On June 10, 2016, FDA’s Center for Devices and Radiological Health (CDRH) issued a draft guidance document, entitled Dissemination of Patient-Specific Information from Devices by Device Manufacturers (Draft Dissemination Guidance), to facilitate the dissemination of “patient-specific information” on medical devices to patients upon request. Although there is no FDA requirement that manufacturers provide such information, CDRH issued the Draft Guidance to encourage manufacturers to do so, noting that “providing patients with access to accurate, useable information about their healthcare when they request it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.” To facilitate such information-sharing, CDRH clarifies that manufacturers can disseminate patient-specific information, as defined in the Draft Guidance, without additional premarket review. This action, along with other similar activities, suggests that FDA has embraced patient engagement by promoting increased patient access to their own health information.
Food and Drug Law Institute Update
Recent Developments in FDA Policies on Patient Access to Health Information