We also saw a surge in the use of wearables due to the pandemic.3 Devices like the Apple Watch and Fitbit, which are typically purchased to improve fitness, took on new significance because many can provide users the ability to do things like monitor blood oxygen saturation levels, which can be helpful in diagnosing COVID-19. Wearables are diverse and plentiful and can track and monitor a vast number of health metrics, including blood glucose, blood pressure, and electrocardiograms to detect atrial fibrillation. It shouldn’t be surprising then that in a recent survey Insider Intelligence found that 80 percent of consumers are willing to wear fitness technology.4
Health and wellness
In 2020, the number of health and fitness app users increased by 27 percent from the prior year.5 Some apps focus on general wellness and health, while some apps are used for diagnosis and treatment of diseases. For example, some consumers use apps like Runkeeper and MyFitnessPal to track different health metrics for informational purposes, while others use apps to track specific health metrics that they can then send to their providers to use in developing and monitoring the patient’s treatment plan – apps like Glucose Buddy, which monitors and tracks glucose levels, medication, A1C, physical activity and carbohydrates intake to help patients manage their diabetes.
Biopharmaceutical company IQVIA conducted a study in 2015 in which it assessed the impact of wellness apps on the U.S. healthcare system. The study concluded that the use of apps in five patient populations that showed reductions in the utilization of acute care services due to app use – diabetes prevention, diabetes, asthma, cardiac rehabilitation and pulmonary rehabilitation – could save the nation’s healthcare system an estimated $7 billion annually. This amount is approximately 1.4 percent of the total cost of healthcare spending in these particular patient populations. According to IQVIA, if this level of savings were extrapolated across total national health expenditure, the cost savings would be $46 billion annually.6
Digital Medical Devices
A digital health technology is classified as a medical device if it meets the definition of Section 201(h) of the Food, Drug, and Cosmetic Act. Typically, if a digital health technology is used to diagnose a disease or condition, or in the cure, mitigation, treatment, or prevention of disease, it may be classified as a medical device. Medical devices can be instruments, machines, materials, as well as software applications. Medical devices are regulated by the U.S. Food and Drug Administration and depending on the classification of the particular device, it may be subject to long and expensive pre-market notification review and approval.
Advances in digital health have resulted in medical devices in healthcare being more consumer-facing, consumer-friendly and cost-effective. For example, once upon a time, one would have to go to a hospital or doctor’s office to be hooked up to machines to receive an electrocardiogram. Now, the latest version of the Apple Watch can perform that same test.
Additionally, consumer-facing digital medical devices played a large role during the pandemic. For example, many clinical trial sponsors used digital medical devices to monitor trial participants during the pandemic. Providers also had their patients use digital medical devices to monitor such health metrics as heart-rates, blood oxygen levels, and temperatures when monitoring a patient’s COVID-19 symptoms.
Artificial Intelligence (“AI”)
The field of artificial intelligence has come a long way from IBM Watson playing against (and beating) two Jeopardy champions in 2011. Now, IBM Watson is helping oncologists to detect cancer and save lives. AI, like IBM Watson, represents exciting and almost limitless possibilities for improving the accuracy of diagnosis and treatment, and increasing the efficiency and efficacy of healthcare while lowering its cost. In 2019, a third of all physicians reported using some type of AI in their practices.7 This number is expected to significantly increase over the next few years as the technology advances and providers become more familiar and comfortable with how to incorporate these technologies into their practices.