- FDA has created a Technology Modernization Action Plan to guide development of the infrastructure it expects to need in the data era.
- TMAP, which FDA published on Wednesday, details the near-term actions the agency plans to take to modernize its computer hardware, software, data and analytics.
- FDA plans to take these actions over the next 12 to 24 months to establish the technological foundation for its future efforts. The agency said the roadmap is designed to equip it to "securely receive, store, exchange, link and analyze data" at scale.
Technological advances are increasing the quantity and variety of data handled by FDA.
The roadmap has three elements. One element covers the modernization of technical infrastructure. FDA wants the modernization agenda to lead to "a robust infrastructure, cloud-forward plans, clear and efficient external data interfaces and a focus on cybersecurity." In pursuing that goal, FDA plans to add internal capabilities while also sourcing infrastructure and software as a service.
The second element of TMAP covers the development of technology products for specific use cases, such as the deployment of artificial intelligence to inform risk-based inspections. This element seeks to leverage FDA’s modernized infrastructure to improve how it handles specific tasks.
FDA plans to build out its product development capabilities to ensure it is equipped to handle the work. The agency will also enlist the support of third parties. In some cases, FDA expects to catalyze work on a product but largely leave the broader biomedical community to develop it.
The final element of FDA's roadmap relates to collaboration. FDA thinks working with other government agencies and the industries they regulate will help it achieve the scale needed to cope with demands of the emerging, data-focused era. FDA cited its work with vendors to test the security of a new, unspecified genomics platform as an example of the near and long-term benefits of collaboration.
"Lessons learned from this partnership will inform FDA's efforts to support regulatory efficiency and facilitate cloud adoption without compromising security or privacy," the agency wrote.
Having published TMAP, FDA now plans to work with third parties to understand their shared goals. This will entail reviewing how FDA will ensure its decisions are informed by high-quality data and how the agency will manage cybersecurity.