate approximately 50% of typical hospital revenues but also account for the largest percentage of deaths (70%) according to HIT Consultant. Caresyntax is used in over 4,000 operating rooms worldwide and claims to have provided optimal care for over 2M patients and be supporting over 30,000 surgeons. According to data from the National Institutes of Health, more than 1M people die annually from complications of surgery worldwide. The Story: Founded in 2013, Caresyntax allows surgeons to operate with the help of machine learning capabilities which reduces the rates of human error. According to the company’s website, Caresyntax uses data from over 10M cases and 50,000 surgeons and then applies its proprietary software and AI to “deliver insights that can be used immediately by the care team as well as longer-term by a variety of stakeholders” to improve patient safety and optimize utilization of the surgical suite. According to Bloomberg “Caresyntax’s platform is used in more than 4,000 operating rooms around the world and collects data before, during, and after surgery. It uses artificial intelligence and software to provide surgeons with insights, such as alerting them to blind spots or helping them determine why a procedure went wrong. The data can also be used to measure surgeons’ performance and assess why some teams have higher readmission rates-valuable information for insurers’ pricing risk or for investors seeking to draw conclusions about surgical volumes.” The company states their platform is HIPAA compliant and a US-certified Patient Safety Organization that has achieved ISO9001certification demonstrating its ability to ensure patient safety and confidentiality. The zero-footprint AI intervention in operating rooms takes form in various AI solutions including pre-op case planning, real-time case annotations, post-op case analytics, and more. All of these tools, when set in place, help surgeons reduce their error rates, assess their performance, and provide better care for their patients The Differentiators: As healthcare looks to continue the shift to practicing value-based care, Caresyntax is helping to position providers in value-based arrangements and where reimbursement is tied to quality and outcomes. For example, as noted by Bloomberg, “the company’s tools could help big insurers...and the government pay for performance” with reimbursements tied to meeting certain pre-defined standards of care. In addition, as demonstrated during the pandemic, elective procedures are very profitable for providers. By applying Caresyntax’s technology hospitals can better optimize the use of the surgical suite and can help them “achieve increased workflow efficiency, patient safety, and surgical performance.” Moreover, Caresyntax also allows surgeons to draw upon external resources to benchmark their performance and consult external experts. As noted by Bloomberg they “offer real-time access to outside experts, such as medical school instructors or medical device representatives through its digital platform.” As such Caresyntax was selected by the American Board of Surgery to provide a platform for its pilot program incorporating video-based assessments into their board certification process. Caresyntax has also partnered with the University of Iowa Health Care and the University of Massachusetts Medical School to improve patient safety and quality of care through various initiatives. Implications: As highlighted by a recent article in HITConsulant, while surgery can be an incredibly profitable financial center for hospitals, often “accounting for as much as 50% of total revenue” it can also be a significant source of risk leading to “70% of cause-specific deaths”. Consequently, services like Caresyntax’s which help providers improve quality and outcomes while optimizing the use of the surgical suite can be quite valuable. With more than 1M people dying annually from complications of surgery worldwide according to the National Institutes of Health and an inpatient complication rate of 11% seen in surgeries, interventions like this are necessary and beneficial. For example, the introduction of a simple surgical safety checklist reduced the death rate by almost 50% (from 1.5% to 0.8%). Given the dramatic results with a simple checklist, tools like an AI-based model hold the potential for even more significant improvements in mortality reduction and benefits in quality. As pointed out by co-founder and CEO Dennis Kogan in the HIT Consultant, “a lot of development going forward is going to focus on proactive risk management: being side by side with physicians at the right moment in time giving them actionable insights.” In addition, for both clinicians and providers to be able to participate in value-based care and take part in contracts with two-sided risk they need to be able to benchmark themselves and reduce variability in order to be able to rationally enter into contracts and reduce variability in costs. As highlighted by Kogan, “for the system [value-based care] to work in settings like an operating room, though, outcomes and surgeon performance need to be measured at a more granular level.” Caresyntax Gets BlackRock Investment in Upsized Funding Round, Caresyntax Raises $100M to Expand Digital Surgery Platform in Key Markets

Our Take: As technology and digital transformation take hold in healthcare, greater focus needs to be placed on meeting provider needs and managing clinical burnout. While the digital transformation of healthcare has both positive aspects for clinician burnout, such as the potential to apply artificial intelligence to help optimize workflows, the ability to focus clinician expertise, and the use of natural language processing to automate workflows, at present the additional burdens related to the implementation of electronic health records (EHRs) and the inefficiencies in workflows introduced by additional administrative and regulatory burdens on clinical workflows have negated the positive impact. ​​Key Takeaways: Replacing a physician lost to burnout costs a healthcare system anywhere from $250 000 to a million dollars. Clinical burnout is a global health crisis with more than 60% of providers reporting at least 1 symptom of burnout. For every hour of clinical face time, physicians spend nearly 2 additional hours on EHRs and desk work within the clinical day. A study reported physicians spend nearly half of their time during office hours on EHR and desk work, including documentation, translation to approximately 2 hours of EHR, and work time for each hour of direct patient care. Research carried out by HIMSS and UK med-tech firm Nuance Communications found 97% of doctors and 99% of nurses surveyed had experienced burnout at some point in their working life. According to Journal Annals of Internal Medicine, the economic impacts of burnout are also significant, costing the U.S. approximately $4.6 billion every year. The Problem: Clinical burnout is a major threat to the US healthcare system. Even prior to the COVID pandemic, clinician burnout was considered a global health crisis with more than 60% of providers reporting at least 1 symptom of burnout. Factors that contribute include digital tools used among different specialties, practice settings, and requirements for compliance and reimbursement (computerized physician order entry, amount of data needed to be entered in EHRs for each clinical encounter). While EHRs can be effective tools, they require comprehensive, timely and continuous training in order to reduce the digital burden on top of physicians' routine clinical duties. In addition, the organizational structure, continued improvement and development of health information technology, and coordination and implementation of policy and regulations will play a key role. The Backdrop: According to Annals of Internal Medicine, for every hour of clinical facetime with patients, physicians spend nearly 2 additional hours on EHRs and desk work during the day. In addition, outside office hours, physicians spend another 1-2 hours of personal time each night (affectionately referred to as “pajama time”), doing additional computer and other clerical work. These additional demands contribute to physician burnout which has significant economic costs. For example, according to a study by HIMSS and Nuance Communications, 97% of doctors and 99% of European nurses surveyed had experienced burnout at some point in their working life and that this impact was nearly universal. According to the Annals of Internal Medicine study noted above, the economic impacts of burnout are significant, costing the U.S. some $4.6 billion every year. These impacts can range from emotional impacts such as energy depletion or exhaustion, increased mental distance from one’s job, feelings of negativism or cynicism related to one’s job to higher rates of turnover, prevalence of substance use disorders, increased malpractice claims, greater physician errors and a higher incidence of unnecessary tests and consultations. While clinical burnout has multiple underlying causes, EHRs have been demonstrated to play a significant role in burnout as they are the intersection of clinical duties and technology. EHRs as they are currently designed and deployed can be overly time-consuming, frustrating, overly complex and require multiple screens to click through to get to relevant information. Moreover, as noted in “Physician Well Being and the Future of Health Information Technology”, EHRs [and other health IT] can be loaded with alerts to “serve population health, quality assurance, risk management, customer service, billing, or research goals, yet the sum result may be an overload of alerts such that some are ignored or clicked through, perhaps without any real attention to priority.” As the article goes on to point out, “to reduce overwhelm, tools are needed to filter, prioritize, and frame information for users and their clinical questions. Implications: Burned-out doctors are more likely to leave their practice or worse. In fact, according to the Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide, over 20% of both male and female physicians reported having thoughts contemplating suicide. At a minimum this reduces patient access to care, impairs care continuation and at worst threatens the physical safety of patients themselves. To improve and ease the burden, comprehensive quality and timely training should help partially mitigate technology-related stress. However, as noted in “Physician Well-Being and the Future of Health Information Technology” from the Mayo Clinic Proceedings, “it would be shortsighted to imagine that simply fixing the EHR will prevent technology related burnout.” In addition, expanding the care team, utilizing scribes including the use of digital scribes, and dividing the documentation with streamlined team-based documentation will ease the load, improve efficiency, productivity and provide quality care. For example, a recent study in the Journal of the American Medical Informatics Association demonstrated physician documentation time was reduced by 50% with scribe implementation, thus allowing more time for patient-facing interactions. In addition, AI based digital scribes that deploy natural language processing can help physicians in the documentation process through use of time-saving, uninterrupted chain of thought processes for documentation. While many of these are still in the early stages of development and require heavy oversight and checking by human scribes (often overseas), they hold great potential. Perhaps most importantly developers and designers of HIT need to fundamentally rethink the way they design their tools for use by clinicians. Increasingly to improve effectiveness and adoption of their products, designers will need to consider the “importance of physician involvement in the design and implementation of HIT [which] cannot be overstated.” Earlier and more frequent physician involvement in development of user experience and user interface should help decrease data entry time by limiting keystrokes and/or mouse clicks through iteratively adjusting the tool’s performance based on user experience and feedback to the design team. Moreover, by more proactively involving physicians (and other clinicians) in the process, developers will move away from a failed alert-based system to one that more appropriately recognizes physician/patient engagement as one of increasingly limited time constraints. For “a strategy of approaching encounter expectations from a perspective of constraints is essential” as it will allow new products to help prioritize and highlight clinical information that needs action and should be acted on in the moment. Related Reading: The Burden of the Digital Environment: A Systematic Review on Organization-Directed Workplace Interventions to Mitigate Physician Burnout Physician Well-being and the Future of Health Information Technology Is Digital Transformation in Healthcare Contributing to Provider Burnout? An Executive Discussion: Leveraging Technology to Mitigate Physician Burnout HITECH to 21st Century Cures: Clinician Burden and Evolving health IT policy IT Contribution to Physician Burnout Remains a Problem Physician Stress and Burnout: the Impact of Health Information Technology

The Driver: Recently Wheel hired its first Chief Commercial Officer just three months after raising $50M in a series B fundraising bringing the total amount the company has raised to date to $66M. In late August Wheel announced that it had hired Tim Kollas who previously worked in Business Development for Amazon Care and as Chief Partnership Officer at 98point6, Inc. according to his LinkedIn profile. Wheel’s fundraising round was led by Lightspeed Ventures with participation from CRV, Silverton Partners, Tusk Venture Partners, J.P. Morgan, and a new investor in Future Shape. According to the company they will use the funds to grow headcount and to expand offerings into specialty care including behavioral health. Key Takeaways: According to Wheel internal data standing up and scaling a virtual care service on your own costs an average of $15MM and takes approximately 15 months. The McKinsey 2020 Virtual Care Study claims that approximately $250B or ~20% of all outpatient, office, and home health spend, could potentially be virtualized. According to the Austin Business Journal, Wheel delivered as many paid consultations in Q2 2021 as in all of 2020. A study by Nuance and HIMSS found that 97% of doctors and 99% of nurses surveyed had experienced burnout at some point in their working life. The Story: According to Forbes, the genesis for Wheel goes back to when CEO and co-founder Michelle Davey was a child and had to undergo over a decade of being “ferried between doctors for her to be diagnosed with an autoimmune condition.” After several stints working in healthcare and recruiting, Davey return to healthcare to work at a telehealth startup to do recruiting. Thinking her previous recruiting experience would give her a leg up in her new role, she was quickly surprised to learn that it had not. In 2018 this lead Davey and her co-founder Griffin Mulcahey to found a matching market for virtual healthcare providers called Enzyme which later became Wheel. According to the firm’s website, Davey and Mulcahey felt that “no one was looking out for those at the center of the healthcare engine: the clinicians on the front lines” and decided found Wheel as “the industry’s first model for delivering high-quality virtual care at scale by empowering clinicians and providing new efficiencies for healthcare companies.” The Differentiators: Unlike some of its competitors which offer branded virtual care services Wheel is one offers a private or “white-label platform that empowers companies to quickly and easily launch virtual care services on its own by providing them with the appropriate back-end infrastructure and software. In addition, while Wheel is helping traditional healthcare providers like hospitals and physician practices offer virtual primary care services, it is also helping non-traditional players like retailers, pharmacies, and employee benefit programs create their own virtual care programs under their own brand. Wheel claims that using their platform is much more efficient than standing up and scaling a virtual care service on your own, which their internal data shows costs an average of $15MM and takes 15 months. Moreover, as noted above, Wheel is looking to expand the breadth of its services beyond just virtual primary care, currently looking to move into behavioral health, labs, and diagnostic care. Interestingly given Wheel’s roots in physician recruitment and staffing, Wheels has a strong background in some of the technical issues involved in scaling a virtual care business. As Davey noted to Forbes about founding the business, one of “the biggest sticking point[s] to scaling digital health startups was understanding the regulations across all 50 states and recruiting licensed clinicians.” It appears that this expertise has aided its growth, as “80% of its growth has been organic, and the company has a 90% retention rate.” Wheel currently has approximately 120 employees and expects to increase that to 200 by year-end. Wheel charges its customers a base fee for its software and then an additional fee per consultation. The Big Picture: As Michelle Davey noted to the Austin Business Journal following Wheel’s series B, “I think we’re at least 10 years ahead of where we would have been” due to the pandemic. Given that both providers and patients were essentially forced to accept and use telehealth overnight both resistance and inertia were pushed to the side out of necessity and a transformative opening has been created for digital health. Wheel and other virtual primary care providers like it (please see our Scouting Report Oxygen: AI-Based, End-to-End, Virtual-First Primary Care) can fundamentally change the delivery of care. For example, according to the McKinsey 2020 Virtual Care Study approximately $250B or ~20% of all Medicare, Medicaid, and Commercial outpatient, office, and home health spend, could potentially be virtualized.” In addition, while there will always be some portion of the patient care that will have to be delivered in person, virtual first primary care allows providers, of all shapes and sizes, to broaden the delivery of care to more patients, and independent of their geographic location. This opens up tremendous opportunities to expand care to the underserved and to broaden care in rural areas where providing access is lacking. In addition, virtual first brings healthcare much closer to other industries by bringing patient care to the patient at the time and place they desire as opposed to the other way around. Virtual primary care also provides a mechanism to address the issue of physician burnout, where over 90% of doctors report experiencing at least one symptom of burnout in their lives. By giving them the ability to create their own virtual practice with a much lower infrastructure incidence of burnout can be reduced. While there are important issues like broadband access that still need to be addressed, technology and demand are clearly changing the nature of healthcare delivery. Behind The Screen: Meet The Startup Powering Telehealth, Telehealth Startup Wheel Hires Chief Commercial Officer to Help Shape Rapid Growth, Telehealth Startup Wheel Raises $50M Series B

Our Take: There are several basic issues and challenges in deploying AI that all clinicians and administrators should be aware of and inquire about to ensure that they are being properly being considered when AI is being implemented in their organization. Applications of artificial intelligence in healthcare hold great promise to increase both the scale of medical discoveries and the efficiency of healthcare infrastructure. As such healthcare-related research and investment has exploded over the last several years. For example, according to the State of AI Report 2020, academic publications in biology around AI technologies such as deep learning, natural language processing (NLP), and computer vision have grown over 50% a year since 2017. In addition, 99% of healthcare institutions surveyed by CB Insights are either currently deploying (38%) or planning to deploy AI (61%) in the near future. However, as witnessed by recent errors discovered surrounding the application of an AI-based Sepsis model, while AI can improve quality of care, improve access and reduce costs, models must be implemented correctly or they will be of questionable value and even dangerous. Key Takeaways: According to Accenture’s “Artificial Intelligence: Healthcare’s New Nervous System” report, AI for health is expected to grow at a 40% CAGR through 2021. Researchers working to uncover insights into prescribing patterns for certain antipsychotic medications found that approximately 27% of prescriptions were missing dosages. Even after doing work to standardize and label patient data, in at least one broad study almost 10% of items in the data repository didn’t have proper identifiers. Academic publications in biology around AI technologies such as deep learning, natural language processing (NLP), and computer vision have grown over 50% a year since 2017. The Problem: While it is commonly accepted that computers can outperform humans in terms of computational speed, in its current state many would argue that artificial intelligence is really “augmented intelligence” defined by the IEEE as “a subsection of AI machine learning developed to enhance human intelligence rather than operate independently of or outright replace it.” Current AI models are still highly dependent upon the quantity and quality of data available for them to be trained on, the inherent assumptions underlying the models as well as the human biases (intentional and unintentional) of those developing the models along with a number of other factors. As noted in a recent review of the book “I, Warbot” about computational warfare by Kings College, AI lecturer Kenneth Payne, “these gizmos exhibit ‘exploratory creativity'-essentially a brute force calculation of probabilities. That is fundamentally different from ‘transformational creativity”, which entails the ability to consider a problem in a wholly new way and requires playfulness, imagination and a sense of meaning.” As such, those creating AI models for healthcare need to ensure they set the guardrails for its use and audit its models both pre and post-development to ensure they conform to existing laws and best practices. The Backdrop: When implementing an AI project there are a number of steps and considerations that should be taken into account to ensure its success. While it is important to identify the best use and type with any kind of project, given the cost of the technical talent involved, the level of computational infrastructure typically needed (if done internally) and the potential to influence leadership attitudes towards the use and viability of AI as an organizational tool, it is even more important here. As noted above one of the most important keys to implementing an AI project is the quantity and quality of data resources available to the firm. Data should be looked at with respect to both quality (to ensure that it is free of missing, incoherent, unreliable, or incorrect values) and quantity. In terms of data quality, as noted in “Artificial Intelligence: A Non-Technical Introduction”, data can be: 1) noisy (have data sets with conflicting data), 2) dirty (have data sets with inconsistent and erroneous data), 3) sparse (have data with missing or no values at all, or, 4) inadequate (have data sets that have contained inadequate or biased data). As noted in an article in “Extracting and Utilizing Electronic Health Data from Epic for Research”, “to provide the cleanest and most robust datasets for statistical analysis, numerous statistical techniques including similarity calculations and fuzzy matching are used to clean, parse, map, and validate the raw EHR data.” which is generally the largest source of healthcare data for AI research. When looking to implement AI it is important to consider and understand the levels of data loss and the ability to correct for it. For example, researchers looking to apply AI to uncover insights into prescribing patterns into second-generation antipsychotic medications (SGAs) found that approximately 27% of the prescriptions in their data set were missing dosages and even after undertaking a 3-step correction procedure, 1% were missing dosages. While this may be deemed an acceptable number it is important to be aware of the data loss and know this information in order to properly evaluate if it is within tolerable limits. In terms of inadequate data, ensuring that data is free of bias is extremely important. While we have all recently been made keenly aware of the impact of racial and ethnic bias on models (ex: facial recognition models trained only on Caucasians) there are a number of other biases which models should be evaluated for. According to “7 Types of Data Bias in Machine Learning” these include: 1) sample bias (not representing the desired population accurately), 2) exclusion bias (the intentional or unintentional exclusion or certain variables from data prior to processing), 3) measurement bias (ex: due to poorly chosen measurements that create systematic distortions of data, like poorly phrased surveys); 4) recall bias (when similar data is inconsistently labeled), 5) observer bias ( when the labelers of data let their personal views influence data classification/annotation), 6) racial bias (when data samples skew in favor of or against certain ethnic or demographic groups), 7) association bias (when a machine learning model reinforces a bias present in a model). In addition to data quality, data quantity is as imperative. For example, in order to properly train machine learning models, you need to have a sufficiently large number of observations to create an accurate predictor of the parameters you’re trying to forecast. While the precise number of observations needed will vary based on the complexity of the data you’re using, the complexity of the model you want to build, and the impact of the amount of “statistical noise” generated by the data itself, an article in the Journal of Machine Learning Research suggested that at least 100,000 observations are needed to train a regression or classification model. Moreover, it is important that numerous data points are not captured or sufficiently documented in healthcare. For example, as noted in the above-referenced article on extracting and utilizing Epic EHR data for study based on research at the Cleveland Clinic in 2018, even after doing significant work to standardize and label patient data, “approximately 9% [1,000 out of 32,000 data points per patient] of columns in the data repository” were not using the assigned identifiers. While it is likely that methods have improved since this research was performed, given the size and resources that an institution like the Cleveland Clinic had to bear on the problem, it indicates the larger size of the problem. Once the model has been developed there should be a process in place to ensure that the model is transparent and explainable by creating a mechanism that allows non-technologists to understand and assess the factors the model used and what parameters it relied most heavily upon in coming to its conclusions. For example, as noted by the State of AI Report 2020, “AI research is less open than you think, only 15% of papers publish their [algorithmic] code” used to weight and create models. In addition, there should be a system of controls, policies, and audits in place that provide feedback as to the potential errors in the application of the model as well as disparate impact or bias in its conclusions. Implications: As noted in “Artificial Intelligence Basics: A Non-Technical Introduction” it’s important to have realistic expectations for what can be accomplished by an AI project and how to plan for it. In the book, the author Andrew Taulli references Andrew Ng, the former Head of Google Brain, who suggests the following parameters; an AI project should take between 6-12 months to complete, have an industry-specific focus, should notably help the company, doesn’t have to be transformative, and, have high-quality data points. In our opinion, it is particularly important to form collaborative, cross-platform teams of data scientists, physicians, and other front-line clinicians (particularly those closest to patients like nurses) to get as broad input on the problem as possible. While AI holds great promise, proponents will have to prove themselves by running targeted pilots and should be careful not to overreach at the risk of poisoning the well of opportunity. As so astutely pointed out in “5 Steps for Planning A Healthcare Artificial Intelligence Project: “artificial intelligence isn’t something that can be passively infused into an organization like a teabag into a cup of hot water. AI must be deployed carefully, piece by piece, in a measured and measurable way.” Data scientists need to ensure that the models they create produce relevant output that provide context and the ability for clinicians to have a meaningful impact upon the results and not just generate additional alerts that will go unheeded. For example, as Rob Bart, Chief Medical Information Officer at UPMC noted in a recent presentation at HIMSS, data should provide “personalized health information, personalized data” and should have “situational awareness in order to turn data into better consumable information for clinical decision making” in healthcare. Along those lines, it is important to take a realistic assessment of “where your organization lies on the maturity curve”, how good is your data, how deep is your bench of data scientists and clinicians available to work on an AI project in order to inventory, clean and prepare your data. AI talent is highly compensated and in heavy demand. Do you have the resources necessary to build and sustain a team internally or will you need to hire external consultants? How will you select and manage those consultants, etc.? All of these are questions that need to be carefully considered and answered before undertaking the project. In addition, healthcare providers need to consider the special relationship between clinician and patient and the need to preserve trust, transparency, and privacy. While AI holds a tremendous allure for healthcare and the potential for it to overcome, and in fact make up for its underinvestment in information technology relative to other industries, all of this needs to be done with a well-thought-out, coherent and justified strategy as its foundation. Related Readings: Artificial Intelligence Basics: A Non-Technical Introduction. Tom Taulli (publishers site) Artificial Intelligence (AI): Healthcare’s New Nervous System An Interdisciplinary Approach to Reducing Errors in Extracted Electronic Health Record Data for Research 5 Steps for Planning a Healthcare Artificial Intelligence Project