Healthcare IT News February 12, 2020
Healthcare providers and device manufacturers are both responsible for putting mitigations in place to address patient safety risks, says FDA’s Suzanne Schwartz.
Because threats and vulnerabilities cannot be eliminated, reducing cybersecurity risks is especially challenging – and medical device manufacturers and health care delivery organizations need to take steps to ensure appropriate safeguards are in place.
The U.S. Food and Drug Administration, in partnership with the MITRE Corporation, has already championed two initiatives to improve medical device cybersecurity preparedness and response.
The first is the development and use of a medical device cybersecurity sandbox to enable security research and technical evaluation of medical device vulnerabilities and potential mitigations across health systems, device manufacturers, and the FDA.
“The FDA recognizes the...