Fostering Medical Innovation: A Plan for Digital Health Devices

The U.S. Food and Drug Administration has been directed by Congress to promote the development of digital health devices, but how will federal regulations affect mobile health technology?

21^st Century Cures Act

At the moment, it appears the federal government is leaning away from placing too heavy a hand on the development of mobile health apps. The 21^st Century Cures Act, passed in December 2016, encourages the development of digital health technology while mostly exempting mobile health apps from the oversight of the FDA:

Congress has already taken a major step to advance these goals in the 21st Century Cures Act. Expanding upon policies advanced by FDA’s Center for Devices and Radiological Health (CDRH), the Act revised FDA’s governing statute to, among other things, make clear that certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of FDA regulation.

The potential of mobile health apps

In the same blog post, Scott Gottlieb, M.D., the U.S. Commissioner of Food and Drugs, wrote that mobile health apps and other digital technologies can transform health care in important ways by:

Empowering consumers to make more and better decisions every day about their own health, monitor and manage chronic health conditions, or connect with medical professionals, using consumer-directed apps and other technologies to help people live healthier lifestyles through fitness, nutrition, and wellness monitoring.

According to the FDA, in 2016 there were 165,000 health-related apps available for smartphones. Some show promise for improving medication adherence or for diabetes management. They can use text message reminders or other communication channels such as email or push notifications to help improve health outcomes for patients.

Mobile health solutions

RxEOB provides mobile health solutions, like the RxEOB®MercuryMessaging™ platform, that can help health care organizations better communicate with members. Mercury uses back-end analytics to automatically initiate relevant communications based on the status of an individual patient.

In addition, platforms and applications can be used to provide health plan members with access to pharmacy cost savings and better plan utilization. For more information, visit www.rxeob.com, or call 804-643-1540.