Dive Brief:

• While not a big surprise, late last week the FDA said it will not regulate fitness trackers and certain mobile health apps, according to Bloomberg BNA.
• The Food and Drug Administration (FDA), which released a final guidance document, said it won't enforce its rules over "general wellness" tools for weight management, physical fitness or mental acuity.
• In addition, the FDA said qualifying wellness products can be standalone products or mobile applications and also can be sold as games.

Dive Insight:

While the gray areas of personal data privacy still remain with these types of devices and apps, most had positive responses to the FDA's decision. Sen. Lamar Alexander (R-TN), chairman of the Senate Health, Education, Labor and Pensions Committee, said the guidance is “exactly right” in a statement. And Keith Barritt, an attorney with Fish & Richardson P.C. in Washington, told Bloomberg BNA in an e-mail that the FDA guidance for clearly defining what technologies are considered wellness products is welcomed.

For employers using such devices and apps in their workplace wellness initiatives, it removes a potential layer of red tape. But there is a caveat. If the health-related technology involved is implanted into a person's body or penetrates the skin, then the "low risk" aspect falls away, and regulation will be in play.