International Standard in the Works to Address Device Cybersecurity

To address cyberthreats to implantable devices, the FDA is working with the International Electrotechnical Commission and the International Organization for Standardization to develop a new standard that is expected to be finalized and published by the end of the year. Devicemakers at a Defense Department meeting last week agreed an international standard would be better than a new FDA rule because it would create a globally harmonized approach to “a security issue that has little regard for national boundaries,” Nick Mankovich, senior director of product security and privacy at Philips Healthcare, said.
Devices & Diagnostics Letter