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This is an important update for the Healthcare industry globally. Specifically those that manufacture medical devices for the U.S market, and those who focus on cybersecurity risk management compliance and legislation.
When president Biden signed the 2023 Appropriations Act, effective 29th December 2023. A law that affects medical device cybersecurity slipped quietly under the radar. Under the Federal Drug Administration, Section C – Medical devices, submissions of medical devices to the FDA will be required to manage cybersecurity risks.
1. To address post market cybersecurity vulnerabilities and exploits, including coordinated vulnerability and patches.
2. Design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure.
3. Provide a software bill of materials, including commercial, open-source, and off-the-shelf software components.
4. Comply with such other requirements as required through regulation to demonstrate reasonable assurance that the device and related systems are cybersecure.
Cyber regulation is making its way across CNI. We have seen an increase in cyber attacks on U.S healthcare and concerns have already been raised about patient safety following recent attacks and the impact of third party supplier chain cyber on device manufacturers.
If you supply medical devices, along with internet enabled services to the U.S. Cybersecurity compliance is a cost of doing business.
Ted Dziekanowski
Rachel V. Rose, JD, MBA
#cybersecurity #cyberriskmanagement #medicalcyber #theaugustagroup
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