Connected Health refers to electronic methods of health care delivery that allow users to deliver and receive care outside of traditional health care settings. Examples include mobile medical apps, medical device data systems, software, and wireless technology.
FDA’s role in connected health continues to evolve along with medical device technology. The FDA’s Center for Devices and Radiological Health (CDRH) plays an important role in enabling a connected health environment while assuring that patients stay safe and the new technologies work as intended. Currently, CDRH is focusing its efforts in several different areas including:
- The convergence of wireless technologies with medical devices (in partnership with the Federal Communications Commission (FCC)),
- Medical devices used in a home environment,
- Mobile medical apps,
- Medical device data systems, and
- The role of software in medical devices
On August 6, 2013, the FDA issued a federal register notice Modifications to the List of Recognized Standards, Recognition List Number: 032 that recognizes voluntary consensus standards to help support and strengthen the interoperability and cybersecurity of networked and connected medical devices.