FDA CIO considers expanding modernization plans

CIO Vid Desai explains how his company's CIO is looking at talent development and emerging technologies across the enterprise.

The Food and Drug Administration is undergoing a long-term transformation of its technology and cybersecurity strategy. CIO Vid Desai's Office of Digital Transformation (ODT) has introduced new initiatives, including a new pilot to develop tech talent, plans to strengthen governance and efforts to foster collaboration across the enterprise.

Desai spoke about these priorities and the FDA's upcoming focus on technology, data and customer experience.

How does your office support evolving technology and workforce priorities?

Desai: We recently celebrated the graduation of our first cohort of the Digital Leadership Program Pilot (DLP). It was an incredible learning journey that combined technology leadership development with personal coaching, peer mentoring, and action learning. The pilot started as a seed of an idea that was mentioned in our Leadership Modernization Action Plan that we published in 2022. Since then, it has grown into an incredible experience and will continue to evolve.

We built on this foundation, developing our original idea that leadership and talent are at the heart of digital transformation. DLP propelled our new goal of cultivating talent and leadership and laid the groundwork for our expanded work. The program develops leaders who can adapt to change from an IT perspective and advances our goal of cultivating talent and leadership as an integral part of our modernization strategy. This is our pipeline of future leaders. We seek bold leaders who use technology as a catalyst to drive change and contribute to the modernization of all areas of the institution.

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

How is artificial intelligence impacting public health, and how is the FDA using this technology?

Desai: The FDA's Center for Devices and Radiological Health (CDRH) has a robust Digital Health Center of Excellence that continues to drive responsible innovation in digital health technologies for medical devices. This regulatory work is separate from the operational work of the ODT, which is not involved in the scientific review of medical device applications or their approval, clearance, or authorization.

ODT is working with all centers at the agency level to advance AI and machine learning in our day-to-day operations to strengthen our ability to regulate products and industries and protect and promote public health. We are focused on AI governance and strategy.

After establishing an agency-wide AI Governance and Advisory Committee last year, we are now preparing to integrate this committee into the FDA Technology Council. Similarly, the recent Executive Order on AI, the subsequent OMB rule, and the CISA AI Risk Framework are all compliance activities in which the ODT will play a leading role in determining responsible use of AI within the agency. This integration ensures that AI is aligned with the new IT strategy. Ensuring the funding and resources needed to support AI and data initiatives is essential to keep up with the rapid evolution of this field.

We continue to prioritize strengthening the secure and reliable capabilities of all FDA centers and offices, and we aim to work with vendors to create acquisition paths and infrastructure that will make AI more widespread across the agency.

What are you most looking forward to this year?

Desai: Innovations in science, particularly in genomics, innovations in technologies such as AI, and the global supply chains of the products we regulate are creating a rapidly changing and transformative environment that we must not only keep up with, but help shape.

We recently released our first FDA Information Technology (IT) Strategy and IT Operations Plan, identifying a set of key goals and objectives. Our organization is committed to advancing support initiatives and strengthening governance over the coming year. Our priorities include continued improvement of our inspection modernization initiatives, particularly in collaboration with our Center and Office partners, as well as enhancing ongoing data analytics activities.

We are also focused on advancing our Veterinary Medicine Center modernization efforts and enhancing our Electronic Submission Gateway (ESG) application, a key initiative under the Prescription Drug User Fee Act. Our focus also extends to strengthening our enterprise data initiatives, including advancing our enterprise master data management program and fully operationalizing our enterprise inspection program. These efforts are critical to maintaining our leadership in technology excellence and innovation.

FDA's Human Food Program initiative is a key focus area, and ODT is committed to supporting this effort from an IT and data perspective, strengthening our core capabilities and advancing the modernization of the enterprise. This includes strengthening our inspection modernization efforts, developing a comprehensive strategy for customer experience to improve access to FDA information and resources, and ultimately enriching the digital experience for public health and internal and external users.

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