Technology Modernization at the FDA
The FDA held a public meeting June 30 to share and receive feedback on the agency’s technology modernization action plan. In closing remarks, Dr. Amy Abernathy, Principal Deputy Commissioner and Acting CIO, summarized the plan’s goals with refreshing simplicity: uniting data, improving data, and using data to achieve the agency’s regulatory mission. The FDA regulates immunizations, drugs, devices, other medical products, animal products, the nation’s food supply, and tobacco. That is no small charge. As noted during the meeting, FDA-regulated products comprise 20 to 25 percent of the world economy.
The FDA’s plan recognizes the need to improve internal systems and adopt modern approaches to using data and sharing it with the companies it regulates, health care providers, and consumers. This includes embracing new sources of data, such as real-world clinical data and patient-sourced information, as well as new uses of data, such as machine learning and artificial intelligence. The plan includes three parts:
Improving the FDA’s technology infrastructure, including use of cloud-based tools and creating efficient external interfaces.
Demonstrating innovation using a product development mindset that focuses on regulatory use cases, such as safety reporting or seafood product inspection.
Collaborating within the agency, across the government and with stakeholders to achieve scale.
The feedback shared by meeting participants, including Dr. Don Rucker, the National Coordinator for Health IT, will resonate with those engaged in modernizing other health IT systems. Among other themes, participants urged the agency to:
Build systems that are based on modern standards and can interoperate.
Take advantage of operational data, including data in electronic health records.
When collecting real-world data minimize burden on those who create it, particularly clinicians.
Collect data once and reuse it.
Strike the right balance between privacy, security and access.
Understand and meet consumer expectations about how their data will be collected, protected and used.
As the still growing pandemic underscores the urgent need to invest in our public health data systems, the FDA’s push to modernize is a welcome step. The agency clearly has much to do, as illustrated by safety reports still collected as pdfs, but is expressing commitment and openness. Those interested in commenting on the agency’s plan can do so through July 30 at regulations.gov, using docket number FDA-2019-N-5799. In particular, FDA has asked for feedback on data standards and policy; data security, privacy and management; and data sharing strategies.