WHAT: FDA position and guidance on medical device interoperability – ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems.
WHY: Interoperable devices with the ability to share information across systems and platforms can:
- Improve patient care,
- Reduce errors and adverse events
- Encourage innovation.
WHO: CDRH – along with hospitals, health care providers, manufacturers, standards development organizations, and other interested parties to promote medical device interoperability.