FDA Releases from Regulation Certain Digital Health Solutions Aimed at Chronic Disease

The Journal of mHealth April 2015

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in The Journal of mHealth, titled “FDA Releases from Regulation Certain Digital Health Solutions Aimed at Chronic Disease.”

Following is an excerpt:

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).”