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Patients Have Right To Device Data, FDA Says, But Precautions Urged

A newly issued draft guidance from FDA states that patients should have access to data recorded by medical devices, including implantable devices such as defibrillators. However, the agency recommends that companies take precautions to avoid misuse of the data. Patient advocates have been asking for access to the information, which is traditionally released only to physicians.

Manufacturers shouldn’t hesitate to share patient-specific information generated by medical devices with its subject, an FDA draft guidance released June 10 makes clear.

The guidelines follow a several-year grassroots effort by patients pushing to gain access to the data recorded by their devices, such as implantable cardioverter defibrillators (ICDs). Historically, the detailed information...

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