“Improving the use of diagnostic test data to inform public health decision-making was the “primary focus” of the Food and Drug Administration’s pandemic response, according to the agency’s chief medical officer for in vitro diagnostics.”
“The FDA recognized early in the pandemic it would need to get better at aggregating and analyzing data at scale to handle the large volume coming in from COVID-19 tests being widely distributed said Sara Brenner, speaking at an AFCEA Bethesda Health IT event panel Feb. 15.”
“’COVID-19 is tip of the spear for what will hopefully be a sea change in terms of patients having the ability to have data from diagnostic tests that are widely distributed and powering our country’s ability to utilize diagnostic testing data at scale for diseases beyond COVID,’ Brenner said.”
“Test data used to improve decision-making requires the creation of regulations for the standardization of data at source. Medical devices developed by the health industry for home and over-the-counter use increasingly permit such standardization.”
“When it comes to tether emerging technologies to existing data standards, it’s the Office of the National Coordinator for Health IT within the Department of Health and Human Services that has to play “bad cop,” added Ryan Argentieri, deputy director of ONC’s Office of Technology.”
“ONC has been pushing the use of open application programming interfaces and recently added new data classes and elements for electronic exchange in draft Version 3 of the U.S. Core Data for Interoperability…” Read the full article here.
Source: FDA made improving diagnostic test data the focus of its pandemic response – By Dave Nyczepir, February 23, 2022. FedScoop.
