The Food and Drug Administration (FDA) last week issued non-binding draft guidance to facilitate the dissemination of patient-specific information obtained through medical devices. The draft guidance is meant to provide recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with patients when they request it.
The FDA said the draft guidance only describes the agency’s current thinking on the topic and should be viewed only as recommendation. It does not establish legally enforceable responsibilities.
Since patients increasingly seek to play an active role in their own healthcare, the FDA issued the guidance to clarify that manufacturers may share 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 specific device.
The agency said it believes that providing patients with access to accurate, useable information about their healthcare from personal information generated by the medical will empower patients to be more engaged with their healthcare providers in making sound medical decisions.
Patient-specific information was defined as “any information unique to an individual patient or unique to that patient’s treatment or diagnosis that, consistent with the intended use of a medical device, may be recorded, stored, processed, retrieved, and/or derived from that medical device.”
The information may include, but is not limited to, recorded patient data, device usage/output statistics, healthcare provider inputs, incidence of alarms, and/or records of device malfunctions or failures, the agency reported.
“This information does not include any interpretations of data aside from those interpretations of data normally reported by the device to the patient or the patient’s healthcare provider,” according to the FDA.
Generally, categories for patient-specific information may include, but are not limited to: (1) data a healthcare provider inputs to record the status and ongoing treatment of an individual patient or (2) information stored by the device to record usage, alarms, or outputs (e.g., pulse oximetry data, heart electrical activity, and rhythms as monitored by a pacemaker).
Patient-specific case logs entered into a medical device by a healthcare provider may be included under this definition, the agency said.
Cumulatively, this information may be used to facilitate continuity of care, to create an adequate patient treatment history and current treatment profile, and to record information relating to medical device functionality.
The FDA recommended that a manufacturer take appropriate measures to ensure that the information provided is interpretable and useful to the patient and to prevent the disclosure of confusing or unclear information that could be misinterpreted.
This document, issued on June 10, was distributed for comment purposes only. Comments and suggestions regarding the draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance, according to the FDA.
Submit electronic comments via www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
Copies of the full guidance document may be obtained by sending an email request to CDRH-Guidance@fda.hhs.gov, including document number 1500067 in the request.
The FDA said that questions about the document should be directed to Sugato De at (301) 796-6270.
