Today, large and persistent gaps are separating scientific advances and the technologies needed to translate advances into new therapies for patients and to protect public health. On September 18, 2019, FDA https://www.fda.gov released their “Technology Modernization Action Plan” (TMAP) to address and close this gap.
TMAP has three elements:
- Modernize FDA’s technical infrastructure
- Increase FDA’s capabilities to develop technology to support their regulatory mission
- Communicate and collaborate with stakeholders to drive technological progress that is interoperable across the system
New personalized therapeutic options and treatments, advanced manufacturing and information technologies, and state-of-the-art solutions such as blockchain, genomics, and real-time analytics have created increased biological complexity.
Also, sophisticated data collection and analysis are reshaping clinical trials resulting in making clinical trial data more efficient to collect and more representative of diverse patient populations. Novel and rapidly evolving technologies also promise to enhance the generation of evidence where the size of a clinical trial is limited as in the case of a rare disease.
Advanced hardware, software, and data technologies will enable FDA to deploy their resources more effectively and efficiently. For these new technologies to achieve their full potential, a modern technical infrastructure must be in place coupled with a close eye on cybersecurity.
FDA plans to collaborate with vendors to conduct a FedRAMP https://fedramp.gov security assessment for a new genomics platform. Lessons learned will help FDA support regulatory efficiency and facilitate cloud adoption without compromising security or privacy.
Modernization of FDA’s technology infrastructure will require collaboration among agencies. FDA’s Office of Information Management and Technology (OIMT) will be responsible for modernizing and maintaining the core technology platform and strategy for the agency. OMIT will work with FDA Centers along with CMS and ONC to build an infrastructure supporting data and computation regulatory tools to be used with greater efficiency.
Development of novel technology products will focus on FDA use cases that will highlight key areas in which new or enhanced technology solutions will bring tangible benefits and reduce the complexity of digital transformation.
The goal for the future is to develop a roadmap for biomedicine, a roadmap to address utilizing cloud technologies for FDA, and provide appropriate data sharing and the application of new technologies like blockchain.
FDA will be communicating with stakeholders on the technology modernization project. Plans are to engage stakeholders not only at public meetings or workshops but also online where products could be demonstrated and tested with participants outside the agency.
Go to https://www.fda.gov/media/130883/download for the report “FDA’s Technology Modernization Action Plan” (TMAP) released September 18, 2019.
To contact FDA OMIT, go to https://www.fda.gov/about-fda/office-operations/office-information-management-and-technology.