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πŸ”πŸ©Ί FDA to Refuse Medical Devices over Cybersecurity Concerns

Chad’s Take:

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πŸ“’ Starting October 1st, FDA will "refuse to accept" medical devices and related systems if they don't meet cybersecurity requirements, as announced on March 29. All new device submissions must include detailed cybersecurity plans. πŸ“

πŸ”§ Manufacturers will be responsible for monitoring, identifying, and addressing post-market cybersecurity vulnerabilities and exploits in a "reasonable timeframe." They must also ensure that their devices and related systems are cybersecure. πŸ”’

πŸ—’οΈ Submissions must include a software bill of materials containing all commercial, open-source, and off-the-shelf software components. πŸ“¦

🎯 This move follows the Consolidated Appropriations Act of 2023 and the PATCH Act, which aimed to address systemic challenges with securing medical devices. πŸ₯

πŸ’‘ Key takeaways:
1️⃣ New submissions must have detailed cybersecurity plans
2️⃣ Manufacturers are responsible for monitoring and addressing vulnerabilities
3️⃣ Submissions must include a software bill of materials

The Chaddington Post: Insider Edition is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.


🌟 Potential actions:
πŸ” Review the FDA guidance: "Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems"
🀝 Collaborate with device manufacturers to ensure compliance with FDA requirements
πŸ’¬ Engage in discussions on improving medical device cybersecurity

Stay safe, and let's work together to make healthcare more secure! πŸ’ͺ

πŸ“š Source:Β https://www.scmagazine.com/news/device-security/fda-will-refuse-new-medical-devices-for-cybersecurity-reasons-on-oct-1

#Cybersecurity,Β #FDA,Β #MedicalDevices,Β #HealthcareIT,Β #CyberRisk

This summary was made in conjunction with yours truly and my AI buddy ChatGPT. We're just here to help! πŸ€–

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The Chaddington Post: Insider Edition - Tech, Cybersecurity
The Chaddington Post: Insider Edition - Tech, Cybersecurity
Authors
Chad Burge