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Care Worn: 11 Companies Using Wearable Technology in Healthcare

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Care Worn: 11 Companies Using Wearable Technology in Healthcare

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When it comes to the latter, wearable devices are giving people a far more active role keeping tabs on their own healthcare. And they're much more than mere Fitbits. From heart monitors and electrocardiogram applications to temperature and reproductive cycle trackers, wearables are becoming more prominent in the day-to-day management of illnesses and chronic conditions.

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Change is a constant in healthcare and medicine. Surgical techniques improve. Patient care becomes more personalized. Drug discovery is streamlined. And, in an increasing number of cases, patient health monitoring no longer requires doctor visits.

When it comes to the latter, wearable devices are giving people a far more active role keeping tabs on their own healthcare. And they're much more than mere Fitbits. From heart monitors and electrocardiogram applications to temperature and reproductive cycle trackers, wearables are becoming more prominent in the day-to-day management of illnesses and chronic conditions.

Are they perfect? Of course not. In late 2018, one medical device analyst predicted that while "there is potential for market growth, there are still questions surrounding the accuracy of wearable devices in replacing traditional medical devices, and the unintended consequences of anxiety and stress associated with constant monitoring."

Still, it's an advance worth noting. Here, then, are 11 prominent players in the field of wearable technology in healthcare.

Ava

Location: San Francisco (US Headquarters) + Zurich (Global)

What it does: Ava is a night-only wearable that helps women naturally track their cycles to understand more about their fertility, pregnancy and overall health. In addition to simple symptom, ovulation and period tracking, the wearable tracks and logs sleep, stress levels and resting heart rate, all within the Ava app.

Industry impact: According a clinical study at the University Hospital of Zurich, Ava identified "an average of 5.3 fertile days per cycle with an accuracy of 89 percent."

GymWatch

Location: Darmstadt, Hessen, Germany

What it does: GymWatch makes smart, wearable devices for efficient strength training. Whether a user is a professional or a beginner, the wearable ensures that exercises are performed accurately and provides immediate feedback.

Industry impact: The GymWatch wearables connect with a mobile app to create custom workouts and analyze movements for audio and visual feedback. Performing exercises correctly is crucial for avoiding injuries and maximizing workouts.

KardiaMobile

Location: Mountain View, California

What it does: KardiaMobile is a product made by AliveCor, a medical device and artificial intelligence company that is developing products for screening, diagnosis and treatment. KardiaMobile is an electrocardiogram (ECG) that attaches to the back of mobile devices like iPhones and Androids. It tracks heart activity and transmits the activity to a mobile app through chest and finger sensors.

Industry Impact: The device is made for both consumers and health professionals, enabling those with heart conditions - or just heart conscious people - to monitor their heart activity anywhere.

Motiv

Location: San Francisco, California

What it does: While fitness and health wearables in the form of watches are common these days, Motiv does things a little differently. Motiv Ring slips onto a user's finger to monitor activity, sleep and heart rate. The ring's app lets users track and adjust their goals.

Industry impact: Motiv Ring is a good alternative for users who are put off by watches and other wearables.

Apple Watch

Location: Cupertino, California

What it does: In addition to many other uses and applications, Apple Watch has a variety of health tracking features that include heart rate notifications about irregular rhythms and heart rates that are too high or too low. The watch even has an electrocardiogram (ECG) app and auto-enabled fall detection for users over 65.

Industry impact: Between the Apple Watch and iPhone health features, users can monitor heart health and store important medical information that's quickly accessible.

FitBit

Location: San Francisco, California

What it does: Fitbit does more than track steps, it also provides an entire health coaching platform that offers solutions for corporate wellness, healthcare systems and researchers. Fitbit's wearable devices track a variety of health factors, from heart rate and sleep to female health and workout paces.

Industry impact: A study done at Arizona State University concluded that wearing a Fitbit monitor and employing mindful expression over five days increases physical activity and promotes positive lifestyle changes.

Garmin

Location: Olathe, Kansas City

What it does: Garmin makes a wide range of devices, including fitness and health tracking wearables for adults and children. Garmin also offers an all day activity tracker that counts steps, distance, intensity and calories, helping users maintain health and fitness goals.

Industry impact: Garmin recently announced that it will work with ActiGraph, a provider of activity and sleep monitoring solutions and an analytics platform within the scientific community. The partnership will use ActiGraph's platform and Garmin's wearables to aid in clinical trials, academic research and the remote monitoring of patients.

My Skin Track UV

Location: New York, New York

What it does: Made by L'Oreal brand La Roche-Posay, My Skin Track UV is a wearable sensor that pairs with a mobile app to track a user's exposure to UV, pollen, humidity and pollution.

Industry impact: The sensor is thumbnail-sized, battery-free and stores up to three months of environmental data. It also measures both UVA and UVB rays.

Owlet

Location: Lehi, Utah

What it does: Owlet creates wearables and cameras for babies and infants that track heart rates and oxygen levels, measure sleep and have audio/video streaming capabilities for monitoring purposes. Owlet's products are tracked via mobile app and provide weekly milestones in a baby's progress.

Industry impact: Owlet's new wearable band for pregnant women monitors heart rates, kick counts and other neonatal indicators.

TempTraq

Location: Westlake, Ohio

What it does: TempTraq is a monitoring sensor for babies and children that tracks temperatures during an illness. The bluetooth sensor is a soft patch placed under a child's arm and sends temperatures to mobile devices so parents can track without manually taking temperatures multiple times.

Industry impact: The sensor lets parents keep track of multiple kids and alerts them about dangerous temperatures without disrupting the wearer. When TempTraq was tested on pediatric cancer patients at Cincinnati Children's Hospital, the device detected fevers and temperature changes that episodic monitoring missed.

Withings

Location: Issy-les-Moulineaux, Île-de-France, France (headquarters) & Cambridge, Massachusetts (US location)

What it does: Withings is a health and wellness company whose products keep people connected to their health. Since creating the first WiFi scale, the company has developed connected wellness devices like health-enabled watches. Withings wearable trackers offer activity tracking and ECGs, as well as heart rate and sleep monitoring.

Industry impact: Though they offer models that resemble other popular brands like AppleWatch or Fitbit, the company's watches mostly come in more traditional styles.

Related Read More Internet of Things Stories
All images via Shutterstock and social media

# data[].attributes.attachment_link.title
Care Worn: 11 Companies Using Wearable Technology in Healthcare

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Change is a constant in healthcare and medicine. Surgical techniques improve. Patient care becomes more personalized. Drug discovery is streamlined. And, in an increasing number of cases, patient health monitoring no longer requires doctor visits. When it comes to the latter, wearable devices are giving people a far more active role keeping tabs on their own healthcare.

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The Role of Wearable Technology in Healthcare Interoperability -

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The Role of Wearable Technology in Healthcare Interoperability -

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Healthcare professionals agree that consistent data exchange between medical technology systems and software solutions (the phenomenon is also known as interoperability) and further data analysis is crucial to shifting from episodic to continuous patient care.

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The Role of Wearable Technology in Healthcare Interoperability -

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Could wearables promote the development of a data-centric approach to healthcare delivery and help solve healthcare interoperability challenges?

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The emerging clinical role of wearables: factors for successful implementation in healthcare - npj Digital Medicine

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The emerging clinical role of wearables: factors for successful implementation in healthcare - npj Digital Medicine

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Wearable technologies promise to redefine assessment of health behaviors, yet their clinical implementation remains a challenge. To address this gap, two of the NIH’s Big Data to Knowledge Centers of Excellence organized a workshop on potential clinical applications of wearables.

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Introduction

Wearable technology, also known as "wearable devices" or simply "wearables", generally refers to any miniaturized electronic device that can be easily donned on and off the body, or incorporated into clothing or other body-worn accessories1. While wearables have established utility in the fitness, gaming and entertainment industries, their role in the healthcare environment remains less clear2. To date most commercially available wearables are limited in scope, tracking one or two health-related variables, and have yet to produce accurate measurement of many markers of health status that they attempt to assess such as heart rate variability, nutrition, and mood. To the extent that wearables overcome these limitations, they hold much promise towards expanding the clinical repertoire of patient-specific measures, and they are considered an important tool for the future of precision health.

Physical activity information is perhaps the most common measurement provided by current wearable devices, thus it serves as a useful example to review the opportunities and difficulties facing digital health development using wearables. Physical activity is a well-established marker of current health status and future health risks, it is a useful estimate of real-life functional performance6, and it has been tracked in health research using body-worn sensors for many decades7,8,9,10. Wearables for remote digital health and physical activity monitoring have been validated in various settings. Given the ubiquity of physical activity monitors, it is surprising their effective incorporation into clinical care remains a challenge, especially in face of the multiple known health benefits of physical activity and the many healthcare scenarios where physical activity information has a clinical use. Key challenges preventing inclusion of physical activity monitoring in routine clinical care include the need for data standardization between the many different commercially available devices and sensor locations, and integration of this data into the electronic health record and clinical workflow.

Previous research suggests that digital health programs incorporating health behavior models and personalized coaching are the most successful17. Yet, knowledge is limited regarding all the factors that may drive successful implementation of wearables into the healthcare environment. Notwithstanding this gap in knowledge, a rapid proliferation of untested digital health applications has led some to dismiss activity monitoring as a health fad that appeals only to fitness fanatics. Deficits in knowledge have also given rise to concerns that wearables could pose health risks by paradoxically reducing healthy behavior rather than promoting it, either through a false assurance of healthy behavior or through discouragement from failure to achieve goals2,23,24,25. At the same time, many reports indicate a beneficial impact on the health of individuals using wearable monitors26,27,28,29,30. Some even indicate that utilization of wearables for clinical care delivery provides health benefits that outpace conventional methods of care6,31,32,33.

These disparate opinions prompted us to seek answers to the current utility of wearables in healthcare. To this end, two of the National Institutes of Health's Big Data to Knowledge (BD2K) Centers of Excellence-the Mobilize Center at Stanford University34 and the Mobile-Sensor-to-Knowledge Center (MD2K)35-organized a workshop on the clinical application of wearables. This invitation-only workshop was led by a practicing physician with expertise in the analysis and clinical interpretation of wearable sensor data, and included 14 stakeholders from diverse backgrounds including: hospital administration, academia, insurance, clinical medicine, and the commercial wearable device industry. The workshop group reviewed and discussed two different digital health interventions that have successfully integrated wearables into their clinical workflow, and that empirically demonstrated superior health outcomes using the digital platform compared to traditional care. The workgroup included a representative from each system with direct knowledge of the development and implementation of their respective program. The workgroup's stated goal was to define the features common to the two sample cases from health systems that allowed the integration of wearables into a successful digital health intervention.

The Ochsner Health System and Kaiser Permanente each designed a digital health program for the management of hypertension and diabetes, respectively. In both programs, commercially available at-home digital device (glucometer at Kaiser, blood pressure monitor at Ochsner) was customized to integrate with the electronic health record (EHR) to wirelessly transmit measurements directly to the EHR. Within this framework, wearables were only one aspect of an integrated care delivery process. The digital monitors provide useful instructions directly to patients, while updating the EHR with new data and promoting more rapid and efficient communication between clinicians and patients when needed.

Within the Ochsner system, home blood pressure monitoring and health behavior data from additional optional wearable connected devices (including physical activity monitor and scale), was utilized in conjunction with health coaching and medication adjustments to track patient health status. A mobile application interface served as a feedback loop sending important information to the treating physician, who is then able to seek additional contact if a patient is not meeting expected goals, or simply continue to monitor if all is going well. Within Kaiser, all patients enrolled in the program are actively managed by their care team, who uses the integrated data in EHR to drive clinical treatment decisions, performed in tandem with diet and physical activity education and coaching, and preventive care. This newly tested approach with wearable connected home monitors contrasted from usual care where patients follow-up with care providers in clinic at designated appointments. The lag time in usual care was overcome by the connected digital monitors allowing real-time two-way communication between patient and care team. The new platform also differed from usual care by providing participants with direct technical support to personally address technical issues. It also incorporated a health support team to tackle health-focused problems such as lifestyle management, medication compliance, nutrition, and health education. These teams added a personalized component to each program that specifically addressed important patient-level health needs.

Both remote glucose monitoring and blood pressure monitoring digital sensors are commercially available and have been described extensively in the literature39,40,41,42. The Ochsner and Kaiser Permanent health systems used devices vetted by their own systems and found to be acceptable for use in their patient cohorts. Given the variability in commercially available products and ongoing validation of their output, each health system should carefully review the available options prior to deployment. A 90-day prospective assessment of the Ochsner digital hypertension management program revealed that 71% of patients treated with the digital health program achieved target blood pressure control, compared to 31% under usual care25. Kaiser Permanente's digital glucose monitoring program reduced time for contacting patients in the program via telephone visits by 50%, and therefore effectively doubled clinicians' capacity to manage patients with diabetes38. Both digital programs had similar features that allowed them to empirically outperform usual care. In this paper, we highlight the workgroup's findings regarding the common key features between these two programs, which underscore the successful implementation of wearables and digital health programs in two different health systems (Fig. 1).

Listed here are the key features identified by the workgroup as responsible for success in digital health programs involving wearables.

Evaluating the shared characteristics of these programs provides insight into the emerging role of wearable technologies in the clinical arena that expand beyond the role of physical activity monitoring. These shared characteristics provide a roadmap for future implementation of wearables into digital health interventions. Successfully designed and implemented, these new technologies can produce measurable benefits, which accrue to patients and the health system. We suggest that all medical institutions interested in utilizing and scaling wearable technology in their clinical workflow should consider the common features that we outline below. In order to highlight areas with near term potential, we finish by offering our insights into the expanding future direction of wearable physical activity monitoring in the clinical workspace.

Features for successful implementation of wearables in clinical environments

The workgroup identified many common features between the Kaiser Permanente and Ochsner Health System digital health interventions. Among them, the workgroup agreed that the following common features were directly related to the successful implementation of wearable technology into the digital patient care platform:

Clearly defined role of wearables to address a specific problem behavior for the disease state

In-line with the scientific method, which begins with a hypothesis, implementation of a successful wearable program requires one to establish a priori goals for the target disease state. In other words, there must be a specific problem that one hopes to address with the wearable technology. As an illustration, Kaiser Permanente and Ochsner identified clinician, patient and system specific problems that were limiting their ability to effectively manage patients with diabetes and hypertension, respectively. For example, clinicians indicated that the frequency and reliability of core disease measures (blood glucose and blood pressure) obtained outside of the clinic were highly variable. Both programs design solutions around this using digital technology applications, including wearables. See Table 1 for an expanded view of the many issues addressed by each program. Simply put, the role of the wearable was clearly defined based on a health-specific need; yet, importantly, the wearable was only one part of a larger digital health program.

Table 1 Examples of solutions to problems addressed by each of the seven identified features of successful digital health interventions that include wearables.

Incorporation of wearables into an integrated system of delivery

Wearables were incorporated into specialized integrated digital care delivery systems, involving health coaching, automated appointment reminders, disease-focused digital education, and automated medication dosing with human assistance when needed36.

In both programs, an at-home digital device (glucometer at Kaiser, blood pressure monitor at Ochsner) was customized to integrate with the electronic health record (EHR) to wirelessly transmit measurements directly to the EHR. Within this framework, and as previously described, wearables serve as only one aspect of the integrated care delivery process, allowing the application to provide useful instructions, while updating the EHR and promoting more rapid and efficient communication between clinicians and patients when needed. Within the Ochsner system, home blood pressure monitoring and health behavior data from wearable connected devices, together with health coaching and medication adjustments, combine to provide useful patient health status information to the treating physician, who is then able to seek additional contact if a patient is not meeting expected goals, or simply continue to monitor if all is going well. Within Kaiser, all patients enrolled in the program are actively managed by their care team, who uses the integrated data to drive clinical treatment decisions, performed in tandem with diet and physical activity education and coaching, and preventive care.

Patient-facing technology support service

Taking a cue from the Apple Store's "Genius bar," which is a physical store to assist customers who wish to initiate use of a new Apple device or troubleshoot problems with an existing device, Kaiser Permanente and Ochsner each established onsite technology assistance (respectively the "Thrive Bar" and "O-Bar") and processes for technology support and troubleshooting. For example, the Ochsner O-Bar is physically located within the medical clinics where staff electronically receive the doctor-recommended digital health intervention and personally assist the patient with selection and purchase of the connected wearable(s), initiation of the health application, and onboarding the application and devices. This increases likelihood of same-day enrollment in the program and shifts the burden of support and technological knowledge from clinicians to the tech support team that is better equipped to help. In addition, the tech team troubleshoots problems with the application and connected devices if they arise, and they provide information and support to patients interested in using additional wellness apps, wearables and connected home devices. All patients who initiate the program are referred to the program by a treating physician, are required to have a smartphone and at least one connected health device (glucometer for the Kaiser program vs. blood pressure monitor for the Ochsner program). The technical support increases patient access to the primary digital health application in addition to other vetted health apps and approved wearables that integrate with the digital health intervention, they facilitate the successful initiation and implementation of the digital health intervention, and ultimately they promote patient engagement and appropriate use of wearables in the clinical setting.

Incorporation of a personalized human experience alongside the wearable technology

The Kaiser and Ochsner digital health programs each include a human element in the care model and do not rely solely on digital technologies. Of course, all patients continue active management of their overall health with their primary physician. With regard to the focused area of the digital health platform, a human element is also involved. Just as the technical support bar personally addresses technical issues, health support teams are included in each program to tackle health-focused problems such as lifestyle management, medication compliance, nutrition, and health education. A health support team includes: health coaches, nurses, allied health professionals and pharmacists, all with training in the specific chronic health condition for which the program has been designed. These teams add a personalized component to each program that specifically address important patient-level health needs, and in a personalized way that is not provided by current wearable technologies. Development of personalization strategies into digital health technologies amplifies the impact of the digital tools and is an area ripe for innovation in order to reduce the human burden in future applications. By potentially increasing user engagement, personalization may help reduce the observed tendency to abandon use of wearables due to wearables "fatigue" after 3-6 months. Health systems interested in a successful digital health intervention should expect to initially invest in staff training to support patients between clinic visits and to encourage behavioral changes that will foster improved outcomes.

Focus on the end-user experience

Analysis of factors influencing technology adoption rates indicates that convenience of use and a pleasant end-user experience are critical elements. In the case of wearables in digital health interventions, apps and devices must be designed with both the clinician and patient users in mind. This was the case during the design and testing phases for each of the digital health programs reviewed by the workgroup. Clinicians are interested in easy access to relevant clinical data, efficient integration of the digital platform into the clinical workflow, and ultimately improved treatment outcomes. At Kaiser, clinician feedback was elicited formally through interviews as well as a survey. Both found that the program was well-received by clinicians, where the majority felt that it improved their ability to provide care and that it saved them time43. For patients, the application's usability and design are important for initial adoption, as are the potential for fewer clinical visits and thus fewer co-payments along with reduced time invested in appointments and travel to clinics. Over time, for both clinicians and patients the convenience of use is a motivating factor.

Each of the sample digital programs established minimum requirements and beyond that provided options based on user preference. For example, in Kaiser Permanente's remote glucose monitoring program, enrolled participants have the option for virtual visits vs. face-to-face visits, based on patient preference. In regard to the use of the wearable device, both Kaiser and Ochsner required a home connected device since it was required for measurement and reporting of the digital health intervention's primary outcome (blood glucose and blood pressure, respectively). At Ochsner, an additional wearable activity monitor was also recommended, but not required since it was not the primary outcome, yet it provided the patient and physician with important information regarding health behavior adjustments that influence the primary outcome. Allowing the users to opt-in or out of these add-on features is another important aspect of end-user design. In fact, better user experience ratings were revealed in the Ochsner digital hypertension health program when compared to usual care, and this was one factor leading to significantly better improvements in patient engagement and ultimately improved hypertension management25,32. This indicates that designing digital health platforms with the user experience in mind is an important aspect of program adoption and success.

Clearly defined reimbursement model

Establishing a reimbursement model in the design of the digital health program is critical for fiscal sustainability and long-term success. As a combination health insurance and healthcare provider with most patients in either risk-based or capitated reimbursement models, Kaiser's program is able to be fiscally sustainable as long as the care provided is clinically equivalent or better, provided improved efficiency, and with equal or better patient satisfaction. It was less straightforward for Ochsner, but no less beneficial. Ochsner self-funded its digital hypertension monitoring program in the initial pilot phase of their program, and afterward performed a proof of concept study in at-risk populations. As a result of this initial investment, they were able to provide health payers with data showing significant improvements in patient health outcomes with reduced overall care costs; thus, they were able to negotiate and establish payment models for this digital health intervention. Other systems may take a similar approach or determine alternate strategies toward sustainable reimbursement models. Recently, the Centers for Medicare & Medicaid Services announced the "Physician Fee Schedule Final Rule," which activates Current Procedural Terminology (CPT) code 99091. This allows unbundling of billing for chronic care services from billing for the collection and interpretation of physiologic- and patient-generated digital health data. There are specific guidelines for reimbursement, and providers meeting the requirements are reimbursed up to $60 per month per patient for a cumulative 30 min of collecting and interpreting data. This new reimbursement model went into effect at the beginning of 2018 and it remains to be seen how this will transform the clinical utilization of wearable device data in healthcare.

Select data sources that fit into existing data architecture

Since health systems vary by structure and functionality of health data infrastructure, selected data sources must be compatible with existing data architecture. Both Kaiser Permanente and Ochsner had established data streams in their electronic health record (EHR) and worked to design their remote digital health monitoring program to fit existing data structures, and to integrate the program into the existing digital clinical workflow. Oschner used the EHR's device integration platform to connect to the built-in patient portal, while Kaiser worked with 3rd parties to develop a direct integration that that bypassed the EHR's patient portal. Patients eligible for the digital health platform by clinical criteria had to next meet technical criteria, which required possession of a smartphone, and then were provided (at Kaiser) or had to be willing to purchase a wireless home monitor (at a discount at Ochsner) from preselected vendors. Stemming from the system design, at Ochsner, patients were required to establish a patient portal account, which they could log into at home to receive and send messages and to access information not delivered through the smartphone application. At Kaiser, the patient portal was optional but encouraged in order to ease communications with the care team. This setup expands the capabilities of the program beyond a simple collection and distilment of data from the connected device and wearable device. It supports two-way communication within a program that includes relevant information about patient comorbidities and other clinically relevant variables already contained in the patients' charts, and make it available to the patient and the entire care team. Patients and physicians are more effectively connected to the health delivery system via apps, home-based devices and wearables. This provides higher patient engagement in both passive and active formats, and it produces clinically meaningful real-time feedback between patients and their care teams.

Program deployment with physician champions and opt-in program expansion

Reviewing the Kaiser Permanente and Ochsner programs revealed that clinician champions are important for program adoption and success. Each system identified at least one physician champion at a single clinical site who was keen to beta test the digital health program, provide feedback, and optimize initial clinical use. The champion also served as the most productive clinician in the early rollout of the program and pilot demonstrations of the program's effectiveness. From here, the program was made available to the other clinicians at the physician champion's site on an opt-in basis. Once established with buy-in from multiple providers at the original clinical site, the health system began to scale the program to other sites. Ochsner's program primarily targeted primary care physicians (PCP), while Kaiser's targeted clinical care managers, and motivations for clinician adoption of the programs were also considered. For example, at Ochsner indirect financial incentives for program use do exist. Specifically, 5% of physician base compensation is tied to quality metrics. For PCPs, hypertension management is among these measures. Since patients using the digital hypertension management system were shown to have better hypertension outcomes than those receiving conventional care, this provided an additional incentive for PCPs to get on board. Interestingly, an internal assessment of physician attitudes about this program reveals that physician adoption was motivated more by the improved efficiency of care than by any perceived financial reward or incentive. At Kaiser, clinicians are tracked on their diabetes performance by monitoring improvements in HbA1c, "touches" (clinical contacts or treatment intensifications), and according to the Healthcare Effectiveness Data and Information Set (HEDIS) measures; however there is no direct financial compensation tied to performance.

Future opportunities

Health systems like Kaiser Permanente and Ochsner have demonstrated feasibility and successful implementation of digital health monitoring programs that incorporate wearables, with significant improvements in health outcomes compared to usual care. We think the common features identified by our workgroup, and described in this paper, will help guide clinicians and health systems to develop additional programs. As technology continues to evolve, these technologies will become an increasingly integral tool for chronic disease management, health maintenance, and disease prevention. Proceeding while aware of past lessons will help move this technology forward at a faster pace. Recently, many authors have decried the limitations in the implementation and utility of wearable technologies into clinical medicine. Here, we chose to highlight the potential and the features common to two current examples of success.

Based on the key features identified above, concerns about the potential paradoxical impact of wearables on healthy behavior appear less significant, especially when wearable information is provided in the context of a comprehensive healthcare augmented by a digital health platform. Wearable sensors and the data they provide are increasing and are expected to become more prevalent in future medical care applications. As demonstrated by the workshop organized by two of the National Institutes of Health's Big Data to Knowledge (BD2K) Centers of Excellence-the Mobilize Center at Stanford University34 and the Mobile-Sensor-to-Knowledge Center (MD2K)35-the future remains promising for wearables in healthcare. Integration of wearable sensors into clothing and footwear will eliminate compliance limitations. Addition of new sensors, improvements in the accuracy of the sensor measures, and expansion of clinical insights from wearable sensors will increase their use in the medical environment.

For example, using the standard activity monitors described above, research teams are actively uncovering digital health markers beyond step counts, calorie counts, and minutes of moderate to vigorous physical activity6. This has led to new insights into musculoskeletal disease mechanisms31,47, and improved rehabilitation through disease-specific physical activity guidelines48. This recent work in the musculoskeletal realm has created the instruments and insights necessary for explorations into digital biomarkers of disease using wearable physical activity monitors49. We predict this will lead to new tools for disease diagnosis, tracking disease progression and response to treatment, and ultimately predictive models supporting patient-specific precision care.

Implementation of digital health monitoring programs described herein should be tempered by some inherent limitations. First, digital health monitoring programs may be accessible to only a small subpopulation of patients, specifically those who are insured, have access to wireless technology and smart phones, as well as integrated health systems with EHRs linked to mobile phone apps. Some patients in remote and hard-to-reach rural areas may be limited by wireless data capacity, yet these individuals can often benefit most from remote digital health monitoring programs. Therefore, health systems may consider providing financial assistance programs to enable access to smart phones and digital sensors for patients in need. There is also a sampling and selection bias with implementation of digital health programs in that patients who are more-health-conscious are more inclined to participate. In the Ochsner and Kaiser Permanent programs, only patients with a smartphone were eligible to enroll, which further raises questions about education, socioeconomic, and motivational biases. Informative missingness is also a potential limitation from the perspective of enrollees who dropped out early and did not contribute to the success rate of the program. Finally, deployment of these programs requires health system investment into the technology required to transfer, store, analyze and package the digital information and data in a HIPPA compliant manner. Despite these limitations, lessons from these two cases of successful implementation of digital health programs may prove useful to health systems interested in developing or deploying their own programs.

Conclusion

Utilization of wearables in healthcare environments is expected to increase. As the technology advances, interest will expand. A multi-stakeholder workgroup was convened by two of the National Institutes of Health's Big Data to Knowledge (BD2K) Centers of Excellence-the Mobilize Center at Stanford University34 and the Mobile-Sensor-to-Knowledge Center (MD2K)35-to evaluate the clinical application of wearables. Reviewing two effective digital health platforms that incorporate wearables, the group outlined the key factors for successful implementation, including: defining specific problems for targeted wearables solutions in specific disease states, incorporating wearable technology solutions into integrated health systems and existing health data infrastructures, focusing on end-user experience, considering reimbursement models inclusive of digital health programs, and establishing partnerships with clinician champions for wearables in the health ecosystem. Overall, wearables herald a new era in healthcare delivery with the potential to transform many aspects of clinical care.

Data availability

This is a qualitative assessment with all of the workgroup's output contained within the descriptions provided in the manuscript.

Acknowledgements

M.S. receives support from the Mobilize Center at Stanford University (NIH grant U54EB020405). We would like to acknowledge Richard Milani, MD, Ochsner Health System, Chief Clinical Transformation Officer, and Jim R. Dudl, MD, Diabetes Lead Care Management Institute & Community Benefit Kaiser Permanente, for providing their expert views and updates on digital health programs in their respective health systems.

Author information

Affiliations

1. Division of Physical Medicine & Rehabilitation, Department of Orthopaedic Surgery, Stanford University, Stanford, CA, USA

Matthew Smuck

2. Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven, CT, USA

Charles A. Odonkor

3. Chief Technology Officer of Innovation, Ochsner, Ochsner Health System, New Orleans, LA, USA

Jonathan K. Wilt

4. Head of Healthcare Products, Digital Health, Nokia Technologies, Cambridge, MA, USA

Nicolas Schmidt

5. Medical Informatics, Kaiser Permanente Southern California, Pasadena, CA, USA

Michael A. Swiernik

Contributions

C.A.O., J.K.W., M.A.S., M.S., and N.S. conceptualized this work. All authors contributed to the acquisition of data and interpretation of the outcomes, to the organization of the important intellectual content, to the approval of the final manuscript, and to ensuring its accuracy.

Corresponding author

Correspondence to Matthew Smuck.

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The authors declare no competing interests.

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Smuck, M., Odonkor, C.A., Wilt, J.K. et al. The emerging clinical role of wearables: factors for successful implementation in healthcare. npj Digit. Med. 4, 45 (2021). https://doi.org/10.1038/s41746-021-00418-3
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# data[].attributes.attachment_link.title
The emerging clinical role of wearables: factors for successful implementation in healthcare - npj Digital Medicine

# data[].attributes.attachment_link.description
Wearable technologies promise to redefine assessment of health behaviors, yet their clinical implementation remains a challenge. To address this gap, two of the NIH's Big Data to Knowledge Centers of Excellence organized a workshop on potential clinical applications of wearables.

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The Role of Wearable Technology in Healthcare Interoperability -

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The Role of Wearable Technology in Healthcare Interoperability -

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Healthcare professionals agree that consistent data exchange between medical technology systems and software solutions (the phenomenon is also known as interoperability) and further data analysis is crucial to shifting from episodic to continuous patient care.

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The Role of Wearable Technology in Healthcare Interoperability -

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Could wearables promote the development of a data-centric approach to healthcare delivery and help solve healthcare interoperability challenges?

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10 Ways Wearables Are Impacting Healthcare

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10 Ways Wearables Are Impacting Healthcare

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Many patients are sharing data from their wearables with doctors, even when they don’t need to track their vitals for medical reasons. Devices track things like sleep patterns and exercise routines, which have an important effect on overall health, but aren’t a part of medical records—until patients share the information and doctors take notes.

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10 Ways Wearables Are Impacting Healthcare

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10 Ways Wearables Are Impacting Healthcare

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Understand How Using Next Generation Wearable Technology will Help to Improve Healthcare

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Understand How Using Next Generation Wearable Technology will Help to Improve Healthcare

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This blog is about key benefits of Wearable technology and also know the challenges of implementing wearable tech in digital Healthcare

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30 Jun 2021

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Wearable Technology in Digital Healthcare

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Home > Blog > Potential Of Wearable Technology In Healthcare - Why To Invest? 30 Jun 2021 Leverage our expertise in Digital Health to improve the quality of patient care We can help you seamlessly manage data with intuitive visualization options to monitor, control your healthcare operations We use cookies We use cookies to improve your experience.

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Wearable Tech in Healthcare: Possibilities and Pitfalls

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Wearable Tech in Healthcare: Possibilities and Pitfalls

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At the University of Waterloo in Ontario, Canada, researchers are developing wearable technology to monitor the overall health of patients with neurodegenerative disorders. The ONDRI@Home project aims to give practitioners an end-to-end perspective on patient health, rather than relying on point-in-time appointment data. The Waterloo work highlights the massive potential of connected healthcare devices.

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Technology Solutions That Drive Healthcare

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Post-Pandemic Possibilities in Healthcare

The potential of wearables for remote patient monitoring is straightforward, according to the Healthcare Information and Management Systems Society: "Wearable technologies enable the continuous monitoring of human physical activities and behaviors, as well as physiological and biochemical parameters during daily life."

Though this functional field began with relatively simple devices - such as smartwatches capable of monitoring steps taken and average heart rate - the market has now expanded to include more in-depth medical information.

At the University of Waterloo in Ontario, Canada, researchers are developing wearable technology to monitor the overall health of patients with neurodegenerative disorders. The ONDRI@Home project aims to give practitioners an end-to-end perspective on patient health, rather than relying on point-in-time appointment data. The Waterloo work highlights the massive potential of connected healthcare devices.
READ MORE: Find out the benefits of implementing wearable devices into patient care plans.
"This technology is here to help us," Gallego says. "It becomes a partner to provide critical medical information on demand."

For family doctors, specialists and ongoing care providers, wearable health monitoring devices provide a window into their patients' daily lives. Armed with actionable information such as heart rate, blood pressure and brain function data, clinicians are better prepared to meet the evolving standards of patient-centered care.

Potential Pain Points for Wearables

However, there are also possible points of concern, Gallego says, that come with wearable implementation at scale, including privacy and data security issues:

Supply chain concerns. Since components of most medical wearables come from multiple providers, "the supply chain must be part of the risk equation," Gallego says. "Attackers can target the device within the device."

Medical malware. When it comes to wearables and security, Gallego notes that the medical Internet of Things "opens the doors for new vectors of attack, including targeted malware and distributed denial of service attacks. What happens if medical devices are compromised?"

Privacy problems. Gallego also highlights the issue of privacy. "Most vendors are driven by device operation rather than the data itself," he says. As a result, robust authentication and authorization is critical to determine how devices collect, send and analyze data.

Global regulatory realities. "The limit is the law," says Gallego. "With different balances of ethics and data collection worldwide, legislation plays a key role in device security."

Increased provider pressures. Gallego notes that the increasing adoption of 5G cellular networking comes with the promise of 10 times the speed of its 4G counterpart, in turn making it easier for devices to collect, send and store data. Increased data volumes, however, can contribute to clinician burnout as the they struggle with "technostress, time pressure and workflow-related issues," according to Healthcare IT News.

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Wearable Tech in Healthcare: Possibilities and Pitfalls

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The potential of wearables for remote patient monitoring is straightforward, according to the Healthcare Information and Management Systems Society: "Wearable technologies enable the continuous monitoring of human physical activities and behaviors, as well as physiological and biochemical parameters during daily life."

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The Endless Possibilities of Wearable Technology in Healthcare

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The Endless Possibilities of Wearable Technology in Healthcare

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Where the Fogg Behavior Model falls apart when it comes to long-term use of wearable technology in healthcare is with the patient’s ability to perform the healthy habit. Someone can have the motivation and a reminder to do something healthy, but not the power to do so at that moment.

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Watches almost became a thing of the past when people started carrying their smartphones in their pockets, but with the integration of technology into wearable devices, the wrist is a popular place to go for information once again. Telling time is just the tip of the iceberg when it comes to the capability of such devices, and there has been excitement about the benefits of wearable technology in healthcare.

The concept of patients wearing devices to connect with their healthcare data and treatment is not new. Diabetics wear glucose monitors. Implanted devices such as pacemakers and defibrillators provide a life-saving, intimate connection with patients rather than a device that sits on a table that needs to be connected.

With the advent of smart technology that sits on the wrist, healthcare providers are able to work with their patients to gather information for their treatment, along with helping them form healthy habits in their lifestyle.

Why are wearables so powerful?

Wearable technology in healthcare has several benefits, including:

It's personal-these devices are present in moments of a patient's life when another technology isn't. People take smartphones and wearable tech with them everywhere-even the bathroom. "It's an advantage that makes wearables powerful," said Robert Havasy, senior director of connected health at HIMSS.

It focuses on healthy habits. Many of the diseases that impact patients most are the result of decisions made over a lifetime, such as diabetes, hypertension and heart disease. Wearable technology can be programmed to help their wearers track their healthy decisions and set goals. "This can go a long way toward the prevention of these diseases before someone gets sick," Havasy said.

It provides just-in-time coaching that is important for habit forming, including meal plans, step counting, etc.

It's affordable, especially in countries outside the United States.

Why the wrist?

"There is a reason that watches have been utilized for a couple of centuries-the wrist is a convenient place to display vital information," Havasy said. The more technology advances, wearable tech will become adopted in society.

While having a smartphone in the pocket has perhaps turned one generation away from using a watch, there are some benefits to having tech devices on the wrist, including:

It's easy to view while you're working, without having to stop what you're doing and pull something out of a pocket

The arm moves more than several other parts of the body, so it's able to track motion.

The wrist has veins and arteries to measure pulse, and the skin is thin enough for sensors to detect blood pressure

More portable for activities such as running, hiking and biking

Providers Are in Favor

A survey conducted by HIMSS revealed that more than half of providers found wearable technology in healthcare helpful in monitoring their patients. They utilize commercial and personal-grade wearables to monitor health conditions and vitals, track medications, follow the recovery of post-op patients, and track sleep.

One deterrent is that patients are the ones that have to manually provide the data to their healthcare providers, and nearly 70% of the physicians surveyed favored finding a way to automatically send them the data.

Their top five concerns for patient use of wearables according to the survey were:

1. Patient technical issues

2. Data not being accurate

3. Patient not wearing device properly

4. False alarms on the device

5. Patient security/privacy concerns.

The physicians noted that the patients who benefitted the most from the technology are those suffering from cardiac conditions or diabetes.

Healthcare versus Medicine

Clinicians are finding that wearable technology in healthcare has the most benefit when applied to healthy lifestyle decisions to prevent diseases.

"A nurse or doctor can tell a patient they need to eat better and exercise at their annual wellness visit, but they cannot follow patients around the other 364 days of the year," Havasy said.

Enter wearable tech, which will allow healthcare providers to give their patients a few things to work on, and they can program their goals into their device and have reminders every day.

Wearable technology in healthcare could complement a physician's care, not replace it. While there are some apps that target specific conditions-such as sugar monitoring apps for diabetic patients-most of the benefits center around lifestyle choices.

Short-Term Results

While there are not a lot of studies on the long-term benefits of wearable technology in healthcare, short-term results in patients may make them worth the cost.

Wearables in healthcare could fall under the Fogg Behavior Model when it comes to decision-making. "Under this model, people are inspired to make a change by their ability to do so, their motivation and by being prompted to," Havasy said. "Wearable technology provides the prompt someone may need to make a healthy decision, such as exercise."

And when it comes to motivation-there is a short-term benefit due to something called the Hawthorne Effect, which means people alter their behavior if they know they are being watched. When someone gets a new wearable that can track their exercise, eating and sleep habits-they are more likely to perform better for a time.

This effect is not permanent, however, so a challenge for healthcare providers is to find a way to make these new habits stick.

"Starting with one new habit at a time could contribute to success and allow the resetting of the Hawthorne effect every time a new one is introduced," Havasy said.

There May be a Will, but Not a Way

Where the Fogg Behavior Model falls apart when it comes to long-term use of wearable technology in healthcare is with the patient's ability to perform the healthy habit. Someone can have the motivation and a reminder to do something healthy, but not the power to do so at that moment.

"A person can't walk out of a work meeting because they get an alarm on their device that says they haven't had enough steps in an hour," Havasy said.

A smartwatch can prompt one to get more sleep, but it will not be able to drown out the sounds of traffic or stop thoughts about work in the middle of the night.

The solution to this would be to integrate systems so that these apps could coordinate with calendars, maps, etc., to provide real-time solutions to problems. Imagine if a wearable device could sense where someone was and tell them that if they walk back and forth between two points of interest a certain number of times, they would hit their step count for the day. Or if it could automatically provide you with a list of healthy options from the menus of nearby restaurants.

As technology continues to advance, the possibilities for how wearable technology can be integrated into healthcare practice are endless.

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The Endless Possibilities of Wearable Technology in Healthcare

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Watches almost became a thing of the past when people started carrying their smartphones in their pockets, but with the integration of technology into wearable devices, the wrist is a popular place to go for information once again.

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Latest trends in medical monitoring devices and wearable health technology

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Latest trends in medical monitoring devices and wearable health technology

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The advancement of wearable technology and growing demand from consumers to take control of their own health has influenced the medical industry, including insurers, providers, and technology companies, to develop more wearable devices such as Fitbits, smartwatches, and wearable monitors.

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Wearable fitness technology has weaved itself into society so that FitBits and smartwatches are seen as mainstream; and the future of wearable devices shows no sign of slowing down.

Piloted by the increasing demand of consumers to monitor their own health, use of wearable technology has more than tripled in the last four years. According to research from Business Insider Intelligence, more than 80% of consumers are willing to wear fitness technology.

This growing demand for wearables has generated a booming market, and now insurers and companies are seeing how supplying wearable health technology to their consumers and employees is beneficial.

What is wearable healthcare technology?

Wearable technology in healthcare includes electronic devices that consumers can wear, like Fitbits and smartwatches, and are designed to collect the data of users' personal health and exercise. US consumer use of wearables jumped from 9% in 2014 to 33% in 2018, according to Accenture.

Examples of Wearable Devices in Healthcare

The advancement of wearable technology and growing demand from consumers to take control of their own health has influenced the medical industry, including insurers, providers, and technology companies, to develop more wearable devices such as Fitbits, smartwatches, and wearable monitors.

Wearable Fitness Trackers

Some of the simplest and most original forms of wearable technology, wearable fitness trackers, are wristbands equipped with sensors to keep track of the user's physical activity and heart rate. They provide wearers with health and fitness recommendations by syncing to various smartphone apps.

The FitBit Flex was an early, popular option for wearable technology consumers. Users were attracted to it's sleek look and ability to track their step progress throughout the day with the device's five indicator lights.

Smart Health Watches

Once only used to count steps and tell time, smartwatches have now transformed into clinically viable healthcare tools. Apple launched the Apple Heart Study app in 2017 to monitor users' heart rhythms and alert those who are experiencing atrial fibrillation.

The company also recently released the "Movement Disorder API" to help researchers gather new insights into Parkinson's disease.

Smartwatches allow users to perform tasks they normally do on their phones - read notifications, send simple messages, make phone calls - while also offering some of the exercise- and health-tracking benefits of fitness trackers.

Wearable ECG Monitors

Wearable ECG monitors are on the cutting edge of consumer electronics, and what sets these monitors apart from some smartwatches, is their ability to measure electrocardiograms, or ECGs. Business Insider recently reported on Withings winning best wearable at the 2019 Consumer Electronics Show with their Move ECG product .

The Move ECG is able to measure an electrocardiogram and send the reading to the user's doctor, as well as detect atrial fibrillation. It's also able to track pace, distance, and elevation, as well as automatic tracking for walking, running, swimming, and biking.

Wearable Blood Pressure Monitors

Omron Healthcare HeartGuide in 2019, the first wearable blood pressure monitor. Though it might look like a typical smartwatch, HeartGuide is an oscillometric blood pressure monitor that can measure blood pressure and daily activity - like steps taken, distance traveled, and calories burned.

HeartGuide can hold up to 100 readings in memory and all readings can be transferred to a corresponding mobile app, Heart , for review, comparison, and treatment optimization. Heart users have the ability to store, track, and share their data with their physician while also gaining insights to determine how personal habits affect their blood pressure.

Biosensors

Biosensors are up and coming wearable medical devices that are radically different from wrist trackers and smartwatches. The Philips' wearable biosensor is a self-adhesive patch that allows patients to move around while collecting data on their movement, heart rate, respiratory rate, and temperature.

Research from Augusta University Medical Center showed that this wearable device registered an 89% reduction in patient deterioration into preventable cardiac or respiratory arrest. This demonstrates the ability wearables have to improve patient outcomes and possibly reduce staff workload.

Advances in & future of medical devices

The wearable healthcare technology market is surging, and its maturation will put more wearable technology in the hands of consumers and US businesses. According to Business Insider Intelligence research, the total installed base of fitness tracker and health-based wearables in the US will grow at an annualized rate of 10% to surpass 120 million by 2023.

This upward trend in wearable fitness technology will influence the decision of insurers, health providers, and companies to take advantage of the benefits of wearable health monitoring devices.

Insurers can lessen the rising cost per patient by using wearables as a means of increasing customer life value. Wearable technology incentivizes behavior that reduces hospital visits and readmissions due to poorly managed personal health - 75% of users agree that wearables help them engage with their own health.

Companies are also seeing benefits in offering wearable healthcare technology to employees. According to Business Insider Intelligence research, healthier corporate culture is shown to reduce employee turnover - employers who offer five or more well-being 'best practices' had an average turnover of 18%, compared to 29% for those that offer two or fewer.

US consumer use of wearables increased from 9% to 33% in just four years, and this number will continue to grow as wearable technology becomes more conventional. Moreover, device connectivity will expand as more accurate wearable sensors are developed, opening the door for insurers and employers to influence healthy lifestyles and boost profitability.

Want to Learn More?

The Digital Health Ecosystem report from Business Insider Intelligence discusses the current and future market landscape of wearable technology in healthcare. It highlights how medical device makers are redirecting toward digital technology in an attempt to better navigate the increasing demand for illness prevention devices.

Some key takeaways from the report include how new tech-focused companies threaten legacy players' bottom lines, as well as how prominent digital health solutions like wearables, EHRs, digital therapeutics, telehealth, and blockchain underpin the progression toward a digital future for healthcare.
Want to learn more about the fast-moving world of digital health? Here are three ways to get access:

1. Purchase & download the full report from our research store. >> Purchase & Download Now

2. Sign up for,Business Insider Intelligence's expert product suite keeping you up-to-date on the people, technologies, trends, and companies shaping the future of healthcare, delivered to your inbox 6x a week. >> Get Started

3. Subscribe to apass to Business Insider Intelligence and gain immediate access to this report and more than 250 other expertly researched reports. As an added bonus, you'll also gain access to all future reports and daily newsletters to ensure you stay ahead of the curve and benefit personally and professionally. >>

The choice is yours. But however you decide to acquire this report, you've given yourself a powerful advantage in your understanding of the fast-moving world of Digital Health.

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Latest trends in medical monitoring devices and wearable health technology

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Wearable fitness technology has weaved itself into society so that FitBits and smartwatches are seen as mainstream; and the future of wearable devices shows no sign of slowing down. Piloted by the increasing demand of consumers to monitor their own health, use of wearable technology has more than tripled in the last four years.

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Wearable Technology: Their Future in Clinical Trials and the Real World

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Wearable Technology: Their Future in Clinical Trials and the Real World

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Patient behaviors and key biological metrics are significantly easier to track with the multitude of wearables at the disposal of clinical researchers. The most frequently used consumer wearables include ActiGraph, Apple Watch, and Fitbit. By February 2020, clinical trials.

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The Innovation Issue Feature: The Future of Healthcare (Part 3)

Can Wearables Be the Future of Clinical Trials?

Patient behaviors and key biological metrics are significantly easier to track with the multitude of wearables at the disposal of clinical researchers. The most frequently used consumer wearables include ActiGraph, Apple Watch, and Fitbit. ¹ By February 2020, clinicaltrials.gov showed that ~460 wearables studies were underway, ¹ and, according to Kaiser Associates and Intel, 70% of clinical trials will incorporate some type of wearable sensors by 2025. ¹

Pharmaceutical and medical device companies are empowered to take advantage of robust data sets to optimize trials and products to improve treatment efficacy. Wearable data can provide profound insights that can be leveraged in product development owing to the depth and breadth of the information that can be collected. Theoretically, wearables can be used across therapeutic areas for deep phenotyping, detection, and interpretation of adverse effects and for clinical trial recruitment. ¹ Clinical trials depend on rich patient data, and collection in a physician's office captures only a snapshot of a participant's data, (e.g., one ECG or phenotype analysis). Conversely, wearables constantly track consumer and patient data over large periods of time, with the potential for real-time feedback, resulting in rich data sets and opportunities to gain more meaningful insights.

Early Adopters

Personal data collected in EHRs, as well as biological data collected via personal wearables and medical devices, are critical components in the success of clinical trials. AI tools can support analysis before and during a trial, and many life science organizations have started to see their value. Novartis has created a proprietary machine learning predictive analytics platform called Nerve Live. Novartis partnered with QuantumBlack, known for collecting data from Formula One races and using machine learning to optimize race operations. With QuantumBlack's help, Novartis piloted the platform to support its global drug development team's plan to simulate country allocation scenarios for clinical studies. The platform tracks all data points of the 550 clinical studies running in parallel and uses analytical software to predict issues in clinical trial execution.

Janssen Pharmaceuticals and Apple announced a collaboration in January 2019, culminating in the launch of a research study that focuses on the use of the Apple Watch's irregular rhythm notifications and the ECG app to improve AF outcomes and early detection.

Verily, a sister company of Google, kicked off Project Baseline in 2017. This was a collaboration with Duke and Stanford universities to collect health data of participants over a four-year timeline. The collection of clinical consultation and survey data produced a large data set, creating a baseline for what it means to be healthy and the transition to disease. The success of the project resulted in a partnership between Verily, Pfizer, Sanofi, Novartis, and Otsuka in mid-2019. Using Verily's platform, patients and clinicians can actively engage in clinical trials that will increase the speed of clinical research. The program aims to map out the human health baseline and carry out clinical studies using technology developed under Verily to research a variety of diseases, including cancer, diabetes, and heart, dermatologic, and mental health diseases. The American Heart Association is using Verily's platform for the "Research Goes Red" registry, an initiative soliciting women across the country to participate in health research, particularly for heart disease. After launching its marketing campaign, it received more than 26,000 registrations, including 8,500 people who provided consent for specific clinical trials and are open to joining additional research opportunities through Project Baseline. ¹

Recruitment and retention in clinical trials can specifically benefit from AI tools, such as machine learning and natural language processing. These tools can find matches between specific patients and trials that are recruiting through integration with electronic health records (EHRs), medical devices, and wearables and recommend these matches to doctors and patients (either in real time at the clinical consultation or as a notification on the patient's wearable). In addition to recruitment, participant retention is a formidable challenge. The application of AI to rich patient data presents the opportunity to track a patient's compliance with a clinical trial's adherence criteria. The data can be presented to clinical trial administrators, allowing them to notify the patient of retention risks and take predictive and preemptive measures rather than practicing reactive management.

AbbVie, a biopharmaceutical company specializing in oncology, immunology, neuroscience, virology, and eye care, began integrating wearables into clinical trials in 2016. ² The company wanted to deploy digital technologies but also wanted to improve the way it designed clinical trials to make them more data-driven. A center of excellence was created for clinical trial design that focused on using large data sets to help teams visualize the required patient population, the impact of their design decisions on patients, and the expected impact of geography and epidemiology. One trial was conducted using the Philips Actigraphy watch to measure sleep quality and itching in patients with atopic dermatitis. In another trial, patients with Parkinson's disease wore wearable devices that measured gait and sleep, which can be more difficult to measure using traditional methods with pen and paper. Patients wore sensors on their arms and legs that continuously and objectively measured Parkinson's motor symptoms and measured the quality of their sleep - something that greatly affects overall quality of life for patients who suffer from the disease. AbbVie subsequently replaced those devices with a wireless patch worn on an arm and leg. The patches are more comfortable and less intrusive for patients.

Broader Adoption

While wearables and AI tools create opportunities to simplify and streamline clinical research, they also elucidate the need to simplify existing processes, roles, and systems in life science companies. In advance of the broad adoption of wearables in clinical trials, researchers will continue to test and validate the feasibility of wearables in studies. Sponsors should also continue to partner with device makers to evolve endpoint data collection and validation. Studies have found that having clinical scientists directly involved in clinical study design and conduct is highly beneficial. ¹ However, R&D scientists are generally not familiar with wearable devices, creating barriers to the adoption of wearable technologies in drug development clinical trials. Juxtapose this with the fact that device engineers lack knowledge and expertise as it pertains to drug development process and regulatory requirements for drug approvals, and collaboration seems necessary to streamline adoption and make wearable technology a standard in clinical studies.

Successful integration of wearables into clinical studies also hinges on meaningful collaboration with regulators to ensure that the scope of the clinical study is well defined and that outcomes can be achieved and implemented. Guidelines such as the Clinical Trials Transformation Initiative support such collaboration through recommendations for the use of mobile technology like wearable devices. One of its first recommendations is for R&D departments to start with a clinical trial endpoint and work backward to ensure that investigators select the right device. Consumer and medical device makers, researchers, technology data platform companies, and regulators must coordinate efforts in order to realize the full potential of this technology.

Growth Opportunities

A multitude of wearable devices are currently available for market consumption, and even more are in development, with promising implications for both overall health and cost efficiency. The global wearable computing devices market accounted for 181.5 million units in 2019, and it is expected to reach 520.1 million units by 2025, registering a compound annual growth rate of 19.9% over the forecast period between 2020 and 2025. ³ The product categories within the wearable tech market exhibit considerable diversity.

Smart clothing, including smart vests, smart bras, smart shoes, smart socks, and smart tights have a multitude of potential applications, including protecting the wearer from environmental hazards. Additionally, with an increase in the cases of chronic diseases worldwide, such as diabetes, cancer, respiratory disorders, and heart diseases, combined with the increase in the number of surgeries performed, the demand for smart fabric in the healthcare sector is expected to increase exponentially. ³ Edema ApS is developing a washable stocking to monitor and measure changes in leg volume for patients suffering from edema in lower limbs. Similarly, in March 2020, Powercast and Liquid X entered a joint venture to help manufacturers implement wearable sensors directly into garments, with potential applications for monitoring patients and athletes. ³

According to Infopulse, over 80% of consumers are eager to wear fitness wearables, indicating interest and concern for monitoring various aspects of their health. ³ Augmented demand will also accelerate the development of personalized healthcare services, smart hospitals, and remote healthcare. In 2019, the FDA authorized the first wearable for hospital use, an AI-powered solution by Current Health. ³ This device traces a patient's health indicators with ICU-level accuracy and indicates threatening conditions, assisting healthcare providers in identifying deteriorating states and facilitating immediate provision of lifesaving services and procedures. Use of exoskeletons is anticipated to increase, as the North American population is slowly aging. In 2018, 16% of the U.S. population was 65 years or older, and by 2050 this number is expected to increase 20%. ³ The growing older population is expected to influence the demand for rehabilitation robots in the form of exoskeletons, something that once sounded like science fiction.

Real-World Evidence

As the healthcare industry focuses increasingly on outcomes, pharma companies are looking to sources beyond randomized clinical trials (RCTs) to measure and demonstrate the value they bring. Real-world evidence (RWE) has been in use for decades, but recent advances in technology and advanced analytics allow it to be employed in new ways. It allows for a better understanding of how patient characteristics and behaviors affect health outcomes, thereby helping to predict disease progression, patient response to therapy, and risk of adverse events - while also increasing the efficiency of R&D investments and accelerating time to market.

Cost and competitive pressures, scientific advances, digitally savvy stakeholders, progressive regulatory shifts, and the increasing breadth and interoperability of data and technologies are among many trends driving participants in the healthcare ecosystem to intensify their focus on value and patient outcomes.

Payers are gradually shifting to outcomes-based contracts, providers are working to gain privileged status with them, and patients are taking more ownership of their own outcomes. In this changing environment, insights from RWE are becoming more important in providing the right treatment to the right patient at the right time, measuring outcomes, and demonstrating the value of interventions. Given the significant disruption to RCTs and the need to rapidly understand burden by patient phenotype, as well as finding potential therapies for COVID-19, RWE is more prominent than it has been in the past.

Pharma companies have been using RWE for decades to inform their decision-making, respond to requests from external stakeholders, and improve their therapies' market positioning. More recently, growing regulatory acceptance, rising demand from payers and physicians, and increasing familiarity with digital and analytics have enabled some companies to derive much broader benefits from RWE.

An average top-20 pharma company that adopts advanced RWE analytics across its entire value chain for in-market and pipeline products could unlock more than $300 million per year over the next three to five years. ⁴ A typical cost base offers scope to save $100 million in development spending through the optimization of RCT design, the use of RWE studies rather than RCTs in some cases, and the implementation of synthetic trial arms. ⁴ Cost savings apart, the introduction of advanced RWE analytics could help companies identify new targets for molecules, accelerate time to market, improve formulary position and payer negotiations, and generate stronger evidence of differentiation and benefit/risk balance for in-market products. Analysis suggests that applying these actions to key assets could generate top-line value of $200 million or more. ⁴

RWE may also support new uses for already approved drugs and/or help determine postapproval requirements for drugs. However, demonstrations of RWE from wearables are small in number to date. This is partially due to the deployment of digital and wearable technology remaining in the sphere of only a few multinational pharmaceutical companies. ⁵ Health insurance companies do not typically pay for digital medicine technology, because their coverage is based on data on patients and their claims. Healthcare systems largely do not yet see the value of wearables in clinical practice. However, multinationals like GlaxoSmithKline, Novartis and Lilly have chief digital officers overseeing integration of mobile and wearable technologies into their clinical trial programs.

These market issues are compounded by issues related to data collection, hosting, sharing, and management. Healthcare systems silos simply cannot handle the continuous stream of real-world data coming from wearable devices. Astonishingly, according to the American Medical Informatics Association, 75% of U.S. clinical centers still use fax machines to share EHRs, ⁵ and few are attempting to incorporate longitudinal real-world data from wearables with EHRs in a seamless environment.

Perhaps the biggest challenge to full wearable integration is data privacy and security. Strategies within the nascent direct-to-consumer wearables industry do not help. Although the American Medical Informatics Association has lobbied to update the 1996 U.S. Health Information Portability and Accountability Act to align wearables' data privacy policies with those in healthcare systems, ⁵ wearables companies are keen to protect their businesses. Consequently, their algorithms are proprietary, and their data cleanup is ill-defined or opaque, further exacerbating innate challenges with data privacy and perception of data security among users.

While wearable technology has seemingly limitless promise in potential applications for health awareness and medicine adherence, how it will be integrated into the provision of drug treatment and patient care in the future remains to be seen. However, despite a number of challenges, tech companies and life science researchers continue to innovate wearable tech solutions across all facets of the healthcare industry.

References

1. Jansen, Yvette; Thornton, Grant. "Wearables & Big Data in Clinical Trials-Where Do We Stand?" VertMarkets, Inc. 25 Feb. 2020. Web.

2. Miseta, Ed. "AbbVie Goes All-In On Wearables and Digital Technologies." VertMarkets, Inc. 07 Aug. 2019. Web.

3. "Global Wearable Computing Devices Market (2020 to 2025)-Growth, Trends & Forecasts." GlobalNewsWire. 24 Jun. 2020. Web.

4. Champagne, David, Alex Davidson, Lucy Pérez, and David Saunders. "Creating Value From Next-Generation Real-World Evidence." McKinsey & Company. 23 July 2020. Web.

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Wearable Technology: Their Future in Clinical Trials and the Real World

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The Innovation Issue Feature: The Future of Healthcare (Part 3) Can Wearables Be the Future of Clinical Trials? Patient behaviors and key biological metrics are significantly easier to track with the multitude of wearables at the disposal of clinical researchers. The most frequently used consumer wearables include ActiGraph, Apple Watch, and Fitbit.

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How wearable devices empower healthcare providers - MedCity News

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How wearable devices empower healthcare providers - MedCity News

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With fewer doctors, efficiency in medicine will become increasingly critical. Wearable devices are a new frontier for healthcare, providing historic longitudinal data and continuous physiological 24-hour monitoring; and early detection of chronic conditions and acute disease onset based on personalized physiological baselines.

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How wearable devices empower healthcare providers - MedCity News

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With rising challenges facing the medical community in the coming years, and as the U.S. population grows more unhealthy, digital devices will be a critical solution for patient care and remote patient monitoring.