As patients continue to demand increasing control over their healthcare, with this comes a desire for more information generated from devices that they use. In recognition of this changing landscape, FDA released a guidance document that seeks to explain how device manufacturers can share patient-specific information that is recorded by a device with a patient when he or she requests it. “FDA believes that providing patients with access to accurate, useable information about their healthcare when they request it (including the medical products they use and patient-specific information these products generate) will empower patients to be more engaged with their healthcare providers in making sound medical decisions. This draft guidance document also outlines considerations for the form in which this information is communicated to help to ensure clarity of content and appropriate context,” the guidance document states.
The guidance document, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” defines “patient-specific information” as any information unique to a patient or his/her treatment or diagnosis, consistent with a device’s intended use, that is “recorded, stored, processed, retrieved and/or derived” from the device. The information can be patient data, device usage, output statistics, healthcare provider inputs, incidence of alarms, records of malfunctions or failures, according to the guidance document.
“The purpose of this guidance is to clarify that that FDA requirements do not prohibit manufacturers from sharing patient-specific information recorded, stored, processed, retrieved and/or derived from a medical device with the patient who is either treated or diagnosed with that device,” FDA stated in a release.
Published on the Federal Register on Friday, June 10, industry has 60 days from the publication date to comment on the guidance document.
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