The FDA Announces Patient Engagement Advisory Committee meeting on utilizing real world data from patient-driven platforms that connect and empower patients

The FDA Announces Patient Engagement Advisory Committee meeting on utilizing real world data from patient-driven platforms that connect and empower patients

On November 15, 2018, the FDA’s Patient Engagement Advisory Committee will hold its second public meeting to discuss how the FDA can utilize patient-driven platforms, such as social media, digital health technology and patient registry data, to inform the regulatory evaluation of medical devices. The number of people turning to the Internet to find and share health information continues to grow.  Social media aids in the creation of virtual patient communities where patients and health care consumers can share their health experiences and seek information from one another. These platforms are potentially rich sources of patient-generated health data, which could be used in some cases as real-world evidence to help protect public health and promote health care innovation. During the meeting on November 15, the Patient Engagement Advisory Committee will discuss whether and how the FDA can harness these patient-driven online and mobile platforms to better engage with patients and consumers, as well as to collect and evaluate real-world data in the form of health information provided by patients and consumers. The Patient Engagement Advisory Committee is the first FDA advisory committee focused entirely on patients and patient-related issues.  Members, including patient representatives, a consumer representative, and a non-voting industry representative (selected based on the topic), provide advice to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. Please see the Federal Register notice for a description of the committee’s specific duties. For information about the upcoming Patient Engagement Advisory Committee meeting, see theFederal Register notice. The FDA is now recruiting individuals to serve as consultants (non-voting members) to the committee.  To apply as a consultant to the committee, please contact the Designated Federal Officer, Letise Williams, E-mail: Letise.Williams@fda.hhs.gov., Tel: 301-79-8398. For more information about the committee’s purpose and membership, see the Patient Engagement Advisory Committee webpage. Food and Drug Administration Center for Devices and Radiological Health