November 20, 2023 at 06:26PM
The FDA has issued updated regulations regarding the cybersecurity requirements for medical devices. The regulations, found in Section 524B of the FD&C Act, went into effect on October 1, 2023. They apply to anyone submitting a premarket application for a “cyber device.” The purpose of the regulations is to ensure the safe and effective use of medical devices. Manufacturers must submit information demonstrating compliance with cybersecurity standards. Security professionals should collaborate with engineers to design devices with security in mind. Non-compliance could result in devices being refused by the FDA.
Meeting Takeaways:
1. The FDA has issued updated regulations on cybersecurity requirements for medical devices, known as Section 524B of the FD&C Act.
2. The new regulations came into effect on October 1, 2023, and will impact chief information security officers (CISOs) and security leaders in medical device companies.
3. The regulations apply to devices that meet the definition of a “cyber device,” which includes software installed or authorized by the sponsor, the ability to connect to the internet, and vulnerability to cybersecurity threats.
4. The new regulations do not apply retroactively, but any changes or updates to devices that require a premarket review will subject the device to the new regulations.
5. The primary purpose of the new regulation is to recognize the importance of cybersecurity in ensuring the safe and effective use of medical devices.
6. Medical device manufacturers are required to submit information demonstrating compliance with cybersecurity standards, including a plan to monitor and address vulnerabilities, processes to assure device and system security, and a software bill of materials.
7. Security professionals and engineering teams need to collaborate from the design stage to ensure security is considered throughout the device’s lifecycle.
8. Medical device companies without experience in explicit security work may need to seek partnerships with experienced security providers, such as Google.
9. Good security hygiene is crucial for medical device companies, as devices that do not comply with the new guidelines may not reach the market.
10. Compliance with the new regulations will require acquiring new skills and tools to meet the guidelines effectively.
These are the key takeaways from the meeting notes regarding the updated FDA regulations on cybersecurity requirements for medical devices.