ePI is not just about how content is delivered. It’s about how regulatory information is created, structured, governed, and maintained over time.
Electronic Product Information (ePI) is often discussed as an evolving submission requirement—a different format that regulatory teams will eventually need to produce, called ePI FHIR. But that perspective misses the bigger picture.
That doesn’t mean organizations need to overhaul everything at once. In reality, many teams can take meaningful steps toward FHIRreadiness without disrupting existing processes. The key is understanding that FHIR introduces a shift in operating model, even if you choose to approach it incrementally.
Why Many Organizations Are Taking a Wait-and-See Approach
Across the industry, there’s a consistent pattern: hesitation. Regulatory teams are watching closely, waiting for clearer signals from health authorities before committing resources. Questions around timing, and regional adoption are still evolving. For many organizations, it feels safer to wait until requirements are more defined.
That instinct is understandable. Regulatory teams are already managing complex workloads, and large-scale transformation efforts are difficult to justify without a clear mandate. But waiting comes with tradeoffs.
When organizations delay preparation, they risk compressing the timeline for adoption. What could have been a gradual, controlled transition becomes reactive, forcing teams to adapt quickly using processes that weren’t designed to scale.
The Hidden Challenge: Document-Centric Processes
At the core of this challenge is how most regulatory content is managed today. Many organizations still rely on document-centric workflows, where content is locked into formats that are difficult to reuse, update, or govern across markets. These processes work, but they weren’t built for the level of flexibility and traceability that structured FHIR submissions introduce.
As a result, when new output requirements emerge, teams often have to retrofit existing content rather than adapt it seamlessly. This creates inefficiencies, increases risk, and makes it harder to maintain consistency across regions.
FHIR doesn’t create these challenges, but it does make them more visible.
A Practical Way to Get Started
The good news is that FHIR readiness doesn’t have to begin with a full transformation. For many organizations, the most effective starting point is also the simplest: work with the content you already have.
By taking approved regulatory documents and converting them into FHIR-compliant outputs through a managed or service-based approach, teams can begin building familiarity with the requirements, without overhauling upstream processes.
This approach offers a few immediate benefits:
- Lower barrier to entry: No need to redesign authoring workflows upfront
- Faster learning cycle: Teams gain hands-on experience with FHIR formats and validation requirements
- Reduced disruption: Existing processes remain intact while capabilities evolve
Just as importantly, it creates a foundation for future progress. What starts as a downstream activity can inform longer-term decisions around structured content, governance, and scalability.
Related: Outsourcing ePI Conversions Without Losing Control
From Output to Operating Model
As organizations gain experience with FHIR, the conversation naturally shifts. What begins as a formatting exercise quickly raises broader questions:
- How should content be structured to support multiple outputs?
- How can updates be managed more efficiently across markets?
- What level of traceability is needed to maintain compliance over time?
This is where FHIR moves beyond format and into operating model.
Organizations that begin to treat regulatory content as a structured, reusable asset—not just a static document—are better positioned to adapt. They can respond more quickly to new requirements, maintain consistency across regions, and support emerging digital channels without duplicating effort.
In this context, FHIR becomes less about compliance and more about capability.
Why This Matters Now
Even as timelines and requirements continue to evolve, the direction is clear: regulatory information is becoming more digital, more structured, and more interconnected.
At the same time, expectations are growing. Not just from health authorities, but from healthcare professionals and patients who rely on accurate, accessible information.
Organizations that invest early in improving how content is managed are better equipped to meet these expectations. They gain:
- Greater control over content quality and consistency
- Improved ability to manage change across markets
- A more scalable foundation for future requirements and digital engagement
Importantly, these benefits extend beyond FHIR itself. They reflect a broader shift toward more modern, flexible approaches to regulatory content management.
What Leaders Should Consider Next
For teams early in their FHIR journey, the goal isn’t to solve everything at once. It’s to take a step that builds momentum without introducing unnecessary complexity.
A useful starting point is to ask: What is the lowest-friction way to begin building ePI readiness today?
For some organizations, that may mean focusing on downstream conversion and validation. For others, it could involve pairing that work with a longer-term roadmap for structured content and governance.
There’s no single path, but there is a common theme. The organizations making the most progress are the ones that start early, learn as they go, and evolve their approach over time.
Related: Prepare for ePI: Outsourcing vs. In-House Implementation
Final Thoughts
ePI and FHIR is often discussed as a future requirement. In reality, it’s already shaping how regulatory content will be managed moving forward. Organizations don’t need to commit to a full transformation to begin. But they do need to start.
Taking a practical, incremental approach allows teams to build readiness now, while creating a clear path toward a more scalable, sustainable content model in the future.
Looking for a practical way to begin your ePI journey? Glemser partners with regulatory teams to turn existing content into ePI-ready outputs, while laying the groundwork for a more scalable content model over time. Contact us today.