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  1. Digital Health Center of Excellence

Diagnostic Data Program

Diagnostic data is information collected and used in the investigation and diagnosis of a disease. This information is critical for the delivery of high-quality, safe patient care. It also aids in the development of innovative treatment methods that stem from public health analytics and research. However, to reach the full potential of diagnostic data, key barriers need to be eliminated:

  • Difficulty in the collection of valuable data from tests conducted in laboratories, clinics, and nontraditional testing locations (for example, at-home or point-of-care).   
  • Consistent erosion of accuracy as the data is transformed between systems.   
  • Insufficient data infrastructure to support the transmission, aggregation, and analytics of high-volume data.  
  • Challenges in data transparency, communication, security, and utility amongst diverse public and private stakeholders.  

To address these challenges, the FDA launched a Diagnostic Data Program, which includes two focus areas to help improve the collection, usability, and portability of data originating from both inside and outside of clinical laboratories.  

  • Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD)  
  • Digital Diagnostics: Over-the-Counter (OTC) and Point-of-Care (POC)
Illustration of a piece of clinical laboratory equipment, under the word SHIELD, which stands for Systemic Harmonization and Interoperability Enhancement for Laboratory Data.
Illustration of a swab, test tube, and test strip under the words OTC/POC, which stand for over-the-counter and point-of-care, respectively.


Digital Diagnostics: OTC/POC


The FDA Broad Agency Announcement provides an opportunity to apply for funding under this program. See Extramural Research for more details.

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