Millions of wearable devices for tracking activity and fitness levels have been sold in the last few years. Now, we are starting to see a plethora of wearables for monitoring health data. By providing round-the-clock measurements of various pieces of health information, wearables promise to significantly improve outcomes and reduce the cost of healthcare.

What Is Patient-Generated Health Data?

Our healthcare system focuses primarily on “episode care”: a doctor will perform a check-up once or twice a year, and compare results to a population average to check for good health. Thus, we usually think of health data only in terms of what can be gathered at the doctor’s office through blood pressure readings, blood collection, urine samples, MRI scans, etc. However, there is a wealth of complementary information collected by patients, referred to as patient-generated health data (PGHD).

The Office of the National Coordinator for Health Information Technology (ONC) defines PGHD as “health-related data created, recorded, or gathered by or from patients (or family members or other caregivers) to help address a health concern.” PGHD can include health history, treatment history, biometric data, lists of symptoms, and even description of lifestyle choices. PGHD can supplement existing clinical data to provide a more comprehensive, up-to-date picture of patient health, providing potential cost savings and bringing improvements in care.

The use of PGHD to supplement data gathered in a clinical setting is not new. People have long kept personal health records in hand-written logs. However, new technologies enabled patients to more easily generate accurate and descriptive data that can be readily shared and tracked with healthcare providers. Examples include home health equipment for taking blood pressure readings, mobile apps for diet tracking, online questionnaires for checking symptoms, and patient portals that enable secured messaging and integration into electronic health records (EHRs).

However, barriers to the use of PGHD remain with these approaches, including usability by patients, concerns about accuracy of manually-entered data, and the need for physicians to evaluate this information and incorporate it into treatment plans. All of these problems could potentially be addressed by data gathered from wearables. They offer the possibility of a high-quality continuous stream of data that can be integrated with other pieces of health information through a secure, standardized route and even be automatically analyzed, all with minimal input from the patient or caregivers.

From Fitness to Health Tracking

Wearables are most commonly associated with fitness and, indeed, the earliest examples were physical activity trackers such as Fitbit. However, they have been making rapid inroads into healthcare uses. Health is now cited as the primary reason for purchasing wearables, and fitness wearables have quickly recognized the possibilities for tracking personal health.

Since 2015, Fitbit has supported compliance with HIPAA, the main US law governing the security and privacy of personal health information. There are now hundreds of wearable devices targeted to improving health by providing patients and caregivers enhanced insight into PGHD, many of which have already achieved compliance with regulatory bodies. A small selection of FDA-approved devices available for purchase include:

• The Ava bracelet, which monitors a woman’s fertility and menstrual cycle to predict fertility dates with 89% accuracy.
• Fever Scout, a soft flexible patch that can remotely track body temperature and share this information with clinicians or caregivers.
• The Leaf patient monitoring system, a wearable sensor that aims to reduce the incidence of pressure ulcers, a difficult-to-treat hospital-associated condition.
• Zio XT, a wearable patch that can help detect atrial fibrillation in patients with similar symptoms.
• BodyGuardian Heart, a pocket-sized wearable monitor that provides mobile cardiac event monitoring.

For more examples, see this list of three dozen wearables that received FDA approval in 2016. A handful of devices currently under FDA evaluation include:

• K’Watch Glucose, a watch-like monitor that uses microneedles to collect and analyze fluid to allow diabetic patients to quickly and painlessly check their glucose levels.
• Omron Project Zero 2.0, a watch-like device that claims to measure blood pressure, sleep and other physical activities with clinical accuracy.

Software platforms to help decode and integrate this wealth of information are also becoming available. In 2015, the Carolina HealthCare System developed MyCarolinas Tracker, the first fitness tracker and EHR integration app, which lets patients upload data from consumer trackers directly to the hospital in almost real time. Another example is PhysIQ, an FDA-approved personalized physiology analytics engine that takes data from wearable and implantable sensors and learns a patient’s unique vital sign patterns to detect small deviations that could be early warning signs of disease.

Researchers at Stanford University recently reported that wearable sensors paired with advanced algorithms can predict the onset of infection, inflammation, and insulin resistance by monitoring heart rate, physical activity, skin temperature and other pieces of health data. A precision health approach based on such data would allow everybody to know their normal baseline measurements, and to use automated data analysis to spot patterns that could signal health problems, thus allowing for early intervention (meaning either prevention or treatment).

What Comes Next?

As we can see from this brief list of examples, there is enormous potential for wearables to provide an unprecedented volume and variety of health data about ourselves. As stated by the FDA, “these advancements are leading to a convergence of people, information, technology and connectivity to improve health care and health outcomes”. Frost & Sullivan estimates that the global healthcare wearable devices market in 2015 was $5.1 billion, and expects it to grow to $18.9 billion by 2020. Many expect wearable data to become a key component of new fee-for-value care models.

Important trends that will enable applications for PGHD include a greater variety of biometric sensors, ability to achieve clinical-grade accuracy, and data integration into EHRs. In order to achieve their full potential, we will have to integrate patient wearable devices into operations without violating compliance, privacy, or continuity of access to the data stream. Many healthcare systems currently lack the technical infrastructure, functional workflows, workforce capacity, and training to support PGHD intake and to obtain actionable insights from the data. Improved guidance and best practices for incorporating PGHD into clinical workflows as well as improved clinical validation will be essential to overcome these hurdles.

Analysts believe that platforms for seamless and secure integration of PGHD will be standard by 2024. If the rapid adoption of wearables for fitness purposes are any indication, we can expect that wearable devices for monitoring health will quickly take hold, and become an integral part of enhanced use and usefulness of PGHD. Our mobile phones, watches, and even clothes will soon continuously monitor our health data and relay it to physicians and/or advanced data analytics algorithms, who will use it to monitor responses to treatment regimes as well as to detect, predict, and even prevent illness.

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