FDA undertaking ‘unprecedented’ data infrastructure modernization during the pandemic

The COVID-19 pandemic has given the Food and Drug Administration an “unprecedented” opportunity to modernize IT systems and data infrastructure that was just “chugging along,” according to one senior agency official.

FDA went from having an “antiquated” system that could only process low volumes of low-complexity COVID-19 reporting to developing a core diagnostic data set with clinical, graphics, testing and results data, said Dr. Sara Brenner, the associate director for medical affairs in the Center for Devices and Radiological Health.

New technologies like rapid antigen tests are being untethered from laboratories so people can self-administer them, but that requires new wireless infrastructure to harmonize data at the source and get it to the FDA and other health agencies tracking COVID-19’s spread, Brenner said.

“This rapid expansion of volume has really just completely blown the wheels off of the conventional data collection and reporting system, which was never really designed for pandemic-scale data transmission,” she said during AFCEA Bethesda‘s Health IT Summit on Tuesday.

COVID-19 tests were the first diagnostic used to track the virus’ spread so FDA could intervene and stop transmission, but now it’s working with other agencies, states, laboratories, clinicians, and device makers to expand the data coming in. The Data Standards and Execution Work Group within the Department of Health and Human Services has begun working with IT infrastructure offices at other agencies to improve data quality and flow.

“We believe that if we’d had a better data infrastructure, we would’ve been able to answer many obvious questions that people needed to know — in terms of supply chain, why do we run out of certain products and goods — better,” said Vid Desai, chief technology officer at FDA. “And that’s certainly going to be a focus for what we’re going to be looking at going forward.”

FDA published a technology modernization action plan last September and quickly followed that with an accelerated data plan. The agency also hired a chief data officer during the pandemic and is forming a data team to address infrastructure issues, Desai said.

One issue the FDA was able to get ahead of is cybersecurity, raising threat levels in mid-March of 2020 when it became clear the agency would play a critical role in COVID-19 therapeutics, diagnostics and vaccinations.

“We also knew that would attract a lot of nefarious, rogue characters who would try and stop our work, and I think our predictions were true,” Desai said. “If you think about all these supply chain attacks that have occurred in the therapeutic and vaccine distribution mechanism, literally every week we see something new there.”