FDA www.fda.gov believes device manufacturers should take certain considerations into account when sharing patient-specific information. This is needed to ensure that the information is usable by patients and also to avoid disclosing confusing or unclear information that could be misinterpreted.
FDA issued their draft guidance on June 10, 2016 in the Federal Register to help disseminate patient-specific information that is recorded, stored, processed, retrieved, and/or derived from medical devices that manufacturers provide to patients.
As patients seek to play an active role in their own healthcare, the FDA document makes recommendations to industry, healthcare providers, and FDA staff on how device manufacturers should share this information with patients.
The draft guidance reports that the information needs to be interpretable, comprehensive, and up-to-date. For example, if a patient requests a history of their own blood pressure measurements from a device, the data should include all available data up through the most recent blood pressure measurement.
It may be appropriate for the device manufacturer to include relevant context so that information is not misinterpreted. For example, when providing data regarding a measured physiological parameter over time, it may be useful to a patient to include information regarding how that parameter was measured and recorded by the device.
For more information go to the June 10 Federal Register pages 37603-37604. To submit comments, go to http://www.regulations.gov. For questions, contact Sugato De at 301-796-6270