Health or Well-Being. Choose Wisely.

Consumer Electronics Devices Aren’t Medical Devices… Yet


Google is expected to introduce Google Fit, a competing service to Apple’s recently introduced HealthKit and Samsung’s Sami, at the Google I/O developers’ conference in San Francisco later this month.

CCS Insight believes that this is a natural extension of Google’s services and we would be surprised if Google doesn’t enter this space. This area of data collection falls at the intersection of wearables, the cloud, big data and the Internet of things — each theme of significant interest to Google. It should be noted that this service would differ from Google Health, Google’s now-defunct personal health records portal that stored patients’ official medical documents and was shut down in 2011.

It would appear at first glance that there is an industry trespass going on. To consumers, it seems that highly regulated and high-priced medical devices designed for extreme accuracy are being challenged by low-cost consumer electronics. Devices such as fitness trackers and one-dollar apps are being haphazardly lumped together under the “health care” label by many industry observers, but health care and well-being are two very different businesses.

This is more than an issue of semantics; consumer electronics and medical devices are still mutually exclusive. We believe that the amalgamation of the two is creating a misunderstanding of the capabilities of wearables and other sensor-filled devices designed for casual lifelogging and fitness tracking. The argument could be made that even slightly accurate data is better than no data at all, but it should be made clear that the quality of the information gathered isn’t necessarily of a professional standard.

The history of mobile phones has taught us that no business is immune to industry crossover. Consumer electronics could certainly encroach on health care-grade medical devices during this decade as the accuracy of low-cost sensors improves and as regulatory bodies including the UK’s Medicines and Healthcare Products Regulatory Agency and the FDA in the US adjust their processes to account for apps. However, device manufacturers and service providers would be wise to temper current consumer expectations of the real-world medical compliance of low-cost wearables and free services and apps.

Click here for more information about CCS Insight’s wearables research.