Image of a patient's arm with a heart monitor and a doctor's hand with a fitness wearable to show difference between wearables.

The difference between clinical wearables and fitness wearables

October 30, 2017 | BY BIOTRICITY

Today, wearable lifestyle devices are readily available to the average and generally healthy person. Lifestyle devices, like the Fitbit fitness trackers or the Apple Watch, are common—over 24.7 million lifestyle devices were shipped in the first quarter of 2017. These devices are considered “lifestyle solutions” that focus on motivating healthy lifestyle choices and encouraging general wellness; they are a category apart from clinical health devices.

Clinical health devices, or clinical wearables, are highly accurate tools prescribed by physicians to help patients monitor their vitals. The accuracy level of these devices is within 90-95% or higher, and when appropriately cleared by the FDA, can be used by healthcare professionals to support diagnoses and treatment plans. Fitness and lifestyle wearables are for healthy individuals to keep tabs on their activity levels, and because their accuracy levels are not as high ( 70-80% ) they should not be used to diagnose or manage health conditions.

It’s all in the intention

According to the FDA, the true distinction between lifestyle (or “low-risk”) devices and medical devices is their intended use. If the wearable is “encouraging a general state of health or healthy activity,” then it is a fitness and lifestyle device. If it is intended for clinical use to improve chronic illness or specific ailments, then it is not “low-risk”, it is a medical grade wearable device. Medical grade wearables must attain an FDA Class II approval, see the flowchart below for clarification:

Biotricity FDA Device Flowchart

 

Medical grade devices must undergo rigorous clinical trials or independent testing that benchmarks their performance against existing technologies before receiving FDA Class II clearance. Fitness wearables, generally, need no FDA clearance or need only obtain a Class I clearance because they won’t directly impact a person’s health or diagnosis. The FDA equates Class I devices to dental floss, and they should be used as such: great tools to maintain an everyday healthy lifestyle, but not diagnostic in any meaningful way.

So, what is a medical wearable?

Ten or fifteen years ago, if you thought of a medical wearable you’d probably think of a diabetic insulin pump or a pacemaker. Medical wearables have come a long way since then. Today they are more portable, and with wireless connection they offer the potential to significantly impact the outcomes and costs of long-term, high-burden conditions such as diabetes, cardiovascular disease, and respiratory diseases like asthma (check out ADAMM, an intelligent asthma monitor).

The upcoming wave of medical grade wearables will be designed with both the physician and the patient in mind as end users. This means that the device data will be easily assimilated into a physician’s workflow and accurate enough to enhance the diagnostic process, while the device use will be reimbursable through billing codes. For patients, this means that they will be using a trusted device with a simple user interface, and that they will be given reliable, constant feedback. Medical wearables, in conjunction with software and mobile apps (such as the Sugar IQ system for diabetics), can offer predictive capabilities that allow patients and healthcare professionals to identify early signs of disease and help prevent exacerbations. With the potential to push the healthcare industry further towards value-based, personalized medicine, medical grade wearables have incredible potential to reshape the healthcare industry and the quality of care patients can expect.

Lifestyle wearable devices are multi-purpose devices, popular among all age groups, and aimed at health and lifestyle markets. They count steps, calculate calories burned, connect like-minded communities, are increasingly stylish, and are generally coupled with impressive GPS technologies. For now, lifestyle wearables should remain in the realm of useful and stylish tools that aid in social connectivity, help people manage their diet, and monitor physical activity. Developers of medical wearable solutions have the opportunity to expound on the success of the lifestyle wearable model by creating solutions that are clinically accurate, improve outcomes and engage patients through gamification and external incentives.