With cyber technologies occupying growing prominence in Japan’s health marketplace, the government has released guidance on protecting medical devices from computer network threats.
The guidance from the Pharmaceutical and Medical Devices Agency (PMDA) does not impose new strictures on the manufacture, sale, or use of medical devices. But it outlines the increased risks from cyber-attacks and unauthorized access to internet networks. It calls for the voluntary implementation by medical device manufacturers of “all reasonable measures” to ensure protection.
According to the PMDA guidance, to date, no cyberattacks on medical devices in Japan have adversely affected patient health. But it cites several incidents in the United States that have been of concern, summarizes measures taken by regulators in the U.S. and in other countries to address such threats, and makes suggestions for tightening regulations in Japan.