Patients Have Right To Device Data, FDA Says, But Precautions Urged
This article was originally published in The Gray Sheet
Executive Summary
A newly issued draft guidance from FDA states that patients should have access to data recorded by medical devices, including implantable devices such as defibrillators.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.