Security News > 2022 > October > Don’t wait for medical device cybersecurity legislation: Act now to save patients’ lives

The US federal government is considering several proposals to regulate medical device cybersecurity compliance to counteract the frequent and clinically impactful cyberattacks experienced by healthcare systems across the country.

The document provides device manufacturers with guidance on how to approach cybersecurity for device design and associated premarket submissions.

The FDA recommends OEMs establish a Secure Product Development Framework to reduce product vulnerabilities and implement medical device cybersecurity requirements.

The proposal requires the FDA to regularly update cybersecurity guidance, publish public information on improving medical device cybersecurity and resource access, and issue a report identifying challenges in cybersecurity for medical equipment, including legacy devices.

Incorporating a medical device cybersecurity solution and instituting real-time threat monitoring helps keep health systems a step ahead of hackers.

Including technology in the medical device cybersecurity plan can improve threat monitoring by managing equipment inventory and identifying vulnerabilities for medical device teams to address.

News URL

https://www.helpnetsecurity.com/2022/10/25/medical-device-cybersecurity-compliance/