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The Patient Device Data Access Act of 2024 amends the Federal Food, Drug, and Cosmetic Act to authorize the FDA to require manufacturers of covered electronic medical devices (such as implanted or remote-monitoring devices) to disclose patient-specific data recorded or transmitted by those devices to patients upon request. The bill specifies that manufacturers must provide such data in understandable formats, publish information about what data their devices collect and how it is used, and notify patients about data access methods and device recalls or updates. The bill does not require manufacturers to redesign devices or disclose data that is inaccessible to them.
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