FDA works with technology industry to promote digital health innovation

Scott Gottlieb, FDA commissioner; Jeff Shuren, Center for Devices and Radiological Health director

Owing to digital advances, we’re experiencing a reimagination of health care delivery. Consumers are now empowered to take more control of their own health information to make better-informed decisions about their medical care and healthy living. These advances enable better health outcomes for patients.

This opportunity is supported by a new technological paradigm of digital health tools, like apps, that enable consumers to have more active engagement and access to real-time information about their health and activities. These tools allow consumers and providers to supersede the traditional, physical constraints of healthcare delivery and make the most of the opportunities offered by mobile technology.

With these advances has come a new swath of companies that are investing in these new opportunities. These firms may be new to healthcare products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Healthcare products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.

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