Shuren To Industry: 'Hire A Hacker'
This article was originally published in The Gray Sheet
Companies say cybersecurity threats keep many CEOs awake at night. CDRH Director Jeff Shuren urge them to consider hiring hackers to conduct penetration testing of their medical devices and help ensure stronger security on their products.
You may also be interested in...
A draft IMDRF guidance released this month aims to set the trend for how regulators around the world oversee cybersecurity of medical devices. According to experts, the document also foreshadows what sponsors can expect from the US FDA in areas such as developing a software bill of materials, as the agency updates its own cybersecurity guidances.
US FDA's device-center head discussed his continued push to make regulations more flexible, plans for least-burdensome training and what's next for NEST, among other topics, at the Food & Drug Law Institute annual gathering in Washington DC.
As reports of potential cybersecurity vulnerabilities and ransomware attacks on health-care institutions have increased in recent years, manufacturers are stepping up efforts to protect their products and reputation. To defend against such attacks companies are developing strategies and hiring hackers who are able to understand potential adversaries.