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Last month we rolled out the Red Carpet for the Grammys and the Oscars, where the conversation is usually centered on the question “Who are you wearing?”

Now that it’s March, let’s talk not about WHO we are wearing, but WHAT we are wearing. Namely, wearable devices in support of digital health.

Innovations in digital health – including wearable health devices, the applications that support them, and the vast amounts of data generated by them – have the potential to change how we manage our health and wellness, conduct research and clinical trials,  store medical records, and interact with doctors. Especially for those suffering from chronic conditions.

And their popularity is growing.

A recent study from eMedCert found that the annual smart-wearable health care market volume will grow from $2 billion in 2014 to $41 billion in 2020 – a compound annual growth rate of 65%. Mobile health app companies invested $220 million during Q1 of 2015. Additionally, according to IDC insights, by 2018, 70% of health care organizations worldwide will invest in consumer-facing technology including apps, wearables, remote monitoring and virtual care.

Benefits and Challanges

While the benefits are clear – including increased patient engagement and adherence, to name a few – challenges abound, especially related to regulations and data privacy:

Not All Wearables Are Created Equal 

According to recent FDA draft guidance, a wellness product crosses into the territory of a medical device when its intended use refers to a specific disease or condition, or it presents an inherent risk to a user’s safety. Given the number of devices that are currently in pilot of launch mode, and as technology often outpaces regulation, we’ll have to keep an eye on these evolving regulations.

Data, Data Everywhere! 

We must also figure out how to best utilize the mass of data from these devices, while ensuring patient privacy and data security. Just as FDA regulations don’t apply to all wearable devices, HIPAA doesn’t apply to most of the information that can be harnessed from health wearables. However, if HCPs are using the data for treatment of a chronic condition, those who are handling and analyzing that data must wrestle with the implications of using it. For example, medical and non-medical data must be kept separate. Also, since data is increasingly stored on the cloud, access controls and encryption must be utilized to ensure patient data security, and avoid HIPAA violations.


With the popularity of health wearables showing no signs of slowing, life science companies are wise to consider an expert partner who can provide engagement solutions and address the common challenges related to wearable, noted above.

I can’t help but wonder if on a future red carpet, we may see celebrities being asked WHAT they are wearing rather than WHO?


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