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 It follows-up on a June 2016 draft guidance, as well as comments by patients and patient advocates at the first Patient Engagement Advisory Committee (PEAC) meeting held earlier this month.


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