With New FDA Guidance on Wearables, Focus Turns to Connecting Tech to Core Wellness Program

by | Aug 26, 2016 | Health Knowledge

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As the National Law Review reports, the FDA recently issued “final guidance for general wellness devices.”

The post continues: “The final guidance exempts from active FDA oversight devices that are intended only for general wellness use and present a low risk to the safety of users and other persons. With regard to the first factor, FDA states that a general wellness product includes those that are intended to (1) maintain or encourage a general state of health or a healthy activity or (2) support a healthy lifestyle to reduce the risk or impact of certain chronic diseases or conditions. The final guidance states that the second type of general wellness claim may only be used “where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”

What does this mean for employee and workplace wellness programs?

The Healthcare Trends Institute writes: “Expect wearables to continue entering the workplace.”

And the reason, according to the Healthcare Trends Institute: “More companies may feel comfortable now implementing them into their wellness program initiatives to help employees stay on track with their fitness activities and to help obtain important health data.”

But employees and leaders who oversee “well run” workplace wellness programs might want to step carefully. As a piece on the Future of Health Care noted: “Mobile technologies allow users to access a wider range of services and better self-manage their care; however, they're only part of the solution.”

Indeed, Interactive Health Chief Information Officer Tim Hardy states in the piece that ““technology is a tool, not a panacea. We must be careful about having an over-reliance on technology. The wave of new apps and technology can cause us to think that the technology alone will cause individuals to make changes. Utilizing technology to enable individuals and make it easier to make change is important, but it must go beyond that. Having a variety of modalities to deliver those resources is also extremely important.”

That's because individuals — even within workplace wellness programs — have personalized health goals and requirements.

The Future of Health Care piece continues: “Hardy believes there needs to be a balance between accessibility of employees' information, personalization of recommendations based on that information and connectivity. He also says it's important not to create a ‘one size fits all' environment. If that occurs, someone will be left out.”

In light of the FDA guidance, it seems important to note that while wearables can be a component of  workplace wellness, many leaders may find it useful to connect them back to the core program.

Written By Laura McKenzie

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