Will Wearables Revolutionize Healthcare?
In 2018, Janet’s* (name changed for privacy) friend recommended that she enroll in an Apple Watch clinical trial for seniors helping to test new ECG technology. With no history of cardiac conditions, she thought of the trial as an exciting opportunity to get a free Apple Watch. One evening, her watch suddenly alerted her of an abnormal arrhythmia. She was later told that she would not have survived the night if she had not gone to the ER. Janet never expected that an Apple Watch would save her life. Stories like Janet’s are becoming more common, but are wearable devices the next healthcare revolution?
Within preventative care and monitoring, wearable devices have numerous benefits and can make the lives of patients and providers much simpler. One of the most common complaints during inpatient hospital stays is the challenges patients face trying to sleep. Typically, different vitals needed to be monitored continuously, requiring a nurse to come in multiple times a night — usually waking the patient in the process while taking blood pressure or temperature. Today wearables have started to change the game. One company, BioIntelliSense, has made sticker-like wearable devices that can continuously monitor patient vitals during inpatient stays remotely. The stuck on device can measure vitals without the nurse needing to manually enter the room or touch the patient. This changes the delivery of care too, as nurses no longer need to divert their time and attention to physically collecting samples and vital signs. In a healthcare system with rising labor shortages, reducing burden goes a long way to ensuring better outcomes and workload management for clinical staff. On the patient end, hospital stays are no longer quite as miserable. For this use case, medical grade wearable technology has created an effective solution that solves multiple pain points.
The BioIntelliSense shows another positive use for wearable devices, but there is a fundamental difference between the BioButton and an Apple Watch. The BioButton is a medical grade wearable device, used currently in medical settings. The medical grade standard also means that the device faces higher levels of scrutiny from regulatory bodies. The FDA does not regulate general wearable devices, particularly if they only claim to generally improve health. The FDA does regulate medical devices, and requires even moderate risk devices to have prior clearance before going to market.
The ECG technology that saved Janet’s life received FDA clearance, in part through trials like the one she was a participant in, but many other devices that are being used in at home settings have not received this type of validation. Few fitness trackers, for example, are examined by the FDA. These devices, though arguably low risk to the consumer, provide an abundance of data that has not been validated and may not yet have a role in health or clinical decision making. Without a clear understanding of what data is needed and what it will be used for, some of these collection devices can increase stress and create negative health outcomes for patients. Much like the WebMD doctors that frustrate clinicians today, having “abnormal” health data outputs from a wearable that is not serving a direct purpose may simply add unnecessary complexity within healthcare. This can be especially true when a device pairs an FDA cleared function, like the ECG on the Apple Watch, with ones that are not examined — calorie trackers, step counters, and other general health functions.
Another key concern for wearables within healthcare are concerns over patient privacy and data safety. Few things are more personal than health information, yet key concerns about data safety have yet to be answered with wearables. As a patient wears their Apple Watch, data on things like their heart rate, sleep schedules, and workout routines are constantly being collected and uploaded to the cloud. Access to this data is offered to researchers and oftentimes third party companies without the user realizing. If you’ve purchased an AppleWatch to track your steps, you may not be aware of the other health information being collected and shared.
Though more normalized for companies to buy data related to online browser history and abandoned shopping carts, broad access to health information feels more personal, and more risky. The potential harm of these devices is not theoretical, in 2018 the exact locations of some US military bases around the world were revealed accidentally through data collected on Strava, a popular fitness tracking app. Clearly, informed consent regarding data collection is not yet fully clear and requires better regulations to help the consumer understand exactly what information their seemingly innocuous watch is collecting.
So, are wearable devices the next frontier in medicine? Perhaps not, but they are a meaningful tool to help bring about a new age in personalized medicine. Used correctly, healthcare pain points across the system can be solved while improving health outcomes for patients. On the flip side, moving too quickly and failing to prioritize rigorous privacy standards and well tested uses for the data may have the opposite effect. And maybe if you receive an Apple Watch this holiday season, you’ll think a little more carefully about what health information you want uploaded to the cloud.
