Picard: FDA has approved the Embrace smartwatch, a wearable device that can track generalized tonic-clonic seizures—sometimes called a grand mal seizure, that involves the entire body—and aid in epilepsy management. Embrace uses advanced AI (advanced machine learning) to monitor for these most dangerous kinds of seizures. It is an example of an AI that is helping save lives today. The Embrace smart watch and AI platform have many other uses, in stress and anxiety disorders, mood disorders and depression, migraine, autism, and more.
In America, one in 26 people will have epilepsy at some point in their life. While risk of death from seizures is rare, more people die in the minutes following a generalized tonic-clonic seizure every year in the U.S. than die in house fires or from SIDS. Death rates are higher if people have seizures when they are alone, for example, at night if they sleep alone. It can be life-saving to arrange for a caregiver who is alerted to come and check on you when you have a seizure. There is a death following a seizure every seven to nine minutes. Embrace can detect these seizures and send an alert to your caregiver.
MHE: Why should wearables be on the radar of healthcare executives?
Beauregard: The wearable device market is expected to nearly quadruple from 118 million units in 2016 to 430 million by 2022, according to market intelligence company Tractica. As a result, healthcare executives must continue to experiment in this space to determine how best to apply these technologies in a healthcare setting.
Picard: Wearables are going to revolutionize how decisions are made in healthcare. Today we rely on questionnaires, known to be inaccurate. Wearables give us objective data.
For example, most decisions in epilepsy treatments are made based on patient self-reports about their seizures. However, for the most dangerous kinds of seizures, even under the best of observation conditions, 50% of them do not get reported. The patient is unconscious. It is almost impossible to report them. Thus, drug efficacy and treatments are today based on very poor information. Improving the data can mean life or death differences for many people, especially if a person is not reporting any seizures, when they are actually having many (usually this is at night when they are missed).
MHE: What does the future hold for wearables?
Beauregard: At UnitedHealth Group, we see a future where wearable health technologies provide real-time biometric feedback, helping people understand the connection between daily micro-behaviors and long-term health, acute and chronic-care management, and healthcare costs. By putting real-time data in peoples’ hands and encouraging them to become more active and engaged, we are helping people take charge of their health and pursue their fitness goals.
Moore: What we’re seeing today is just the tip of the iceberg. There is an enormous opportunity to help people better understand their health and wellness, and drive behavior change that leads to better health outcomes. In the future, sensor technology will be able to track even more critical health metrics. At Fitbit, we continue to explore new forms of detection and continue to develop best-in-class health and wellness sensors on the wrist. Two areas we are currently exploring are atrial fibrillation and sleep apnea.
In addition, Fitbit recently announced a new female health tracking feature that can track menstrual cycles and symptoms along with other health and fitness stats in one place on the Fitbit app, providing women with a more holistic view of their overall health and wellness. This could potentially create one of the largest databases of female health data—which may help develop personalized insights and predictive algorithms in the future.
The regulatory environment is also evolving, evidenced by the FDA’s innovative Precertification (Pre-Cert) Pilot Program for software as a medical device (SaMD). We applaud the FDA’s commitment to this fresh approach as they work to define a new regulatory pathway for SaMD and we are proud to be part of this type of innovative program. The potential for technology to make a positive impact on the health of so many people has never been greater, and we welcome a process that allows us to accelerate innovation while preserving quality and safety standards.
Picard: At MIT, using wearables and smartphone data, with advanced AI algorithms built at the MIT Media Lab, we are now able to not only detect and recognize important changes in healthy young adults related to their stress and mood, but we are also able to forecast how they will change tomorrow night.
Imagine if your wearable can accurately forecast that your mood is 30% likely to get worse, and your stress 20% likely to get worse tomorrow if you keep doing what you’re doing, but also that you can change this “health weather forecast” by following a few evidence-based personalized suggestions. It could recommend what, for you, is most likely to work—perhaps changing this afternoon's meeting to a walking meeting outdoors, calling a good friend while you're both sitting in traffic, and going to bed two hours earlier. While it won't be perfect—no weather forecast is—it could use your data to help you make better decisions for staying healthy. Patients can get better control over how to stay well.