Does FDA Have a Handle on the Digital Future of Medicine?

The Digital Band is warming up. AI, ML, Big Data—for the FDA, these are going to be complicated beats, for sure.

In mid-September (2023), the FDA released a comprehensive digital strategic plan—an IT roadmap in effect—covering the period from 2024 to 2027.

If you want to read the 11 page report yourself, here is the link: FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy).

Where Is the FDA Heading?

This is the first time the agency has created an actual roadmap for its digital future.

And, where is that road leading to? Technology “maturity,” says the agency, in the following four areas…

• Technology
• Data
• Enterprise management
• Cybersecurity

This initiative comes under the FDA’s Office of Digital Transformation.

As always, the agency wants input from stakeholders (seriously, who is NOT a stakeholder in the coming world of digital medicine?) and FDA centers.

It’s an ambitious vision. Can the FDA meet the diverse needs of its internal and external constituents in an increasingly AI based digital future?

Begin Where You Are

For better or worse, the FDA starts with an existing IT framework—indeed, unavoidably, it is the cornerstone of its IT strategy for the next three years. It’s a robust foundation, for sure, but must evolve according to the four bullet points listed above.

FDA’s broad objectives? “Foster innovation, enhance public health outcomes, and lead the FDA into a new era of scientific and technological advancement.”

Important to note, incorporated in this plan is a new Office of Regulatory Affairs model.

Six Digital Goals for FY 2024-2027

Despite the rapid evolution of digital technologies and resources, scarcity of technical talent and real concerns over governance in the face of AI and Big Data, the agency does hope to bridge the gap between its current digital capabilities and the coming digital future.

The IT Strategy for Fiscal Years 2024 to 2027, has six key goals:

1. Create a Shared OneFDA Ecosystem: Enhance cross-functional collaboration and shift the FDA’s culture towards a more integrated approach.
2. Strengthen IT Infrastructure: Modernize and secure the underlying IT infrastructure, ensuring adaptability and quick resolution of technology issues.
3. Modernize Enterprise Services and Capabilities: Optimize the IT services portfolio to provide stable, resilient, and adaptive solutions that are aligned with mission needs.
4. Share Data for Mission Outcomes: Make critical data assets widely available to drive efficiency, excellence, and promote public health innovation.
5. Adopt AI and Mission-Driven Innovations: Proactively identify opportunities and risks related to emerging technologies such as AI.
6. Cultivate Talent and Leadership: Develop comprehensive technology expertise, leadership, and a robust talent pipeline to keep pace with change.

If, as the agency hopes, it does manage to move into a shared enterprise collaboration frame with stakeholders and cross-sector partners then, it would be a paradigm shift. The key, naturally, is a mix of funding and agency politics.

The digital band has already started playing. Can the elephant learn the new dance?