Title: Navigating Medical Device Cybersecurity: A Guide to Compliance with Section 524B Summary: The recent passage of Section 524B under the Consolidated Appropriations Act, 2023, signifies a crucial step in enhancing medical device cybersecurity. Effective from March 29, 2023, this legislation mandates that medical device manufacturers comply with specific cybersecurity standards. Failure to meet these requirements by October 1, 2023, could lead to the U.S. Food and Drug Administration (FDA) rejecting premarket submissions. The importance of medical device cybersecurity cannot be overstated, as cybersecurity incidents can disrupt patient care across healthcare facilities. Section 524B applies to various entities, including medical device manufacturers, healthcare providers, health systems, third-party device servicers, patient advocates, and organizations utilizing third-party medical devices. To align with Section 524B, organizations can take proactive steps and leverage established cybersecurity practices. The National Institute of Standards and Technology (NIST) Special Publication 800-53, which provides security and privacy controls, is a valuable resource. The FDA’s guidance outlines four key requirements under Section 524B: Submit a Plan: Develop a plan to monitor, identify, and address postmarket cybersecurity vulnerabilities in a timely manner. Utilize NIST controls for effective monitoring, logging, security alerts, intrusion detection systems, and vulnerability scanning. Develop Processes and Procedures: Design, develop, and maintain processes ensuring reasonable assurance of device and related system cybersecurity. Follow NIST controls for secure software development, configuration management, and change management processes. Provide a Software Bill of Materials (SBOM): Supply a comprehensive SBOM, including commercial, open-source, and off-the-shelf software components. Leverage software composition analysis tools to create and update SBOMs, adhering to NIST guidelines. Comply with Requirements: Demonstrate reasonable assurance that devices and related systems are cybersecure. Adhere to NIST controls for secure development practices, including data protection through cryptography and implementation of access controls. The FDA will work with organizations until October 1, 2023, to enhance cybersecurity documentation. Beyond this date, premarket submissions lacking cybersecurity plans may be refused. Therefore, it is imperative for organizations involved in the medical device ecosystem to take prompt action, align with Section 524B, and prioritize cybersecurity to safeguard patient care and data.
August 7, 2023