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

 
• By Sue Darcey

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 It follows-up on a June 2016 draft guidance, as well as comments by patients and patient advocates at the first Patient Engagement Advisory Committee (PEAC) meeting held earlier this month.

Cellnovo pump on arm

Manufacturers and physicians need to share the patient-specific information that is recorded with vital signs devices like blood pressure monitors, implantable devices or diagnostics upon the patient's request, FDA clarified in a final guidance on the topic released Oct. 27.

"Providing patients with accurate and complete information about their diagnosis and treatment, including the data collected from medical devices like blood pressure or heart rhythm monitors, allows patients to be better informed about their health and more active

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