When Dr. Amy Abernethy joined the Federal Drug Administration in 2019, she was committed to preparing the agency’s technology infrastructure for the coming data revolution. After months of developing a technology modernization action plan and new data modernization strategy, a real-world public health emergency reinforced the criticality of her focus.
“What has become increasingly clear is that the core substrate to addressing COVID-19 is data and it is critical to the agency’s mechanisms to address the pandemic,” Abernethy told Health Catalyst’s Sadiqa Mahmood, as they prepare for their upcoming keynote discussion at the Healthcare Analytics Summit, HAS 20.
Recognizing the value of real-time diagnostic and clinical data, the FDA joined Health Catalyst and dozens of other stakeholders in two Accelerator projects: the Therapeutic Evidence Accelerator and the COVID-19 Diagnostics Evidence Accelerator.
Comprised of health data aggregation and analytics experts, including leaders from FDA, major technology companies, academic research institutions, device manufacturers, payers, and health systems, this all-hands-on-deck approach sought to share insights, compare results and answer key questions to inform the collective COVID-19 response. How can multiple levels of stakeholders evaluate the real-world performance of diagnostic and antibody tests? What do those test results and data reveal about the prevalence of disease, chains of transmission, and individual and population-level immunity?
“Health Catalyst is utilizing real-world data in the diagnostic (e.g., nucleic acid or antigenic) and antibody testing (e.g., serological) space,” explained Mahmood. “We are leveraging our own COVID-19 registry powered by Touchstone to evaluate viral diagnostic and antibody tests, gain a deeper understanding of the prevalence of SARS-CoV-2 in specific populations, variation in practice around test administration and potentially answer critical questions on immunity. These collaborative efforts have not only improved the FDA’s processes – including data collection and hypothesis generation – but also driven meaningful changes in real-world outcomes.”
While the collaboration was powerfully executed, the lack of standardization created challenges for the working groups. Public health departments and providers rely not only on varying information systems and data formats but comply with disparate data standards, ultimately limiting effective data-sharing and efficiency. New rules issued by the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) recognize the importance of interoperability and expressly prohibit information blocking in pursuit of greater API transparency, data sharing, and patient access.
“Health Catalyst’s Interoperability Suite’s focus on data aggregation unites providers and reduces the greatest administrative burdens that come with sifting through disparate data in different formats,” noted Abernethy.
As the FDA, other federal agencies, and even global ministries use real-world data to address important public health issues – including but not limited to the ongoing pandemic – interoperability measures will need to be enhanced to ensure important healthcare data is more widely and securely available. The coronavirus pandemic has underscored the need for real-time data collection and regular information sharing. The key is to empower the complete exchange of clinical data and enable multiple levels of stakeholders to each use it effectively.
For Dr. Abernethy, one thing is clear: “We’re still at the beginning of the journey.”
Register for HAS 20 to see Dr. Amy Abernethy’s keynote discussion, happening on Wednesday, September 2.
Read about the FDA’s efforts to harness real-world data to inform its COVID-19 response here.
