13 © Springer Nature Switzerland AG 2021, corrected publication 2022 A. B. Bhatt (ed.), Healthcare Information Technology for Cardiovascular Medicine, Health Informatics, https://doi.org/10.1007/978-3-030-81030-6_2 Chapter 2 Digital Health Solutions and Wearable Devices Jennifer M. Joe, Jaydeo Kinikar, Monique Smith, Michael J. Carr, Ethan Bechtel, Stephen Randall, and Leah Ammerman Digital health has been defined by the Healthcare Information and Management Systems Society (HIMSS) as “Digital health connects and empowers people and populations to manage health and wellness, augmented by accessible and supportive provider teams working within flexible, integrated, interoperable and digitally- enabled care environments that strategically leverage digital tools, technologies and services to transform care delivery” [1]. J. M. Joe (*) Vanguard.Health, Boston, MA, USA e-mail: jen@vanguard.health.com J. Kinikar VP, Virtual Care Offering Management, Best Buy Health, Boston, MA, USA M. Smith Health DesignED: The Acute Care Design and Innovation Center, Emory University School of Medicine, Atlanta, GA, USA e-mail: monique.antoinette.smith@emory.edu M. J. Carr Emory University School of Medicine, Atlanta, GA, USA e-mail: michael.j.carr@emory.edu E. Bechtel OhMD, Burlington, VT, USA e-mail: ethan@ohmd.com S. Randall Medaica Inc., Brooklyn, NY, USA e-mail: stephen.randall@medaica.com L. Ammerman IC Solutions & Partnerships, Boston Scientific, Boston, MA, USA e-mail: Leah.Ammerman@bsci.com The original version of this chapter was revised. The correction to this chapter can be found at https://doi.org/10.1007/978-3-030-81030-6_11
14 Generally, digital health refers to technological solutions that go beyond the traditional electronic medical record. Important concepts that are frequently talked about are included in the table below (Table 2.1). Most digital health solutions will typically involve 2–3 of these concepts. For example, a smart blood pressure monitor acts as a wearable device for the patient, which gathers data, stores it locally and transmits it via applications to the physician. Using algorithms, clinicians can assess populations of patients for blood pressure trends, highlighting those who are “out of range” to optimize medical therapy [2]. Eventually, increased sophistication in algorithms which receive clinician feedback and guidance can lead to the application of machine learning for hypertension management. Table 2.1 Digital health overview Wearables The classic example that has become somewhat ubiquitous is the activity tracker watch that reports steps, distance, heart rate, calories and sleep quality. There are also headbands that will track concentration and even bras that monitor heart rhythms. Sensors For a wearable to be useful, they often have sensors attached to them that are doing the measuring. Due to the use of pulse oximetry monitors that are attached to a patient’s finger on almost every clinical visit, the concept of a sensor attached to a wearable is very familiar. In healthcare, the quality of the sensor is important. New sensors enter the market daily, however, their accuracy for clinical decision making is often not proven. Software Applications This is the software, often in the form of a phone application, sometimes with a desktop version, that collects the data and displays it in a meaningful way. When done well, this data will do two important things—inform and change the patient’s behavior for better health, and go to the clinical team so that this data can be incorporated into the patient’s chart for the entire clinical team to use. Data Data is being gathered, stored, and shared. Important questions in healthcare is where the data is stored, who has access to the data, and is the data being delivered in a consistent and meaningful way? The biggest complaint in healthcare is “interoperability,” or the simple concept of data moving from one source to another in a meaningful way. For example, if your watch collects three heart rates for you, how does the watch Iabel that data so that your electronic medical record can suck it in, and also label it in a meaningful way? A heart rate of 130 is appropriate If you’re sprinting, and pathological if you’re sleeping. Big Data This refers to a mass of data that informaticians are analyzing, interpreting, and looking for patterns. Informaticians will write algorithms to predict based on large collections of data, and this is referred to as artificial intelligence. Augmented Reality Augmented reality enhances reality or adds an overlay on top of what you’re seeing and hearing in the environment. Google Glass is a classic example. It has a small screen that overlays on top of what you’re seeing, possibly telling you the name of a building that you’re looking at, or giving you directions with arrows overlaying the streets you are actually looking at. Virtual Reality Virtual reality is a much more immersive experience, requiring the technology to replace what you are seeing and hearing in reality. This is commonly delivered with a special VR headset. AR and VR haven’t fully found homes within healthcare however, their most promising use-cases have been for pain control, meditation and surgical education. Population Health This is the use of big data, algorithms and software to help give clinicians an overview of the overall health of the population they are managing. J. M. Joe et al.
15 2.1 Clinicians as Digital Health Champions Healthcare has been described as the “last frontier” of digital transformation in large part because of its complexity and heterogeneity [3]. Privacy issues may limit software developer’s access to clinician expertise and intuition and if a solution fails, it can result in significant morbidity and even mortality. A clinician will be best suited to influence the development of a digital solution that will be useful for their specific patient population. The practice of medicine is now highly subspecialized and influenced by prolific research. Clinicians also have considerable experience with particular diagnoses and their patients’ unique psycho- social needs. Additionally, the clinician often has insight into the full care-team picture. For digital health to successfully infiltrate medicine, it needs clinicians as digital health champions. (Table 2.2). 2.1.1 Evaluating a Digital Solution For a digital solution to be widely adopted, it must prove that it has a meaningful impact on care. This is often done as a randomized, clinical trial, however to move at the pace of current day digital health, clinicians will be essential to guiding widely accepted surrogate endpoints and definitive endpoints such as blood pressure measurements, adherence to guideline directed medical therapy and hospital admissions [4]. One of the biggest hurdles is making sure the digital health solution fits into the clinical environment and workflow. Due to compliance, the electronic medical record, payer requirements and billing requirements, healthcare seems like a huge mess of unnecessary paperwork and checkboxes. The digital health solution may fit into an already existing workflow, and preferably integrate into the electronic medical record [5]. For any digital health solution to work, it must have a clinician championing it’s through the system [6]. It’s often the clinician champion that will introduce the solution into their environment, get other stakeholder buy-in, and shepherd it through the process of information technology integration, security and legal compliance, testing on a small group, validation on a larger group, and then roll out at scale. The clinician has an important role as the digital health advocate. They can guide the community on the benefits and the challenges they may encounter, guide Table 2.2 The advantages of clinicians as digital health champions 1. Understand the problem to be solved 2. Know what patients need 3. Open to novel or creative solutions 4. Assess meaningful impact on care 5. Develop clinical workflow and promote telemedicine adoption 2 Digital Health Solutions and Wearable Devices
16 developers of solutions, including pharma, biotech, medical device manufacturers, non-traditional healthcare like Google and Amazon, as well as clinicians and hospital or practice managers and stakeholders. 2.2 Successfully Implementing a New Digital Health Solution Many cardiovascular clinicians are approached and interested in working with new digital health solutions. However, the challenge is often in seeing the product which is offered and matching it to a need in your practice. At the same time, patient and provider adoption needs to be addressed in the early stages of development, whether via eliciting feedback, running “pilots”, or acknowledging and solving for the most vexing care delivery problems. There are a few key steps which can help the new digital health clinician and administrator in selecting and templating a novel care mechanism or workflow (Fig. 2.1). 1. Quick Wins: Start with challenges which may be easiest to address. This offers a short-term, realistic attempt to implement a digital solution. This will garner patient, clinician and administrative trust in digital health solutions). 2. Cross the Finish Line: Iterate on problems with other solutions that have recently been tried. Multiple attempts to fix an existing flaw in care delivery demonstrates dedication to addressing the problem, while increasing the likelihood that stakeholders will be willing to try a novel digital solution if standard approaches have proven unsuccessful. 3. Measurable Endpoints: Working with the digital health team to scope the problem, this ensures that the issue to be addressed is well-defined and creates measurable endpoints for patient care (improved access, financial recovery, use of guideline directed medical therapy). After each iteration of a solution, clinical team feedback is key to growth and improvement. Once a “final model” is in place, testing and validation should be part of the overall plan with the digital health company. It is important to recognize that creating a solution, which is Quick Wins Solve a simple challenge with digital health Measurable Endpoints Define “success” prior to starting Find the Right Fit Determine the magnitude of the digital solution required Cross the Finish Line Complete ongoing process improvements with digital health solutions Fig. 2.1 Successful implementation of a new digital health solution J. M. Joe et al.
17 modular from the beginning can allow for faster updates as clinical needs and workflow evolve in the practice. 4. Find the Right Fit: Some problems require small tech solutions while others need a well-established digital platform or system-wide implementation. There are advantages to small tech providers and larger firms. Small providers can be nimble and responsive to your needs and changes whereas larger providers may be more reliable long term. Assessing the importance of integration and consumer (both patient and clinician) support are both essential in evaluating digital health solutions and vary across novel and established platforms. Evaluating a digital solution requires understanding the exact problems that need to be solved or the part of the workflow that is best treated virtually. Once a practice builds their digital solution, larger scale adoption may necessitate partnering with community organizations, pharmaceutical, device and technology companies. Successful implementation requires buy-in from administration, providers and patients with a clear alignment and understanding of the goals of using virtual care in addition to traditional in-person visits. 2.3 Wearable Devices Telemedicine has become a mainstay of outpatient care. Patient level data, often obtained using wearables will likely play a role as patient adoption increases. These digital health tools abound is a necessity to scale telemedicine use and may improve access to advanced cardiac care (Fig. 2.2). In this chapter, we will explore considerations for designing clinically relevant wearables and measuring their value (Fig. 2.3). Determining the future of wearables will require engagement of patients, clinicians and industry (Fig. 2.4). 2.3.1 Wearables: Considerations for Designing Wearables Strategy Across the Patient Journey Essential to the successful integration of digital health into any telemedicine system, is understanding the clinical, operational and financial goals of technology implementation (Table 2.3). Clear definition of the intended effect of digital health will enable staff workflow, promote patient and provider adoption and engender support from leadership. The adoption of wearable devices is dependent primarily on ease of use, wireless accessibility and potential patient health benefits. Familiarity with the device that is being used as well as clinician recommendation can be catalysts for patient adoption (Table 2.4). 2 Digital Health Solutions and Wearable Devices
18 2.3.2 New Technologies: Integrating and Measuring to Deliver Value Choosing the right digital health technology is only half the battle. Rest of the battle lies in generating buy-in from your key stakeholders for adoption and then driving continuous value realization to ensure you are getting ROI and continued investment support. A holistic framework to integrate and measure value is through Quadruple Aim (Fig. 2.5). The goal of the Quadruple Aim is to enhance patient experience, improve population health, reduce costs, and improve the work life of health care providers, including clinicians and staff. The Quadruple Aim is widely accepted as a compass to optimize health system performance. If you can link the value of your digital health initiative to one or more pillars of Quadruple Aim, you can then articulate the impact and ROI on KPIs that matter most to your stakeholders- administrators, clinicians and patients. OUTPATIENT SURGICAL CENTERS PRIMARY CARE & COMMUNITY CLINICS SPECIALTY PHARMACY URGENT CARE CLINICS COMMUNITY HOSPITALS ACADEMIC MEDICAL CENTERS SPECIALTY CARE HOSPITALS BEHAVIORAL HEALTH COMPOUNDING PHARMACY LONG-TERM ACUTE CARE AT HOME HEALTH & HOSPICE CARE INPATIENT REHABILITATION OUTPATIENT REHABILITATION NETWORK OUTPATIENT CARE REHABILITATIVE CARE PATIENT ACUTE CARE Fig. 2.2 Using telemedicine throughout the inpatient to outpatient cycle to reduce readmissions and increase convenience and quality of care. (From MGB Quality and Safety. Copyright permission from Mass General Brigham) J. M. Joe et al.
19 2.3.2.1 Value Pillar 1: Improving Clinician Experience Physician burnout is affecting the majority of physicians today and results in huge cost to the organization. Several healthcare systems have implemented telehealth programs in the ED to reduce patient wait times and help clinicians better manage patients. Similarly, there are new digital health technologies that automate certain workflows and reduce nursing workload, which in turn drive better adoption. With every digital health technology, the usability, product interactions and E2E user experience can make a big difference in improving clinician experience over old care paradigms. So think about how your digital health technology is improving clinician experience, how can you quantify it? Workflow Integration Connectivty & Compatibility Clinical Evidence What clinical proof points are availble for this wearables solution? Has it been sufficiently tested in clinical environment? What evidence is available for clinical, operational and financial outcomes in a proper end-to-end clinical study? How is data transferred from the wearable to EMR/informatics platform? Is it Bluetooth? WiFi? 5G? what is the hub/relay/bridge that provides connectivity? Is it 1:1 or 1: many? How does this hub fit into existing IT infrastructure? What about home? How easy is it to configure and connect at home for elderly at risk patient? Is it compatible with other monitoring devices or does it cause interference? Is it compatible with pacemakers and implantable defibrillators? How seamless is data transfer and integration with informatics platform? How frequently is data collected? More continuous for hospital applications while every few min to every hour for home long term RPM. Does it require custom integration, or it supports standard interoperability such as HL7 feed? And how is wearables vital sign data validated in EMR? Fig. 2.3 Integrating telemedicine into clinical workflow based upon technological compatibility and clinical evidence 2 Digital Health Solutions and Wearable Devices
20 2.3.2.2 Value Pillar 2: Better Outcomes Every organization measures and reports key outcomes on a regular basis. This creates several opportunities for digital health technologies to drive impact and adoption. There are clear KPIs such readmissions, length of stay, # of code blues, etc. that could be measured and improved. For example, the VA has reduced readmissions significantly with a combination of telehealth and remote patient monitoring. Patient Experience Clinician Experience Clinical Performance How is the wear experience on frail skin? Does it cause skin rash? Has wearable adhesive been tested for biocompatibility? Can patient shower with the wearable? Does it require disturbing patient frequently or at night to take measurements? Does it provide mobility and freedom of ambulation? How long does it take to onboard patient on new wearable including association, calibration & pairing? How does it fit into existing clinical/nursing workflows? Does it reduce workload during rounding or create more nursing burden? In general, not all wearables are equal when it comes to clinical accuracy & performance, even after getting required regulatory approval. Evaluate stated accuracy & performance of key parameters-is it accurate & precise enough to replace mandated vital sign measurement as a standard care (e.g, HR) ? or is it good enough to provide accurate enough trending information to aid in early detection of an adverse event (e.g, BP measurements) What do claims and indications say? Does it provide ambulatory measurements? Sensitivity to ambulation can provide wrong measurements and false alarms For cardiac patients, difference between single lead to multi-lead ECG wearable could be significant. However, it goes back to what problems you are trying to solve in which care setting. Post-op cardiac patient will require proper Telemetry vs diagnostic arrhythmia detection at wearable patch. Fig. 2.4 Using telemedicine to enhance patient experience, clinician experience and clinical performance J. M. Joe et al.
21 2.3.2.3 Value Pillar 3: Lower Costs There are tremendous cost savings that could be achieved by digital health. For example, the cost of undetected patient deterioration could result in loss of millions of dollars due to readmissions and penalties. Wearables and remote patient monitoring can help detect patient decompensation early and help potentially costly code blues and readmissions with proper early interventions. What are the cost levers that your digital technology can impact? Where do you see the most impact? Table 2.3 What clinical, operational and financial problems are you trying to solve? Hospital Home • Clinical: – Post-op patient monitoring/PACU, discharge readiness, early detection of deterioration in General Ward/Step down unit, preventing code blues and ICU throwback, reducing falls, cardiac patient monitoring – Target patient populations: Cardiac (CHF, MI, arrhythmias, BP), Diabetes (ulcer, infections), Respiratory (COVID-19, COPD, P.E. emphysema, Sepsis), Neurological, Post-Op (Knee and hip surgery) • Operational: – Seamless transitions, workflow/rounding efficiency, low nurse: patient ratio, risk stratification, alarm fatigue, patient and staff satisfaction, lack of PPE, HAI concerns • Financial: – Length of stay, ICU throwbacks, limited ICU bed capacity, revenue and margin • Clinical: – At-risk population, Readmission within first week and 30–60–90 days – Chronic disease management for long term (COPD, CHF, Arrhythmia, Hypertension, Diabetes) – Infectious disease quarantine • Operational: – Lack of real-time visibility into patient’s health – Emergency services vs early prediction of adverse events – Limited Home Health Agency support • Financial: – Readmission penalties – Costly intervention/EMS – Value based Care penalties Table 2.4 Future opportunities for wearables and digital health tech Emerging • Smartphone, wearable-based sensors • Ingestible sensors • Manual and automatic biometric data collection • Automatic biometric data collection • Monitoring heart rate, steps, food intake, etc. • Digestible pill for tracking medication adherence Experimental • Artificial intelligence and machine learning • Virtual and augmented reality • Diagnosis and treatment recommendations • Simulated therapy • Imaging interpretations • Chat bot for mental health • Provider training • Tele-rehabilitation 2 Digital Health Solutions and Wearable Devices
22 2.3.2.4 Value Pillar 4: Improved Patient Experience Patient centric innovation helps improve patient experience, outcomes and adoption. It is also one of the key quality metrics that healthcare organizations measure and improve upon. A key imperative of digital health technology needs to be improving patient experience. It could be telehealth reducing wait times for patients or wearables providing freedom of movement in the hospitals or remote data collection from the comfort of their homes. How is your technology helping patients deal with their condition? How is it helping to normalize their lives? 2.4 Conclusion Wearables hold significant promise for being a useful adjunct to cardiac outpatient management by allowing continuous data input for analysis of baselines and trends. They also offer opportunities for patient engagement, self-advocacy and goal setting. For digital health technologies to permeate clinical care across all populations there are several features which should be met. Ease of use with a natural daily instinct to include the wearable in their daily routine. Simple instructions to overcome limitations of digital and health literacy. Instruction available in text and with diagrams, but also online via audio and video to adapt to all learning styles for Better outcomes Improved Clinician Experience Improved Patient Experience Lower Costs QUADRUPLE AIM ACHIEVED Fig. 2.5 Quadruple aim. Source: https://digital.ahrq. gov/acts/quadruple-aim J. M. Joe et al.
23 optimal understanding of its use. These mechanisms will aid those with visual, hearing or learning impairment by having accessible options for engagement, and ease the burden on clinical practices who can direct patients to this information. Minimizing the steps needed to transmit data is also essential with an ideal goal of automated data transmission. Case Report Leveraging an internal innovation center, Health DesignED: the Emory Acute Care Design and Innovation Center to tackle the special technical needs of the Emory Rural Tele-EMS Network (ER-TEMS) [8]. Physician Leaders: Monique Smith, MSc, MD, Founding Director of the Emory Acute Care Design + Innovation Center and Michael J. Carr, MD, Project director and Principle investigator ER-TEMS. The COVID-19 pandemic has highlighted and intensified the increasing disparity in healthcare throughout the United States, which is particularly notable in underserved communities. One such community, which composes almost 20% (approximately 60 million people) of the population of the United States, are residents of rural communities. In 2019, the CDC reported that “Rural populations experience substantial health disparities when compared with more urban populations, including a higher prevalence of diseases such as obesity, increased mortality rates, and lower life expectancies.”[9] Contributing significantly to this disparity in a community that is on average already sicker are the more than 120 rural hospitals—seven of which were in Georgia, that have closed in the United States in the last 10 years and the alarming 453 rural hospitals that are at risk of closing based upon performance levels [10]. This in turn, increases the time to care for patients by prolonging EMS response and transport times, which leads to poorer outcomes. In a response to this, Emory has recently created the Emory Rural Tele- EMS Network to enhance timely diagnosis and treatment for rural Georgia patients. Emory physicians will provide clinical support to Grady EMS rural service providers. Currently, Grady EMS provides EMS services in 14 rural counties of Georgia. During an EMS encounter, critical patients will have a comprehensive telehealth visit with a physician to assess for pathology including cardiac arrest and arrhythmias, acute coronary syndromes, acute strokes, major trauma, labor and delivery emergencies, and hypertensive disorders. Once diagnosed, EMS personnel can provide care onsite, ultimately shortening time to the initiation of care, and subsequently transport the patient to the most suitable rural healthcare facility. 2 Digital Health Solutions and Wearable Devices
24 Although telehealth has become an increasingly accessible form of care, it is often not used in the prehospital environment and even less in rural areas. In rural environments where care delivery centers are scarce, the use of telehealth visits during EMS encounters has tremendous potential to change the EMS delivery model. One of the few models of prehospital telehealth visits was initiated by Houston’s Fire Department in 2014. The Emergency Telehealth and Navigation (ETHAN) program assessed and dispositioned patients using telehealth visits prior to transport to the appropriate care level e.g. Emergency Department (ED). The result of this initiative was a 56% reduction in unnecessary ambulance ED visits and 44 min reduction in total ambulance “back- in-service” times [11]. Overall, the researchers of the ETHAN program determined that these changes converted to $928,000 of societal annual cost savings and $2468 cost saving per ED visits averted [12]. Under the ER-TEMS network, an Emory Healthcare Network Emergency Physician provides a video telehealth visit to rural Grady EMS crews and evaluates and suggests management of initial patient care. If specialized care is needed, the Emergency Provider may access the vast network of specialty services within the Emory Healthcare Network. Subsequent to the consultation, all patient data, including biometric data, EKGs, and patient charts are uploaded to a streaming cloud. The Emergency Provider then informs the receiving facility, typically a critical access hospital (CAH) or hospital in a medically underserved area (MUA), of the incoming patient’s arrival and any treatment plans that have been started. This allows EMS personnel to focus all of their attention on the patient’s care. The receiving facility is given access to the cloud over the internet providing access to patient information and biometric data. Prior to the Emory Rural Tele-EMS initiative, Emory had a robust telehealth network in multiple specialties, including the ICU, nephrology, and neurology and psychiatry starting as early as 2014. This network has accelerated and expanded rapidly in response to the COVID-19 pandemic. In the Spring of 2020, Emory Healthcare had successfully completed over 70,000 virtual visits. The pivot to telehealth prominence has been afforded by Medicare’s 1135 waiver expansion, which allows telemedicine visits to be charged at the same rate as in-person emergency visits. Despite Emory’s considerable telemedicine experience, the Emory Rural Tele-EMS has radically different technological requirements. Firstly, Rural Tele-EMS needed a platform that would work both inside and outside the hospital. Secondly, the platform had to work in low bandwidth settings given the rural environment in which care would take place. To address this, the Emory Acute Care Design and Innovation Center was responsible for J. M. Joe et al.
25 pinpointing, assessing, and testing solutions. A team was delegated to identify and evaluate solutions from Philips®, Zoll®, Verizon®, Stryker®, and swyMed® corporations. Ultimately, Emory decided on swyMed, [13] which owns a patent on moving data in resource low settings and allows Emory to conduct telemedicine visits with transmission as low as 60 kilobits per second (kbps). This significantly increases the geographic reach of telemedicine utilization.Additionally, the Emory Acute Care Design and Innovation Center found it paramount that the telemedicine platform be able to integrate into EMS specific technology. SwyMed is integrated with Zoll—the X-series monitor/defibrillator used on Grady ambulances, hospital electronic medical record systems, and a number of other relevant medical devices and applications. This integration allows streaming directly from the Zoll-X monitor into the telemedicine interface, which can then be viewed on a desktop computer, or an app on a smartphone or tablet. The Zoll-X monitor has functionality that allows automatic streaming of the X-series data to the physician on the far-side of the video call while staying in the video call through just a press of a button. The swyMed interface is also HIPAA-compliant and encrypts the connection between the physician, ambulance, and the receiving hospital. Furthermore, connectivity in rural settings requires special consideration. Thus, it was important for the Emory Acute Care Design and Innovation Center to identify the best data connectivity infrastructure. In Georgia, Verizon has the dominant cellular infrastructure. Resultantly, the Emory Acute Care Design and innovation Center’s team contacted Verizon and confirmed that both Emory and swyMed could work with the Verizon network. Together, Emory and Verizon identified the AirLink MG-90 router (Sierra Wireless®, Vancouver, Canada) as the optimal solution. The AirLink MG90 offers up to 600 Mbps downlink and 150 Mbps uplink speeds over LTEAdvanced Pro, 1.3 Gbps over dual radio, dual concurrent 3x3 MIMO 802.11 ac Wi-Fi, and 5-port Gigabit Ethernet. Grady EMS upgraded their entire system to use the AirLink MG-90 routers. Additionally, they created a list of ambulances that don’t use the AirLink MG-90 router, and a plan and budget to install the neededAirLink MG-90 router. This case report underscores that different technological requirements exist for different environments in which telemedicine takes place. Despite the existence of a robust telemedicine platform within the Emory Healthcare Network, this massive initiative was only made possible by having a dedicated internal innovation center, the EmoryAcute Care Design and Innovation Center, to meaningfully and quickly roll out a complicated new care delivery system (Fig. 2.6). 2 Digital Health Solutions and Wearable Devices
26 Used with Permission of Emory Department of Emergency Medicine. Case Report: Remote Clinical Exam MEDAICA Introduction Medaica is a digital health company extending the capability of remote exams over any telehealth system, simply and affordably. The Company’s first product is a consumer-focused digital stethoscope, designed specifically for telehealth systems at a price point that opens up the power and potential of remote care to all users. Medaica was founded by serial entrepreneurs with proven global experience in MedTech, Healthcare, Consumer Electronics and scaling mass volume hardware and software platforms. The Problem J. M. Joe et al.
27 Existing telehealth systems provide video conferencing and/or chat applications, some with scheduling management and Electronic Medical Record (EMR) integration. Although telehealth is becoming increasingly popular, especially in light of COVID-19, it is currently limited to only a few practice areas, such as mental health, dermatology, pediatrics and the common cold. Auscultation is an important part of a clinical exam that is missing in telemedicine sessions. Addressing that need, not only has the potential to improve the effectiveness of remote care for both the clinician and patient, but also improve the utility and value of telehealth. Medaica conducted extensive market research to surface the less obvious challenges of developing a product that required some level of behavioral change—both from doctors and consumers. Related to the introduction of blood pressure devices, pulse oximeters and, more recently, devices like the Kardia EKG, where patients use tools previously available only to clinicians, Medaica understood that clinicians AND patients need to recognize and want more valuable telemedicine sessions through such devices. The question was, would this be an acceptable proposition for both sides of the equation? Insights The Medaica design team (based in the USA and UK) spoke with many clinicians and received consistent feedback that most electronic stethoscopes are too complicated and too expensive for daily use. Furthermore, most electronic stethoscopes cleared by the FDA for use by clinicians, are NOT cleared for use by a “lay person” and, in a telemedicine session, it would be the patient, not the doctor, using the device. Medaica also interviewed medical IT staff who are often the ones tasked with “making it work.” IT professionals don’t see the “wow” of a new device first but see the increased workload it might present. Incumbent proprietary solutions can create workflow silos that become increasingly difficult to manage and support. Solution providers need to understand and appreciate the time-consuming process of integrating IT services, devices and systems, and must not assume a doctor, clinic, or hospital will willingly adopt yet another proprietary solution. If every medical device only works with a specific telehealth platform, those devices ultimately become unsupported islands. That is not a sustainable strategy for a business or a medical practice. At a detailed level, on top of familiar “hot button” issues including but not limited to data privacy and development of more telehealth pay-codes etc., examples of the less obvious but real-world challenges facing clinicians that also surfaced were: • Artificial Intelligence AI, even when positioned as “Assisted Intelligence” which is arguably a friendlier and more accurate term of art, was often 2 Digital Health Solutions and Wearable Devices
28 received as a threat not a benefit; At best it was a partial solution. For example, if a company offered an electronic stethoscope with AI that helps diagnose atrial fibrillation, the clinician still needed other devices, tests and protocols to diagnose other conditions such as arrhythmias, congenital heart disease, coronary artery disease, cardiomyopathy etc. • Besides often generating a myriad of pairing issues, connecting a Bluetooth stethoscope during a telehealth session resulted in that device taking over the audio channel and the clinician being unable to talk with the patient. • Devices that might not function before or during an exam because the battery was drained. • Single purpose devices that often cost several hundred dollars were deemed not economically viable for a scalable solution and therefore did not warrant the time investment on the clinician’s side to evaluate and/or integrate. The resulting Venn diagram that became Medaica’s mantra, was for its solutions to be; Affordable, Simple and Interoperable. The Solution Among Medaica’s many different design decisions was their choice of using a USB cable (with adaptors for any laptop, desktop or mobile device) rather than Bluetooth. That simplified the electronic design and user experience, reduced the cost, avoided potential interference issues and removed the need for batteries. As a USB device, the Medaica stethoscope is “plug and play” and in its simplest form can securely send audio files, together with an “auscultation map” to the clinician either in store and forward or live modes. The product design went through a number of iterations. It needed to be easy to hold but also easy to position in relation to the patient being able to position the device on an “auscultation map” in self-exam mode. One of the early designs was essentially a stethoscope head but was rejected because the user’s hand would be covering the head and/or made a simple button push awkward (see Figs. 2.7 and 2.8). The chosen design direction was to be more recognizably a stethoscope (see Fig. 2.9). The head of the device is easy to see (or detect for assisted positioning approaches) when the user is placing the device in a specific auscultation position. The design is easy to manufacture and can be completely sealed and therefore also has the advantage that it is washable to IP6X standards. These decisions were made prior to COVID-19 flaring up but become even more compelling within that context. There were many technology decisions not only aimed at making the device easy to use, but easy to deploy and to potentially establish standard telehealth methods for patients and clinicians to quickly and easily share auscultation sounds. One of those decisions was to use two microphones configured for plug and play with any telehealth system, enabling both auscultation sounds and an independent channel for the user to speak, which also doubles for ambient/room noise reduction. J. M. Joe et al.
29 Because Medaica’s solutions are designed to enhance existing telehealth solutions, not compete with them, they worked extremely hard to make sure that the clinician could continue to use whatever system they were already using, with the added benefit of adding auscultation to the exam. The pillars of that process were: • Balance clinician AND patient ease of use to get a more valuable and informed telehealth consultation for both sides. • Enable healthcare professionals to leverage existing workflows and systems. • Don’t compete with telehealth platforms—provide plug and play, agnostic, interoperability to any telehealth platform. Enable value-add to open their platforms to new specialties and stickier users. • KISS (Keep It Simple Solutions)—solutions that work in the minimum number of steps with minimal behavioral change. • Affordable—solutions that are priced for consumer scale. OhMD Case Report In the spring of 2020, the healthcare industry was rocked by the novel coronavirus disease (COVID-19). Almost overnight, HIPAA-compliant telehealth became a necessity for healthcare providers across the United States. Software companies everywhere raced to meet the demand. Among them was OhMD, a HIPAA-compliant texting platform that saw an obvious opportunity for growth. When OhMD first launched video visits in early 2020, they expected it to be the clear solution to the sudden demand for telehealth. Providers quickly signed up for the new feature so they could continue working when social distancing measures went into place. While the video tool offered an essential alternative to in-person visits, there were obvious gaps in the new workflow. One practice that approached OhMD about the shortfalls was The Heart Medical Group in Van Nuys, CA. Providers wondered how to coordinate with patients to get them on the video call at the right time, and how to continue the conversation around treatment, payment and follow-up once they both clicked “end call”. Essentially they needed to recreate the full in-office workflow of a patient visit, from check-in to intake to provider, and back to check-out. To meet this need, OhMD was able to fall back on its core competency -- text messaging. With the addition of video visits, OhMD could now prompt a video visit appointment as a substitute for sitting down with a provider in the exam room and use secure texting to enable the rest of the practice workflow: • The day before the visit (or anytime prior, in the case of same-day appointments), the care team texts the patient an appointment reminder and 2 Digital Health Solutions and Wearable Devices
30 includes any forms that the patient needs to complete prior to the appointment. The patient taps the link to fill and submit the forms from their smartphone. • Immediately before the appointment, the provider texts the patient to confirm they’re ready. They send the patient a link which they tap to begin the video visit. • When the call ends, the timestamps are stored in the patient thread for billing reference. • The patient can then be reassigned in OhMD to administrative staff who handle payment through texted links, schedule necessary follow-up, and even request reviews. The benefits of a sound telehealth strategy are of particular benefit to cardiologists and other specialties that deal with chronic illness. Some of the benefits to The Heart Medical Group include: • OhMD allows patients who use remote patient monitoring (RPM) devices to text their provider with real time data on their health so they can make timely, appropriate recommendations on a patient’s care. • The ease and immediacy of texting strengthens the patient-provider relationship and improves patient adherence to care plans. Using a familiar, palatable channel like texting gives patients access to healthcare regardless of their fluency with technology. • Telemedicine offers cost-saving benefits. Communication through texting helps patients save money on co-pays by reducing trips to the office. The effective deployment of telemedicine can also produce systematic savings by better triaging patients in lower acuity healthcare settings, reducing costly hospitalizations. • Leveraging a platform like OhMD allows doctors to better allocate their time. Doctors can reduce unnecessary office visits, quickly and easily facilitate necessary visits, and improve chronic care management. This allows doctors to deliver the highest quality of care while focusing on revenue generation. Cardiologists have found great success using OhMD for mixed telemedicine: a combination of traditional in-person care, virtual video visits, and twoway patient texting. OhMD has seen the incorporation of telemedicine increase provider capacity and accessibility, continuity of care, and overall quality of care. Although many providers viewed have adopted telehealth solutions as a short-term solution to care delivery during the COVID-19 pandemic, it has become clear that it adds indelible value to the healthcare system (Fig. 2.10). J. M. Joe et al.
31 Fig. 2.6 Telemedicine emergency medical service triaging 2 Digital Health Solutions and Wearable Devices
32 Fig. 2.7 Awkward button placement (thumb) Fig. 2.8 OK button placement, but obscures head position J. M. Joe et al.
33 Fig. 2.9 Good button placement, good visibility of head position, comfortable to hold and separate body/voice mics Fig. 2.10 OhMD video visit platform sample 2 Digital Health Solutions and Wearable Devices
34 Case Study: ASK ANGIE™ PCI procedures and devices are complex. There are times (day or night) when questions arise. ASK ANGIE is a technology provided by Boston Scientific that uses merged reality to instantly bring clinical expertise to the cath lab so that teams can confidently and efficiently perform complex cases, without delays, to deliver the best patient care. The merged reality functionality of ASKANGIE allows certified Boston Scientific clinical representatives to give step-by-step guidance visually – as if they are in the cath lab in person. Clinicians can also use the tool to connect with their peers. In addition to merged reality calling, ASK ANGIE provides on-demand education that can help bring new lab staff up to speed or refresh tenured staff on procedures and technologies. ASK ANGIE delivers virtual support from expert reps for complex PCI devices and procedures. The solution was initially piloted for 6 months, at remote facilities, with the help of clinician champions. The clinician champions saw the value and potential of the technology to meet their needs and helped work through the approval process to pilot the technologies with key stakeholders at their facility. We showed proof of concept through our minimum viable product (MVP) which supported ANGIOJET, a mechanical thrombectomy device. This tool is commonly used for emergency treatment of blocked arteries and thus cath lab staff frequently ask for support with device setup with little notice. To measure success, we looked at app usage and number of cases supported remotely. By selecting the right technology up front during the pilot, we were able to generate quick wins to fuel future innovation and maximize the potential for usage and adoption of the technology. After receiving feedback from users during initial pilots, we expanded the product scope to include J. M. Joe et al.
35 additional technologies. Eventually, we found the right fit by delivering educational content that supported all Complex PCI procedures, not just thrombectomy. It is important not to be wedded to any preconceived assumptions when rolling out a new digital health technology. We initially thought only remote facilities would be interested in ASKANGIE. During the pilot we learned that clinicians at larger facilities and in metropolitan areas found just as much value in the technology as remote facilities. COVID-19 has expanded the need and use case for this technology with facilities across the globe. 2 Digital Health Solutions and Wearable Devices
36 J. M. Joe et al.
37 Acknowledgement The Emory Rural Tele-EMS Network is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling $1.2 million with 100 percentage funded by HRSA/HHS and zero percentage funded by non government source(s). The contents are those of Emory University and do not necessarily represent the official views of, nor an endorsement, by HRSA/HHS, or the U.S. Government. References 1. Snowdon, A. (2020) Digital health. 2. Fisher ND, Fera LE, Dunning JR, Desai S, Matta L, Liquori V, et al. Development of an entirely remote, non-physician led hypertension management program. Clin Cardiol. 2019;42(2):285–91. 3. Staib A, Sullivan C, Prins JB, Burton-Jones A, Fitzgerald G, Scott I. Uniting emergency and inpatient clinicians across the ED–inpatient interface: the last frontier? Emerg Med Australas. 2017;29(6):740–5. 4. Guo C, Ashrafian H, Ghafur S, Fontana G, Gardner C, Prime M. Challenges for the evaluation of digital health solutions—a call for innovative evidence generation approaches. NPJ Digit Med. 2020;3(1):1–14. 5. Garg S, Williams NL, Ip A, Dicker AP. Clinical integration of digital solutions in health care: an overview of the current landscape of digital technologies in cancer care. JCO Clin Cancer Infor. 2018;2:1–9. 6. Van Velthoven MH, Cordon C. Sustainable adoption of digital health innovations: perspectives from a stakeholder workshop. J Med Internet Res. 2019;21(3):e11922. 7. Malec B. Healthcare information and management systems society 2016. J Health Adm Educ. 2016;33(4):625. 2 Digital Health Solutions and Wearable Devices
38 8. Estes C. 1 In 4 rural hospitals are at risk of closure and the problem is getting worse. Forbes. 2020 Feb 24; 9. James R, Champagne-Langabeer T, et al. Cost-benefit analysis of telehealth in pre-hospital care. J Telemed Telecare. 2017;23(8):747–51. 10. Langabeer JR, Gonzalez M, et al. Telehealth-enabled emergency medical services program reduces ambulance transport to urban emergency departments. West J Emerg Med. 2016;17(6):713–20. 11. Garcia MC, Rossen LM, Bastian B, Faul M, Dowling NF, Thomas CC, Schieb L, Hong Y, Yoon PW, Iademarco MF. Potentially excess deaths from the five leading causes of death in metropolitan and nonmetropolitan counties—United States, 2010–2017. CDC Surveillance Summaries. 2019. p. 1–11. 12. Sierra Wireless. AirLink® MG90/MG90 5G high performance multi-network vehicle routers. Retrieved from Sierra Wireless: https://www.sierrawireless.com/products-and-solutions/ routers-gateways/mg90/ 13. swyMed. Why swyMed? Retrieved from swyMed: http://swymed.com/why-swymed-overview/ J. M. Joe et al.
RkJQdWJsaXNoZXIy MTYzOTI3MA==