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Wearable Devices are Coming to a Doctor Near You

Seth Golbe

A readout from a wearable device on a smartphone

Wearable fitness trackers, the fancy watches you see people wearing today, are making a splash in the corporate wellness space. These devices track activity levels,  sleep and can even count the calories you eat. Newer models can even track blood pressure, oxygen saturation in the blood and stress levels. The simplicity of these devices is also a big business, with Credit Suisse estimating the industry to be worth between $3 – $5 billion, and over 50,000 apps available for download.

Wearables Devices as Medical Devices

As these devices continue to grow in prominence they will begin to become more involved in the world of healthcare, with the information collected ultimately ending up in the hands of a doctor. This will include more data than just how many steps you took, however. Devices are already in development that can track your heart rate or detect head injuries, in real time.

A Holter Monitor is portable electrocardiogram that collects data on the patient’s heart for as long as the battery lasts, typically 24-48 hours as a patient about their daily life, according to the American Heart Association. The device is the size of a small camera, with multiple electrodes on various points on your body connected with adhesive tape. It allows doctors to determine the wearer’s blood oxygen levels and whether or not their medication is working, as well as collet information on vital signs. After the prescribed period, the patient returns the device to their doctor, who analyzes the data. A wearable device will soon be released that can track all of these things, sent to your doctor in real time, that is the size of a Band-Aid, without uncomfortable electrodes and tape.

Reebok’s CheckLight is a cap that, when worn, can detect the severity of head injuries and alert players, trainers and physicians when it is recommended to seek medical attention. The xPatch from X2 Biosystems serves a similar function, but sticks behind an athlete’s ear. It is important to note that these devices can only recommend that you visit a doctor, and cannot diagnose a concussion.

Devices like these could also extend into medical research as well. Intel announced a partnership with the Michael J. Fox Foundation to improve how Parkinson’s disease is monitored. The program works through a combination of wearables devices and an analytics program to collect the data and process it in order to measure symptoms and track the progress of the disease. This will result in a large data set allowing researchers to examine Parkinson’s like they never have before.

Wearable devices like these could create a change in how doctors diagnose patients. An algorithm, like that being developed by Intel, could analyze incoming data and highlight any anomalies it discovers. This provides another source of information to doctors, in addition to patient symptoms and experiences, which only provide part of the picture. This technology could also be used to track whether a patient is complying with their care regime and medication, preventing unnecessary trips to the doctors to determine if the patient is observing their treatment. These changes will not only improve patient care, but will reduce healthcare costs through fewer doctor visits and improved diagnosis.

Challenges to Wearable Medical Devices

While these devices look promising to the future of healthcare, there are barriers preventing them from taking off like the current wearables market. First among them is that trackers like the heart monitor mentioned above, would not be consumer devices like a FitBit, but instead be prescription medical devices that would require approval from the Food & Drug Administration (FDA). The FDA approval process, though necessary to ensure patient safety and prevent quackery, can be long and difficult to navigate. This is especially true for the tech companies creating these products, who are developers with no experience in dealing with this kind approval.

The FDA has issued draft guidance stating that they will not monitor “general wellness products” that are of low risk to user safety. Low risk is determined by whether or not a product is invasive; technology that if not controlled will hurt the user, or raises questions of usability and biocompatibility. Whether or not the devices of the future are considered low risk will be determined as they progress.

Another roadblock to wearable medical devices is HIPAA compliance and privacy concerns in general. If the device handles protected health information, then it must be HIPAA compliant. If the application does not meet these standards, then the developers may be subject to potential civil and criminal fines. If a wearable device tracks health information, but does not share it with a physician then it is not required to meet HIPAA, but the purpose of these tools is to assist doctors, so these future devices need to meet the regulations.

Conclusion

The future looks bright for wearable devices. They will soon be capable of performing tasks that will make the lives of patients with chronic conditions easier, and allow doctors to monitor these patients anywhere, with up to the minute updates. While this may spell a change in how patients are diagnosed and how diseases are researched, there are a few impediments in the road. FDA approval and privacy are important concerns for patients, and while these organizations are aware of the growing trend of wearable devices, whether developers are able to meet these demands remains to be seen.

Wearable medical devices could greatly enhance the efficacy of corporate wellness programs. The CDC estimates that chronic diseases account for 75 percent of healthcare costs, costs that corporate wellness programs are designed to reduce. Advancements in wearables could lead to a better understanding of these ailments, and real time updates to physicians could lead to better medication adherence. These developments will make great strides in the treatment of chronic conditions and eliminating unnecessary doctor’s visits, thereby reducing overall healthcare costs.

The Corporate Health & Wellness Association (CHWA), in an effort to expand the reach of wearables devices and help employers utilize the benefits of them, will continue to focus on the ins and outs of wearable devices in the workplace. These initiatives include the 2014 Fitness Wearable Device Think Tank, the $500,000 Wearables Giveaway Contest, Wearable PR & Social Media Marketing Blitz, the 2015 Fitness Wearable Device Think Tank & Challenge and more. As the wearables market shifts from a consumer driven model to a medical driven model, you can be sure the CHWA will be at the forefront.

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