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Today, the U.S. Food and Drug Administration (FDA) launched a web page to communicate the mission-critical priorities of data and technology innovations and to provide information and resources on the FDA’s Diagnostic Data Program.The new web page also describes:
- the significant challenges that impede data collection and analysis, which may adversely impact patients, providers, and organizations;
- the Diagnostic Data Program, which includes the two focus areas of Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) and Digital Diagnostics: Over-the-Counter (OTC) and Point-of-Care (POC), including work to help develop long-term solutions that improve capture, harmonization, transmission, and utility of diagnostic data and maintain the integrity of data as it moves between systems;
- planned improvements to the collection, usability, and portability of data originating from both inside and outside of clinical laboratories; and
- opportunities to be involved in the program, including through submission of advanced research and development proposals to support regulatory science and innovation.
Questions?
If you have questions about the diagnostic data program, contact DiagnosticDataProgram@fda.hhs.gov
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