Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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A newly issued draft guidance from FDA states that patients should have access to data recorded by medical devices, including implantable devices such as defibrillators.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.


Related Content

Patients Have Rights To Their Own Device-Generated Data, FDA Clarifies





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts