Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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 Rights To Their Own Device-Generated Data, FDA Clarifies

Executive Summary

Patients have absolute rights to their own medical data as recorded by devices such as blood pressure and heart rhythm monitors, FDA clarified in an Oct. 27 guidance. It follows-up on a June 2016 draft guidance, as well as comments by patients and patient advocates at the first Patient Engagement Advisory Committee (PEAC) meeting held earlier this month.

You may also be interested in...

Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation

Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.

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A newly issued draft guidance from FDA states that patients should have access to data recorded by medical devices, including implantable devices such as defibrillators.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

White House To Deliver 25 Million Face Masks To Low-Income Americans

The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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