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?
21st 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 21st 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.
- April 2020
- March 2020
- December 2018
- November 2018
- July 2018
- April 2018
- March 2018
- February 2018
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- December 2016
- November 2016
- October 2016
- September 2016
- August 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015 View More