This bill amends federal law to allow the FDA to require manufacturers of certain medical devices to give patients access to their own health data collected by those devices. The law applies to electronic devices that are implanted in patients' bodies or used for remote health monitoring, such as pacemakers and continuous glucose monitors. When a patient requests their data, manufacturers would need to provide it in an understandable format and disclose on their websites what types of data their devices collect and how they use that information. The bill does not require device redesigns or force manufacturers to disclose data they cannot actually access, and it imposes civil penalties for non-compliance. The bill directs the FDA to issue regulations governing these requirements while considering previous agency guidance on the topic from 2017, but does not establish a specific timeline or funding for implementation.
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