Patient Device Data Access: Your Health Data, Your Control
This act aims to make it easier for patients to access data collected by their medical devices, such as pacemakers or remote monitoring devices. Manufacturers may be required to disclose this information in an understandable format, allowing you to better track your health and treatment. The act also mandates notifications about product recalls or software updates.
Key points
You have the right to request access to your data collected by implanted or remotely monitored medical devices from the manufacturer.
Manufacturers may be required to provide data in a format understandable to you, and in your preferred format if practicable.
Companies will need to publish on their websites what data is collected by devices, how it's used, and how you can access it.
You will receive notifications about device recalls, software updates, or error messages generated by the device.
The act does not require manufacturers to disclose data inaccessible to them or to redesign devices to enable data disclosure.
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