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US Lawmakers in both houses of Congress have introduced the Protecting and Transforming Cyber Health Care (PATCH) Act. The PATCH Act would: (1) enable the implementation of critical cybersecurity requirements for medical device manufacturers applying for premarket approval through the Food and Drug Administration (FDA); (2) require manufacturers to design, develop, and maintain updates and patches throughout the lifecycle of their devices and (3) require manufacturers to create a software bill of materials (SBOM) for their product and its components.
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