For Immediate Release: Oct. 27, 2017

Media Inquiries

  Stephanie Caccomo
  301-348-1956

"Providing patients with accurate and complete information about their diagnosis and treatment, including the data collected from medical devices like blood pressure or heart rhythm monitors, 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,” said FDA Commissioner Scott Gottlieb, M.D. “This guidance is one of several steps the FDA is taking across the agency to encourage transparency through greater access to health information – such as recent efforts to improve access to reports of adverse drug reactions and steps we will take soon to increase the access patients and providers have to the bottom line medical information that we evaluate as part of our drug review program. We’re committed to continuing to identify new ways the agency can help foster transparency and patient access to accurate clinical information as a way to improve patient outcomes and health care delivery ."

The FDA issued the final guidance on Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request to clarify that FDA requirements do not prohibit manufacturers from sharing patient-specific information recorded, stored, processed, retrieved and/or derived from a legally-marketed medical device with the patient who is either treated or diagnosed with that device. The policy described in the guidance applies to medical devices that store inputs from health care providers regarding the status or ongoing treatment for a patient and to medical devices that directly record information about usage, alarms or outputs. The FDA expects that patients would be most interested in access to information from devices that monitor physiological signals that can relate to health outcomes (e.g., pulse oximeters, blood pressure monitors, heart rhythm monitors, hemodynamic recording systems, electroencephalograms, sleep diagnostic devices, etc.).

For More Information:

• FDA: Final Guidance-- Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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