FDA-cleared data accuracy in consumer wearables: Increasingly important yet often overlooked

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clinical wearables


clinical wearables

The wearable technology market is growing rapidly. With more than 30 percent of adults in the United States using the devices, the global market is set to exceed $380.5 billion by 2028. As the market evolves, wearables are expected to get more personal, powerful and stylish. And, we’re starting to see wearables transition from fitness to health devices. However, many device manufacturers are overlooking the most important aspect to consumers who want to use their devices for healthcare purposes: improved device accuracy and FDA clearance.

Wearable technology first appeared on the market in the early 2000s in the form of step counters, sleep trackers and general wellness devices. They didn’t include the wide variety of features currently available like heart rate, body temperature, or activity level monitoring. They weren’t intended to serve a medical application, and there certainly wasn’t a focus on whether they were providing users with accurate data under all circumstances. That’s a reality that still holds true today – the majority of devices currently on the market are still inconsistent in the accuracy of the data they provide users. This presents challenges for consumers who assume the data is accurate or “close enough” because they’re using this data to better understand their health or to potentially raise concerns with their physician. Until wearable technology companies position themselves as medical device companies, these devices are going to continue to come up short when applied to a medical setting.

Wearable companies tend to shy away from seeking FDA clearance for a few key reasons. First, they see themselves as consumer device manufacturers, not medical device companies, so they don’t organize themselves to produce a medical-grade device. Often, they aren’t hiring employees with medical device product development backgrounds, nor are they creating an infrastructure that can support developing such a device. Second, it’s costly to go this route. It can often take longer to develop, iterate, test and hone your product to the specifications required to receive FDA clearance. Some manufacturers have blurred the distinction between wellness and medical devices by seeking FDA approval for a specific feature of their device, like Apple and FitBit gaining FDA clearance for ECG monitoring and atrial fibrillation detection. This type of blended device approval, where aspects of the technology have clearance, but not the device overall – will only continue to muddy the waters as consumer devices wade into the medical device environment.

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There are significant advantages for consumers related to data privacy when using a wearable device that has FDA clearance, as the protection of personal medical data (Protected Health Information, or PHI) was mandated by the agency with the introduction of the Health Insurance Portability and Accountability Act (HIPAA) . Because user data and privacy concerns are top of mind, especially when it comes to women’s health, users can rest assured that their health data is treated with the same level of security as their medical records. As consumers better understand their right to medical privacy, they will have higher expectations for wellness wearables that aren’t bound to data privacy regulations. When FDA clearance is granted, it will communicate a stamp of approval that means privacy controls are in place which prevent access to a person’s PHI without their permission.

There’s a significant opportunity for medical grade wearable manufacturers in telehealth and virtual healthcare visits, which surged to new heights during the pandemic. The convenience and accessibility appeal to patients and practitioners so much so that the telehealth market has stabilized at a rate 38 times higher than pre-pandemic levels. Consider that 80 percent of United States residents live in what is considered healthcare deserts. These can be in rural areas and inner cities, and what it implies is that medical grade FDA approved wearable devices have an opportunity to truly help detect potential health issues and provide medical professionals with data about a patient’s particular situation without the need to travel for medical care.

The lines between consumer and medical grade devices will continue to blend together as the market evolves. For companies looking to enter the medical device wearable arena, my advice is to take the best of both worlds and develop a product that offers what you would expect from a medical device in terms of accuracy, reliability, data quality and FDA approval. Then, pair that with what you would expect from a consumer device – aesthetic appeal, comfort, usability, and cost effectiveness. Bringing high quality, reliable devices that consumers trust and want to use to the market not only sets the bar higher for other players, but it also helps support a healthcare environment that is more accessible and equitable for people around the world.

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