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  1. Digital Health Center of Excellence

Diagnostic Data Program

Diagnostic data includes information collected and used in the diagnosis of a disease or condition. It may be used to understand the true performance of diagnostic tests used in the real-world. Further, diagnostic data may aid 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, portability, and utility 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 Diagnostic Data Program has funded several extramural contracts and awards to conduct projects and research and develop analytics solutions with a wide range of partners. Learn more about the past and current program portfolio, and consider getting involved if your organization is interested in helping the mission and goals of the program.

Opportunities to engage:

Diagnostic Data Program Meeting

On September 26 and 27, 2023, the Diagnostic Data Program (DxD) convened a meeting with contract awardees, FDA staff, program managers, and leaders from various government agencies. During this meeting awardees presented their work while also providing opportunities for stakeholders to discuss topics surrounding the In Vitro Diagnostics (IVD) ecosystem, with emphasis placed on diagnostic data ingestion, harmonization and standardization.

The meeting placed an emphasis on ensuring seamless data capture and flow, crucial for timely and informed decision making during public health emergencies, such as COVID-19. Discussions also included identifying and prioritizing data sources to be integrated while evaluating new opportunities for collaboration. Other topics such as ways to improve quality of IVD data using reference datasets, communicate IVD device data, and use AI to make optimal use of IVD data were also addressed.

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