The Journal of mHealth Vol 2 Issue 2 (Apr 2015) | Page 20

FDA Releases from Regulation Certain Digital Health Solutions

FDA Releases from Regulation
Certain Digital Health Solutions
Aimed at Chronic Disease
By Bradley Merrill Thompson
FDA recently has been looking for ways
to lighten the regulatory burden on digital
health, and this is especially true for those
developing solutions for chronic condition
management and treatment. On January
20, 2015, FDA proposed a new guidance
document on “General Wellness: Policy
for Low Risk Devices.” While the document addresses digital health solutions for
keeping healthy people healthy, the more
interesting part of the document focuses
on helping those suffering from chronic
conditions. It’s that latter category that I’d
like to examine in this article.
Under this proposed guidance, FDA
does not plan to regulate digital health
solutions and other products that make
“an intended use claim that associates
the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and
where it is well understood and accepted
that healthy lifestyle choices may play an
important role in health outcomes for
the disease or condition).” More specifically, FDA intends not to regulate products intended “to promote, track, and/or
encourage choice(s), which, as part of a
healthy lifestyle, may help:”
1. “reduce the risk of certain chronic
diseases or conditions;” or
2. “living well with certain chronic
diseases or conditions.”
Elsewhere in the guidance document
FDA explains that only low risk apps fall
within this unregulated category.
That’s the framework. FDA packs a lot
of nuances into those two sentences.
Let’s start unpacking it.
Overarching Scope: Healthy
Lifestyle
This whole category revolves around the
concept of helping people adopt healthy
lifestyles. Indeed, this is the beginning
and the end of this category. The

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