Just as smartphones and tablets displaced the once-dominant PC, wearable technology has begun to take over the tech-scene. They have been projected to reach $4.5 billion in revenue this year and $53.2 billion in global retail revenue by 2019 (Juniper Research). These devices are popping up everywhere from smartwatches, fitness bracelets, and even smart-clothing and jewelry, but what if your wearable gadget could potentially save and/or prolong your life?
It is probably safe to say that we have all heard of, worn, or witnessed someone wearing an insulin pump, glucose monitor, hearing aids and/or prescription eye glasses, but we now live in a world where science fiction has turned reality. A world where contact lenses are embedded with microchips that monitor your health while improving your vision (Google and Novartis, “Smart Lens”). A vest that could save your life from sudden cardiac death (Zoll, “LifeVest”). A ‘build your own’ onesie that can detect your infant’s breathing and movement to help reduce SIDS (Mimo, “Smart Infant Monitor”). IBM, Apple, Medtronic, and Johnson & Johnson are even teaming up to develop the HIPAA-enabled “Watson Health Cloud” to collect the estimated million gigabytes of data per individual.
The age of wearable devices is upon us and a revolution in healthcare has emerged. Consumers, Physicians and the medical community, as well as investors, need to know that they can trust the data from the product, so accuracy and availability is essential! Since the risk of life or limb from a fitness bracelet is obviously not as high as the “LifeVest”, safety guidelines have already been drafted to regulate wearable tech devices, as well as the smartphone apps that accompany them.
The FDA released its initial draft guidance for General Wellness: Policy for Low Risk Devices on January 20, 2015 and its draft guidance for Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices on February 9, 2015. This guidance identifies that they will not regulate “wellness” wearables that encourage a healthy lifestyle or reduce the risk of developing a chronic disease, but wearable Medical Devices that claim to treat, diagnose, or restore a structure or impaired function due to a disease, however, are regulated the same as all other medical devices and do require FDA approval. Basically, your Fitbit isn’t going to be regulated by the FDA as long as its claims are preventative and in a low-risk category. The FDA’s intention is to continue to focus their resources on technology products that pose a higher risk.
These devices offer numerous solutions to patients as well as to physicians and home healthcare professionals, equipping them with tools to track and manage the patients’ health information easily and effectively - ranging from medical and safety critical, to leisure and entertainment. In the case of medical and safety critical, this creates unique concerns and imposes new constraints that existing human factors theories may not fully support.
General Wellness: Policy for Low Risk Devices (Draft Guidance) (January 20, 2015)
Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (Draft Guidance) (January 20, 2015)
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (Final Guidance) (February 9, 2015)
Mobile Medical Applications (Final Guidance) (February 9, 2015)