FDA CIO Looks to Expand Modernization Plans

The Food and Drug Administration has been undergoing a long-term effort to transform its technology and cybersecurity strategies. Led by CIO Vid Desai, the Office of Digital Transformation (ODT) has introduced new initiatives such as a new pilot to develop the technical workforce, a plan to strengthen governance and efforts that boost collaboration across the enterprise.

Desai spoke to GovCIO Media & Research about these priorities and FDA’s upcoming focuses on technology, data and the customer experience.

How is your office supporting evolving tech and workforce priorities?

Desai: We recently celebrated the graduation of the very first cohort of our Digital Leadership Program pilot (DLP). It’s been an incredible learning journey that combines technology leadership development with individual coaching, peer mentoring and action learning. The pilot started as a seed of an idea referenced in the Leadership Modernization Action Plan we published in 2022. It has since grown into an incredible experience that will continue to evolve.

We built on this foundation and expanded our initial thinking that leaders and people are the heart of digital transformation. The DLP advances our new goal to cultivate talent and leadership and has laid the groundwork for expanded work. The program builds change-adept leaders through an IT lens and advances our goal to cultivate talent and leadership as an integral part of our modernization strategy. This is our pipeline of future leaders. We’re looking for bold leaders who will drive change and help modernize all areas of the agency by using technology as a catalyst.

We plan to apply the lessons learned and continuously improve the pilot as we expand within ODT and across agency IT teams.

Where is artificial intelligence impacting public health, and how is FDA leveraging the technology?

Desai: FDA’s Center for Devices and Radiological Health (CDRH) has a robust Digital Health Center of Excellence that continues to advance responsible innovation in digital health technologies for medical devices. That regulatory work is separate from ODT’s operational work and ODT has no role in the scientific review of a device submission or its approval, clearance or authorization.

ODT works, at the agency-level, in partnership with all of our centers to advance AI and machine learning in the day-to-day operations where it strengthens our ability to regulate the products and industries and to protect and promote public health. We are significantly focused on AI governance and strategy.

Following the establishment of our agency-wide AI Governance and Advisory Board last year, we are now poised to integrate this board into the FDA Technology Council. Similarly, the recent AI executive order, subsequent OMB rule and CISA AI Risk Framework are all compliance activities where ODT will be taking a leading role to determine responsible AI use within the agency. This integration will ensure that AI aligns with our new IT strategy. Securing the necessary funding and resources to support our AI and data initiatives will be crucial for keeping pace with the rapid evolution of this field.

We continue to prioritize the enhancement of secure and reliable capabilities for all FDA centers and offices. Collaborating with vendors, we aim to produce an acquisition path and infrastructure that enables more widespread AI across the agency.

What are you most excited about this year?

Desai: The innovations in science and particularly genomics, the innovations in technology like AI and a global supply chain for the products we regulate create a rapidly changing and transforming environment that we need to not just keep up, but also help shape.

We recently released the inaugural FDA Information Technology (IT) Strategy and IT Operating Plan and identified a series of key goals and objectives. Our organization is deeply committed to advancing our supporting initiatives and strengthening governance over the next year. Our priorities include continuous improvements in our inspection modernization initiative, particularly enhancing ongoing data analytics activities in collaboration with our center and office partners.

We are also dedicated to advancing the Center for Veterinary Medicine’s modernization effort and enhancing the Electronic Submissions Gateway (ESG) application, a vital commitment under the Prescription Drug User Fee Act. Our focus also extends to bolstering our enterprise data initiatives, including advancing our Enterprise Master Data Management Program and bringing our enterprise inspection program into full production. These efforts are essential for maintaining our leadership in technology excellence and innovation.

The FDA’s Human Foods Program initiative is a critical focus area, and ODT is dedicated to supporting this effort from an IT and data perspective, aiming to strengthen our core capabilities and advance enterprise modernization. This includes enhancing our inspection modernization efforts and developing a comprehensive strategy on the customer experience to improve access to FDA information and resources, ultimately enriching public health and internal and external users’ digital experience.