New CDRH Web Page on Diagnostic Data Program

CDRH has launched a new Web page to discuss “mission-critical priorities of data and technology innovations” and provide information and resources on its Diagnostic Data Program. The page describes two focus areas: (1) Systemic Harmonization and Interoperability Enhancement for Laboratory Data, and (2) Digital Diagnostics: Over-the-Counter and Point-of-Care, including plans to help develop long-term solutions to improve capture, harmonization, transmission, and utility of diagnostic data and maintain data integrity as it moves between systems.

The Web page also discusses challenges that impede data collection and analysis, and planned improvements to the collection, usability, and portability of data originating from both inside and outside of clinical laboratories. Additionally, it offers opportunities to be involved in the program, including the submission of advanced research and development proposals to support regulatory science and innovation.