Maintaining its steady pace of modernizing medical device policies, the FDA finalized new guidance designed to ensure patients have access to data stored in medical devices.
The guidance, drafted in June 2016 after reports surfaced that patients were unable to obtain the data generated by implanted devices like pacemakers, encourages manufacturers to share patient data whenever feasible. Although some manufacturers previously argued that turning over patient information would require FDA approval, the finalized guidance (PDF) solidifies the agency’s position that companies can share data at the request of a patient without undergoing an additional premarket review.
In a statement released by the FDA, Commissioner Scott Gottlieb, M.D., said data like heart rhythm and blood pressure readings “allows patients to be better informed about their health and more active participants in their health care decisions.”
“We want to eliminate any policy obstacles that might prevent manufacturers from sharing with patients their own personal health information captured by their legally marketed medical devices,” Gottlieb said. “This guidance is one of several steps the FDA is taking across the agency to encourage transparency through greater access to health information.”
Data shared by manufacturers should be “comprehensive and contemporary,” the guidance states, including data up to the most recent measurement. The FDA clarifies that manufacturers may also format the data so its usable for the patient.
However, the FDA acknowledged that not all devices are designed to record or transmit patient data, and in some cases data is not even accessible to the manufacturer. Those instances would fall outside of the FDA’s guidance as they would require a device redesign.
The finalized guidance is the most recent at an agency that is clearly trying to modernize its policies, particularly when it comes to increasingly connected medical devices. Last week, for example, the FDA finalized new guidance to allow manufacturers to make software updates to devices without resubmitting a 510(k) approval.
Under Gottlieb, the agency has also launched a new precertification pilot program that looks to reshape the agency’s approach to mobile health technology. Apple, Fitbit, Samsung and Verily are among the companies selected to participate.