The National Evaluation System for health Technology Coordinating Center (NESTcc), in partnership with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), is soliciting concepts for test-cases that use patient-generated health data (PGD) to characterize and evaluate patient outcomes, perspectives, and preferences on the management and treatment of their condition. The solicitation for concepts is open to all medical device stakeholders, including manufacturers, health system providers, health payers, academia, and non-profits, including patient advocacy groups and should involve prevention, diagnosis, treatment, or surveillance with a medical device, imaging, or diagnostic technologies.
The goals of the test-cases are to:
(1) Explore the feasibility of generating and using patient-generated data for regulatory and coverage purposes using the NESTcc Data Network and identify the characteristics of the infrastructure necessary to support this.
(2) Improve the understanding of the opportunities and challenges of using the NESTcc Data Network to support studies that capture and evaluate patient-generated data to identify and measure health outcomes that matter most to patients.
(3) Provide learnings to advance patient input and involvement in the regulatory process.
(4) Contribute to NESTcc’s development of operational processes (e.g., contracting, IRB, data sharing agreements, publication policies).
Please be aware that the deadline for submitting recommendations for test-cases has passed. Submissions are currently under review by the NESTcc team. Information regarding confidentiality of submissions is below. A full description of this opportunity, including a summary of the review process and approximate timeline, is available here. Please contact us at NESTcc@mdic.org with any additional questions.
To learn more about targeted test-case concepts that leverage patient-generated health data and the selection and review process, download the NESTcc PGD Call for Concepts Webinar presentation here.