FDA Diagnostic Data Program new webpage announced

Aimed at the diagnostics market, solutions with Diagnostic Data interoperability will help in patient care, but also aid in clinical trial operations and improve data for filings and regulatory review.  Real challenges exist, however, since some instrumentation used in clinical diagnostic labs is also used in other industries (e.g., immuno-assay plate readers, mass spectrometers).  There have been a number of industry led consortia over the past 2 decades that have made strides in laboratory data interoperability, but broad acceptance has not been achieved.

A new webpage was recently announced for the Diagnostic Data Program.  The program is aimed at improving portability and usability of diagnostic data.  The FDA notes 4 barriers to be eliminated to help achieve high-quality safe patient care:

• 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.  

Two specific activities are also planned for actions:

• Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD)  (webpage link)
• Digital Diagnostics: Over-the-Counter (OTC) and Point-of-Care (POC) (webpage link)

With more than 70 organizations participating, SHEILD addresses the challenges with lab data sharing (standards, IVD devices, lab workstations and electronic health records. Harmonization of data standards and taxonomy are essential to the process SNOMED-CT and LOINC are two examples. Many more details are available at the webpage.

 

The recent growth and expected increased use in coming years of point-of-care (POC) and over-the-counter (OTC) tests used in homes has resulted in some data not being available for physicians and public health authorities to make evidence-based decisions. Many more details are available at the webpage.

 

Additionally, funding is under the FDA Extramural Research program.