In the late 1960s, Timothy Leary advised people to “Turn on, tune in, drop out” by using psychedelic drugs. Fifty years later, the message might be “Turn on, sync in, stay connected 24/7”.

Young and healthy individuals are wearing devices and using apps to track cardiac activity, steps walked, calories burned, sleep patterns, and more. Some track out of curiosity, others for competition. They call themselves “Quantifed Selfers.”

But beyond consumer apps, wearable monitoring devices are emerging that can help several generations to monitor and safeguard their health. Senior citizens and others at risk no longer need to rely solely on a call button worn around their neck to signal an emergency situation. They, or their care provider, can proactively monitor vital signs and foresee a problem developing or a change in activity that can be tracked by sensors and relayed to their healthcare provider, who can then alert them to come in.

Apple’s highly anticipated Healthkit service promises to be a major player. Reuters reports that the Apple service will work with major health providers at Mount Sinai, the Cleveland Clinic, and Johns Hopkins, as well as medical records systems firms. Apple has said that its Healthkit will be a framework available to third parties for storage and data aggregation.

Just how all these medical records and health data will be kept, by whom, and how the data will be kept private and secure are questions yet to be answered. And what of the regulatory issues involved? As devices and apps become more than fancy pedometers, how will the FDA be able to handle regulating all of the medical innovations that are sure to flood the market? How does HIPAA apply if a patient downloads an app without reading the terms of use?

U.S. Senator Charles E. Schumer (D-NY) recently called for federal protections against the sharing of personal data by makers of wearable fitness trackers. He called it a “privacy nightmare” if the data being gathered can be sold to third parties, like employers, insurance providers, and other companies, without the users’ consent. He urged the Federal Trade Commission to require fitness device and app companies to tell consumers if their information is being shared and give them a chance to opt out. If fitness data is a concern, how much more of a nightmare is the thought of real medical records being shared without a patient’s knowledge.

On the manufacturing side, there are other concerns, including developing power sources small enough to fit the smallest devices; materials that are stronger, lighter, and hypoallergenic; safety issues for the user and for the device; hacker avoidance; and data transmission.

In this issue, the Feature articles from Technology Leaders in Electronics both chose to address the area of wearables. One discusses the need for ways to protect the electronics from body-generated static that could short out a wearable device. The other article provides an overview of different trends, and the challenges faced by designers in balancing power sources and performance in wearable healthcare devices.

Beth G. Sisk


Medical Design Briefs Magazine

This article first appeared in the September, 2014 issue of Medical Design Briefs Magazine.

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